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Product Guide

Ace Use in Pregnancy & Lactation


Paracetamol is safe in all stages of pregnancy
& lactation.
Active Ingredient
Paracetamol. Preparation
500 mg Tablet, XR Tablet, 120 mg/5 ml Syrup,
Indication 120 mg/5 ml Suspension, 15 ml & 30 ml
Fever, headache, toothache, earache, bodyache, Paediatric Drops (80 mg/ml), 60, 125, 250 & 500
myalgia, dysmenorrhoea, neuralgia & sprains. mg Suppository.
Pain of colic, back pain, chronic pain of cancer,
inflammatory pain, & post-vaccination pain &
fever of children. Rheumatism & osteoarthritic
pain & stiffness of joints in fingers, hips, knees,
wrists, elbows, feet, ankles & top & bottom of Ace Plus
the spine.
Active Ingredient
Dosage & Administration Paracetamol & Caffeine.
Tablet: Adult 1-2 tablets every 4 to 6 hours up
to a maximum of 4 g (8 tablets) daily. Children Indication
(6-12 years) 1/2 to 1 tablet 3 to 4 times daily. Fever, headache, migraine, muscle ache,

A XR Tablet: 2 tablet every 6 to 8 hourly upto a backache, toothache & menstrual pain.
maximum of 6 tablets daily. Syrup & Suspension:
Children Under 3 months: 10 mg/kg body Dosage & Administration
weight (reduce to 5 mg/kg if jaundiced) 3 to Adults : 1-2 tablets every 4-6 hours. Maximum
4 times daily. 3 months to below 1 year : 1/2 dose: 8 tablets daily. Not recommended for
to 1 teaspoonful 3 to 4 times daily. 1-5 years: children below 12 years.
1-2 teaspoonful 3 to 4 times daily. 6-12 years
: 2-4 teaspoonful 3 to 4 times daily. Adults 4-8 Contraindication & Precaution
teaspoonful 3 to 4 times daily. Paediatric Drop: Hypersensitivity to Paracetamol, Caffeine or
Children Upto 3 months: 0.5 ml (40 mg) 4 to 11 any other components of it.
months: 1.0 ml (80 mg). 1 to 2 years: 1.5 ml (120
mg) Dose can be repeated, every 4 hours. Side Effect
Suppository: Suppository should be This combination may cause skin rashes,
administered rectaly. Children 3 months - 1 neutropenia & gastrointestinal disturbances
year : 60-120 mg 4 times daily. Children below etc. High dose administration may cause
5 years : 125-250 mg, 4 times daily. Children hepatotoxicity.
6-12 years : 250-500 mg, 4 times daily. Adults &
children over 12 years : 0.5 - 1 mg, 4 times daily. Use in Pregnancy & Lactation
Although there is epidemiological evidence
Contraindication & Precaution of the safety of Paracetamol in pregnancy &
Known sensitivity to Paracetamol. lactation, medical advice should be sought
before using this product.
Side Effect
Side Effects are significantly mild, though Drug Interaction
haematological reactions have been reported. It increases the Effect of chloramphenicol &
Pancreatitis, skin rashes, & other allergic coumarin anticoagulant. Risk of hepatotoxicity of
reactions occur occasionally. Paracetamol may be increased in alcoholics or in
patients taking other anti-epilectic medications.
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Product Guide
Precaution dry mouth, nausea, vomiting, anorexia, anxiety,
Should be given cautiously in the following confusion, euphoria, insomnia, nervousness,
cases: In patients with hepatic or renal failure, in somnolence pruritus, rash, increased sweating
patients taking other hepatotoxic medication. etc.
Prolonged use of the drug without consulting
a physician should be avoided. Use in Pregnancy & Lactation
Pregnancy Category C, should be used during
Preparation pregnancy only if the potential benefit justifies
Paracetamol 500 mg & Caffeine 65 mg. the potential risk to the fetus. its safety in
infants & newborns has not been studied.

Preparation
Acetram TM
Paracetamol 325 mg & Tramadol HCl 37.5 mg
Tablet.
Active Ingredient
Paracetamol 325 mg & Tramadol HCl 37.5 mg.

Indication Adryl
Acetram tablet is indicated for the management

A
of moderate to moderately severe pain in Active Ingredient
adults & also indicated for the short-term (five Diphenhydramine.
days or less) management of acute pain.
Indication
Dosage & Administration For the treatment of following: 1) Seasonal,
Acetram tablet can be administered without perennial & vasomotor rhinitis, 2) urticaria,
regard to food. For the management of pain, angioneurotic edema, anaphylaxis, 3) pruritus,
the recommended dose is 1 or 2 tablets every 4) preanesthetic medication, emesis, motion
4 to 6 hours as needed for pain relief up to a sickness, 5) miscellaneous including menieres
maximum of 8 tablets per day. diseases & parkinsonism, 6) cough & cold.
In case of short-term (five days or less) Sometimes it may use as a night time sleep aid
management of acute pain, the recommended & for the short-term management of insomnia.
dose is 2 tablets every 4 to 6 hours as needed
for pain relief up to a maximum of 8 tablets per Dosage & Administration
day. Most allergic conditions are controlled with 25
to 50 mg i.e., (12.5 to 25 ml of syrup) 3 to 4 times
Contraindication & Precaution a day.
This is contraindicated in any situation where Children 6 to 12 years of age : 10 mg i.e.,
opioids are contraindicated. This combination (5 ml of syrup) 3 to 4 times a day.
preparation should be used with caution Children 1 to 6 years of age: 5 mg i.e.,
when taking medications such as tranquilizers, (2.5 ml of syrup) 3 to 4 times a day.
hypnotics or other opiate containing analgesics. In motion sickness: Adults : 25 to 50 mg 3 to 4
times a day. Children (above 9.1 kg): 12.5 to 25
Side Effect mg 3 to 4 times a day (5mg/ kg/ 24 hours).
The following adverse reactions may happen In parkinsonism: Adults: 25 to 50 mg 3 to 4 times
to this therapy: asthenia, fatigue, hot flushes, a day. Children (above 9.1 kg) : 12.5 to 25 mg 3
dizziness, headache, tremor, abdominal pain, to 4 times a day (5mg/ kg/ 24 hours).
constipation, diarrhea, dyspepsia, flatulence, In insomnia: Adults & children over 12 years of
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Product Guide
old : A dose of 20 to 50 mg is used as hypnotic
in insomnia. Afun
In cough & cold: Adults: 25 mg every 4 hrs. Not
to exceed 150 mg in 24 hours. Children (6 to 12 Active Ingredient
years) : 12.5 mg every 4 hours. Not to exceed Clotrimazole.
75 mg in 24 hours. Children (2 to 6 years): 6.25
mg every 4 hours. Indication
Dermatomycoses due to Candida, Trichophyton,
Contraindication & Precaution Moulds & other fungi, skin diseases showing
Contraindicated for the premature or newborn superinfections with these fungi e.g. inter
infants. Any patients in whom drowsiness is digital mycoses, paronychia, Candida vulvitis,
undesirable e.g. drivers, machine operators. balanitis, pityriasis versicolor & erythrasma.
Patients with known hypersensitivity to
Diphenhydramine or any components of the Dosage & Administration
product. Patients should be cautioned not 2-3 times daily.
to operate vehicles or hazardous machinery
until their response to the drug has been Contraindication & Precaution
determined. Hypersensitivity to clotrimazole.

Side Effect

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Drug Interaction
Antituberculous agent, para-aminosalicylic Local irritation or burning may occur in very
acid (PAS), alcohol, other CNS depressants few cases.
(hypnotics, sedatives, tranquilizers, etc), MAO
inhibitors. Use in Pregnancy
It is recommended that Clotrimazole should
Side Effect be used in pregnancy only when considered
Side effects include drowsiness, dizziness, necessary by the physician.
dryness of mouth, blurred vision, nausea &
vomiting. Preparation
10 mg/gm Cream.
Uses in Pregnancy & Lactation
Should be used in pregnancy only if clearly
needed. Use in lactating mother is not
recommended. Afun VT
Preparation Active Ingredient
10 mg/5 ml Syrup. Clotrimazole.

Indication
Vaginitis, vaginal itching, burning discharge
associated with recurrent vaginal yeast
infections (vaginal candidiasis) due to Candida
or Trichomonas, Super-infections with
Clotrimazole-sensitive bacteria.

Dosage & Administration


Afun VT: 3 consecutive nights, 2 Afun vaginal
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Product Guide
tablets are inserted as deeply as possible into after instilling Olopatadine Hydrochloride
the vagina. Afun VT 500: Single dose. ophthalmic solution before they insert their
contact lenses.
Contraindication & Precaution
Hypersensitivity to Clotrimazole. This is best Use in Pregnancy & Lactation
achieved when lying on the ones back with Should be used in pregnant women only if the
the knees slightly bent. It is recommended that potential benefit to the mother justifies the
the treatment should be timed as so to avoid potential risk to the fetus. Caution should be
the menstrual period. For prevention of re- exercised when Olopatadine Hydrochloride
infection the partner should be treated locally ophthalmic solution is administered to a
with Clotrimazole cream at the same time. Afun nursing mother.
VT is colorless & do not stain the underwear.
Side Effect
Side Effect Headaches have been reported at an incidence
Local irritation or burning sensation. of 7%. The following adverse experiences have
been reported in less than 5% of patients:
Use in Pregnancy Asthenia, blurred vision, burning or stinging,
It is recommended that Clotrimazole should cold syndrome, dry eye, foreign body sensation,
be used in pregnancy only when considered hyperemia, hypersensitivity, keratitis, lid edema,

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necessary by the physician. nausea, pharyngitis, pruritus, rhinitis, sinusitis, &
taste perversion.
Preparation
500 mg Vaginal Tablet with an applicator. Preparation
0.1% Eye Drops.

Alacot Eye Drops


Alacot DS Eye Drops
Active Ingredient
Olopatadine 0.1%. Active ingredient
Indication Olopatadine 0.2%
Indicated for the treatment of the signs &
symptoms of allergic conjunctivitis. Indication
Alacot DS Eye Drops is indicated for the
Dosage & Administration treatment of the signs & symptoms of allergic
One drop in each affected eye two times per conjunctivitis.
day at an interval of 6 to 8 hours.
Dosage & Administration
Contraindication & Precaution One drop in the affected eye once a day.
Olopatadine Hydrochloride ophthalmic solution
is contraindicated in persons with a known Contraindication & Precaution
hypersensitivity to Olopatadine Hydrochloride. Olopatadine Hydrochloride ophthalmic
Olopatadine Hydrochloride ophthalmic solution solution is contraindicated in persons with
should not be used to treat contact lens related a known hypersensitivity to Olopatadine
irritation. Patients who wear soft contact lenses Hydrochloride. Olopatadine HCl ophthalmic
should be instructed to wait at least ten minutes solution should not be used to treat contact
lens related irritation. Patients who wear soft
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Product Guide
contact lenses should be instructed to wait at
least ten minutes after instilling Olopatadine Alarid
Hydrochloride ophthalmic solution before
they insert their contact lenses. Active Ingredient
Ketotifen.
Side Effect
Headaches have been reported at an incidence Indication
of 7%. The following adverse experiences have Symptomatic treatment of allergic conditions
been reported in less than 5% of patients: including rhinitis & conjunctivitis. Prophylactic
Asthenia, blurred vision, burning or stinging, treatment of bronchial asthma.
cold syndrome, dry eye, foreign body sensation,
hyperemia, hypersensitivity, keratitis, lid Dosage & Administration
edema, nausea, pharyngitis, pruritus, rhinitis, Adults : 1 mg twice daily with food. If necessary
sinusitis, & taste perversion. the dose may be increased to 2 mg twice daily
in severe cases. Children above 3 years : 1 mg
Use in Pregnancy & Lactation twice daily with food. Patients known to be
There are no adequate & well controlled studies easily sedated should begin treatment with
in pregnant women. Because animal studies 0.5 to 1 mg at night for the first few days or as
are not always predictive of human responses, directed by the physician. Use in elderly : Same
as adult dose or as advised by the physician.

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this drug should be used in pregnant women
only if the potential benefit to the mother
justifies the potential risk to the fetus. It is not Contraindication & Precaution
known whether topical ocular administration A reversible fall in the platelet count has been
could result in sufficient systemic absorption observed in a few patients receiving Ketotifen
to produce detectable quantities in the human concomitantly with oral antidiabetic agent &
breast milk. Nevertheless, caution should be it has been suggested that this combination
exercised when Olopatadine Hydrochloride should therefore be avoided. Although there
ophthalmic solution is administered to a is no evidence of any teratogenic effect,
nursing mother. recommendations for Ketotifen in pregnancy
or when breast feeding can not be given.
Use in Children It is important to continue the previous
It is not recommended for use in children treatment for a minimum of two weeks after
below 3 years. starting Ketotifen to avoid the possibility of
exacerbation of asthma. This applies specially
Preparation to systemic corticosteroids & ACTH because
Each plastic dropper bottle contains 5 ml of of the possible existence of adrenocortical
Olopatadine HCl USP 0.2% sterile solution. insufficiency in steroid dependent patient.

Side Effect
Drowsiness & in isolated cases, dry mouth &
slight dizziness may occur at the beginning of
treatment but usually disappear spontaneously
after a few days.

Preparation
1 mg Tablet, 1 mg/ 5 ml Syrup.
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Product Guide

Alarid Eye Drops Alatrol


Active Ingredient Active Ingredient
Ketotifen Fumarate. Cetirizine.

Indication Indication
For the treatment of signs & symptoms (itchy, Seasonal Allergic Rhinitis, Perennial Allergic
watery, red & swollen eyes & eyelids) of allergic Rhinitis, Chronic Idiopathic Urticaria, & Pruritus.
conjunctivitis including vernal kerato- It is also used in allergen induced asthma.
conjunctivitis, vernal-keratitis, blepharitis,
blepharo-conjunctivitis, & giant papillary Dosage & Administration
conjunctivitis. Administered with or without food. Adults &
Children 6 years & older :
Dosage & Administration Tablet: 1 tablet daily. Syrup: 2 teaspoonfuls
Adults & children 3 years & older:1 drop in the once daily or 1 teaspoonful twice daily.
affected eye(s) twice daily, every 8-12 hours, In patients with decreased renal function
not more than twice per day. (Creatinine clearance 11-31 ml/min), patients
on hemodialysis (Creatinine clearance less than
Contraindication & Precaution 7 ml/min) & in hepatically impaired patients , a

A Hypersensitivity to Ketotifen or any of the


components. Alarid 0.025% eye drops should
dose of 1/2 tablet or 1 teaspoonful once daily
is recommended. Children 2-6 years : Syrup:
not be instilled while the patient is wearing 1 teaspoonful once daily or 1/2 teaspoonful
lenses. twice daily. Children 6 months - <2 years :
Syrup: 1/2 teaspoonful once daily. The dose in
Side Effect children 12-23 months of age can be increased
1-2%: Burning/stinging, punctate corneal to a maximum dose as 1/2 teaspoonful every
epithelial erosion. <1%: Blurring of vision upon 12 hours. Paediatric Drops: 1 ml, once daily. The
drug instillation, dry eyes, eyelid disorder, dose in children 12-23 months of age can be
conjunctivitis, eye pain, photophobia, increased to a maximum dose as 1 ml, every 12
subconjunctival haemorrhage. hours.

Use in Pregnancy & Lactation Contraindication & Precaution


Systemic levels after ocular administration are Hypersensitivity or idiosyncrasy to cetirizine or
much lower than after oral use. Caution should to its parent compound ,hydroxyzine.
be exercised when prescribing to pregnant Caution should be exercised when driving a car
women. or operating a heavy machinery. Concurrent
use with alcohol or other CNS depressants
Use in Children should be avoided because additional
Children under 3 years of age: Consult with a reduction in alertness & additional impairment
doctor. of CNS performance may occur.

Preparation Drug Interaction


0.025% Eye Drops. No clinically significant drug interactions have
been found.
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Product Guide
Use in Pregnancy & Lactation Side Effect
Cetirizine should be used in pregnancy only if Epigastric pain, diarrhoea, headache, nausea,
clearly needed. Use in lactating mother is not vomiting, dizziness, constipation, pruritis & dry
recommended. mouth.

Preparation Use in Pregnancy & Lactation


10 mg Tablet, 5 mg/5 ml Syrup, 2.5 mg/ml Should not be administered during pregnancy
Paediatric Drops. & in women thought to be pregnant.

Pediatric Use
For children of 12 months & above.
Almex Preparation
400 mg Tablet & 200 mg / 5 ml Suspension.
Active Ingredient
Albendazole.

Indication
Single or mixed intestinal infections caused by Ambrox
various helminths.

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Active Ingredient
Dosage & Administration Ambroxol.
12 to 24 months: 200 mg as a single dose
(Half of Almex 400 tablet or 5 ml Almex Indication
suspension). Adults & children (over 2 Productive cough, Acute & chronic
years): Ascariasis, enterobiasis, trichuriasis & inflammatory disorders of upper & lower
hookworm infestation - 400 mg (One Almex respiratory tracts associated with viscid mucus
400 tablet or 10 ml Almex suspension) single including acute & chronic bronchitis, laryngitis,
dose. Strogyloidiasis or taeniasis - 400 mg once Pharyngitis, sinusitis & rhinitis associated
daily for three consecutive days. Giardiasis - 400 with viscid mucus, Asthmatic bronchitis,
mg once daily for five days. Hydatid disease bronchial asthma with thick expectoration,
(Echinococcosis) - 400 mg twice daily for 28 Bronchiectasis, Chronic pneumonia
days. For cystic echinococcosis the 28-days
course may be repeated after 14 days without Dosage & Administration
treatment to a total of three treatment cycles. Paediatric Drops: 0 - 6 months old - 0.5 ml, 2
For alveolar echinococcosis, 400 mg twice times a day, 6 - 12 months old - 1 ml, 2 times
daily for 28 days followed by 14 days without a day, 1 - 2 years old -1.25 ml, 2 times a day.
treatment may need to continue for months or Syrup : 2 -5 years old - 2.5 ml (1/2 teaspoonful),
years. 2-3 times a day, 5 - 10 years old - 5 ml (1
teaspoonful), 2-3 times a day, 10 years old &
Contraindication & Precaution adults - 10 ml (2 teaspoonful), 3 times a day.
Should only be used in the treatment of Ambrox 75 SR Capsule: Adults & children over
echinococcosis if there is constant medical 12 years old - 1 capsule, once daily
supervision with regular monitoring of serum
transaminase concentrations & of leucocyte & Side Effect
platelet counts. Epigastric pain, stomach overfill feeling may
occur occasionally. Rarely eruption, urticaria or
angioneurotic edema has been reported.
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Product Guide
Contraindication & Precaution after stopping treatment. Ambrisentan is
Known hypersensitivity to Ambroxol or contraindicated in patients with Idiopathic
Bromhexine. Should be given cautiously to Pulmonary Fibrosis (IPF) including IPF patients
patients with gastric & duodenal ulceration or with pulmonary hypertension (WHO Group 3).
convulsive disorders. Patients with hepatic &
renal insufficiency should take it with caution. Side Effect
Decreases in hemoglobin concentration &
Drug Interaction hematocrit have followed administration of
Ambroxol should not be taken simultaneously other endothelin receptor antagonists & were
with antitussives (e.g. Codeine). observed in clinical studies with Ambrisentan.

Use in Pregnancy & Lactation Drug interaction


It is advised not to use in pregnancy, especially Multiple dose co-administration of
during the1st trimester. Safety during lactation Ambrisentan & Cyclosporine resulted in an
has not been established yet. approximately 2-fold increase in Ambrisentan
exposure in healthy volunteers; therefore, limit
Preparation the dose of Ambrisentan to 5 mg once daily
6 mg/ml Paediatric Drops, 15 mg/5 ml Syrup, when co-administered with Cyclosporine.
75 mg SR Capsule.

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Use in Pregnancy & Lactation
Pregnancy Category X. It is not known whether
Ambrisentan is excreted in human milk.
Ambrisan TM
Breastfeeding while receiving Ambrisentan is
not recommended.
Active Ingredient
Use in Children
Ambrisentan
Safety & effectiveness of Ambrisentan in
pediatric patients have not been established.
Indication
Pulmonary Arterial Hypertension
Preparation
5 mg Tablet.
Dosage & Administration
Initial treatment is 5 mg once daily, & can
be increased to 10 mg once daily if 5 mg is

Amistar
tolerated. Tablets may be administered with or
without food.

Contraindication & Precaution Active ingredient


Ambrisentan may cause fetal harm when Amikacin USP
administered to a pregnant woman.
Ambrisentan is contraindicated in women who Indication
are or may become pregnant. If this drug is used Amikacin (Amistar) is indicated in the short-
during pregnancy, or if the patient becomes term treatment of serious infections due
pregnant while taking this drug, the patient to susceptible strains of Gram-negative
should be apprised of the potential hazard to bacteria. Amikacin is effective in bacterial
a fetus. Pregnancy must be excluded before septicemia (including neonatal sepsis); in
the initiation of treatment with Ambrisentan & serious infections of the respiratory tract,
prevented during treatment & for one month bones & joints, central nervous system
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Product Guide
(including meningitis) & skin & soft tissue; intra- be reduced and/or the intervals between doses
abdominal infections (including peritonitis); & increased to avoid accumulation of the drug.
in burns & postoperative infections (including Route of administration
post-vascular surgery). Clinical studies have For most infections the intramuscular route is
shown Amikacin also to be effective in serious preferred, but in life-threatening infections, or
complicated & recurrent urinary tract infections in patients in whom intramuscular injection is
due to those organisms. not feasible the intravenous route may be used.
Amikacin was effective in infections caused Intraperitoneal use
by gentamicin and/or tobramycin-resistant Amikacin may be used as an irrigant after
strains of Gram-negative organisms, recovery from anesthesia in concentrations of
particularly Proteus rettgeri, Providencia 0.25% (2.5 mg/ml).
stuartii, Serratia marcescens, & Pseudomonas
aeruginosa. Amikacin has also been shown Contraindication & Precaution
to be effective in staphylococci infections & Amikacin Injection is contraindicated in patients
may be considered as initial therapy under with a known history of hypersensitivity to
certain conditions in the treatment of known Amikacin, any constituents of the injection.
or suspected staphylococcal disease such as,
severe infections where the causative organism Side Effect
may be either a Gram-negative bacterium or a The adverse effects have been reported with

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staphylococcus. the use of Amikacin are tinnitus, vertigo, partial
reversible or irreversible deafness, skin rash,
Dosage & Administration drug fever, headache, paraesthesia, nausea &
Adults & children: 15mg/kg/day in two equally vomiting.
divided doses (equivalent to 500 mg b.i.d.
in adults): use of the 100mg/2ml strength is Drug Interaction
recommended for children for the accurate Concurrent or serial use with other neurotoxic,
measurement of the appropriate dose. ototoxic or nephrotoxic agents, particularly
Neonates & premature infants: An initial bacitracin, cisplatin, amphotericin B,
loading dose of 10mg/kg followed by 15mg/ cyclosporine, tacrolimus, cephaloridine,
kg/day in two equally divided doses. paromomycin, viomycin, polymyxin B, colistin,
Elderly: Amikacin is excreted by the renal route. vancomycin, or other aminoglycosides
Renal function should be assessed whenever should be avoided either systemically or
possible & dosage adjusted as described under topically because of the potential for additive
impaired renal function. effects. Increased nephrotoxicity has been
Life-threatening infections and/or those reported following concomitant parenteral
caused by Pseudomonas: The adult dose may administration of aminoglycoside antibiotics
be increased to 500 mg every eight hours & cephalosporins. The risk of ototoxicity
but should neither exceed 1.5g/day nor be is increased when Amikacin is used in
administered for a period longer than 10 days. conjunction with rapidly acting diuretic drugs,
A maximum total adult dose of 15g should not particularly when the diuretic is administered
be exceeded. intravenously. Such agents include furosemide
Urinary tract infections: (other than & ethacrynic acid which is itself an ototoxic
pseudomonal infections): 7.5mg/kg/day in agent. Irreversible deafness may result.
two equally divided doses (equivalent to 250 The use of Amikacin is not recommended in
mg b.i.d. in adults). patients under the influence of anaesthetics
Impaired renal function: In patients with or muscle-relaxing drugs (including ether,
impaired renal function, the daily dose should halothane, d-tubocurarine, succinylcholine
10
Product Guide
decamethonium, atracurium, rocuronium, vecuronium or in patients receiving massive transfusions
of citrate-anticoagulated blood) as neuromuscular blockade & consequent respiratory depression
may occur. If blockade occurs, calcium salts may reverse this phenomenon. Indomethacin may
increase the plasma concentration of Amikacin in neonates.
In patients with severely impaired renal function, a reduction in activity of aminoglycosides may
occur with concomitant use of penicillin-type drugs.
There is an increased risk of hypocalcaemia
when aminoglycosides are administered with bisphosphonates.
There is an increased risk of nephrotoxicity & possibly of ototoxicity when aminoglycosides are
administered with platinum compounds.
Concomitantly administered thiamine (vitamin B1) may be destroyed by the reactive sodium
metabisulfite component of the Amikacin sulfate formulation.

Use in Pregnancy & Lactation


Amikacin rapidly crosses the placenta into the fetal circulation & amniotic fluid & there is a
potential risk of ototoxicity in the fetus. There is no information available regarding the safety of
this drug during breastfeeding.

Use in Children

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Safety & effectiveness of Amikacin for injection in children or adolescents under 16 years have
not been established.

Preparation
Amistar 500 IM/IV Injection: Each box contains 5 ampoules in Alu-PVC blister pack. Amistar 100 IM/
IV Injection: Each box contains 5 ampoules in Alu-PVC blister pack.

Amodis
Active Ingredient
Metronidazole.

Indication
All forms of amoebiasis (intestinal & extra-intestinal disease including liver abscess & that
of symptomless cyst passers) Trichomoniasis Giardiasis Bacterial vaginosis Acute
ulcerative gingivitis Anaerobic infections including septicaemia, bacteremia, peritonitis, brain
abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis
etc. Anaerobically-infected leg ulcers & pressure sores Acute dental infections (e.g. acute
pericoronitis & acute apical infections) Surgical prophylaxis (prevention of postoperative
infections due to anaerobic bacteria, particularly species of bacteroides & anaerobic streptococci
Chronic symptomatic peptic ulcer disease (as an agent of triple therapy to eradicate H. pylori-the
most important aetiological factor of peptic ulcer)
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Product Guide
Dosage & Administration

Indication Duration Adults & Children


of dosage children over
in days 10 years 7-10 years 3-7 years 1-3 years

Trichomoniasis** 7 200 mg t.i.d. or 100 mg t.i.d. 100 mg 50 mg t.i.d.


400 mg b.i.d. b.i.d.

2 800 mg in the
morning & 1.2
gm at night

1 2.0 gm as a
single dose
Invasive intestinal 5 800 mg t.i.d. 400 mg t.i.d. 200 mg 200 mg t.i.d.
amoebiasis q.i.d.
Extra intestinal 5-10 400 -800 mg 200 -400 mg 100-200 mg 100 -200

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amoebiasis (including t.i.d. t.i.d q.i.d mg t.i.d
liver abscess) &
symptomless amoebic
cyst passers
Giardiasis 3 2.0 gm once 1.0 gm once 600-800 mg 500 mg
daily 1.0 gm daily once daily once daily
once daily
600-800 mg
500 mg
Acute ulcerative 3 200 mg t.i.d. 100 mg 100 mg 50 mg t.i.d.
gingivitis mg t.i.d. b.i.d.

Acute dental infections 3 -7 200 mg t.i.d.

Bacterial vaginosis 5-7 400500 mg


twice daily
1 2.0 gm as a
single dose
Leg ulcers & pressure 7 400 mg t.i.d.
sores
Anaerobic infections 7 Either 400 mg 7.5 mg/kg 7.5 mg/kg 7.5 mg/kg
every 8 hours t.i.d. t.i.d t.i.d
or 500 mg every
8 hours
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Product Guide
Surgical prophylaxis 400500 mg 7.5 mg/kg 7.5 mg/kg 7.5 mg/kg
2 hours t.i.d. t.i.d. t.i.d.
before surgery;
up to 3 further
doses of
400500 mg
may be given
every 8
hours for
high-risk
procedures

Side Effect
Metalic taste, furred tongue, nausea, vomiting, diarrhoea, drowsiness, rashes & mild reversible
leucopenia may be observed during treatment.

Drug Interaction
Metronidazole interacts with Warfarin, Nicoumalone, Phenytoin, Phenobarbitone, Fluorouracil,

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Disulfiram, Lithium, Cimetidine etc.

Use in Pregnancy & Lactation


Not recommended during first & later trimesters. Breast feeding should be delayed until 48 hours
after discontinuing metronidazole in the mother.

Presentation
400 mg Tablet, 500 mg Tablet & 200 mg/5ml Suspension.

Amodis 500 IV
Active Ingredient
Metronidazole.

Indication
Amodis 500 IV is indicated in the prophylaxis & treatment of infections in which anaerobic
bacteria have been identified. It is indicated in:
1.The prevention of postoperative infections due to anaerobic bacteria
2.The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotizing pneumonia,
osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulites, & post operative wound infections
from which pathogenic anaerobes have ben isolated.

Dosage & Administration


Amodis 500 IV should be infused intravenously at an approximate rate of 5 ml/min. Oral
medication should be substituted as soon as feasible. Treatment for 7 days should be satisfactory
13
Product Guide
for most patients, but the physician might
decide to prolong treatment. Anadol
For bacterial infections:
Adults: 500 mg (100 ml) 8 hourly. Active Ingredient
Children: 7.5 mg/kg (1.5 ml/kg) 8 hourly. Tramadol.
For treatment before & during surgery:
Adults: 500 mg (100 ml) shortly before Indication
operation, repeated 8 hourly Post-operative pain, Colic & spastic pain,
Children: 7.5 mg/kg (1.5 ml/kg) 8 hourly. Cancer pain, Joint pain, Neck & back pain, Pain
associated with osteoporosis.
Side Effect
Pain, tenderness, redness or swelling over vein Dosage & Administration
in which the medicine is given. Other side Usual doses are 50-100 mg every four to six
Effects are unsteadiness, fever or chills, sore hours. For acute pain an initial dose of 100 mg
throat, headache, numbness, tingling pain or is required.
weakness in the hands or feet, pain, seizures,
skin itching, unusual tiredness or weakness, Contraindication & Precaution
vaginal irritation or discharge. Hypersensitivity, acute intoxication with
alcohol, hypnotics, centrally acting analgesics,
opioids or psychotropic drugs. Tramadol

A
Drug Interaction
Metronidazole shows drug interaction with should be used with caution in patients with
the following: alcohol or alcohol-containing increased intracranial pressure or head injury
beverages, Barbiturates, Carbamazepin, & patients with acute abdominal conditions.
Cimetidine, Disulfiram, Fluorouracil, Lithium,
Methadone, Phenytoin, Warfarin etc. Side Effect
Dizziness/vertigo, nausea, constipation,
Use in pregnancy & lactation headache, somnolence, vomiting, pruritus,
Studies have not been done in humans. CNS stimulation, asthenia.
Metronidazole has not been shown to cause
birth defects in animal studies; however, use is Drug Interaction
not recommended during the first trimester of Monoamine oxidase (MAO) inhibitors,
pregnancy. Use is not recommended in nursing Carbamazepine.
mothers since metronidazole passes into the
breast milk. Use in Pregnancy & Lactation
Tramadol should be used during pregnancy
Precaution only if the potential benefit justifies the risk to
Metronidazole should be given with caution the fetus.
in the following conditions- anaemia or other
blood disorders, liver disease, disease of Preparation
nervous system, seizures etc. 50 mg Capsule, 100 mg SR Capsule, 100 mg/2
ml Injection, 100 mg Suppository.
Preparation
100 ml solution of Metronidazole for
intravenous infusion.
14
Product Guide

Anclog with history of symptomatic atherosclerotic


diseases (ischemic stroke, myocardial infarction
or acute coronary syndrome).
Active Ingredient
Clopidogrel. Dosage & Administration
Once daily.
Indication
Atherosclerotic disease (ischemic stroke, Contraindication & Precaution
myocardial infarction or established peripheral Hypersensitivity to any of the components or
arterial disease), prophylactically in patients at NSAIDs. Active pathological bleeding such
the risk of thrombo-embolic disorders such as as peptic ulcer or intracranial hemorrhage or
myocardial infarction & stroke. bleeding disorders like hemophilia. Recent
history of gastrointestinal bleeding.

Dosage & Administration Side Effect


One tablet once daily. Abdominal pain, nausea, vomiting, neuralgia,
paraesthesia, rash, pruritis.
Contraindication & Precaution
Hypersensitivity, Active pathological bleeding Drug Interaction
such as peptic ulcer or intracranial hemorrhage.

A
This combination may enhance the effect of
anticoagulants.
Side Effect
Hemorrhage, abdominal discomfort, nausea, Use in Pregnancy & Lactation
vomiting, diarrhoea, headache, dizziness, The combination drug should be avoided
vertigo, paraesthesia, rash, pruritus, hepatic & during the last three months of pregnancy.
biliary disorder, neutropenia may occur. It is not recommended for use during breast
feeding because of the possible risk of
Drug Interaction developing Reyes syndrome.
Aspirin, NSAIDs should be used with cautions
to patients taking Clopidogrel. Use in Children
Safety & efficacy in the pediatric population
Use in Pregnancy & Lactation have not been established.
Clopidogrel should be used in pregnant women
& nursing mothers only if clearly needed. Preparation
(Clopidogrel 75 mg + Aspirin 75 mg)/Tablet
Preparation
75 mg Tablet.

Anclog Plus Anespine TM

Active Ingredient
Active Ingredient Bupivacaine HCl & Dextrose Monohydrate.
Clopidogrel + Aspirin
Indication
Indication Spinal anesthesia for-
Prevention of atherosclerotic events in patients
Urological surgery (lasting 2-3 hours)
15
Product Guide
Lower limb surgery (lasting 2-3 hours) characterized by numbness of the tongue,
Lightheadedness, dizziness & tremors, followed
Abdominal surgery (lasting 45-60 minutes) by convulsions & cardiovascular disorders.
Dosage & Administration
Spinal anesthesia for surgery: 2-4 ml (10-20 Use in Pregnancy & Lactation
mg Bupivacaine Hydrochloride). The spread of Bupivacaine enters the mothers milk but in
anesthesia obtained with Anespine depends such small quantities that there is generally no
on several factors including the volume of risk of affecting the child at therapeutic dose
solution & the position of the patient during levels. There is no evidence of untoward Effects
& following the injection. When injected in the in human pregnancy.
L3-L4 intervertebral space with the patient in
the sitting position, 3 ml of Anespine spreads Use in Children
to the T7-T10 spinal segments. With the patient Until further experience is gained in patients
receiving the injection in the horizontal younger than 18 years, administration of
position & then turned supine, the blockade Anespine in this age group is not recommended.
spreads to T4-T7 spinal segments. It should be
understood that the level of spinal anesthesia Preparation
achieved with any local anesthetic can be Intraspinal injection, each ml containing
unpredictable in a given patient. The Effects Bupivacaine HCl 5 mg & Dextrose Monohydrate

A
of Anespine exceeding 4 ml have not yet been 80 mg.
studied & such volumes can therefore not be
recommended.

Contraindication & Precaution Angilock


Spinal anesthesia should only be undertaken
by clinicians with the necessary knowledge Active Ingredient
& experience. Patients with hypovolemia due Losartan Potassium.
to any cause can develop sudden & severe
hypotension during spinal anesthesia. Indication
It is contraindicated in patients with a Hypertension: Angilock is indicated for the
known hypersensitivity to it or to any local treatment of hypertension. It may be used alone
anesthetic agent of the amide type. The or in combination with other antihypertensive
following conditions preclude the use of agents, including diuretics.
spinal anesthesia: severe haemorrhage, severe Hypertensive patients with Left Ventricular
hypotension or shock & arrhythmias, such as Hypertrophy: Angilock is indicated to reduce
complete heart block, which severely restrict the risk of stroke in patients with hypertension
cardiac output. & left ventricular hypertrophy.
Nephropathy in Type 2 Diabetic Patients:
Side Effect Angilock is indicated for the treatment of
The safety of Bupivacaine is comparable to diabetic nephropathy with an elevated serum
that of other local anesthetics used for spinal creatinine & proteinuria (urinary albumin to
anesthesia. In rare cases Bupivacaine has creatinine ratio 300 mg/g) in patients with
been associated with allergic reactions & type 2 diabetes & a history of hypertension.
anaphylactic shock. Spinal anesthesia itself
can cause hypotension & bradycardia due Dosage & Administration
to sympathetic blockade and/or vasovagal Adult hypertensive patients: The usual starting
fainting. Systemic adverse reactions are dose of Angilock is 50 mg once daily. 25 mg
16
Product Guide
used in patients with possible depletion of Contraindication & Precaution
intravascular volume (e.g., patients treated with Losartan is contraindicated in patients who
diuretics) & patients with a history of hepatic are hypersensitive to any component of this
Impairment. Angilock can be administered product. Do not co-administer aliskiren with
once or twice daily with total daily doses ranging Losartan in patients with diabetes. It is also
from 25 mg to 100 mg. The effect of losartan contraindicated during 2nd & 3rd trimester
is substantially present within one week but of pregnancy & in severe hepatic impairment.
in some studies the maximal effect occurred In patients who are intravenously volume
in 3-6 weeks. No initial dosage adjustment is depleted (e.g. those treated with high-dose
necessary for elderly patients or for patients diuretics), symptomatic hypotension may
with renal impairment, including patients on occur. These conditions should be corrected
dialysis. A lower dose should be considered for prior to the administration of losartan or a
patients with a history of hepatic impairment. lower starting dose should be used. A lower
There is no therapeutic experience in patients dose should be considered for patients with a
with severe hepatic impairment. Therefore, history of hepatic impairment. Losartan should
losartan is contraindicated in patients with not be used with potassium-sparing diuretics.
severe hepatic impairment.
Pediatric hypertensive patients greater than or Side Effect
equal to 6 years of age: The usual recommended Dizziness, rash, Angioedema involving

A
starting dose is 0.7 mg/kg once daily (up swelling of the face, lips and/or tongue &
to 50 mg total) administered as a tablet or serious hypotension (particularly on initiating
a suspension. Dosage should be adjusted treatment in salt-depleted patients) or renal
according to blood pressure response. Doses failure (mainly in patients with renal artery
above 1.4 mg/kg (or in excess of 100 mg) daily stenosis) may be encountered during Losartan
have not been studied in pediatric patients. potassium treatment.
Angilock is not recommended in pediatric
patients less than 6 years of age or in pediatric Use in Pregnancy & Lactation
patients with glomerular filtration rate less Pregnancy Catagory D. Losartan potassium
than 30 mL/min/1.73 m2. should not be used in pregnancy & if pregnancy
Hypertensive patients with Left Ventricular is detected Losartan potassium should be
Hypertrophy: The usual starting dose is 50 mg discontinued as soon as possible. Losartan
of Angilock once daily. Hydrochlorothiazide potassium should not be used in lactating
12.5 mg daily should be added and/or the mother.
dose of Angilock should be increased to
100 mg once daily followed by an increase in Drug Interaction
hydrochlorothiazide to 25 mg once daily based No drug interaction of clinical significance has
on blood pressure response. been identified.
Nephropathy in Type 2 Diabetic Patients: The
usual starting dose is 50 mg once daily. The Preparation
dose should be increased to 100 mg once 25 mg, 50 mg & 100 mg Tablet.
daily based on blood pressure response.
Angilock may be administered with insulin
& other commonly used hypoglycemic agents
(e.g., sulfonylureas, glitazones & glucosidase
inhibitors). Angilock may be administered
with other antihypertensive agents, & with or
without food.
17
Product Guide

Angilock Plus Plus may be followed as long as the patients


creatinine clearance is greater than 30 mL/min.
In patients with more severe renal impairment,
Active Ingredient loop diuretics are preferred to thiazides, so
Losartan Potassium + Hydrochlorothiazide. Angilock Plus is not recommended.
Patients with Hepatic Impairment: Angilock
Indication Plus is not recommended for titration in
Hypertension: Angilock Plus is indicated patients with hepatic impairment because the
for the treatment of hypertension. This fixed appropriate 25 mg starting dose of losartan
dose combination is not indicated for initial cannot be given.
therapy of hypertension, except when the Severe hypertension: The starting dose of
hypertension is severe enough that the value Angilock Plus for initial treatment of severe
of achieving prompt blood pressure control hypertension is one tablet of Angilock Plus
exceeds the risk of initiating combination 50/12.5 once daily. For patients who do not
therapy in these patients Hypertensive patients respond adequately to Angilock Plus 50/12.5
with Left Ventricular Hypertrophy: Angilock after 2 to 4 weeks of therapy, the dosage
Plus is indicated to reduce the risk of stroke in may be increased to one tablet of Angilock
patients with hypertension & left ventricular Plus 100/25 once daily. The maximum dose
hypertrophy. is one tablet of Angilock Plus 100/25 once

A
daily. It is not recommended for use as initial
Dosage & Administration therapy in patients with intravascular volume
Hypertension: The usual starting dose is depletion (e.g., patients treated with diuretics).
Angilock Plus 50/12.5 one tablet once daily. Hypertensive Patients with Left Ventricular
More than two tablets of Angilock Plus Hypertrophy: Treatment should be initiated
50/12.5 or one tablet of Angilock Plus 100/25 with Angilock 50 mg once daily. Angilock
once daily is not recommended. Maximum Plus 50/12.5 substituted if the blood pressure
antihypertensive effect is attained about three reduction is inadequate. If additional blood
weeks after initiation of therapy. Patients pressure reduction is needed, Angilock
whose blood pressure is not adequately Plus 100/12.5 may be substituted, followed
controlled with losartan or hydrochlorothiazide by Angilock Plus 100/25. For further blood
monotherapy, may be switched to Angilock pressure reduction other antihypertensives
Plus 50/12.5 once daily. If blood pressure should be added.
remains uncontrolled after about three weeks Angilock Plus may be administered with other
of therapy, the dose may be increased to one antihypertensive agents. Angilock Plus may
tablet of Angilock Plus 100/12.5 or two tablets be administered with or without food.
of Angilock Plus 50/12.5 or one Angilock
Plus 100/25 once daily. Patients whose blood Contraindication & Precaution
pressure is not adequately controlled with This combination is contraindicated in patients
losartan 100 mg monotherapy, may be who are hypersensitive to any component of this
switched to Angilock Plus 100/12.5 once daily. product. Because of the hydrochlorothiazide
If blood pressure remains uncontrolled after component, this product is contraindicated
about three weeks of therapy, the dose may be in patients with anuria or hypersensitivity to
increased to 2 tablets of Angilock Plus 50/12.5 other sulfonamide-derived drugs. Do not co-
or one Angilock Plus 100/25 once daily. administer aliskiren with this combination in
patients with diabetes. Periodic determination
Patients with Renal Impairment of serum electrolytes to detect possible
The usual regimens of therapy with Angilock electrolyte imbalance should be performed
18
Product Guide
at appropriate intervals. All patients receiving Preparation
thiazide therapy should be observed for Tablet: Losartan potassium 50 mg +
clinical signs of fluid or electrolyte imbalance. Hydrochlorothiazide 12.5 mg, Losartan
Serum & urine electrolyte determinations are potassium 100 mg + Hydrochlorothiazide
particularly important when the patient is 25 mg & Losartan potassium 100 mg +
vomiting excessively or receiving parenteral Hydrochlorothiazide 12.5 mg.
fluids. Hyperuricemia may occur or frank
gout may be precipitated in certain patients
receiving thiazide therapy. Because losartan
decreases uric acid, losartan in combination
with hydrochlorothiazide attenuates the
diuretic-induced hyperuricemia. In diabetic
Angivent MR
patients, dosage adjustments of insulin or
Active Ingredient
oral hypoglycemic agents may be required.
Trimetazidine Hydrochloride.
Hyperglycemia may occur with thiazide
diuretics. Thus latent diabetes mellitus may
Indication
become manifest during thiazide therapy.
Long-term treatment of angina pectoris.
Side Effect
Dosage & Administration

A
Abdominal pain, Edema/swelling, Palpitation,
1 tablet at mealtimes in the morning & evening.
Back pain, Dizziness, Cough, Sinusitis, Upper
respiratory infection, Rash.
Contraindication & Precaution
Severe depression, severe renal failure
Use in Pregnancy & Lactation
(creatinine clearance <15 ml/min), as a
Pregnancy Catagory D . Because of the
precaution in the absence of currently available
potential for adverse Effects on the nursing
studies.
infant, a decision should be made whether to
discontinue nursing or discontinue the drug,
Side Effect
taking into account the importance of the drug
Rare cases of gastrointestinal disorders.
to the mother.
Use in Pregnancy & Lactation
Drug Interaction
Pregnancy: Studies in animals have not
Losartan potassium: Concomitant use
demonstrated a teratogenic Effect. However,
of potassium-sparing diuretics (e. g.,
in the absence of clinical data & for safety
spironolactone, triamterene, amiloride),
reasons, prescription should be avoided during
potassium supplements, or salt substitutes
pregnancy.
containing potassium may lead to increases
Breastfeeding: In the absence of data,
in serum potassium. Hydrochlorothiazide :
breastfeeding is not recommended during
Alcohol, barbiturates or narcotics: potentiation
treatment.
of orthostatic hypotension may occur. Other
antihypertensive drugs additive Effect or
Preparation
potentiation. Cholestyramine & colestipol
35 mg modified release Tablet.
resins: Absorption of hydrochlorothiazide is
impaired in the presence of anionic exchange
resins.
19
Product Guide

Anleptic total daily dose of 200 mg. This daily dose


may be increased by up to 200 mg/day using
increments of 100 mg every 12 hours for tablets
Active Ingredient or XR tablets, or 50 mg (1/2 teaspoon) q.i.d. for
Carbamazepine. suspension, only as needed to achieve freedom
from pain. A total dose of 1200 mg daily
Indication shouldnt be exceeded. Maintenance: Control
Anleptic is indicated for of pain can be maintained in most patients with
Partial & secondary generalized tonic- 400-800 mg daily. However, some patients may
clonic seizures be maintained on as little as 200 mg daily, while
Primary generalized tonic-clonic seizures others may require as much as 1200 mg daily.
Trigeminal neuralgia At least once every 3 months throughout the
Prophylaxis of bipolar disorder treatment period, attempts should be made to
reduce the dose to the minimum Effective level
Dosage & Administration or even to discontinue the drug.
Epilepsy: The tablets or syrup can be taken without
Adults & children over 12 years of age - Initial: regards to meal.
Either 200 mg b.i.d. for tablets & XR tablets, or
1 teaspoon q.i.d. for suspension (400 mg/day). Contraindication & Precaution

A
Maintenance: usually 800-1200 mg daily. This medicine should not be used if anybody is
Children 6-12 years of age - Initial: Either allergic to one or any of its ingredients. It can
100 mg b.i.d. for tablets or XR tablets, or 1/2 not be used also in the following conditions:
teaspoon q.i.d. for suspension (200 mg/day). Problems with the electrical message
Maintenance: usually 400-800 mg daily. pathways in the heart (atrioventricular block).
Children under 6 years of age - Initial: 10- History of decreased blood cell production by
20 mg/kg/day b.i.d. or t.i.d. as tablets, or the bone marrow (bone marrow depression).
q.i.d. as suspension.Maintenance: Ordinarily, Hereditary blood disorders called porphyrias.
optimal clinical response is achieved at daily Allergy to tricyclic antidepressants, eg
doses below 35 mg/kg. If satisfactory clinical amitriptyline.
response has not been achieved, plasma levels People who have taken a monoamine-oxidase
should be measured to determine whether inhibitor antidepressant (MAOI) in the last 14
or not they are in the therapeutic range. No days.
recommendation regarding the safety of
Carbamazepine for use at doses above 35 mg/ Side Effect
kg/24 hours can be made. Dizziness, drowsiness, ataxia, dry mouth,
abdominal pain, nausea, vomiting, anorexia,
Combination therapy: Carbamazepine may be leucopenia, proteinuria, bradycardia, heart
used alone or with other anticonvulsants. When failure & hypotension. Erythematous skin rash,
added to existing anticonvulsant therapy, aplastic anemia may also be observed.
the drug should be added gradually while
the other anticonvulsants are maintained or Use in Pregnancy & Lactation
gradually decreased, except phenytoin, which Pregnancy category D. Carbamazepine & its
may have to be increased. epoxide metabolite are transferred to breast
milk. Because of the potential serious side
Trigeminal Neuralgia: Initial: On the first day, Effects, decision should me made whether to
either 100 mg b.i.d. for tablets or XR tablets, discontinue nursing or discontinue the drug.
or 1/2 teaspoon q.i.d. for suspension, for a
20
Product Guide
Preparation hypersensitivity to Nitroglycerin.
200 mg Tablet, 200 mg CR Tablet, 100 mg/5 ml Also contraindicated in patients who are using
(100 ml) Suspension. sildenafil citrate since sildenafil citrate has been
shown to potentiate the hypotensive Effects of
organic nitrates.

Anril Only the smallest dose required for Effective


control of the acute anginal attack should
be used. Excessive use may lead to the
Active Ingredient
development of tolerance. This drug should
Nitroglycerin.
be used with caution in patients who may be
volume-depleted or are already hypotensive.
Indication
Indicated for the acute relief of an attack or
Drug Interaction
acute prophylaxis of angina pectoris due to
Antihypertensive drugs, beta-adrenergic
coronary artery disease.
blockers, phenothiazines, calcium channel
blockers, alcohol, aspirin, ergotamine & related
Dosage & Administration
drugs.
0.5 mg Sublingual Tablet: One tablet should
be dissolved under the tongue at the first sign

A
Side Effect
of an acute anginal attack. The dose may be
Headache, facial flushing, dizziness, nausea,
repeated approximately every five minutes,
vomiting, feelings of weakness, postural
until relief is obtained. If the pain persists
hypotension, reflex tachycardia etc.
after a total of 3 tablets in a 15-minute period,
prompt medical attention is recommended.
Use in Pregnancy & Lactation
400 mcg spray: At the onset of an attack, 1 or 2
Pregnancy : Pregnancy Category C.
metered sprays should be administered under
Nitroglycerin should be given to pregnant
the tongue. No more than 3 metered sprays
women only if clearly needed.
are recommended within a 15-minute period.
Nursing Mothers: Caution should be exercised
If the chest pain persists, prompt medical
when Nitroglycerin Spray is administered to a
attention is recommended. Anril Spray may be
nursing woman.
used prophylactically 5 to 10 minutes prior to
engaging in activities which might precipitate
Use in Children
an acute attack. Injection: The usual dose range
Safety & Effectiveness of nitroglycerin in
is 10 - 200 mcg/min. Dose up to 400 mcg/
pediatric patients have not been established.
min may be required during some surgical
procedures.
Preparation
2.6 mg SR (Sustained Release) Tablet : Adults &
0.5 mg Sublingual Tablet, 400 mcg spray, 5 mg/
Elderly Patients: Dosage should be adjusted to
ml IV Injection, 2.6 mg SR (Sustained Release)
the requirements of
Tablet.
the individual patient but will usually be 1 or 2
tablets taken three times daily.
The lowest effective dose should be used.

Contraindication & Precaution


Contraindicated in patients with early
myocardial infarction, severe anemia, increased
intracranial pressure & those with a known
21
Product Guide

Ansulin Ansulin N Injection 40 IU/ml & 100 IU/ml,


Ansulin 30/70 Injection 40 IU/ml and100 IU ml,
Ansulin 50/50 Injection 100 IU/ml.
Active Ingredient Cartridges (3 ml):
Insulin Human (rDNA) Ansulin R Pen Cartridge, Ansulin N Pen
Cartridge, Ansulin 30/70 Pen Cartridge, Ansulin
Indication 50/50 Pen Cartridge
Type 1 & Type 2 Diabetes Mellitus.

Dosage & Administration



The average range of total daily insulin
requirement for maintenance therapy in type Antazol
1 diabetic patients lies between 0.5 & 1.0 IU/
kg. In pre-pubertal children it usually varies Active Ingredient
from 0.7 to 1.0 IU/kg, whereas in insulin Xylometazoline.
resistant cases, e.g. during puberty or due to
obesity, the daily insulin requirement may be Indication
substantially higher. Initial dosages for type 2 Nasal congestion, seasonal & perennial allergic
diabetic patients are often lower, e.g. 0.2 to 0.6 rhinitis , sinusitis.
IU/kg/day.

A
Dosage & Administration
Contraindication & Precaution Adults: 2 or 3 drops adult formula (0.1%) 2-3
Hypoglycemia or the patients who have allergic times daily. Children under 12 yrs : 1 or 2 drops
reaction to insulin or any of the excipients. childrens formula (0.05%) in each nostril 1-2
Inadequate dosing or discontinuation times daily. Not to be used in infants less than
especially in type 1 diabetes, may lead to 3 months.
hyperglycemia. Hypoglycemia may occur if
the insulin dose is too high in relation to the Contraindication & Precaution
insulin requirement. Omission of a meal or Patients with trans-sphenoidal
unplanned, strenuous physical exercise may hypophysectomy or surgery exposing the dura
lead to hypoglycemia. mater, hypersensitive to Xylometazoline.

Side Effect Side Effect


Hypoglycemia is the most common adverse Burning sensation, local irritation, nausea,
effect during insulin treatment & symptoms of headache, & dryness of the nasal mucosa.
hypoglycemia may occur suddenly. Few cases Systemic cardiovascular Effects have occurred,
of the allergic reaction such as red & swollen & this should be kept in mind when giving
or itching are reported. It usually disappears in Antazol to people with cardiovascular disease.
a few days.
Preparation
Use in Pregnancy & Lactation 0.05% & 0.1% Nasal Drops.
Insulin can be used during pregnancy &
lactation if required.

Preparation
Vials (10 ml):
Ansulin R Injection 40 IU/ml and100 IU/ml,
22
Product Guide

Antazol Plus times daily. 6-12 years: 2 mg 3-4 times daily or


as directed by the physician.

Active Ingredient Side Effect


Sodium Cromoglycate & Xylometazoline. Drowsiness, dizziness, headache, psychomotor
impairment, urinary retention, dry mouth,
Indication blurred vision & gastro-intestinal disturbances.
Prophylaxis & treatment of allergic rhinitis
accompanied by nasal congestion. Contraindication & Precaution
It should be used with caution in epilepsy,
Dosage & Administration prostatic hypertrophy, glaucoma & hepatic
Adults (including the elderly) & children: one disease. The ability to drive or operate
spray to each nostril four times daily. machinery may be impaired.

Contraindication & Precaution Preparation


Known sensitivity to any ingredients of the 2 mg/5 ml Syrup.
preparation.

Side Effect
No serious side effects have been reported.
Antiva
A Occasional irritation of the nasal mucosa,
wheezing & tightness of the chest has been
Active Ingredient
reported. Xylometazoline causes mild side
Effects such as nasal irritation, dryness of Adefovir Dipivoxil .
the nose, sneezing, headache, insomnia,
drowsiness & palpitations. Indication
Antiva is indicated for the treatment of chronic
Preparation hepatitis B in adults with evidence of active
(2.6 mg + 0.0325 mg)/spray, Metered Dose viral replication & either evidence of persistent
Nasal Spray. elevations in serum aminotransferases (ALT or
AST) or histologically active disease.

Dosage & Administration


Antista The recommended dose of Antiva in chronic
hepatitis B patients with adequate renal
Active Ingredient function is 10 mg, once daily, taken orally,
Chlorpheniramine. without regard to food.

Indication Contraindication & Precaution


Allergic conditions including urticaria, Adefovir Dipivoxil is contraindicated in patients
sensitivity reactions, angioneurotic oedema, with previously demonstrated hypersensitivity
hay fever, vasomotor rhinitis, cough, common
to any of the components of the product.
cold, motion sickness.
Side-Effect
Dosage & Administration
Adults : 4 mg 3-4 times daily. Children: Up to 1 The most common side effects of Adefovir
(one) year: 1 mg twice daily. 1-5 yers: 1mg 3-4 Dipivoxil are weakness, headache, stomach
23
Product Guide
pain & nausea. Severe acute exacerbations of Contraindication
hepatitis have been reported in patients who Liver disease, myalgia, myopathy &
have discontinued anti-hepatitis B therapy. hypersensitivity to the drug.

Use in Pregnancy & Lactation Drug Interaction


Adefovir dipivoxil should be used during Cyclosporin, fibric acid derivatives,
pregnancy only if clearly needed & after careful erythromycin, azole antifungals, or niacin
(nicotinic acid).
consideration of the risks & benefits.Mothers
should be instructed not to breast-feed if they
Use in Pregnancy & Lactation
are taking Adefovir Dipivoxil. Atorvastatin is contraindicated in pregnancy &
while breast-feeding.
Use in Children
Safety in pediatric patients below 12 years of Preparation
age is not established. 10 mg, 20 mg & 40 mg Tablet.

Preparation
10 mg Tablet.

Apsol
Anzitor Active Ingredient
AB
Amlexanox.
Active Ingredient
Atorvastatin. Indication
For the treatment of Aphthous ulcers.
Indication
For reduction of elevated total cholesterol, LDL- Dosage & Administration
cholesterol, apolipoprotein B, & triglycerides in 1. Apply the paste as soon as possible after
patients with primary hypercholesterolemia noticing the symptoms of an aphthous
(heterozygous familial & non familial), ulcer. Continue to use the paste four times
Fredrickson Type IIa, IIb, III & IV dyslipidemia. daily, preferably following oral hygiene after
breakfast, lunch, dinner, & at bedtime.
Dosage & Administration 2. Dry the ulcer(s) by gently patting it with a
Usual dose is 10 mg once daily. Dosage range is soft, clean cloth.
Anzitor 10 to 80 mg once daily. 3. Wash hands before applying.
4. Moisten the tip of the index finger.
Side Effect 5. Squeeze a dab of paste approximately 1/4
Side effects are mild & transient. Reversible inch (0.5 cm) onto a finger tip.
myositis, headache, altered liver-function tests 6. Gently dab the paste on to the ulcer. Repeat
& gastro-intestinal effects including abdominal the process if more than one ulcer.
pain, flatulence, diarrhoea, nausea & vomiting. 7. Wash hands when done applying.
Thrombocytopenia, rash & hypersensitivity 8. Wash eyes promptly if they come in contact
reactions, insomnia, angioedema, anorexia, with the paste.
asthenia, paraesthesia, peripheral neuropathy, 9. Use the paste until the ulcer heals. If
alopecia, pruritus, rash, impotence, chest pain, significant healing or pain relief has not
hypoglycemia & hyperglycemia. occurred in 10 days, consultation with the
24
Product Guide
physician is required.

Contraindication & Precaution


Amlexanox oral paste is contraindicated
in patients with known hypersensitivity
to Amlexanox or other ingredients in the
formulation. Wash hands immediately after
applying Amlexanox oral paste, directly to
ulcers with the finger tips. In the event that a
rash or contact mucositis occurs, discontinue
use.

Side Effect
Adverse reactions reported by 1-2% of patients
were transient pain, stinging and/or burning
at the site of application. Infrequent (< 1%)
adverse reactions in the clinical studies were
contact mucositis, nausea, & diarrhea.

Use in Pregnancy & Lactation

A Pregnancy: US FDA pregnancy Category B. This


drug should be used during pregnancy only if
clearly needed.
Nursing Mothers: Amlexanox was found in the
milk of lactating rats; therefore, caution should
be exercised when administering Amlexanox
oral paste to a nursing woman.

Use in Children
Safety & Effectiveness of Amlexanox oral paste
in pediatric patients have not been established.

Preparation
Tube containing 5 gm oral paste.
25
Product Guide

Ariprex TM

Active Ingredient
Aripiprazole.

Indication
Schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder, irritability
associated with autistic disorder, agitation associated with schizophrenia or bipolar mania.

Dosage & Administration


Initial Dose Recommended M a x i m u m
Dose Dose
Schizophrenia adults 10-15 mg/day 10-15 mg/day 30 mg/day
Schizophrenia adolescents (ages 13-17 2 mg/day 10 mg/day 30 mg/day
years)
Bipolar mania adults: monotherapy 15 mg/day 15 mg/day 30 mg/day
Bipolar mania adults: adjunct to lithium or 10-15 mg/day 15 mg/day 30 mg/day

A
valproate
Bipolar mania pediatric patients (10-17 2 mg/day 10 mg/day 30 mg/day
years): monotherapy or as an adjunct to
lithium or valproate
As an adjunct to antidepressants for the 2-5 mg/day 5-10 mg/day 15 mg/day
treatment of major depressive disorder
adults
Irritability associated with autistic disorder- 2 mg/day 5-10 mg/day 15 mg/day
pediatric patients (ages 10-17 years)

Oral formulations: Administer once daily without regard to meals.


IM injection: Wait at least 2 hours between doses. Maximum daily dose 30 mg.

Side Effect
Vomiting, nausea, akathisia, extrapyramidal disorder, somnolence, sedation, dizziness, insomnia,
tremor, restlessness, fatigue, blurred vision, salivary hypersecretion, constipation, pyrexia,
drooling, decreased appetite.
Special warnings & precautions for use
Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse
events (eg, stroke, transient ischemic attack, including fatalities).
Suicidality & antidepressants: Increased risk of suicidality in children, adolescents, young & adults
with major depressive disorder.
Tardive dyskinesia: Discontinue if clinically appropriate.
Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes
that include hyperglycemia/diabetes mellitus, dyslipidemia, & body weight gain.
26
Product Guide
Orthostatic hypotension: Use with caution Dosage & Administration
in patients with known cardiovascular or Suspension: Daily 4 times, after meals & at
cerebrovascular disease. bedtime; Adult & children over 12 years: 1-2
Seizures/Convulsions: Use cautiously in teaspoonful (5-10 ml) Suspension; Children 2 -
patients with a history of seizures. 12 years: 1-2 teaspoonful (2.5-5 ml) Suspension.
Chewable Tablet: Daily 4 times, after meals &
Contraindication & Precaution at bedtime; Adult & children over 06 years: 1-2
Known hypersensitivity to Aripiprazole. Use tablets; children 6-12 years: 1 tablet.
caution when operating machinery.
Contraindication & Precaution
Drug Interaction This medicinal product is contraindicated
Caution should be exercised when Aripiprazole in patients with known or suspected
is taken in combination with other centrally hypersensitivity to the active substances or to
acting drugs & alcohol. Carbamazepine could any of the excipients.
cause an increase in Aripiprazole clearance &
lower blood levels. Ketoconazole, quinidine, Side Effect
fluoxetine or paroxetine can inhibit Aripiprazole Very rarely (<1/10,000) patients may develop
elimination & cause increased blood levels. allergic manifestations, such as urticaria or
bronchospasm, anaphylactic or anaphylactoid
Use in Pregnancy & Lactation reactions.

A Pregnancy: Pregnancy category C. It should be


avoided during pregnancy. Drug Interaction
Lactation: It is recommended that women Interaction with other medicinal products &
receiving Aripiprazole should not breast-feed. other forms of Interaction are unknown.

Preparation Use in Pregnancy & Lactation


10 mg & 15 mg Tablet. AsyntaTM can be given in pregnant & lactating
mother.

Use in Children
Asynta TM
AsyntaTM suspension can be given in children
over 2 years of age. AsyntaTM tablet can be
given in children over 6 years of age.
Active Ingredient
Suspension: Each 5 ml suspension contains
Preparation
Sodium Alginate USP 500 mg & Potassium
Chewable Tablet & Suspension.
Bicarbonate USP 100 mg.
Chewable Tablet: Each chewable tablet contains
Sodium Alginate USP 500 mg & Potassium
Bicarbonate USP 100 mg.

Atreon
Indication TM
Treatment of symptoms of gastroesophageal
reflux such as acid regurgitation, heartburn
& indigestion (related to reflux), for example, Active ingredient
following meals, or during pregnancy, or in Aztreonam
patients with symptoms related to reflux
oesophagitis.
27
Product Guide
Indication
Atreon is indicated in the treatment of the following infections caused by susceptible aerobic
Gram-negative micro-organisms-
Urinary tract infections: Pyelonephritis, cystitis (initial & recurrent) & asymptomatic bacteriuria
(including those due to pathogens resistant to the aminoglycosides, cephalosporins or penicillins).
Gonorrhea: Acute uncomplicated urogenital or anorectal infections.
Lower respiratory tract infections: Including pneumonia, bronchitis & lung infections in patients
with cystic fibrosis.
Skin & soft tissue infections: Postoperative wounds, ulcers & burns.
Meningitis: Caused by Haemophilus influenzae or Neisseria meningitidis.
Gynecological infections: Pelvic Inflammatory Disease (PID), endometritis & pelvic cellulitis.
Intra-abdominal infections: peritonitis.
Bacteraemia/septicemia: Septicemia caused by Escherichia coli, Klebsiella pneumoniae,
Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens & Enterobacter species.
Bone & joint infections: Osteomyelitis, septic arthritis. Aztreonam is also indicated for adjunctive
therapy to surgery in the management of infections caused by susceptible organisms. Patients
with serious Pseudomonas infections may benefit from concurrent use of Aztreonam & an
aminoglycoside because of their synergistic action.

Dosage & Administration


Dosage Guideline
Type of infections Dose Frequency (hours)
A
Adults*
Urinary tract infections 500 mg or 1 g 8 or 12
Moderately severe systemic infections 1 g or 2 g 8 or 12
Severe systemic or life-threatening infections 2g 6 or 8
*Maximum recommended dose is 8 g per day.
Pediatric patients**
Mild to moderate infections 30 mg/kg 8
Moderate to severe infections (2 years or older) 30 mg/kg 6 or 8
**Maximum recommended dose is 120 mg/kg/day.

Intramuscular administration
The dose should be given by deep injection into a large muscle mass. Aztreonam is well tolerated
& should not be admixed with any local anesthetic agent.
For each gram of Aztreonam add at least 3ml Water for Injections or 0.9% Sodium Chloride
Injection B.P. & shake well.
Dose Minimum volume of diluent to be added
0.5 gm 1.5 ml
1.0 gm 3.0 ml

Intravenous administration
28
Product Guide
A bolus injection may be used to initiate taste. Abdominal distension has been noted in
therapy. The dose should be slowly injected children.
directly into a vein, or the tubing of a suitable Rare cases of C. Difficile -associated diarrhoea,
administration set, over a period of 3 to 5 including Pseudomembranous colitis, or
minutes. gastro-intestinal bleeding have occurred.
Renal: Aztreonam was not associated with
Contraindication & Precaution changes in renal function in healthy subjects.
This preparation is contraindicated in patients Local Reactions: Discomfort at the IV injection
with known hypersensitivity to Aztreonam site & phlebitis; mild discomfort was noted at
or any other component in the formulation. IM injection site.
Patients having hypersensitivity reactions Miscellaneous: Following reactions were
to penicillins or cephalosporins should be reported rarely: Vaginitis, candidiasis,
treated with Aztreonam only if the potential hypotension, seizure, weakness, paraesthesia,
benefit outweighs the potential risk of a confusion, dizziness, vertigo, insomnia,
severe allergic reaction. Antibiotic associated tinnitius, headache, breast tenderness, altered
Pseudomembranous colitis has been reported taste, muscle aches, fever, malaise, sneezing &
with many antibiotics including Aztreonam. nasal congestion.
Drugs which delay peristalsis, e.g. opiates &
diphenoxylate with atropine may prolong and/ Drug Interaction
or worsen the condition & should not be used. Concomitant administration of probenecid

A Concurrent therapy with other antimicrobial


agents & Aztreonam is recommended as initial
or furosemide & Aztreonam cause clinically
insignificant increases in the serum levels
therapy in seriously ill patients who are at risk of Aztreonam. Unlieke broad spectrum
of having an infection due to pathogens that antibiotics, Aztreonam produced no effects on
are not susceptible to Aztreonam. Appropriate the normal anaerobic intestinal flora.
monitoring of liver function in hepatic impaired
patients is recommended during therapy. Use in Pregnancy & Lactation
Pregnancy
Side Effect Pregnancy Category B. Aztreonam crosses the
Aztreonam is generally well tolerated. In placenta & enters the fetal circulation. So it
clinical studies following adverse effects were should be used during pregnancy only if the
reported- potential benefit justifies the potential risk.
Hypersensitivity: Anaphylaxis, angioedema, Lactation
bronchospasm. Aztreonam is excreted in breast milk in
Dermatologic: Rash; pruritus; petechiae; concentrations that are less than 1% of
purpura; diaphoresis; flushing; urticaria; concentrations determined in simultaneously
erythema multiforme; toxic epidermal obtained maternal serum. Temporary
necrolysis & exfoliative dermatitis. discontinuation of nursing is recommended.
Hematologic: Eosinophilia; increases in
prothrombin & partial thromboplastin Use in Children
time; thrombocytosis, thrombocytopenia, Recommended for children of one week &
leukocytosis, neutropenia, anemia, older. Aztreonam for injection should be
pancytopenia. administered intravenously to pediatric
Hepatobiliary: Transient elevations of hepatic patients with normal renal function. There
transminases & alkaline phosphatase levels. are insufficient data regarding intramuscular
Gastrointestinal: Diarrhoea, nausea, vomiting; administration to pediatric patients or dosing
abdominal cramps, mouth ulcer & altered in pediatric patients with renal impairment.
29
Product Guide
Preparation Dosage & Administration
500 mg, 1 gm & 2 gm Injection A small amount of ointment should be applied
to the affected area three times daily. The area
treated may be covered with gauze dressing if
desired.
B-50 Forte Contraindication & Precaution
In individuals with a history of hypersensitivity
Active Ingredient
to any of its components. If a reaction suggesting
Vitamin B-complex.
sensitivity or chemical irritation should occur
with the use of Mupirocin Ointment, treatment
Indication
should be discontinued & appropriate
Glossitis, stomatitis, cheilosis, beriberi
alternative therapy for the infection should be
polyneuritis.
instituted. As with other antibacterial products,
prolonged use may result in overgrowth of
Dosage & Administration
nonsusceptible organisms, including fungi.
Capsule : 1-2, 3 times daily or as directed by
When used on the face care should be taken
the physician. Syrup : 2-3 teaspoonful daily.
to avoid the eyes.
Injection : 2 ml daily IV or IM.

B
Drug Interaction
Contraindication & Precaution
The effect of the concurrent application of
Hypersensitivity to the components.
Mupirocin & other drug products has not been
studied.
Side Effect
Rarely allergic reactions.
Use in Pregnancy & Lactation
The drug is classified as Pregnancy Category
Drug Interaction
B. Thus, this drug should be used during
Can decrease the efficacy of levodopa.
pregnancy only if clearly needed. Caution
should be exercised when it is administered to
Use in Pregnancy & Lactation
a nursing woman.
It is safe to use B-50 Forte in pregnancy &
lactation.
Use in Children
The safety & effectiveness of Mupirocin have
Preparation
been established in the age range of 2 months
Capsule, 100 ml & 200 ml Syrup, Injection.
to 16 years.

Side Effect

Bactrocin
Burning, stinging, pain, itching , rash, nausea,
erythema, dry skin, tenderness, swelling,
contact dermatitis, & increased exudate.
Active Ingredient
Mupirocin. Preparation
2 % Ointment.
Indication
Topical treatment of impetigo due to
Staphylococcus aureus & Streptococcus
pyogenes.
30
Product Guide

Barif Use in Pregnancy & Lactation


TM

Pregnancy Category C: Febuxostat should be


used during pregnancy only if the potential
Active Ingredient benefit justifies the potential risk to the fetus.
Febuxostat. It is not known whether this drug is excreted
in human milk. Caution should be exercised
Indication when Febuxostat is administered to a nursing
Barif is indicated for the chronic management woman.
of hyperuricemia in patients with gout.
Use in Children
Dosage & Administration The safety & efficacy of Febuxostat in
Recommended at 40 mg or 80 mg once daily. children (under 18 years of age) has not been
The recommended starting dose is 40 mg once established.
daily. For patients who do not achieve a serum
uric acid less than 6 mg /dL after 2 weeks with Preparation
40 mg, 80 mg is recommended. 40 mg tablet & 80 mg tablet.

Contraindication & Precaution


Febuxostat is contraindicated in patients being

Beclomin
treated with azathioprine, mercaptopurine, or

B
TM
theophylline. HFA Inhaler
Gout Flare: An increase in gout flares is
frequently observed during initiation of anti- Active Ingredient:
hyperuricemic agents, including Febuxostat. If a Beclometasone.
gout flare occurs during treatment, Febuxostat
need not be discontinued. Prophylactic therapy Indication
may be beneficial for up to six months. Preventive treatment for asthma.
Cardiovascular Events: A higher rate of
cardiovascular thromboembolic events was Dosage & Administration
observed in patients treated with febuxostat Adults (including the elderly): The usual
than allopurinol in clinical trials. starting dose is 200 micrograms twice a day. In
Liver Enzyme Elevation: Transaminase more severe cases the starting dose may need
elevations have been observed in febuxostat to increase to 600 to 800 micrograms per day.
-treated patients. Children: 50 to 100 micrograms should be given
two, three or four times daily in accordance to
Side Effect the response. Alternatively, 100 micrograms or
The most common adverse events associated 200 micrograms twice daily should be given.
with the use of Febuxostat may include liver The usual starting dose is 100 micrograms
function abnormalities, nausea, arthralgia, & twice daily Beclometasone.
rash.
Use in Pregnancy & Lactation
Drug Interaction There is inadequate evidence of safety in
Concomitant administration of Febuxostat with human pregnancy. The use of Beclometasone
azathioprine, mercaptopurine or theophylline dipropionate in mothers breast feeding their
could increase plasma concentrations of these babies requires that the therapeutic benefits
drugs resulting in severe toxicity. of the drug be weighed against the potential
hazards to the mother & baby.
31
Product Guide

Contraindication & Precaution Benzapen


Contraindicated in patients with known
sensitivity. Care is necessary in patients with Active Ingredient
active or quiescent pulmonary tuberculosis. Benzathine Penicillin.

Side Effect Indication


Candidiasis of the mouth & throat (thrush) Penicillin-sensitive infections, acute otitis
occurs in some patients. media, syphilis, diphtheria carriers &
prophylaxis against rheumatic fever &
Preparation streptococcal infections,
HFA Inhaler : 100 or 250 mcg/puff , 200 puffs.
Dosage & Administration
0.3 to 1.2 million units up to 2.4 million units as
a single dose repeated every five to seven days.
Becospray Contraindication & Precaution
History of Penicillin hypersensitivity, should
Active Ingredient not be used in infants.
Beclomethasone.
Indication
Seasonal & perennial allergic rhinitis including
Side Effect
Sensitization & allergic reactions, acute, life- B
threatening anaphylactic reactions are rare,
hay fever & non-allergic (vasomotor) rhinitis.
but they do occur.

Dosage & Administration Drug Interaction


Adults : 02 sprays in each nostril twice daily. No potentially hazardous interactions have
Children (6 to 12 years of age) : 01 spray in each been described.
nostril twice daily. Children under 6 years of
age : Not recommended. Use in Pregnancy & Lactation
Benzapen injection should not be administered
Contraindication & Precaution during pregnancy unless clearly indicated.
History of hypersensitivity.
Preparation
12 lac units/vial Injection.
Side Effect
Rare. Nasal septum perforation, sprays, dryness
& irritation of the nose & throat, unpleasant
taste & smell & epistaxis, wheezing, cataract
reported.
Beovit
Active Ingredient
Drug Interaction Thiamine HCl.
None is known.
Indication
Preparation Beriberi & Wernicks encephalopathy, neuritis
50 mcg/spray, Nasal Spray. associated with pregnancy & pellagra.
32
Product Guide
Dosage & Administration lesions, acne & perioral dermatitits. Long-
Prophylaxis- 3 to10 mg daily. Mild chronic term continuous topical therapy should be
deficiency- 10 to 25 mg daily. Severe deficiency- avoided where possible, particularly in infants
200 to 300 mg daily. & children. If applied to the eyelids, care is
needed to ensure that the preparation does
Contraindication & Precaution not enter the eye, as glaucoma might occur.
There is no absolute contraindication.
Side Effect
Side Effect Local atrophic changes in the skin such as
Anaphylactic reactions rarely occurs. Transient thinning, striae, & dilatation of the superficial
mild soreness might happen. blood vessels, sufficient systemic absorption
to produce the features of hypercorticism &
Drug Interaction suppression of the HPA axis.
No hazardous drug interactions have been
reported. Use in Pregnancy & Lactation
Topical administration of corticosteroids to
Use in Pregnancy & Lactation pregnant animal can cause abnormalities
The drug may be given safely to neonates, of fetal development including cleft palate
children, pregnant & lactating women & elderly & intrauterine growth retardation & fetal
patients. ototoxicity.

B Preparation Preparation
100 mg Tablet. 10 gm Cream.

Betameson-N Bicozin
Active Ingredient Active Ingredient
Betamethasone Dipropionate & Neomycin Thiamine, Riboflavin, Pyridoxine, Nicotinamide
Sulphate. & Zinc

Indication Indication
Eczema, prurigo nodularis, psoriasis, Treatment & prevention of B-vitamins & Zinc
neurodermatoses, seborrhoeic dermatitis, deficiencies.
contact sensitivity reactions, systemic
steroid therapy in generalized erythroderma, Dosage & Administration
secondarily infected insect bites & anal & Bicozin Syrup : Adults : 10 ml (2 teaspoonfuls) 2
genital intertrigo; specially when scondary to 3 times daily, Children : 10 ml (2 teaspoonfuls)
bacterial infection is present. 1 to 3 times daily, Infants: 5 ml (1 teaspoonful)
1 to 2 times daily. Bicozin Tablet : Adults &
Dosage & Administration Children over 30 kg : 1 to 2 tablets 2 to 3 times
Apply sparingly 2-3 times daily, reducing daily
frequency as condition responds.
Contraindication
Contraindication & Precaution In patients with a known hypersensitivity to
Untreated bacterial, fungal or viral skin any of the ingredients of this product.
33
Product Guide
Side Effect constipation or diarrhoea may occur.
Generally well tolerated.
Use in Pregnancy & Lactation
Drug Interaction Recommended.
Generally no interactions have been observed.
Drug Interaction
Use in Pregnancy & Lactation No interactions have been observed. Since, the
Recommended. Iron is complex bound, ionic interaction with
foodstuff components (phytates, oxalates,
Preparation tannin, etc.) & concomitant administrations
100 ml & 200 ml Syrup; Tablet. of medicaments (tetracyclines, antacids) are
unlikely to occur.

Preparation
100 ml Syrup.
Bicozin-I
Active Ingredient
Iron (III) Hydroxide Polymaltose Complex
Bisocor
BC
INN , Thiamine Hydrochloride BP , Riboflavin-
5-Phosphate Sodium BP , Pyridoxine
Hydrochloride BP , Nicotinamide BP & Zinc Active Ingredient
Sulphate Heptahydrate BP. Bisoprolol Fumarate.

Indication Indication
Bicozin-I syrup is indicated for the treatment Bisocor (Bisoprolol) is indicated in the
& prevention of Iron, B-vitamins & Zinc management of hypertension & in the
deficiencies. treatment of angina. It may be used alone or
in combination with other antihypertensive
Dosage & Administration agents.
Adults: 5 ml-10 ml (1-2 teaspoonful) 3 times
daily or as recommended by the physician. Dosage & Administration
Children: 5 ml (1 teaspoonful) 3 times daily or The dose of Bisocor must be individualized to
as recommended by the physician. the needs of the patient. The usual starting
Infants: 0.33 ml/kg body weight daily or as dose is Bisocor 5 mg once daily. In some
recommended by the physician. patients, Bisocor 2.5 mg may be an appropriate
starting dose. If the antihypertensive Effect of
Contraindication & Precaution Bisocor 5 mg is inadequate, the dose may be
Bicozin-I syrup is contraindicated in patients increased to Bisocor 10 mg & then, if necessary,
with a known hypersensitivity to any of the to 20 mg once daily.
ingredients of this product.
Contraindication & Precaution
Bisoprolol is contraindicated in patients with
Side Effect cardiogenic shock, overt cardiac failure, second
Bicozin-I syrup is generally well tolerated. or third degree AV block, & marked sinus
However, a few side-effects of oral Iron bradycardia. Impaired renal or hepatic function:
preparations, including nausea, vomiting, Use caution in adjusting the dose of Bisoprolol
34
Product Guide
in patients with renal or hepatic impairment. & Hydrochlorothiazide BP 6.25 mg.
Risk of anaphylactic reaction: While taking
beta-blockers, patients with a history of severe Indication
anaphylactic reaction to a variety of allergens Management of hypertension.
may be more reactive torepeated challenge,
accidental, diagnostic or therapeutic. Such Dosage & Administration
patients may be unresponsive to the usual Bisoprolol is an Effective treatment of
doses of epinephrine used to treat allergic hypertension in once-daily doses of 2.5 to 40
reaction. mg, while Hydrochlorothiazide is effective
in doses of 12.5 to 50 mg. In clinical trials of
Use in Pregnancy & Lactation Bisoprolol/Hydrochlorothiazide combination
Pregnancy: Bisoprolol should not be used therapy using Bisoprolol doses of 2.5 to 20 mg
during pregnancy unless clearly necessary. & Hydrochlorothiazide doses of 6.25 to 25 mg,
If treatment with Bisoprolol is considered the antihypertensive Effects increased with
necessary, the uteroplacental blood flow & the increasing doses of either component.
foetal growth should be monitored.
Lactation: It is not known whether this Contraindication
drug is excreted in human milk. Therefore, It is contraindicated in patients in cardiogenic
breast-feeding is not recommended during shock, overt cardiac failure, second or third
administration of Bisoprolol. degree AV block, marked sinus bradycardia,

B Side Effect
anuria & hypersensitivity to either component
of this product or to other sulfonamide-derived
Fatigue, dizziness, headache, disturbances of drugs.
the gut such as nausea, vomiting, diarrhoea,
constipation or abdominal pain, cold or Precaution
numb extremities, e.g. hands & feet, muscle Hyperuricemia or acute gout may be
weakness or cramps, slower than normal heart precipitated in certain patients receiving
beat (bradycardia), worsening of heart failure, thiazide diuretics. Warning signs or symptoms
sleep disturbance, depression, breathing of fluid & electrolyte imbalance include dryness
difficulties due to a narrowing of the airways of mouth, thirst, weakness, lethargy, drowsiness,
(bronchospasm) in people with asthma or restlessness, muscle pains or cramps, muscular
COPD. fatigue, hypotension, oliguria, tachycardia &
gastrointestinal disturbances such as nausea &
Preparation vomiting. Hypokalemia may develop.
2.5 mg, 5 mg & 10 mg tablet If withdrawal of this combination therapy is
planned, it should be achieved gradually over
a period of about 2 weeks. Patients should be
carefully observed.

Bisocor Plus TM
Side Effect
Generally well tolerated. Most side Effects
Active Ingredient have been mild & transient. Side Effects which
Bisocor Plus 2.5/6.25 tablet: Each film coated may occur: fatigue, dizziness, headache,
tablet contains Bisoprolol Fumarate USP 2.5 mg bradycardia, arrhythmia, peripheral ischemia,
& Hydrochlorothiazide BP 6.25 mg. chest pain, palpitations, rhythm disturbances,
Bisocor Plus 5/6.25 tablet: Each film coated cold extremities, claudication, orthostatic
tablet contains Bisoprolol Fumarate USP 5 mg hypotension, diarrhoea, constipation, nausea,
35
Product Guide
dyspepsia, rhinitis, pharyngitis etc.
Brofex
Drug Interaction
This combination drug may potentiate the Active Ingredient
action of other antihypertensive agents used Dextromethorphan.
concomitantly. This combination drug should
not be combined with other beta-blocking Indication
agents. Patients receiving catecholamine- Chronic dry cough/unproductive cough, Acute
depleting drugs, such as reserpine or dry cough which is interfering with normal
guanethidine, should be closely monitored function or sleep.
because the added beta-adrenergic blocking
action of Bisoprolol Fumarate may produce Dosage & Administration
excessive reduction of sympathetic activity. Adults & Children over 12 years: 15 to 30 mg
In patients receiving concurrent therapy with 3-4 times per day. Children between 6-12
clonidine, if therapy is to be discontinued, years : 5-15 mg up to 4 times per day. Children
it is suggested that this combination drug between 2 - 6 years : 2.5-5 mg up to 4 times
be discontinued for several days before the per day.
withdrawal of clonidine. This combination drug
should be used with caution when myocardial Contraindication & Precaution
depressants or inhibitors of AV conduction, Concomitant use of MAO inhibitors is

B
such as certain calcium antagonists (particularly contraindicated with Dextromethorphan.
of the phenylalkylamine [verapamil] &
benzothiazepine [diltiazem] classes) or Side Effect
antiarrhythmic agents, such as disopyramide, Rare, but nausea & dizziness sometimes occur.
are used concurrently. Excitation, confusion & respiratory depression
Both digitalis glycosides & beta-blockers slow may occur after overdosage.
atrioventricular conduction & decrease heart
rate. Concomitant use can increase the risk of Drug Interaction
bradycardia. Two fatal interactions have been reported in
patients taking therapeutic doses of phenelzine
Use in Pregnancy & Lactation & dextromethorphan.
Pregnancy Category C. There are no adequate
& well-controlled studies in pregnant women. Preparation
Bisoprolol Fumarate & Hydrochlorothiazide 10 mg/5 ml Syrup.
should be used during pregnancy only if the
potential benefit justifies the risk to the fetus. Use
in Nursing Mothers: Bisoprolol Fumarate alone
or in combination with Hydrochlorothiazide has
not been studied in nursing mothers. Bromolac TM

Preparation Active Ingredient


Bisocor Plus 2.5/6.25 tablet: Bromocriptine.

Indication
Dysfunctions associated with
hyperprolactinemia including amenorrhea
with or without galactorrhea, infertility or
36
Product Guide
hypogonadism. Prolactin-secreting adenomas, pimozide. Concomitant use of Bromocriptine
Acromegaly, Parkinsons Disease. with other ergot alkaloids is not recommended.

Dosage & Administration Use in Pregnancy & Lactation


General: It is recommended that Bromocriptine Pregnancy Category B.
mesilate be taken with food. Patients should be Nursing Mothers: Bromocriptine should not be
evaluated frequently during dose escalation to used during lactation in postpartum women.
determine the lowest dosage that produces
a therapeutic response. Hyperprolactinemic Use in Children
Indications: The initial dosage is 1.25 mg to 2.5 No data are available for bromocriptine use in
mg tablet daily. An additional 2.5 mg tablet pediatric patients under the age of 8 years.
may be added to the treatment regimen as
tolerated every 2-7 days until an optimal Preparation
therapeutic response is achieved. Acromegaly: 2.5 mg Tablet.
The initial recommended dosage is 1.25 to
2.5 mg on retiring (with food) for 3 days. An
additional 1.25 to 2.5 mg should be added to
the treatment regimen as tolerated every 3-7
days until patient obtains optimal therapeutic
benefit. Parkinsons Disease: The initial dose of
Bufocort TM

B Bromocriptine mesilate is 1.25 mg of a 2.5 mg


tablet twice daily with meals.
Active Ingredient
Prolactinomas: 2.5 mg to 3.75 mg daily
Inhibition of lactation: 5 mg (1 tablet twice) Budesonide & Formoterol Fumarate Dihydrate.
daily with morning & evening meals for 14 days
Indication
Contraindication & Precaution Bufocort Cozycaps are indicated in the regular
Safety & efficacy of bromocriptine mesilate treatment of asthma. They are also indicated in
have not been established in patients with the symptomatic treatment of severe chronic
renal or hepatic disease. Care should be obstructive pulmonary disease (COPD),
exercised when administering Bromocriptine with a history of repeated exacerbations
therapy concomitantly with other medications despite regular therapy with long-acting
known to lower blood pressure. bronchodilators.

Side Effect Dosage & Administration


The incidence of adverse effects are: nausea , Asthma : Dosage is individual & should be
headache, dizziness, fatigue, lightheadedness, adjusted according to disease severity. When
vomiting, abdominal cramps, nasal congestion, control has been achieved, the dose should
constipation, diarrhea & drowsiness. A slight be titrated to the lowest Effective dose. For
hypotensive effect may accompany treatment. Bufocort there are two treatment approaches

Drug Interaction (A) Maintenance Therapy: Patients should be


Bromocriptine may interact with dopamine advised to have their separate rapid acting
antagonists, butyrophenones, & certain other bronchodilator available for rescue use at all
agents. Compounds in these categories result times.
in a decreased efficacy of Bromocriptine:
phenothiazines, haloperidol, metoclopramide, Adults (18 Years & Older)
37
Product Guide
Bufocort - 200 Cozycaps: & angio-oedema can occur in some patients.
1-2 Cozycaps, twice daily, maximum dose is 4 Cutaneous hypersensitivity reactions, tremor,
Cozycaps, twice daily. palpitations, & headache have been reported.
Bufocort - 400 Cozycaps:
1 Cozycaps, twice daily, maximum dose is 2 Use in Pregnancy & Lactation
Cozycaps, twice daily. Administration of Bufocort Cozycaps in
Adolescents (12-17 Years) pregnant women & lactating mother should
Bufocort - 200 Cozycaps: only be considered if the expected benefit is
1-2 Cozycaps, twice daily. greater than any possible risk to the foetus.
Bufocort - 400 Cozycaps:
1 Cozycap, twice daily. Use in Children
Children (6-11 Years) Safety in pediatric patients below 6 years of age
Bufocort - 200 Cozycaps: is not established.
1 Cozycap, twice daily.
Preparation
(B) Single Maintenance & Reliever Therapy 200 & 400 Cozycap.
(For Bufocort -200 only) Patients take a daily
maintenance dose of Bufocort & in combination
take Bufocort as needed in response to
symptoms. Patients should be advised to
always have Bufocort available for use.
Burna B
Patients should take 1 additional Cozycap as
needed in response to symptoms. If symptoms Active Ingredient
persist after a few minutes, an additional Silver Sulfadiazine.
Cozycap should be taken. Not more than
6 Cozycap s should be taken on any single Indication
occasion. The topical prophylaxis against bacterial
colonization & infection in burn wounds.
COPD (Chronic Obstructive Pulmonary Disease)
Dosage & Administration
Bufocort 200 Cozycaps: Once to twice daily to a thickness of
2 Cozycaps , twice daily. approximately 1/16 inches or 1.5 mm.

Contraindication & Precaution Contraindication


BufocortCozycaps are contraindicated in It is contraindicated in patients who are
patients with a history of hypersensitivity to hypersensitive to it or any of the other
any of the components of the drug product. It ingredients in the preparation.
should be administered with caution in patient
with severe cardiovascular disorders, including Side Effect
heart rhythm abnormalities, diabetes mellitus, Several cases of transient leukopenia have
untreated hypokalaemia, or thyrotoxicosis. been reported in-patients receiving Silver
Sulfadiazine therapy. Other infrequently
Side-Effect occurring events include skin necrosis,
Hoarseness & candidiasis (thrush) of the mouth erythema multiform, skin discoloration,
& throat, cardiac arrhythmias, muscle cramps & burning sensation, rashes & interstitial
hypersensitivity reactions, including rash, oedema nephritis.
38
Product Guide
Use in Pregnancy & Lactation Use in Elderly
Pregnancy Category : B Monitoring of serum calcium & phosphate is of
Nursing Mother: It is not known whether Silver course indicated for elderly patients.
Sulfadiazine is excreted in human milk.
Preparation
Preparation Calcium 500 mg Tablet.
1% Cream.

Calbo 500 Calbo-C


Active Ingredient Active Ingredient
Calcium Carbonate. Calcium Lactate Gluconate, Calcium Carbonate
& Ascorbic Acid (Vitamin-C).
Indication
The treatment or prevention of calcium Indication
depletion. Indicated in increased demand for Calcium &

C
Vitamin-C, e.g. pregnancy, lactation, periods of
Dosage & Administration rapid growth (childhood, adolescence), in old
Daily 500-1500 mg calcium is recommended. age; During infectious disease & convalescence;
Treatment of calcium & vitamin C deficiency;
Side Effect Osteoporosis; Premenstrual syndrome;
Constipation, Hypercalcaemia. Postmenopausal problems; Adjuvant in colds
& influenza.
Contraindication & Precaution
Hypercalcaemia & hyperparathyroidism, Dosage & Administration
Hypercalciuria & nephrolithiasis, Zollinger- Adults & children of school age : 1 effervescent
Ellison syndrome, Concomitant digoxin tablet daily, Children 3 to 7 years : 1/2
therapy (requires careful monitoring of serum effervescent tablet daily, Infants : As prescribed
calcium level). by the physician. Dissolve one tablet in half
glass (100 ml) of water.
Drug Interaction
Digoxin & other cardiac glycosides, tetracycline, Contraindication & Precaution
Vitamin D primary phosphate binder. Hypercalcemia, Severe hypercalciuria, Severe
renal failure, Patients with hyperoxalauria,
Use in Pregnancy & Lactation Glucose - 6 - phosphate dehydrogenase
Calcium containing drugs have been widely deficiency, Iron overload, Larger doses
used in pregnancy by way of oral calcium may lead to gastrointestinal tract upset. For
supplementation or antacid therapy. Calcium patients with mild hypercalciuria (exceeding
Carbonate can be used in lactating women too. 300 mg = 7.5 mmol/24 hours), with mild or
moderate impairment of renal function or with
Use in Children a history of urinary concrements, monitoring
Calcium Carbonate has been extensively of calcium excretion in the urine is required.
studied in children & infants with chronic renal If necessary, the dosage should be reduced or
failure & is both safe & effective. therapy should be discontinued. High doses
39
Product Guide
of Vitamin-D & derivatives should be avoided Contraindication & Precaution
during treatment with this preparation unless Hypercalcemia & hyperparathyroidism
especially indicated. Hypercalciuria & nephrolithiasis
Side Effect
Hypersensitivity to the component of

this preparation
In rare case bloating & diarrhea can occur. In
predisposed patients prolonged treatment
Severe renal insufficiency.
with high doses may promote the formation of
Drug Interaction
calculi in the urinary tract.
It has possible interaction with digoxin,
antacids containing calcium, aluminum or
Drug Interaction
magnesium, other calcium supplements,
Potentially hazardous interactions: Digoxin,
calcitriol or other Vitamin-D supplements;
Tetracycline, Frusemide, Pentagastrin,
tetracycline, Doxycycline, aminocycline or
Aminophylline, Erythromycin, Nitrofurantoin,
oxytetracycline etc. So before taking any of
Conjugated estrogens, Chloramphenicol.
these drugs consultations of the physicians are
Potentially useful interactions: Vitamin-D,
needed.
Oxytocin & Prostaglandins. Vitamin-C enhances
iron absorption.
Side Effect
Also there may be allergic reactions, irregular

C
Use in Pregnancy & Lactation
heartbeats, nausea, vomiting, decreased
Calcium containing drugs have been widely
appetite dry mouth & drowsiness.
used in pregnancy by way of oral calcium
supplementation or antacid therapy. Calcium
Use in Pregnancy & Lactation
Carbonate can be safely used in lactating
It should be used as directed by the physician
women. Vitamin-C may be taken safely during
during pregnancy & lactation.
pregnancy & lactation.
Preparation
Preparation
(Calcium 500 mg + Vitamin-D 200 I.U.)/Tablet.
500 mg Effervescent Tablet.

Calbo-D Calbo-D Vita


Active Ingredient Active Ingredient
Calcium + Vitamin-D. Calcium + Vitamin-D.

Indication Indication
Calcium & Vitamin-D is used for the treatment Prevention & treatment of calcium & vitamin D
of osteoporosis, osteomalacia, rickets, tetany, deficiency, Calcium & vitamin D supplement as
& parathyroid disease. It is also used as routine an adjunct to specific therapy in the prevention
supplement & phosphate binder in chronic & treatment of Osteoporosis for patients who are
renal failure. at risk of calcium & vitamin D deficiency.

Dosage & Administration Dosage & Administration


Adults, elderly & children: 1 tablet in the Adult & adolescents: 1-2 tablets daily
morning & 1 tablet at night. Children: 1 tablet daily
40
Product Guide
Contraindication & Precaution
Hypercalcemia & hyperparathyroidism Calbo Forte
Hypercalciuria & nephrolithiasis
Hypersensitivity to the component of this Active Ingredient
preparation Each effervescent tablet contains Calcium
Severe renal insufficiencies Lactate Gluconate, Calcium Carbonate,
Ascorbic Acid (Vitamin-C) & Vitamin-D.
Drug Interaction
It has possible interaction with Digoxin, Antacids Indication
containing Calcium, Aluminum or Magnesium, Indicated as an adjunct to specific therapy for
other Calcium supplements, Calcitriol, osteoporosis; Increased demand for Calcium,
Tetracycline, Doxycycline, Aminocycline or Vitamin-C & Vitamin-D, e.g. pregnancy,
Oxytetracycline etc. So while taking Calbo-D lactation, periods of rapid growth (childhood,
with any of these drugs consultations of the adolescence), in old age; During infectious
physicians is needed. disease & convalescence; Treatment of calcium,
vitamin-C & vitamin-D deficiency; Osteoporosis;
Side Effect Premenstrual syndrome; Postmenopausal
Orally administered Calcium Carbonate may problems; Adjuvant in colds & influenza.
be irritating to the GI tract. It may also cause
Dosage & Administration

C
constipation. Hypercalcemia is rarely produced
by administration of Calcium alone, but may Adults & children of school age:
occur when large doses are given to patients 1 effervescent tablet daily
with chronic renal failure. Also there may be Children 3 to 7 years:
allergic reactions, irregular heartbeats, nausea, effervescent tablet daily
vomiting, decreased appetite dry mouth & Infants: As prescribed by the physician
drowsiness, skin rash. Dissolve one tablet in half glass (100 ml) of
water.
Use in Pregnancy & Lactation
Calbo-D effervescent tablets can be used Contraindication & Precaution
during pregnancy, in case of a calcium Hypercalcemia, severe hypercalciuria, severe
& vitamin D deficiency. However, for renal failure, patients with hyperoxalauria,
supplementation starting during the third glucose - 6 - phosphate dehydrogenase
trimester of pregnancy, the daily intake should deficiency, iron overload,
not exceed 1500 mg calcium & 1000 IU vitamin Larger doses may lead to gastrointestinal
D. Calbo-D effervescent tablets can be used tract upset, bone metastasis or other
during breast-feeding. malignant bone disease, sarcoidosis, primary
hyperparathyroidism, vitamin-D overdosage.
Preparation For patients with mild hypercalciuria (exceeding
Calcium 600 mg + Vitamin-D 800 I.U.)/Tablet. 300 mg = 7.5 mmol/24 hours), with mild or
moderate impairment of renal function or with
a history of urinary concrements, monitoring
of calcium excretion in the urine is required.
If necessary, the dosage should be reduced
or therapy should be discontinued. Since
citrate salts have been reported to increase
aluminium absorption, this preparation which
contains citric acid as a constituent, should be
41
Product Guide
used with caution in patients with severely latent tetany & during pregnancy & lactation.
impaired renal function, especially those
receiving aluminium-containing preparations. Dosage & Administration
Children : 1 tablet daily, Adolescents: 1-2
Side Effect tablets daily,
In rare case, mild gastrointestinal disturbances Adults : 2 tablets daily or as directed by the
(bloating, diarrhea) can occur. In predisposed physician
patients prolonged treatment with high doses
may promote the formation of calculi in the Contraindication & Precaution
urinary tract. Following administration of Hypercalcemia & hyperpara-thyroidism,
vitamin-D supplements occasional skin rash Hypercalciuria & nephrolithiasis,
has been reported. Hypercalciuria & in rare Hypersensitivity to any component of
cases hypocalcaemia have been seen in long this product, Severe renal insufficiency,
term treatment with vitamin-D at high doses. Concomitant digoxin therapy (requires careful
monitoring of serum calcium level). Calcium
Use in Pregnancy & Lactation salts should be used cautiously in patients
During pregnancy & lactation treatment with sarcoidosis, renal or cardiac disease, & in
with Calbo Forte should always be under the patients receiving cardiac glycosides. Patients
direction of a physician. During pregnancy & with a history of stone formation should also

C
lactation, requirements for calcium & vitamin-D be recommended to increase their fluid intake.
are increased but in deciding on the required High doses of Vitamin D should be avoided
supplementation allowances should be made during calcium therapy unless specifically
for availability of these agents from other indicated.
sources.
Side Effect
Preparation Constipation, Hypercalcemia.
Each effervescent tablet contains Calcium
Lactate Gluconate 1000 mg, Calcium Carbonate Drug Interaction
BP 327 mg, Ascorbic Acid (Vitamin-C) BP 500 Tetracycline, fluoride preparations, Vitamin D
mg & Vitamin-D BP 400 I.U. & Verapamil. The intestinal uptake of calcium
maybe reduced by concomitant ingestion of
certain foods (e.g. spinach, bran, & other cereal
products, milk & milk products).

Use in Pregnancy & Lactation


Calbo Jr Calcium containing drugs have been widely
used in pregnancy. Calcium Carbonate can be
Active Ingredient safely used in lactating women.
Calcium Carbonate.
Preparation
Indication Calcium 250 mg Chewable Tablet.
Raised calcium requirement for children
& adolescents at times of rapid growth,
inadequate intake of calcium in the diet due
to malnutrition, prevention & treatment of
osteoporosis, disorders of osteogenesis & tooth
formation (in addition to specific treatment),
42
Product Guide

Calboral-D Drug Interaction


It has possible interaction with digoxin,
antacids containing Calcium, Aluminum or
Active Ingredient Magnesium, other Calcium supplements,
Calcium Carbonate USP (from coral source) + Calcitriol, Tetracycline, Doxycycline,
Vitamin-D USP. Aminocycline or Oxytetracycline etc. So while
taking Calboral-D with any of these drugs
Indication consultations of the physicians is needed.
Calcium & Vitamin-D is used for the treatment
of: Osteoporosis, Osteomalacia, Rickets, Tetany Use in Pregnancy & Lactation
, Parathyroid disease It should be used as directed by the physician
during Pregnancy & Lactation.
Dosage andadministration
One tablet in the morning & one tablet at night. Preparation
Tablet.
Contraindication
Hypercalcemia & hyperparathyroidism,
Hypercalciuria & nephrolithiasis,
Hypersensitivity to the component of this
preparation, Severe renal insufficiencies,
Calboplex
C Concomitant digoxin therapy (requires careful
monitoring of serum Calcium level).
Active Ingredient
Calcium, Vitamin-D & Multiminerals.
Side Effect
Orally administered Calcium Carbonate may
Indication
be irritating to the GI tract. It may also cause
The well balanced formula helps to maintain
constipation. Hypercalcemia is rarely produced
strong bones & teeth as well as the health of the
by administration of Calcium alone, but may
heart, muscles & nerves. It is also indicated for
occur when large doses are given to patients
bone development & constant regeneration
with chronic renal failure. Also there may be
of bone, for the prevention & treatment of
allergic reactions, irregular heartbeats, nausea,
osteoporosis.
vomiting, decreased appetite dry mouth
& drowsiness. Following administration of
Dosage & Administration
vitamin-D Supplements occasion skin rash has
1 tablet twice daily, preferably 1 tablet in the
been reported.
morning & 1 tablet in the evening or as directed
by the physician. It is best taken with or just
Precaution & Warning
after main meals with a full glass of water.
When hypercalcemia occurs, discontinuation
of the drug is usually sufficient to return serum
Contraindication & Precaution
Calcium concentrations to normal. Calcium
Hypercalcemia & hyperparathyroidism,
salts should be used cautiously in patients
Hypercalciuria & nephrolithiasis,
with sarcoidosis, renal or Cardiac disease, & in
Hypersensitivity to the component of this
patients receiving cardiac glycosides. Patients
preparation, Severe renal insufficiency.
with a history of stone formation should also
be recommended to increase their fluid intake.
Drug Interaction
It has possible interaction with digoxin,
antacids containing calcium, aluminum or
43
Product Guide
magnesium, other calcium supplements, levels should be determined at 4 weeks, 3 & 6
calcitriol or other Vitamin-D supplements; months & at 6 monthly intervals thereafter.
tetracycline, Doxycycline, aminocycline or Renal osteodystrophy (dialysis patients)
oxytetracycline etc. The initial daily dose is 0.25 mcg in patients
with normal or only slightly reduced serum
Side Effect calcium levels, doses of 0.25 mcg every other
Orally administered Calcium Carbonate may day are sufficient.
be irritating to the GI tract. It may also cause Hypoparathyroidism & rickets
constipation. Hypercalcemia is rarely produced The recommended initial dose of Calcitrol
by administration of calcium alone, but may is 0.25 mcg per day given in the morning.
occur when large doses are given to patients In patients with renal osteodystrophy or
with chronic renal failure. hypoparathyroidism & rickets if within 2-4
weeks no satisfactory response is not observed
Use in Pregnancy & Lactation by usual dose then dose may be increased at
It should be used as directed by the physician two to four week intervals.
during pregnancy & lactation.
Contraindication & Precaution
Preparation Calcitrol is contraindicated in patients with
Tablet. known hypersensitivity to any of its ingredients.

C
Calcitrol is also contraindicated in all diseases
associated with hypercalcemia. During
Calcitrol therapy as soon as the serum calcium
level rise to 1 mg/100 ml above normal or
Calcitrol serum creatinine rises above 120 micromole/L
the dosage of Calcitrol should be substantially
Active Ingredient reduced or treatment stopped altogether until
Calcitriol. normocalcemia ensues.

Indication Side Effect


The incidence of adverse Effects reported from
For the treatment of established osteoporosis clinical use of Calcitriol over a period of 15
Increases spine density & total body years in all indication is very low. Occasional
calcium acute symptoms include anorexia, headache,
vomiting & constipation. Chronic Effects may
Significantly increases BMD include dystrophy, fever with thirst etc.
Reduces the rate of new vertebral fracture in
women with post-menopausal osteoporosis Drug Interaction
Uncontrolled intake of additional calcium
Restores bone metabolism in patients with containing preparations should be avoided.
predialysis chronic renal failure
Concomitant treatment with a thazide diuretc
For the treatment of hypoparathyroidism & increases the risk of hypercalcemia. Calcitriol
rickets dosage must be determined with care in
patients undergoing treatment with digitalis,
Dosage & Administration as hypercalcemia in such patients may
Postmenopausal osteoporosis precipitate cardiac arrhythmias. Magnesium
The recommended dosage for calcitrol is 0.25 containing drugs (eg. antacids) may cause
mcg twice daily. Serum calcium & creatinine hypermagnesemia. The dosage of phosphate
44
Product Guide
binding agents must be adjusted in accordance
with the serum phosphate concentration. Camlodin Plus
Use in Pregnancy & Lactation Active Ingredient
There is no evidence to suggest that vitamin D is Amlodipine + Atenolol.
teratogenic in humans even at very high doses
Calcitrol should be used during pregnancy Indication
only if the benefits outweigh the potential risk Hypertension not controlled by monotherapy,
to the fetus. Mothers may breast feed while Patients with angina pectoris & hypertension as
taking Calcitrol but serum calcium levels of the co-existing diseases, Post MI, Refractory angina
mother & infant should be monitored. pectoris where nitrate therapy has failed.

Preparation Dosage & Administration


Licap. Initiated with a single dose of Amlodipine 5
mg + Atenolol 50 mg. Depending upon the
therapeutic response, titration of the dosage is
recommended. In elderly patients, it is advisable
to initiate the therapy with Amlodipine 5 mg +

Camlodin Atenolol 25 mg tablet.

C Active Ingredient
Amlodipine.
Contraindication & Precaution
Hypersensitivity to any of the component.
Bronchospasm: The combination should be
used with caution in patients with airway
Indication obstruction. Renal Impairment: Caution may
Hypertension, stable angina, vasospastic be necessary if the creatinine clearance is less
angina. than 30ml/min. Hepatic impairment: Caution
may be necessary in the use of the combination
Dosage & Administration in patients with severe liver damage. Drug
5-10 mg once daily. withdrawal: Any discontinuation should be
gradual & under observation.
Contraindication & Precaution
Known hypersensitivity. Drug Interaction
Disopyramide, Ampicillin, Oral antidiabetic &
Side Effect insulin.
Headache, oedema, fatigue, nausea, flushing,
dizziness, gum hyperplasia; erythema Side Effect
multiforme. Well tolerated. Overall side Effects include
fatigue, headache, edema, nausea, drowsiness,
Drug Interaction anxiety & depression.
Digoxin, Warfarin, Cimetidine.
Use in Pregnancy & Lactation
Use in Pregnancy & Lactation Pregnancy: The combination should be
Not recommended. used during pregnancy only if the expected
benefit outweighs the potential foetal risk.
Preparation Lactation: Nursing mothers should not use the
5 mg Tablet. combination. If its use is considered necessary,
45
Product Guide
breast feeding should be stopped. nervousness, anxiety, tremor, & decreased
libido. Dermatologic: Flushing, hot flashes,
Preparation rash, skin nodule, & dermatitis. Digestive: Dry
(Amlodipine 5 mg + Atenolol 50 mg)/Tablet, mouth, nausea, abdominal pain, constipation,
(Amlodipine 5 mg + Atenolol 25 mg)/Tablet. diarrhea, dyspepsia, & esophagitis. Metabolic
& Nutritional: Hypokalemia. Musculoskeletal:
Back pain, musculoskeletal pain, cramps,
& muscle cramps. Respiratory: Pharyngitis.
Urogenital: Sexual problems such as impotence,
& polyuria.
Camlopril Use in Pregnancy & Lactation
Pregnancy Categories C (first trimester) & D
Active Ingredient
(second & third trimesters). Nursing Mothers:
Amlodipine + Benazepril.
It is recommended that nursing should
be discontinued while this combination is
Indication
administered.
Hypertension.
Preparation
Dosage & Administration

C
Capsule.
Amlodipine is an effective treatment of
hypertension in once-daily doses of 2.5-10 mg
while Benazepril is effective in doses of 10-80
mg.

Camlosart TM
Contraindication & Precaution
In patients who are hypersensitive to Benazepril,
to any other ACE inhibitor, or to Amlodipine. Active Ingredient
Impaired Renal Function: Should be used Amlodipine + Olmesartan.
with caution in patients with severe renal
disease. Patients with Congestive Heart Failure: Indication
Calcium channel blockers should be used with Hypertension, alone or with other
caution in patients with heart failure. Patients antihypertensive agents. It can be used as
with Hepatic Failure: In patients with impaired initial therapy.
hepatic function, caution should be exercised
when administering this combination to Dosage & Administration
patients with severe hepatic impairment. One tablet (5/20 mg) once daily. Maximum
dose two tablets (10/40 mg) once daily. May
Drug Interaction be taken with or without food.
Diuretics, Potassium-sparing diuretics
(spironolactone, amiloride, triamterene, & Contraindication & Precaution
others) or potassium supplements, Lithium. Contraindication: Hypersensitivity to any of
the component of this combination product.
Side Effect Precaution: When pregnancy is detected, this
Generally mild & transient. The most common combination drug should be discontinued as
reasons for discontinuation of therapy with soon as possible. Symptomatic hypotension
this combination were cough. Body as a may occur after initiation of therapy. Exercise
Whole: Asthenia & fatigue. CNS: Insomnia, caution, when administering this combination,
46
Product Guide
particularly in patients with severe aortic 320 mg, once daily. In elderly patients, therapy
stenosis. Patients may develop increased should be initiated at 2.5 mg of Amlodipine. May
frequency, duration, or severity of angina or be administered with other antihypertensive
acute MI on starting calcium channel blocker agents.
therapy or at the time of dosage increase.
Patients with Congestive Heart Failure: Calcium Contraindication & Precaution
channel blocker should be used with caution Hypersensitivity to any component of the
in patients with Impaired Renal Function / product, avoid fetal or neonatal exposure,
Hepatic Impairment/congestive heart failure. assess for hypotension, warn patients with
severe obstructive coronary artery disease
Side Effect about the risk of myocardial infarction or
Edema, dizziness, flushing, palpitation, increased angina, titrate slowly in patients
vomiting, diarrhoea, rhabdomyolysis, alopecia, with impaired hepatic or severely impaired
pruritus, urticaria etc. renal function.

Drug Interaction Side Effect


No significant drug interactions have been The most common side effects include
observed when used individually or in peripheral edema, nasal congestion, sore
combination. throat & discomfort when swallowing, upper

C
respiratory tract infection, dizziness etc.
Use in Pregnancy & Lactation
Not recommended. Use in Pregnancy & Lactation
Not recommended.
Use in Children
Safety & effectiveness have not been Use in Children
established. Safety & effectiveness is not established.

Preparation Preparation
Amlodipine 5 mg + Olmesartan 20 mg Tablet. (Amlodipine 5 mg + Valsartan 80 mg)/ Tablet,
Amlodipine 5 mg + Olmesartan 40 mg Tablet. (Amlodipine 5 mg + Valsartan 160 mg)/ Tablet.

Camoval Candex
TM

Active Ingredient Active Ingredient


Amlodipine + Valsartan. Nystatin.

Indication Indication
Hypertension. Candidiasis.

Dosage & Administration Dosage & Administration


Once daily, orally, with or without food. Children: In intestinal & oral candidiasis (thrush)
Maximum dose: Amlodipine 10 mg & Valsartan 1,00,000 units (1 ml) should be dropped into
47
Product Guide
the mouth four times daily. The longer the
suspension is kept in contact with the affected Carbizol
area in the mouth, before swallowing, the
greater will be its effect. For prophylaxis in Active Ingredient
the newborn the suggested dose is 1,00,000 Carbimazole.
units (1 ml) once daily or as prescribed by the
physician. Adult: For the treatment of intestinal Indication
or esophageal candidiasis 5,00,000 units (5 ml) Management of hyperthyroidism, thyrotoxi-
by mouth 3 or 4 times daily. The dose may cosis (including thyroid storm), & also for the
be doubled, if required. For prophylaxis of preparation of patients for thyroidectomy. It
intestinal candidiasis in adults 10,00,000 units can also be used in combination with radio-
(10 ml) daily. For prophylaxis to suppress the active ablative therapy.
over growth of Candida albicans in patients
receiving broad spectrum antibiotic therapy Dosage & Administration
10,00,000 units (10 ml) daily. For the treatment Adults: The initial dose: 20 - 60 mg, in 2-3 di-
of dental sores & oral infection 1,00,000 units vided doses until the patient is euthyroid. Daily
(1 ml) suspension should be dropped into dosage should be divided.
the mouth four times daily. Older people
with intestinal candidiasis who are unable to Maintenance regimen: Dose is gradually re-
duced to maintain a euthyroid state. Final dos-

C
swallow tablets should be given 5,00,000 units
(5 ml) suspension four times daily. age is usually in the range of 5 - 15 mg/day
which may be taken as a single daily dose.
Contraindication & Precaution Neonates & Children below 12 years:
Hypersensitivity. The usual initial dose is 250 mcg /Kg/day in di-
vided doses.
Side Effect
Oral irritation or sensitization, nausea, Duration of treatment: 18 to 24 months
diarrhoea, gastrointestinal distress, nausea &
vomiting. Rash, including urticaria has been Contraindication & Precaution
reported rarely. Patients with known hypersensitivity to Car-
bimazole or other thiourea antithyroid agents.
Drug Interaction
Not known. Pregnancy & Lactation
Recommended but the smallest effective dose
Use in Pregnancy & Lactation should be used least overdosage adversely
Nystatin should be prescribed during affects the foetus.
pregnancy only if the potential benefits to be
derived outweigh the possible risks involved; Use in Children
caution should be exercised when Nystatin is Recommended
prescribed for nursing woman.
Drug Interaction
Preparation Iodine or iodine excess may decrease the
1 lac unit/1 ml Suspension. response to Carbimazole.

Side Effect
Rarely seen; rash, pruritis, skin pigmentation,
paraesthesias, urticaria, headache, arthralgia,
48
Product Guide
& gastro-intestinal disturbances. Indication
Treatment of hypertension.
Preparation
5 mg Tablet. Dosage & Administration
Initial dose should be one Chlorthalidone
25 mg + Atenolol 50 mg (Cardipro 50 Plus)
tablet once a day. If an optimal response is not
Cardipro achieved, the dosage should be increased to
one Chlorthalidone 25 mg + Atenolol 100 mg
tablet once a day.
Active Ingredient
Atenolol.
Contraindication & Precaution
Sinus bradycardia; heart block greater than first
Indication
degree; cardiogenic shock; overt cardiac failure
Hypertension, angina pectoris, cardiac
anuria; hypersensitivity to this product or to
arrhythmia, myocardial infarction.
sulfonamide-derived drugs. This combination
may aggravate peripheral arterial circulatory
Dosage & Administration
disorders. Periodic determination of serum
Cardipro 50 mg once daily, can be raised to 100-
electrolytes to detect possible electrolyte
200 mg.

C
imbalance should be performed at appropriate
intervals. Patients should be observed for
Contraindication & Precaution
clinical signs of fluid or electrolyte imbalance;
Second & third degree heart block, Untreated
ie, hyponatremia, hypochloremic alkalosis, &
heart failure, Cardiogenic shock.
hypokalemia.
Side Effect
Side Effect
Cold extremities, fatigue, vivid dreams,
Most adverse Effects have been mild &
insomnia, diarrhoea, constipation, impotence
transient. The adverse Effects observed for this
& paraesthesia.
combination are essentially the same as those
seen with the individual components.
Drug Interaction
Verapamil, Class 1 anti-arrhythmic drug (e.g.
Drug Interaction
disopyramide), Clonidine, Indomethacin.
Other antihypertensive agents, Catecholamine
depletor (e.g. reserpine).
Use in Pregnancy & Lactation
Recommended.
Use in Pregnancy & Lactation
Pregnancy Category D. Caution should
Preparation
be exercised when this combination is
50 mg & 100 mg Tablet.
administered to a woman who is breast-
feeding.

Cardipro Plus Use in Children


Safety & Effectiveness in pediatric patients have
not been established.
Active Ingredient
Atenolol + Chlorthalidone. Preparation
(Atenolol 50 mg + Chlorthalidone 25 mg)/Tablet.
49
Product Guide

Carva
Active Ingredient
Aspirin.

Indication
Antithrombotic action, mediated through inhibition of platelet activation, secondary prophylaxis
following myocardial infarction & unstable angina or cerebral transient ischemic attacks.

Dosage & Administration


150 mg at diagnosis & 75 mg daily thereafter.

Contraindication
Hypersensitivity to aspirin, hypoprothrombinaemia, haemophilia & peptic ulceration, asthma.

Side Effect
Hypersensitivity, asthma, urate kidney stones, chronic gastro-intestinal blood loss, tinnitus,
nausea & vomiting.

Drug Interaction

C
Oral anticoagulants, oral hypoglycemic, phenytoin, probenecid, sulphonamides.

Use in Pregnancy & Lactation


Aspirin should be avoided during the last 3 months of pregnancy. It should not be used by patients
who are breast feeding.

Preparation
75 mg Tablet.

Cavir TM

Active Ingredient
Entecavir 0.5 mg & 1 mg Tablet.

Indication
Chronic hepatitis B virus infection in adults with evidence of active viral replication & either
evidence of persistent elevations in serum Aminotransferase (ALT or AST) or histologically active
disease.

Dosage & Administration


Cavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before
the next meal).
Nucleoside-treatment-naive (16 years): 0.5 mg once daily.
Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations (16 years): 1 mg
once daily.
Decompensated Liver Disease: Recommended dose is 1 mg once daily.
50
Product Guide
Renal Impairment: Dosage adjustment is recommended for patients with creatinine clearance less
than 50 ml/min, including patients on hemodialysis or Continuous Ambulatory Peritoneal Dialysis
(CAPD), as shown below-
Dosage of Entecavir in patients with renal impairment:
Dosage of Entecavir in patients with renal impairment
Creatinine 50 30 to <50 10 to <30 <10,
clearance Hemodialysis or CAPD
( ml/min)

Dose 0.5 mg every 0.5 mg every 0.5 mg every 0.5 mg every 7 days
24 hrs 48 hrs 72 hrs

Contraindication & Precaution


Entecavir is contraindicated in patients with known hypersensitivity to Entecavir or any component
of the product. Lactic acidosis: Lactic acidosis & severe hepatomegaly with steatosis, including
fatal cases have been reported with the use of nucleoside analogues alone or in combination
with antiretrovirals. Exacerbations of hepatitis B after discontinuation of treatment: severe acute

C
exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis
B therapy, including Entecavir.

Side Effect
The most common side effects are headache, fatigue, dizziness & nausea.
Drug Interaction
Coadministration of Entecavir with drugs that reduce renal function or compete for active
tubular secretion may increase serum concentration of either Entecavir or the coadministered
drug. Coadministration of Entecavir with Lamivudine, Adefovir Dipivoxil, or Tenofovir Disoproxil
Fumatare did not result significant drug interactions.

Use in Pregnancy & Lactation


Pregnancy: USFDA pregnancy category C. There are no data on the Effect of Entecavir
on transmission of HBV from mother to infant. Therefore, appropriate care should be taken.
Lactation: It is not known whether entecavir is excreted in human milk. Mothers should be
instructed not to breast feed if they are taking Entecavir

Use in Children
Safety & Effectiveness of Entecavir in pediatric patients below the age of 16 years have not been
established.

Preparation
0.5 mg & 1 mg Tablet.
51
Product Guide

Ceevit Ceevit Forte


Active Ingredient Active Ingredient
Ascorbic acid & Sodium Ascorbate. Vitamin C (Ascorbic acid).

Indication Indication
Scurvy, pregnancy, lactation, infection, Treatment or prevention of Vitamin C
trauma, burns, cold exposure, following Deficiency, Scurvy, Infection, Trauma, Burns,
surgery, fever, stress, peptic ulcer, cancer, Cold exposure, Following Surgery, Fever, Stress,
methaemoglobinaemia haematuria, Cancer, Methaemoglobinaemia & Children
dental caries, pyorrhea, acne, infertility, receiving unfortified formulas. Also indicated
in Hematuria, Dental Caries, Gum Diseases,
atherosclerosis, fractures, leg ulcers, hay fever,
Pyorrhea, Acne, Infertility, Atherosclerosis,
vascular thrombosis prevention, levodopa Fractures, Leg ulcers, Hay fever, Vascular
toxicity, succinyl-choline toxicity, arsenic thrombosis prevention, Levodopa toxicity,
toxicity etc. Arsenic toxicity & etc.

Dosage & Administration Dosage & Administration


1-2 tablets daily. One tablet daily with a meal or as directed by

C
physician. Dissolve one tablet in half glass (100
Contraindication & Precaution ml) of water & drink instantly.
There is no serious contraindication to the
administration of Vitamin C. Contraindication & Precaution
There is no serious contraindication to the
Side Effect administration of Vitamin C. Diabetes, patients
Diarrhoea, hyperoxaluria may occur. prone to recurrent renal calculi & those on
sodium restricted diets or anticoagulant
Drug Interaction therapy should not take excessive doses of
Ascorbic acid increases the apparent half-life of ascorbic acid over an extended period of time.
paracetamol & enhances iron absorption from
the gastro intestinal tract. Side Effect
Generally ascorbic acid is well tolerated.
Use in Pregnancy & Lactation However, few side Effects including stomach
The drug is safe in normal doses in pregnant upset, diarrhea, mouth sores or frequent
women, but a daily intake of 5 gm or more is urination may be seen.
reported to have caused abortion. The drug
may be taken safely during lactation. Drug Interaction
Limited evidence suggests that ascorbic acid
Preparation may influence the intensity & duration of action
250 mg Tablet. of by hydroxycoumarin.

Use in Pregnancy & Lactation


During pregnancy & lactation usual dose is
safe.

Preparation
Vitamin C 1000 mg Effervescent Tablet.
52
Product Guide

Cef-3
Active Ingredient
Cefixime.

Indication
Urinary tract infections, upper & lower respiratory tract infections, acute otitis media, gonococcal
urethritis & enteric fever.

Dosage & Administration


200-400 mg as a single dose or in 2 divided doses daily for 7-14 days, Child dose : 8 mg/kg daily as
a single dose or in two divided doses for 7-14 days.

Contraindication & Precaution


Known hypersensitivity to Cephalosporin group of drugs.

Side Effect
Diarrhoea, nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache & dizziness.

C Use in Pregnancy & Lactation


Pregnancy Category B.
Caution should be exercised when Cefixime is administered to a nursing mother.

Preparation
200 mg Capsule, 200 mg Tablet, 400 mg Capsule, 400 mg Tablet 100 mg/5 ml Suspension (30 ml,
40 ml & 50 ml), 200 mg/5ml Suspension, 25 mg/ml Paediatric Drops.

Cefotil
Active Ingredient
Cefuroxime.

Indication
1. Upper respiratory tract infections, for example, ear, nose & throat infections such as otitis media,
sinusitis, tonsillitis & pharyngitis. 2. Lower respiratory tract infections: for example, acute bronchitis,
acute exacerbations of chronic bronchitis & pneumonia. 3. Skin & soft tissue infections: such as
furunculosis, pyoderma, & impetigo. 4. Genito-urinary tract infections: such as pyelonephritis,
urethritis, & cystitis. 5. Gonorrhoea: acute uncomplicated gonococcal urethritis, & cervicitis. 6. Early
Lyme disease & subsequent prevention of late Lyme disease.

Dosage & Administration


Adults : 250 mg b. i.d. upto 500 mg b. i. d. should be given. For urinary tract infections a dose of
125 mg b.i.d is usually adequate. A single dose of one gram is recommended for the treatment
53
Product Guide
of uncomplicated gonorrhoea. Children : The usual dose is 125 mg b. i. d., or 10 mg/kg b. i. d. to a
maximum of 250 mg daily. The usual course of therapy is 7-10 days. Cefuroxime should be taken
after food for optimum absorption. Parenteral Dosage : Adults : 750 mg to 1.5 g IM or IV every 8
hourly, usually 5 to 10 days. Infants & children (>3 months) : 50 to 100 mg/kg/day in equally divided
doses every 6 to 8 hours.

Contraindication & Precaution


Known allergy to Cephalosporins. As with other antibiotics, prolonged use of Cefuroxime may
result in the over growth of non-susceptible organisms (e.g. Candida, Enterococci, Clostridium
difficile), which may require interruption of treatment. Pseudomonas colits has been reported
with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in
patients who develop serious diarrhoea during or after antibiotic use.

Side Effect
Nausea & vomiting.

Use in Pregnancy & Lactation


While all antibiotics should be avoided in the first trimester if possible. Cefuroxime has been safely
used in later pregnancy to treat urinary & other infections. Caution should be exercised when

C
Cefuroxime is administered to a nursing mother.

Preparation
125 mg, 250 mg & 500 mg Tablet, 125 mg/5 ml Suspension, 750 mg IM/IV Injection, 1.5 gm IV
injection.

Cefotil Plus
Active Ingredient
Cefuroxime & Clavulanic Acid

Indication
Pharyngitis/Tonsillitis, Acute Bacterial Otitis Media, Acute Bacterial Maxillary Sinusitis, Acute
Bacterial Exacerbations of Chronic Bronchitis & Secondary Bacterial Infections of Acute Bronchitis,
Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-
lactamase negative strains), Uncomplicated Skin & Skin-Structure Infections, Uncomplicated
Urinary Tract Infections, Uncomplicated Gonorrhea, (urethral & endocervical), Early Lyme disease
(erythema migrans), Septicemia, Meningitis, Switch therapy (injectable to oral) after surgery when
patients condition is improved
54
Product Guide
Dosage & Administration

Infection Dosage Duration (days)


Pharyngitis/Tonsillitis 250 mg b.i.d. 5-10
Acute Bacterial Maxillary Sinusitis 250 mg b.i.d. 10
Acute Bacterial Exacerbations of Chronic 250 - 500 mg b.i.d. 10
Bronchitis
Secondary Bacterial Infections of Acute 250 - 500 mg b.i.d. 5-10
Bronchitis
Uncomplicated Skin & Skin-Structure 250 - 500 mg b.i.d. 10
Infections
Community Acquired Pneumonia 250 - 500 mg b.i.d. 5-10
MDR Typhoid Fever 500 mg b.i.d. 10-14
Uncomplicated Urinary Tract Infections 250 mg b.i.d. 7-10
Uncomplicated Gonorrhea 1,000 mg single dose -
Lyme Disease 500 mg b.i.d. 20

C
Pediatric Patients (03 months to 12 years, who can swallow tablet whole)
Infection Dosage Duration (days)
Acute Otitis Media 250 mg b.i.d. 10
Acute Bacterial Maxillary Sinusitis 250 mg b.i.d. 10

Contraindication & Precaution


Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to Cephalosporins
& in patients with Pseudomonas Colitis.

Side Effect
Generally Cefuroxime-Clavulanic Acid is well tolerated. Major adverse reactions which may occur
are diarrhea, nausea, vomiting, transient elevation in AST, ALT, LDH, & eosinophilia. Other adverse
events that may occur are abdominal pain, abdominal cramps, flatulence, indigestion, headache,
vaginitis, rash, itch, dysuria, sleepiness, thirst, anorexia etc.

Drug Interaction
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area
under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity
may result in a lower bioavailability of Cefuroxime & tend to cancel the effect of postprandial
absorption.
55
Product Guide
Use in Pregnancy & Lactation during the first 6 weeks of life. Its safety in
All antibiotics should be avoided in the first human pregnancy has not been established.
trimester if possible. However, Cefuroxime- Therefore it should not be used in pregnancy
Clavulanic Acid can be safely used in later unless absolutely indicated. Mothers receiving
pregnancy to treat urinary tract & other Ceftriaxone should not breast-feed. In severe
infections. Cefuroxime-Clavulanic Acid is renal impairment accompanied by hepatic
excreted into the breast milk in small quantities insufficiency, dosage reduction is required.
& consequently caution should be exercised
when it is administered to a nursing mother. Side Effect
Ceftriaxone is generally well tolerated. A
Preparation few side-Effects such as diarrhea, nausea &
Cefotil Plus 250 Tablet: Each box contains 10 vomiting, stomatitis & glossitis, rash, pruritus,
tablets in blister pack. urticaria, edema & erythema multiforme,
Cefotil Plus 500 Tablet: Each box contains 6 eosinophilia, thrombocytopenia, leukopenia,
tablets in blister pack. & neutropenia, elevations of SGOT or SGPT,
bilirubinemia, headache, hyperactivity,
nervousness, sleep disturbances, confusion,
hypertonia & dizziness.

C
Drug Interaction

Ceftron A possible disulfiram-like reaction may occur


with alcohol.

Active Ingredient Preparation


Ceftriaxone. 250 mg IV, 250 mg IM, 500 mg IV, 500 mg IM, 1
gm IV, 1 gm IM & 2 gm IV Injection.
Indication
Renal & urinary tract infections, Lower
respiratory tract infections, particularly
pneumonia, Gonococcal infections, Skin &
soft tissue, bone & joint infections, Bacterial Cerevas
meningitis, Serious bacterial infections e.g.
septicemia, ENT infections, Infections in cancer Active Ingredient
patients, Prevention of postoperative infection, Vinpocetine.
Perioperative prophylaxis of infections
associated with surgery, Typhoid fever. Indication
Acute Cerebro-Vascular Accidents (Strokes):
Dosage & Administration Ischemic strokes due to cerebral thrombosis,
Adults & children (12 years & over): 1 gm once cerebral embolism, acute circulatory disorder,
daily. In severe infections : 2-4 gm daily, normally hypertensive crisis; the acute cardiovascular
as a single dose every 24 hours. Children (under disorders, reversible ischemic neurological
12 years) : 20-50 mg/kg/day. In severe infection: deficit (RIND), complete stroke (CS), multi-
up to 80 mg/kg/day may be given. infarct dementia, cerebral arteriosclerosis,
hypertensive encephalopathy, post-
Contraindication & Precaution apoplectic conditions with the background of
Hypersensitivity to Cephalosporin antibiotics. hemorrhagic strokes etc. Geriatrics: For relief
It is contraindicated in premature infants of psychosomatic symptoms in the elderly
due to cerebral insufficiency e.g. forgetfulness,
56
Product Guide
memory disturbances, slow thinking, lack of symptoms of intermittent claudication, as
concentration, dizziness, mood instability, indicated by an increased walking distance.
aphasia, sleep disturbances, vasovegetative
symptoms of menopausal syndrome etc. Dosage & Administration
Ophthalmology: Vascular disorder of the The recommended dosage of Cilosta is 100
choroid & retina due to arteriosclerosis. mg bid, taken at least half an hour before or
Vasospasm, macula degenerations, arterial or two hours after breakfast & dinner. A dose
venous thrombosis or embolism or glaucoma of 50 mg bid should be considered during
secondary to above mentioned disorders. coadministration of Ketoconazole, Itraconazole,
Otology: For the treatment of impaired hearing Erythromycin, & Diltiazem.
of vascular toxic (iatrogenic) origin presbyacusis.
Menieres disease, cochleovestibular neuritis, Contraindication & Precaution
tinnitus & dizziness of labyrinth origin. Cilostazol is contraindicated in patients
with congestive heart failure of any severity.
Dosage & Administration Cilostazol is also contraindicated in patients
1-2 tablets thrice daily, the maintenance dose is with known or suspected hypersensitivity to
one tablet thrice daily. any of its components. There is no information
with respect to the efficacy or safety of the
Contraindication & Precaution concurrent use of Cilostazol & Clopidogrel.

C
Contraindicated to pregnant & breastfeeding
women. Caution should be exercised in Drug Interaction
patients with history of high blood pressure & Omeprazole & Erythromycin significantly
heart disease. increased the systemic exposure of Cilostazol
and/or its major metabolites. Population
Drug Interaction pharmacokinetic studies showed higher
Individuals using blood-thinning medications, concentrations of Cilostazol among patients
including aspirin, should not use Vinpocetine. concurrently treated with Diltiazem.

Side Effect Side Effect


Transient hypotension, tachycardia may occur. The most common side Effects are headache,
diarrhoea, vomiting, leg cramps, rash etc.
Use in Children The less frequent side Effects are anorexia &
No proven safety. oedema.

Preparation Use in Pregnancy & Lactation


5 mg tablet. Pregnancy: There are no adequate & well
controlled studies in pregnant women.
Lactation: Transfer of Cilostazol into milk
has been reported in experimental animals.
Because of the potential risk to nursing infants,
Cilosta a decision should be made to discontinue
nursing or to discontinue Cilostazol.
Active Ingredient
Cilostazol. Preparation
100 mg Tablet.
Indication
Cilosta is indicated for the reduction of
57
Product Guide

Cinaron Dosage & Administration


1 tab thrice daily.

Active Ingredient Contraindication & Precaution


Cinnarizine. Not known.

Indication Side Effect


Cerebral circulatory disorders: a. Prophylaxis Somnolence & GI disturbance.
& maintenance therapy for symptoms of
cerebral vascular spasms & arteriosclerosis. Drug Interaction
b. Sequelae of cerebral & cranial trauma. Not known.
c. Postapoplectic disorders d. Migraine 2.
Peripheral circulatory disorders: Prophylaxis Use in Pregnancy & Lactation
& maintenance therapy for symptoms of Risk benefit ratio is considered.
vascular spasms & arteriosclerosis (obliterating
arteritis, thromboangiitis, Raynauds disease, Use in Children
diabetes, acrocyanosis pernio, etc.) such as Not established.
intermittent claudication, trophic disturbances,
pregangrene, trophic & varicose ulcers, Preparation
paresthesia, nocturnal cramps, cold extremities.

C
Tablet.
3. Disorders of balance.

Dosage & Administration


Cinaron 15 to 30 mg three times daily.

Side Effect
Ciprocin
Somnolence & gastrointestinal disturbances. Active Ingredient
Ciprofloxacin.
Use in Pregnancy & Lactation
The safety of Cinnarizine in human pregnancy Indication
has not been established although studies in Urinary tract infections, lower respiratory
animals have not demonstrated teratogenic tract infections, skin & soft tissue infections,
bone & joint infections, G.I. tract infections,
Effects. Therefore, it is not advisable to uncomplicated gonorrhoea, Ciprocin 750
administer Cinnarizine in pregnancy. tablet is specially indicated for the treatment
of pseudomonal infections of lower respiratory
Preparation tract; severe infections particularly due to
15 mg Tablet. pseudomonas, staphylococcus & streptococci.
Ciprocin750 is also indicated in surgical
prophylaxis.

Cinaron Plus
Dosage & Administration
Urinary Tract Infection : Acute
Uncomplicated-100 mg or 250 mg b.i.d. 3 Days,
Mild/Moderate & Severe/Complicated-500 mg
Active Ingredient b.i.d. 7 to 14 Days. Severe/Complicated 750 mg
Cinnarizine + Dimenhydrinate. twice daily 7 to 14 Days. Lower Respiratory Tract
Infection : Mild/Moderate 500 mg b.i.d., Severe/
Indication Complicated 750 mg b.i.d 7 to 14 Days. Acute
Vertigo & Peripheral arterial disorders. Sinusitis : Mild/Moderate 500 mg b.i.d. Infectious
Diarrhea : Mild/Moderate/Severe 500 mg b.i.d.
58
Product Guide
Typhoid Fever : Mild/Moderate 500 mg b.i.d. Pediatric Dosage: 10 mg/kg to 20 mg/kg b.i.d. (maximum
750 mg per dose) for 10 to 21 days.

Precaution & Warning


It should be used with caution in patients with suspected or known CNS disorders such as arteriosclerosis
or epilepsy or other factors which predispose to seizures & convulsion. Do not split, crush, or chew the
tablet.

Side Effect
Nausea & other gastrointestinal disturbances, headache, dizziness, skin rashes, Crystalluria.

Use in Pregnancy & Lactation


The safety & Effectiveness of ciprofloxacin in pregnant & lactating women have not been established.

Use in Children
From 1 years & above.

Contraindication
Patients with a history of hypersensitivity to Ciprofloxacin or to other quinolones.

Preparation

C
Ciprocin 250 mg, 500 mg, 750 mg Tablet & 250 mg Powder for Suspension.

Ciprocin Eye/Ear Drops


Active Ingredient
Ciprofloxacin.

Indication
Eye: Corneal ulcer, bacterial Conjunctivitis.
Ear: Otitis externa, acute otitis media, chronic suppurative otitis media.

Dosage & Administration


Eye: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected
eye every 15 minutes for the first 6 hours & then two drops into the affected eye every 30 minutes for
the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third
to fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued
after 14 days if corneal re-epithelization has not been occurred. Ear: For all infections, 2 - 3 drops every
2 - 3 hours initially.
Contraindication & Precaution
Hypersensitivity, overgrowth of non-susceptible organisms.
Side Effect
Local burning or discomfort, crusting, crystals/scales, foreign body sensation, itching, conjunctival
hyperemia & a bad taste.
Drug Interaction
Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin.
59
Product Guide
Use in Pregnancy & Lactation
Ciprofloxacin ophthalmic solution should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Preparation
0.3% Eye/Ear Drops.

Ciprocin 200 IV
Active Ingredient
Ciprofloxacin.

Indication
Ciprocin IV is indicated for the treatment of following infections caused by sensitive bacteria-

Urinary Tract Infection


Lower Respiratory Tract Infection
Nosocomial Pneumonia
Skin & Skin Structure Infection
Bone & Joint Infection
Complicated Intra-Abdominal Infection
Acute Sinusitis CD
Chronic Bacterial Prostatitis
Infectious diarrhea
Inhalational Anthrax
Dosage & Administration
Indication Severity Dose Frequency Days
Urinary Tract Mild to Moderate 200 mg q12h 7-14 days
Severe or Complicated 400 mg q12h 7-14 days
Lower Respiratory Infection Mild to Moderate 400 mg q12h 7-14 days
Severe or Complicated 400 mg q8h 7-14 days
Nosocomial Pneumonia Mild or Moderate or Severe 400 mg q8h 7-10 days
Skin & Skin Structure Mild to Moderate 400 mg q12h 7-14 day
Infection Severe or Complicated 400 mg q8h 7-14 day
Bone & Joint Mild to Moderate 400 mg q12h 4-6 weeks
Infection Severe or Complicated 400 mg q8h 4-6 weeks
Intra-Abdominal Infection Complicated 400 mg q12h 7-14 day
Acute Sinusitis Mild to Moderate 400 mg q12h 10 days

Chronic Bacterial Prostatitis Mild to Moderate 400 mg q12h 18 days


60
Product Guide
Contraindication & Precaution the treatment of the following infections
Ciprofloxacin is contraindicated in persons with when caused by susceptible anaerobic
a history of hypersensitivity to ciprofloxacin, any bacteria or susceptible strains of gram positive
member of the quinolone class of antimicrobial bacteria such as streptococci, staphylococci
agents. Concomitant administration with & pneumococci: Upper respiratory tract
tizanidine is contraindicated. infections, Lower respiratory tract infections,
Side Effect: Nausea, diarrhea, central nervous Skin & soft tissue infections, Bone & joint
system disturbance, local I.V. site reactions, liver infections, Pelvic infections, Intra-abdominal
function tests abnormal, eosinphilia, headache, infections, Septicemia & endocarditis, Dental
restlessness, & rash. infections. As an alternative therapy when used
in combination with quinine or amodiaquine
Drug Interaction for the treatment of multi-drug resistant
Concurrent administration of ciprofloxacin Plasmodium falciporum infection
with theophylline may lead to elevated serum
concentrations of theophylline & prolongation Dosage & Administration
of its elimination half-life. This may result in Adults: Serious Infections: 150 mg - 300 mg
increased risk of theophylline-related adverse every six hours. More severe infections: 300 mg
reactions. Probenecid interferes with renal - 450 mg every six hours.
tubular secretion of ciprofloxacin & produces Pediatric Patients: Serious Infections:
an increase in the level of ciprofloxacin in the 8 - 16 mg/kg/day divided into three or four

C serum.
Use in Pregnancy & Lactation: The safety &
equal doses.
More severe infections: 16 - 20 mg/kg/day
Effectiveness of Ciprofloxacin in pregnant & divided into three or four equal doses.
lactating women have not been established.
Ciprofloxacin is excreted in human milk. Contraindication & Precaution
Clindamycin is contraindicated in patients
Use in Children previously found to be sensitive to Clindamycin
Ciprofloxacin is usually not recommended or lincomycin or any of the ingredients of this
for use in children. However, if the benefited medicine.
of ciprofloxacin therapy are considered to
overweight the potential risk, the dosage Side Effect
should be 5-10 mg/kg/day in two divided doses, The adverse effects have been reported with
depending on the severity of the infections. the use of Clindamycin are abdominal pain,
oesophagitis & oesophagial ulcer, nausea,
Preparation vomiting & diarrhoea, pruritus, skin rashes,
Ciprocin 200 IV: Each box contains 1 bag of 100 urticaria.
ml solution for intravenous infusion.
Use in Pregnancy & Lactation
Pregnancy: Pregnancy Category B: Clindamycin
should be used in pregnancy only if clearly
Climycin TM
needed.
Lactation : Clindamycin has been reported
Active Ingredient to appear in breast milk. Therefore, it is not
Clindamycin. recommended for nursing mothers if not
clearly needed.
Indication
Climycin has been shown to be Effective in
61
Product Guide
Use in Children Tretinoin is excreted in human milk. Exercise
When Clindamycin is administered to newborns special caution while applying Clindamycin or
& infants (birth to 16 years) appropriate Tretinoin to a nursing mother.
monitoring of organ system functions is
desirable. Preparation
15 gm Gel.
Preparation
150 mg & 300 mg Capsule.

Clobam
Clinface Gel Active Ingredient
Clobazam.
Active Ingredient
Indication
Clindamycin Phosphate & Tretinoin.
Clobam relieves anxiety, tension, irritability,
restlessness, epilepsy & response in the
Indication
treatment of fear, depressive mood, sleep
Clinface Gel is indicated for the topical
disturbances.
treatment of Acne vulgaris.

C
Dosage & Administration
Dosage & Administration
Adults: 20-30 mg daily in divided dosage or as
Before sleep
a single dosage at bed time, Children: Over 3
Wash the face gently with a mild soap & years up to 1/2 of the adult dose.
water, then pat the skin dry.
Apply the Gel with finger tips through the Contraindication & Precaution
face gently.
Hypersensitivity to benzodiazepines,
In the morning
respiratory depression, acute pulmonary
Apply a sunscreen after the application of Gel. insufficiency & in irreversible bronchial
Do not wash your face more than 2 or 3 times obstruction, hepatic or renal disease.
a day. Apply the sunscreen cream as needed.
Side Effect
Contraindication & Precaution
Drowsiness, ataxia, fatigue, confusion,
Clinface Gel should not be administered
vertigo & these may diminish with continued
to individuals who are hypersensitive to
therapy. Occasionally dry mouth, headache,
Clindamycin or Tretinoin or any other
hypersensitivity reactions & respiratory
component of the Gel. Clinface Gel should not
depression may occur.
be applied to eyes, nose, ear, lips, cut, burn &
other infections. After the application of the
Drug Interaction
Gel, keep away from sunlight.
The administration of alcohol results in
significantly higher serum concentrations of
Side Effect
clobazam. The concurrent administration of
Erythema, scaling, nasopharyngitis, dry skin,
hypnotic or antidepressants with sedative
cough, sinusitis & diarrhea are the common
activity may cause an increase in side Effects,
side effects.
particularly tiredness or drowsiness.
Use in Pregnancy & Lactation Preparation
It is not known whether Clindamycin or 10 mg Tablet.
62
Product Guide

Clofenac anorexia. Rare: gastro-intestinal bleeding,


peptic ulcer (with or without bleeding or
perforation), bloody diarrhoea. In isolated
Active Ingredient cases: lower gut disorders (e.g., non-specific
Diclofenac. haemorrhagic colitis & exacerbations of
ulcerative colitis or Crohns proctocolitis),
Indication pancreatitis, glossitis, constipation, etc.
Arthritic conditions: Rheumatoid Arthritis,
Osteoarthritis, Ankylosing spondylitis, acute Drug Interaction
Lithium & digoxin, anticoagulants, antidiabetic
gout, acute musculoskeletal disorders such as
agents, cyclosporin, methotrexate, quinolone
periarthritis (e.g., frozen shoulder), tendinitis,
antimicrobials, diuretics.
tenosynovitis, bursitis, other painful conditions
resulting from trauma, including fracture, low back Use in Pregnancy & Lactation
pain, sprains, strains, dislocations, orthopaedic, Diclofenac tablets & injection should not
dental & other minor surgery. be prescribed during pregnancy, very small
quantities may be detected in breast milk but
Dosage & Administration no undesirable effects on the infant are to be
50 mg : Adults: 75 - 150 mg daily in 2 to 3 divided expected.
doses, preferably after food. The recommended
maximum daily dose of diclofenac is 150 mg. Preparation

C
Children: In juvenile chronic arthritis, 1-3 mg of 25 mg & 50 mg tablet, 50 mg DT (Dispersible
diclofenac/kg body wt. daily in divided doses. Tablet),100 mg SR tablet, 100 mg TR capsule,
1% Emulgel & Gel, 12.5 mg, 25 mg, 50 mg &
Elderly patients: In elderly or debilitated patients,
100 mg Suppository, 3 ml Inj. & Plus Inj.
the lowest effective dosage is recommended.
Emulgel & Gel: Should be rubbed gently into
the skin. Depending on the size of the affected
site to be treated 2-4 gm gel should be applied
3 - 4 times daily & rubbed in lightly. Suppository:
Should be administered rectally. Adults: 50 mg
or 100 mg suppository only: 75-150 mg daily,
in divided doses. Children (1-12 years): 12.5 mg
ClopiroxTM 1% Cream
or 25 mg suppository only: 1-3 mg/kg daily, in Active ingredient
divided doses. Ciclopirox Olamine

Contraindication & Precaution Indication


Diclofenac is contraindicated for those Dermal infections: Tinea pedis, Tinea cruris
patients who are hypersensitive to diclofenac. & Tinea corporis due to Trichophyton
In patients with active or suspected peptic rubrum, Trichophyton mentagrophytes,
ulcer or gastrointestinal bleeding, or for those Epidermophyton floccosum & Microsporum
patients in whom attacks of asthma, urticaria canis, candidiasis (moniliasis) due to Candida
or acute rhinitis are precipitated by aspirin albicans, & Tinea (pityriasis) versicolor due
or other NSAIDs possessing prostaglandin to Malassezia furfur. It is also highly effective
synthetase inhibiting activity, diclofenac is also against some gram negative & some
contraindicated.
gram positive bacteria. Owing to its anti-
inflammatory effects, Ciclopirox Olamine
Side Effect
Epigastric pain, nausea, vomiting, diarrhoea, alone is sufficient to treat mild to moderate
abdominal cramps, dyspepsia, flatulence, inflammatory fungal infections.
63
Product Guide
Dosage & Administration
Should be gently massaged onto the affected & surrounding skin areas twice daily for four
weeks. Clinical improvement with relief of pruritus & other symptoms usually occurs within the
first week of treatment. If a patient shows no clinical improvement after four weeks of treatment,
the diagnosis should be redetermined. Patients with Tinea versicolor usually exhibit clinical &
mycological clearing after two weeks of treatment.

Contraindication & Precaution


Ciclopirox Olamine cream is contraindicated in individuals who have shown hypersensitivity to
any of its components.

Side Effect
Ciclopirox Olamine cream is well tolerated with a low incidence of adverse reactions reported in
clinical trials.

Use in Pregnancy & Lactation


Pregnancy category B. It is not known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, caution should be exercised when Ciclopirox Olamine cream or
is administered to nursing women.

Use in Children
Safety & effectiveness in children below the age of 10 years have not been established. C
Preparation
10 gm Cream

Clotinex TM

Active Ingredient
Enoxaparin.

Indication
Treatment of deep vein thrombosis
Unstable angina, myocardial infarction
Prophylaxis of venous thromboembolic disease
Dosage & Administration:
Indications Recommended Dosage Schedule
Treatment of deep Subcutaneously 100 anti-Xa IU/kg twice daily for 10 days or
vein thrombosis, with Subcutaneously 150 anti-Xa IU/kg once daily for 10 days
or without pulmonary
embolism Oral anticoagulant therapy should be initiated when appropriate
& enoxaparin sodium treatment should be continued until a
therapeutic anticoagulant effect has been achieved.
64
Product Guide
Treatment of unstable Subcutaneously 100 anti-Xa IU/kg twice daily for 2 - 8 days
angina & non-Q- Should be administered concurrently with oral aspirin (100 to
wave myocardial 325 mg once daily). Treatment with enoxaparin sodium in these
infarction, administered patients should be prescribed for a minimum of 2 days & continued
concurrently with aspirin until clinical stabilization.
Prevention of thrombus Recommended dose is 100 anti-Xa IU/kg.
formation in extra For patients with a high risk of hemorrhage, the dose should be
corporeal circulation reduced to 50 anti-Xa IU/kg for double vascular access or 75 anti-Xa
during hemodialysis IU/kg for single vascular access.
During hemodialysis, enoxaparin sodium should be introduced
into the arterial line of the circuit at the beginning of the dialysis
session.
Prophylaxis of venous Patients undergoing general surgery with a moderate risk of
thromboembolic disease thromboembolism (e.g. abdominal surgery):
in surgical patients Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml)
once daily for 7 to 10 days. The first injection should be given 2
hours before the surgical procedure.

C Patients undergoing orthopedic surgery with a high risk of


thromboembolism:
Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10
days. The first injection should be given 2 hours before the surgical
procedure.
Longer treatment duration may be appropriate in some patients
like continued therapy with 4000 anti-Xa IU once daily for 3 weeks
following the initial therapy has been proven to be beneficial in
orthopaedic surgery.
Prophylaxis of venous Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6 - 14 days
thromboembolic disease
in medical patients
65
Product Guide
Dose in Elderly patients:
No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment:

No dosage adjustment is recommended in patients with moderate & mild renal impairment.
For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage
adjustments are recommended: Prophylactic dose ranges: 2000 anti-Xa IU once daily; Therapeutic
dose ranges: 100 anti-Xa IU/kg once daily.
Dose in Hepatic Impairment:
Caution should be used in hepatically impaired patients.

Contraindication & Precaution


Contraindication: Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other
low molecular weight heparins. Patients with active major bleeding & conditions with a high
risk of uncontrolled hemorrhage including recent hemorrhagic stroke. Precaution: Enoxaparin
Sodium should be injected by deep subcutaneous route in prophylactic & curative treatment & by
intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin
Sodium should be used with caution in conditions with increased potential for bleeding. It is
recommended that the platelet counts be measured before the initiation of the treatment &
regularly thereafter during treatment. C
Side Effect
Hemorrhage (bleeding), thrombocytopenia, elevations of serum amino transferase, pain, bluish
marks at injection site, skin rash at injection site, cases of neuraxial hematomas with concurrent
use of enoxaparin & spinal/epidural anesthesia or spinal puncture have resulted in varying degrees
of neurological injuries.

Drug Interaction
Agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy
unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and
derivatives), NSAIDs (including ketorolac), ticlopidine, clopidogrel, dextran 40, glucocorticoids,
thrombolytics & anticoagulants, other anti platelet aggregation agents including glycoprotein
IIb/IIIa antagonists.

Use in Pregnancy & Lactation


Pregnancy category B. It should be used during pregnancy & lactation only if clearly needed.

Use in Children
Safety & Effectiveness have not been established.

Preparation
40 mg (4000 anti-Xa IU/0.4 ml) pre-filled syringe injection, 60 mg (6000 anti-Xa IU/0.6 ml) pre-filled
syringe injection & 80 mg (8000 anti-Xa IU/0.8 ml) pre-filled syringe injection
66
Product Guide

Colicon TM
Colimax TM

Active Ingredient Active Ingredient


Dicycloverine HCl. Colchicine USP 0.6 mg

Indication Indication
Irritable bowel syndrome, Infantile colic, Colchicine is approved by US FDA for the
GIT spasm, Diverticulitis, Abdominal colic, prevention & treatment of acute gout attack.
Diarrhoea, Dysentery.
Dosage & Administration
Dosage & Administration Prophylaxis of gout flare:
Adults : 10 to 20 mg three to four times a day. 0.6 mg (1 tablet) once or twice daily in adults
Maximum recommended oral dose is 160 mg & adolescents older than 16 years of age.
daily in divided dose. Children : Children over Maximum dose 1.2 mg/day (2 tablets).
6 months of age- 5 to 10 mg three times a day.
Treatment of acute gout attack:
Contraindication & Precaution 1.2 mg (2 tablets) at first sign of a gout flare
Obstructive uropathy, Obstruction disorder followed by 0.6 mg (1 Tablet) one hour later.
in GIT, Severe ulcerative colitis, Unstable The maximum recommended dose for

C
cardiovascular status in acute hemorrhage, treatment of acute gout attack is 1.8 mg over
Glucoma, Myasthenia gravis, Patients with a 1 hour period.
hypersensitivity to dicycloverine hydrochloride. The maintenance dose will be as same as the
prophylactic dose, which should be resumed
Side Effect after 12 hours of the acute treatment course.
Insomnia, headache, weakness, confusion, Contraindication: Patients with renal or hepatic
increased ocular tension, urinary hesitancy, impairment should not be given Colchicine in
palpitations etc. Conjunction with permeable glycoprotein or
strong CYP3A4 inhibitors (ex.: Clarithromycin
Use in Pregnancy & Lactation or Cyclosporine)
Pregnancy Category B. Dicycloverine should be
used during pregnancy only if clearly needed.
Dicycloverine should not be used in case of Side Effect
lactating mother. Myelosuppression, leucopenia,
granulocytopenia, thrombocytopenia &
Drug Interaction aplastic anemia have been reported. Diarrhea
Antiarrhythmic agents, antihistamines, & pharyngolaryngeal pain may occur.
antipsychotic agents, benzodiazepines, MAO
inhibitors, narcotic analgesics, nitrates & Drug Interaction
nitrites, sympathomimetic agents, tricyclic Co-administration of permeable glycoprotein
antidepressants & other drugs having (P-gp) and/or CYP3A4 inhibitors (e.g.,
anticholinergic activity. clarithromycin orcyclosporine) have been
demonstrated to alter the concentration of
Preparation Colchicine.
10 mg Tablet & 10 mg/5 ml Syrup (50 ml).
Use in Pregnancy & Lactation
Pregnancy Category C. There are no adequate
67
Product Guide
& well-controlled studies in pregnant women. Contraindication & Precaution
Colchicine is excreted into human milk. Caution Renal disease or renal dysfunction (e.g., as
should be exercised when administered to a suggested by serum creatinine levels > 1.5 mg/
nursing woman. dL [males], > 1.4 mg/dL [females] or abnormal
creatinine clearance), Congestive heart failure
Use in children requiring pharmacologic treatment, Known
Gout is rare in pediatric patients. Safety & hypersensitivity to metformin hydrochloride,
effectiveness of Colchicine in pediatric patients Acute or chronic metabolic acidosis, including
have not been established. Patient less than 16 diabetic ketoacidosis, with or without coma.
years of age is not recommended Pregnant mothers: Pregnancy Category B.
Metformin should not be used during pregnancy
Preparation unless clearly needed. Nursing mothers :
0.6 mg Tablet. Because the potential for hypoglycemia in
nursing infants may exist, a decision should
be made whether to discontinue nursing or to
discontinue the drug, taking into account the
importance of the drug to the mother.
Comet Side Effect
Active Ingredient Diarrhea, nausea, vomiting, flatulence,

C
Metformin HCI. asthenia, indigestion, abdominal discomfort,
headache etc.
Indication
Management of type 2 diabetes mellitus. Drug Interaction
Furosemide, Nifedipine, Cationic drugs (e.g.,
Dosage & Administration amiloride, digoxin, morphine, procainamide,
Adults : Starting dose of Comet (Metformin quinidine, quinine, ranitidine, triamterene,
Hydrochloride tablet) is 500 mg twice a day or trimethoprim, or vancomycin).
850 mg once a day, given with meals. Dosage
increases should be made in increments of Preparation
500 mg weekly or 850 mg every 2 weeks, up 500 mg,750 mg & 850 mg Tablet, 1 gm Tablet,
to a total of 2000 mg per day, given in divided XR 500 mg & XR 1 gm tablet.
doses. Starting dose of Comet XR (Metformin
Hydrochloride extended release tablet) is 500
mg once daily with the evening meal. Dosage
increases should be made in increments of
500 mg weekly, up to a maximum of 2000 mg
once daily with the evening meal. If glycemic
control is not achieved on Comet XR 2000 mg
Comprid
once daily, a trial of Comet XR 1000 mg twice
Active Ingredient
daily should be considered. Pediatrics : Starting
Gliclazide
dose of Comet is 500 mg twice a day, given with
meals. Dosage increases should be made in
Indication
increments of 500 mg weekly up to a maximum
Indicated for the treatment of type 2 diabetes
of 2000 mg per day, given in divided doses.
in association with dietary measures when
dietary measures alone are inadequate to
68
Product Guide
control blood glucose. with renal insufficiency have been treated
satisfactorily using Gliclazide at reduced doses.
Dosage & Administration
The usual initial dose of Comprid is 40 to 80 Side Effect
mg daily, gradually increased, if necessary Hypoglycemia may occur in concurrent
up to 320 mg daily until adequate control is conditions such as hepatic & renal diseases,
achieved. A single dose should not exceed alcohol intoxication & adrenal & pituitary
160 mg. When higher doses are required it insufficiency. Mild gastro-intestinal
should be taken twice daily, according to the disturbances including nausea, dyspepsia,
main meals of the day. For extended release diarrhea, & constipation have been reported
tablet the initial recommended dose is 30 but these types of adverse reactions can be
mg daily, even in elderly patients (>65 years); avoided if Gliclazide is taken during a meal.
the daily dose may vary from 30 to 120 mg Allergic dermatological reactions including
taken orally, once daily. Comprid XR should rash, pruritus, erythema, bullous eruption have
be taken with food because there is increased been reported during treatment with the drug
risk of hypoglycemia if a meal is taken late. but are not known to be directly attributable
It is recommended that the medication be to it.
taken at breakfast time. If a dose is forgotten,
the dose taken on the next day should not Drug Interaction
be increased. Dose titration should be carried The hypoglycemic effect of Gliclazide may be

C out in steps of 30 mg, according to the fasting


blood glucose response. Each step should
potentiated by NSAID (in particular aspirin),
phenylbutazone, sulfonamides, coumarin
last for at least two weeks. Comprid XR is an derivatives, MAOIs, beta-adrenergic blockers,
extended release tablet & therefore, should be tetracyclines, chloramphenicol, clofibrate,
neither broken nor chewed. Comprid XR 30, cimetidine & miconazole tablets.Ingestion of
can replace Gliclazide 80 mg tablets, tablet alcohol may also increase the hypoglycemic
for tablet, for doses of 1 to 4 tablets per day. effect of Gliclazide. Some drugs may on the
Elderly: Plasma clearance of Gliclazide is not contrary, reduce its activity e.g. barbiturates,
altered in the elderly & steady state plasma corticosteroides, thiazide diuretics, thyroid
levels are similar to those in adults under 65 hormones, laxatives & oral contraceptives.
years. Clinical experience in the elderly shows
that it is effective & well tolerated. Use in pregnancy & Lactation
Pregnancy: Gliclazide should not be used in
Contraindication & Precaution pregnancy. Nursing mothers: No study has
Gliclazide should not be used in juvenile onset reported its presence in human breast milk.
diabetes, diabetes complicated by ketosis However, other sulfonylureas have been found
& acidosis, diabetes undergoing surgery, in milk & there is no evidence to suggest that
after severe trauma or during infections, gliclazide differs from the group in this respect.
patients known to have hypersensitivity to
other sulfonylureas & related drugs, diabetic Use in children
pre-coma & coma, severe renal or hepatic Should not be used below 18 years.
insufficiency, combination with miconazole
tablets. Preparation
Care should be exercised with patients having Comprid tablet: Each box containing 60
hepatic & or renal impairment & a small starting tablets in blister pack.
dose should be used with careful patient Comprid XR 30 tablet: Each box containing 30
monitoring. In long term clinical trials, patients tablets in blister pack.
69
Product Guide
Comprid XR 60 tablet: Each box containing 30 dietary supplement to prevent Osteoarthritis.
tablets in blister pack.
Dosage & Administration
1 - 2 tablets, three times daily. Doses can
tapered after 60 days as per requirement.
Contifil
TM

Contraindication & Precaution


Proven hypersensitivity to these ingredients is
Active Ingredient
a contraindication.
Theophylline.
Indication Side Effect
Asthma, chronic bronchitis, emphysema. No demonstrable side effects. Mild & reversible
intestinal flatulence occurs rarely.
Dosage & Administration
One tablet 12 hourly, at least 1 hour before or Preparation
2 hour after meal. (Glucosamine Sulfate 250 mg + Chondroitin
Contraindication & Precaution Sulfate 200 mg)/Tablet.
Hypersensitivity to theophylline, peptic ulcer
disease, seizure disorders.
Side Effect
Irritation, nausea, vomiting, abdominal
discomfort, palpitations, a fall in blood pressure, Cotrim D
headache, diarrhoea & insomnia.
Active Ingredient
Drug Interaction Sulphamethoxazole & Trimethoprim.
Theophylline can potentiate hypokalemia
resulting from 2-agonist therapy, steroids, Indication
diuretics & hypoxia. Particular caution is Respiratory tract infections, genito-urinary
advised in severe asthma. tract infections, skin infections, acute & chronic
Use in Pregnancy & Lactation osteomyelitis, acute brucellosis, septicaemia,
Theophylline should not be recommended nocardiosis & other infections caused by
during pregnancy & lactation. susceptible organisms.

Preparation Dosage & Administration


300 mg SR & 400 mg SR Tablet. Tablet : 2 tablet twice daily. In severe cases,
3 times/day. DS Tablet : 1 tablet twice daily.
Suspension : 1-2 teaspoonful twice daily.

Contilex Contraindication & Precaution


Hepatic & renal insufficiency, blood dyscrasias,
Active Ingredient sulphonamides sensitivity, megaloblastic
Glucosamine + Chondroitin. anaemia, pregnancy & during nursing.

Indication Side Effect


Treatment of osteoarthritis of fingers, shoulder Exfoliative dermatitis, Stevens-Johnson
joints & weight bearing joints of the body. As a syndrome & toxic epidermal necrolysis (Lyells
70
Product Guide
syndrome) are rare. Nausea & vomiting, Dosage & Administration
diarrhoea, glossitis, stomatitis, anemia, Administration: Defiron is exclusively to be
granulocytopenia, purpura & agranulocytosis. administered intravenously by drip infusion, by
slow injection or directly into the venous limb
Preparation of the dialyser & is not suitable for intramuscular
(400 mg + 80 mg)/Tablet, (800 mg +160 mg)/ use & for total dose infusion (TDI), where the
DS Tablet, (200 mg + 40 mg)/5 ml Suspension. full dose of Iron required, representing the
patients total Iron deficit is administered in
one complete infusion. Before administration
of the first therapeutic dose, a test dose should
be given. If any allergic reactions or intolerance
occurs during administration, the therapy must

Defiron be stopped immediately.

Normal Dosage
Active Ingredient Adults & Elderly: 5-10 ml Defiron (100-200 mg
Iron Sucrose Injection. Iron) once to three times a week depending on
the hemoglobin level.
Indication Children: There is limited data on children
Defiron is indicated for the treatment of Iron under study conditions. If there is a clinical

D deficiency in the following indications:



need, it is recommended not to exceed 0.15 ml
Defiron (3 mg Iron) per kg body weight once
Where there is a clinical need for a rapid Iron to three times per week depending on the
supply haemoglobin level.

In patients who cannot tolerate oral Iron Contraindication & Precaution


therapy or who are non-compliant The use of Iron Sucrose is contraindicated in
In active inflammatory bowel disease where patients with evidence of Iron overload, in
oral Iron preparations are ineffective patients with known hypersensitivity to Iron
Sucrose or any of its inactive components &
Non-dialysis dependent-chronic kidney in patients with anaemia not caused by Iron
disease (NDD-CKD) patients receiving an deficiency. It is also contraindicated in patients
erythropoietin with history of allergic disorders including
Non-dialysis dependent-chronic kidney asthma, eczema & anaphylaxis, liver disease &
disease (NDD-CKD) patients not receiving infections.
erythropoietin
Side Effect
Hemodialysis dependent-chronic kidney Hypotension, cramps/leg cramps, nausea,
disease (HDD-CKD) patients receiving an
headache, vomiting & diarrhea. Some of these
erythropoietin
symptoms may be seen in patients with chronic
Peritoneal dialysis dependent-chronic kidney renal failure or on hemodialysis not receiving
disease (PDD-CKD) patients receiving an intravenous iron.
erythropoietin
It is also indicated in the treatment of Iron Use in Pregnancy & Lactation
deficiency anaemia in patients undergoing Pregnancy Category-B. This drug should be
surgical procedures, patients donating blood, used during pregnancy only if clearly needed.
postpartum patients. It is not known whether this drug is excreted in
71
Product Guide
human milk. Because many drugs are excreted controlled. For maintenance in chronic asthma,
in human milk, caution should be exercised doses should be titrated to the lowest dose that
when Iron Sucrose is administered to a nursing controls symptoms. Other conditions: The dose
woman. of Deflacort (Deflazacort) depends on clinical
need titrated to the lowest effective dose for
Preparation maintenance. Starting doses may be estimated
Iron 20 mg/ml IV Injection (5 ml). on the basis of ratio of 5mg prednisone or
prednisolone to 6mg.
Hepatic Impairment: In patients with hepatic
impairment, blood levels of may be increased.
Therefore the dose of Deflacort (Deflazacort)
should be carefully monitored & adjusted
Deflacort to the minimum effective dose. Renal
Impairment- In renally impaired patients, no
special precautions other than those usually
Active ingredient
adopted in patients receiving glucocorticoid
Deflazacort
therapy are necessary.
Elderly
Indication
In elderly patients, no special precautions
Anaphylaxis, asthma, severe hypersensitivity

D
other than those usually adopted in patients
reactions Rheumatoid arthritis, juvenile chronic
receiving glucocorticoid therapy are necessary.
arthritis, polymyalgia rheumatica Systemic
The common adverse effects of systemic
lupus erythematosus, dermatomyositis,
corticosteroids may be associated with more
mixed connective tissue disease (other than
serious consequences in old age.
systemic sclerosis), polyarteritis nodosa,
Children
sarcoidosis Pemphigus, bullous pemphigoid,
There has been limited exposure of children to
pyoderma gangrenosum Minimal change
Deflazacort in clinical trials.
nephrotic syndrome, acute interstitial nephritis
In children, the indications for glucocorticoids
Rheumatic carditis Ulcerative colitis, Crohns
are the same as for adults, but it is important that
disease
the lowest effective dosage is used. Alternate
Uveitis, optic neuritis Autoimmune haemolytic
day administration may be appropriate.
anaemia, idiopathic thrombocytopenic
Doses of Deflacort (Deflazacort) usually lie in
purpura Acute & lymphatic leukaemia,
the range 0.25 - 1.5 mg/kg/day. The following
malignant lymphoma, multiple myeloma
ranges provide general guidance:
Immune suppression in transplantation
Juvenile chronic arthritis: The usual
maintenance dose is between 0.25 - 1.0 mg/
Dosage & Administration
kg/day.
Adults: For acute disorders, up to 120 mg/day
Nephrotic syndrome: Initial dose of usually
Deflacort (Deflazacort) may need to be given
1.5 mg/kg/day followed by down titration
initially. Maintenance doses in most conditions
according to clinical need.
are within the range 3 - 18 mg/day. Rheumatoid
Bronchial asthma: On the basis of the potency
arthritis: The maintenance dose is usually
ratio, the initial dose should be between 0.25 -
within the range 3 - 18 mg/day. The smallest
1.0 mg/kg on alternate days.
effective dose should be used & increased if
necessary. Bronchial asthma: In the treatment
Contraindication & Precaution
of an acute attack, high doses of 48-72 mg/
Hypersensitivity to or any of the ingredients.
day may be needed depending on severity &
Patients receiving live virus immunisation.
gradually reduced once the attack has been
72
Product Guide
The following clinical conditions require The following types of medicine may
special caution & frequent patient monitoring interact with Deflazacort
is necessary: A Cardiac disease or congestive Estrogens, hypoglycaemics, antihypertensives,
heart failure (except in the presence of diuretics, coumarin anticoagulants,
active rheumatic carditis), hypertension, nondepolarising, muscle relaxants, salicylates,
thromboembolic disorders. Glucocorticoids antacids, oral contraceptives, vaccines, liver
can cause salt & water retention & increased enzyme inducers, liver enzyme inhibitors,
excretion of potassium. Dietary salt restriction & betaagonists & xanthines.
potassium supplementation may be necessary.
Gastritis or oesophagitis, diverticulitis,
ulcerative colitis if there is probability of Use in pregnancy & lactation
impending perforation, abscess or pyogenic Pregnancy Deflazacort does cross the
infections, fresh intestinal anastomosis, active placenta. However, when administered for
or latent peptic ulcer. Diabetes mellitus or a prolonged periods or repeatedly during
family history, osteoporosis, myasthenia gravis, pregnancy, corticosteroids may increase the
renal insufficiency. Emotional instability risk of intra-uterine growth retardation. As
or psychotic tendency, epilepsy. Previous with all drugs, corticosteroids should only be
corticosteroid-induced myopathy. Liver prescribed when the benefits to the mother &
failure. Hypothyroidism & cirrhosis, which may child outweigh the risks.
increase glucocorticoid effect. Nursing Mother Corticosteroids are excreted

D Ocular herpes simplex because of possible


corneal perforation.
in breast milk, although no data are available
for Deflazacort. Doses of up to 50 mg daily
of Deflazacort are unlikely to cause systemic
Side Effect effects in the infant. Infants of mothers taking
The incidence of predictable undesirable higher doses than this may have a degree of
effects, including hypothalamic-pituitary- adrenal suppression but the benefits of breast
adrenal suppression correlates with the feeding are likely to outweigh any theoretical
relative potency of the drug, dosage, timing risk.
of administration & the duration of treatment.
Musculoskeletal such as osteoporosis etc. Use in Children
Fluid & electrolyte disturbance such as Corticosteroids cause dose-related growth
oedema & heart failure etc. Ophthalmic such as retardation in infancy, childhood & adolescence
glaucoma, papilloedema etc. Gastrointestinal which may be irreversible.
such as dyspepsia, peptic ulceration etc.
General such as anaphylaxis & rare incidence Preparation
of benign intracranial hypertension. 6 mg tablet.
Withdrawal symptoms & signs .Too rapid a
reduction of corticosteroid dosage following
prolonged treatment can lead to acute adrenal
insufficiency, hypotension & death.

Drug interaction
Delipid
Rifampicin, rifabutin, carbamazepine,
Active Ingredient
phenobarbital, phenytoin, primidone,
Gemfibrozil.
aminoglutethimide, ketoconazole, insulin,
acetazolamide & carbenoxolone may interact Indication
with Deflazacort. It is recommended in the treatment of
73
Product Guide
type IIa, type IIb, type III, type IV & type V intraocular pressure), constipation, nausea,
hyperlipoproteinemia. difficulty with micturation; cardiovascular
side-Effects, sweating, tremors, rashes &
Dosage & Administration hypersensitivity reaction (including urticaria
1.2 g daily in 2 divided doses may vary between & photosensitivity), behavioral disturbances
0.9-1.5 g daily or as directed by the physician. (particularly in children) hypomania or mania
(particularly in elderly), interference with sexual
function; blood sugar changes, increased
Contraindication & Precaution
appetite, weight gain (occasionally weight loss)
Alcoholism, hepatic impairment, gallstone,
& pregnancy & to patients hypersensitive to
Drug Interaction
Gemfibrozil.
Imipramine should not be used in combination
with Monoamine Oxidase Inhibitors (MAOI),
Side Effect
anticholinergic agents, antihypertensive
Abdominal pain & epigastric pain or dyspepsia,
agents, methylphenidate, levodopa,
pruritus, rash, headache, dizziness, blurred
antipsychotic drug, cimetidine, barbiturates, &
vision, painful extremities & rarely myalgia.
oral contraceptives.
Drug Interaction
Use in Pregnancy & Lactation
Anticoagulant dosage may need to be
Treatment with Imipramine should be avoided

D
reduced. Caution should be taken when used
during pregnancy, unless the anticipated
concomitantly with Lovastatin.
benefits justify the potential risk to the fetus.
Preparation
Preparation
300 mg Capsule.
25 mg Tablet.

Depram TM

Active Ingredient
Imipramine. Deprex TM

Indication Active Ingredient


Antidepressant. Olanzapine.

Dosage & Administration Indication


1 tab 3 times daily Acute & maintenance treatment of
schizophrenia & related psychoses
Contraindication & Precaution where positive symptoms (e.g. delusions,
Recent myocardial infarction, arrhythmias hallucinations, disordered thinking, hostility
(particularly heart block), not indicated in & suspiciousness), acute manic or mixed
manic phase, severe liver disease episodes in bipolar disorder.

Side Effect Dosage & Administration


Dry mouth, less sedation, blurred vision The recommended starting dose for Deprex is
(disturbances of accommodation, increased 10 mg/day, administered as a single daily dose
74
Product Guide
without regard to meals. Dosage & Administration
Change wet & soiled diapers promptly, cleanse
Contraindication & Precaution the diaper area & allow drying. Apply ointment
Hypersensitivity, narrow-angle glaucoma, liberally as often as necessary, with each diaper
prostatic hypertrophy, or paralytic ileus & change, especially at bedtime or anytime when
related conditions. Neuroleptic Malignant exposure to wet diapers may be prolonged.
Syndrome (NMS): unexplained high fever
without additional clinical manifestations of Contraindication & Precaution
NMS, all antipsychotic medicines, including For external use only. When using this product
olanzapine must be discontinued. Olanzapine avoid contact with eyes stop use & ask a doctor
should be used cautiously in patients who if condition worsens or does not improve within
have a history of seizures or have conditions 7 days. This may be a sign of a serious condition.
associated with seizures. Keep out of reach of children. If swallowed, get
medical help immediately.
Side Effect
Frequent: somnolence & weight gain. Side Effect
Occasional: dizziness, asthenia, akathisia, Not known.
increased appetite, peripheral oedema,
orthostatic hypotension, & mild, transient Use in Children
anticholinergic Effects including constipation & Recommended.

D dry mouth; transient, asymptomatic elevations


of hepatic transaminases, ALT, AST. Preparation
Ointment 25 gm.
Preparation
5 mg & 10 mg Tablet.

Dermasol
Active Ingredient
Clobetasol Propionate.
De-rash Indication
Active Ingredient Eczema, psoriasis, hypertrophic lichen planus,
Zinc Oxide. localized bullous disorders, keloid scarring,
pretibial myxoedema, vitiligo. Suppression of
Indication reaction after cryotherapy.
De-rash (Zinc Oxide) helps treat & prevent
diaper rash while it moisturizes & nourishes the Dosage & Administration
skin. The zinc oxide based formulation provides Once or twice daily until improvement occurs,
a protective barrier on the skin against the should not be continued for more than four
natural causes of irritation. De-rash (Zinc weeks.
Oxide) spreads onto babys skin smoothly & be
wiped off easily, without causing irritation to Contraindication & Precaution
the affected area. Impetigo, tinea corporis & Herpes simplex,
75
Product Guide
scabies, acne vulgaris, rosacea, gravitational hyperkeratosis, the anti-inflammatory effect of
ulceration. Dermasol-N can be enhanced (if necessary) by
occluding the treatment area with polythene.
Side Effect Treatment should not be continued for more
Adrenal suppression, prolonged & intensive than 7 days without medical supervision. If a
treatment with a highly active corticosteroid longer course is necessary, it is recommended
preparation may cause atrophic changes, such that treatment should not be continued for
as thinning, striae & dilatation of the superficial more than 4 weeks without the patients
blood vessels. condition being reviewed.
Elderly: Dermasol-N is suitable for use in elderly.
Use in Pregnancy & Lactation Caution should be exercised in cases where a
Clobetasol Propionate should be avoided decrease in renal function exists & significant
during pregnancy. systemic absorption of Neomycin Sulphate
may occur.
Use in Children Children: Dermasol-N is suitable for use in
Should not be used children below the age of children (2 years & over) at the same dose as
12 years. adults. A possibility of increased absorption
exists in very young children, thus Dermasol-N
Preparation is not recommended for use in neonates &
0.05% Cream & Ointment in 10 gm & 20 gm infants (younger than 2 years).
pack.
Contraindication & Precaution D
This medication is contraindicated in rosacea,
acne vulgaris & perioral dermatitis, primary
cutaneous viral infection (eg-Herpes simplex,
chicken pox) & hypersensitivity to the

Dermasol-N preparation.

Side Effect
Active Ingredient Prolonged use of large amount or treatment
Clobetasol Propionate BP, Neomycin Sulphate of extensive areas can result in sufficient
BP & Nystatin BP. systemic absorption to produce the features
of hypercortisolism. The effect is more likely
Indication to occur in infants & children & if occlusive
Short courses treatment of eczemas dressings are used. Prolonged & intensive
Neurodermatoses treatment with highly active corticosteroid
preparations may cause local atrophic changes
Psoriasis (excluding widespread plaque
in the skin such as thinning, striae, & dilatation
psoriasis) where secondary bacterial infection
of the superficial blood vessels, particularly
or fungal infection is present, suspected or
when occlusive dressings are used, or when
likely to occur.
skin folds are involved. There are reports of
Other inflammatory conditions which do not
pigmentation changes & hypertrichosis with
respond satisfactorily to less active steroids.
topical steroids.
Dosage & Administration
Use in Pregnancy & Lactation
Adults: Apply sparingly to the affected area
There is little information to demonstrate the
once or twice daily until improvement occurs.
possible effect of topically applied Neomycin
In very resistant lesion, specially where there is
76
Product Guide
in pregnancy & lactation. However, Neomycin risk of generalized pustular psoriasis &
present in the maternal blood can cross the development of local or systemic toxicity due
placenta & may give rise to a theoretical risk of to impaired barrier function of the skin. If
foetal toxicity, thus the use of the preparation used on psoriasis, careful patient supervision
is not recommended in pregnancy & lactation. is important. Appropriate antimicrobial
The safety of Clobetasol Propionate has not therapy should be used whenever treating
been established in lactating mothers. inflammatory lesions which have become
infected. Any spread of infection requires
Preparation withdrawal of topical corticosteroid therapy
15 gm Cream & Ointment & systemic administration of antimicrobial
agents. Bacterial infection is encouraged by the
warm, moist conditions induced by occlusive
dressings, & so the skin should be cleansed
before a fresh dressing is applied.

Dermasol -S
TM
Side Effect
As with other corticosteroids, prolonged use of
large amounts or treatment of extensive areas,
Active ingredient can result in sufficient systemic absorption
Clobetasol Propionate BP. to produce the features of hypercortisolism.

D Indication
It is indicated in the topical therapy of
This effect is more likely to occur in infants &
children, & if occlusive dressings are used. Local
atrophy may occur after prolonged treatment.
recalcitrant corticosteroid-responsive In rare instances, treatment of psoriasis with
dermatoses of the scalp, including recalcitrant corticosteroids (or its withdrawal) is thought to
cases of psoriasis & seborrheic dermatitis. have provoked the pustular form of the disease.
If signs of hypersensitivity appear with the use
Dosage & Administration of Clobetasol Propionate Scalp Solution then
Apply required quantity of spray once or twice application should be stopped immediately.
daily to the affected areas of the scalp & gently
rub in. Drug Interaction
Drug interaction may be observed with
Contraindication & Precaution other potential corticosteroid containing
It is contraindicated in condition like- preparation.
Infections of the scalp
Hypersensitivity to the preparation Use in Pregnancy & Lactation
Use is not indicated in dermatoses in children Topical administration of corticosteroids to
under one year of age pregnant animals can cause abnormalities
Care must be taken to keep the preparation of foetal development. The relevance of
away from the eyes. Long-term continuous this finding to human beings has not been
therapy with Clobetasol Propionate Scalp established; however, topical steroids should
Solution should be avoided where possible, not used extensively in pregnancy, i.e. in large
particularly in infants & children, as adrenal amounts for prolonged periods. The safe use of
suppression can occur even without occlusion. Clobetasol Propionate during lactation has not
Topical corticosteroids may be hazardous in been established.
psoriasis for a number of reasons including
rebound relapses, development of tolerance,
77
Product Guide
Use in Children in patient with osteoporosis, cardiomyopathy,
Not recommended for use in children under hypertension, renal insufficiency & latent
one year of age. tuberculosis.

Preparation Side Effect


Each container contains 25 ml Solution. Endocrine & metabolic disturbances,
fluid & electrolyte disturbances, musculo-
skeletal Effects, gastro-intestinal Effects,
dermatological Effects, ophthalmic Effects,
CNS Effects & immunosuppressive Effects
Dexonex have been associated with prolonged systemic
glucocorticoid therapy.
Active Ingredient
Use in Pregnancy & Lactation
Dexamethasone.
US FDA pregnancy category C. Glucocorticoids
appear in breast milk. Mothers taking high
Indication
dosages of corticosteroids should be advised
Various types of dermatological disorders &
not to breast-feed.
allergic Disorders; Severe Respiratory Disorders
like - severe Bronchial Asthma, non-specific
Use in Children

D
chronic Obstructive lung disease; Primary
In order to minimize the potential growth
/ secondary Adrenocortical insufficiency;
Effects of corticosteroids, pediatric patients
Ocular inflammatory conditions which are
should be titrated to the lowest Effective dose.
unresponsive to topical corticosteroids;
Adjunctive therapy for various rheumatic
Preparation
disorders; other indications where
0.5 mg Tablet & 5 mg/ml IV or IM Injection.
glucocorticoid therapy is required.

Dosage & Administration


In general dexamethasone dosage depends on
the severity of the condition & the response of
the patient.
Adults: Daily oral dosages vary from 1 to 10 mg,
according to individual response.
Children: Daily oral dosages vary from 0.03-
Dexonex Eye/Ear Drops
0.20 mg/kg body weight, according to the Active Ingredient
individual response. Dexamethasone Phosphate.

Contraindication & Precaution Indication


Contraindicated in patients with gastric & For the treatment of the following conditions:
duodenal ulcers; systemic & ophthalmic fungal Ophthalmic: Steroid responsive inflammatory
infections; viral infections - varicella & herpes conditions of the palpebral & bulbar
genitalis infections, viral infections of the eye; conjunctiva, cornea, & anterior segment of
glaucoma & hypersensitivity to corticosteroids. the globe, such as allergic conjunctivitis, acne
The lowest possible dose of dexamethasone rosacea, superficial punctate keratitis, herpes
should be used to control the condition under zoster keratitis, iritis, cyclitis, selected infective
treatment. The reduction should be gradual. conjunctivitis when the inherent hazard of
Dexamethasone should be used with caution
78
Product Guide
steroid use is accepted to obtain an advisable adequate & well-controlled studies in pregnant
diminution in edema & inflammation; corneal women. This drug should be used during
injury from chemical or thermal burns, or pregnancy only if the potential benefit justifies
penetration of foreign bodies. the potential risk to the fetus. Caution should be
Otic: Steroid responsive inflammatory exercised when Dexamethasone ophthalmic
conditions of the external auditory meatus, solution is administered to a nursing woman.
such as allergic otitis externa, selected purulent Pediatric Use: Safety & efficacy in pediatric
& nonpurulent infective otitis externa when the patients below the age of 18 have not been
hazard of steroid use is accepted to obtain an established.
advisable diminution in edema & inflammation.
Side Effect
Dosage & Administration Glaucoma with optic nerve damage, visual
Eye: Instill one or two drops of solution into acuity & field defects, posterior subcapsular
the conjunctival sac every hour during the cataract formation, secondary ocular infection
day & every two hours during the night as from pathogens including herpes simplex,
initial therapy. When a favourable response is perforation of the globe. Rarely, stinging &
observed, reduce dosage to one drop every burning may occur.
four hours. Later, further reduction in dosage to
one drop three to four times daily may suffice Preparation
to control symptoms. Ear: Clean the aural canal Dexamethasone Phosphate 1 mg/ml.

D thoroughly & sponge dry. Instill the solution


directly into the aural canal. A suggested initial
dosage is three or four drops two or three times
a day. When a favourable response is obtained,
reduce dose gradually & eventually discontinue.
If preferred, the aural canal may be packed with
Dexonex-C TM

a gauze wick saturated with solution. Keep the Eye/Ear Drops


wick moist with the preparation & remove from
the ear after 12 to 24 hours. Treatment may be Active Ingredient
repeated as often as necessary at the direction Dexamethasone Phosphate & Chloramphenicol.
of the physician.
Indication
Contraindication & Precaution Eye: For steroid-responsive inflammatory
Epithelial herpes simplex keratitis (dendritic ocular conditions for which a corticosteroid is
keratitis), acute infections stages of vaccinia, indicated & where bacterial infection or a risk
varicella, & many other viral diseases of the of bacterial ocular infection exists. It is also
cornea & conjunctiva, Mycobacterial infection indicated in chronic anterior uveitis & corneal
of the eye, Fungal diseases of ocular or injury from chemical radiation or thermal
auricular structures, perforation of a drum burns or penetration of foreign bodies. The
membrane. Hypersensitivity to any ingredient combination can also be used for post-
of this product. operative inflammation & any other ocular
The possibility of persistent fungal infections inflammation associated with infection.
of the cornea should be considered after Ear: Otitis externa, Otitis media & chronic
prolonged corticosteroid dosing. suppurative otitis media.

Use in Pregnancy & Lactation Dosage & Administration


US FDA Pregnancy category C. There is no Eye: Bacterial Conjunctivitis: The recommended
79
Product Guide
dosage regimen for the treatment of bacterial
conjunctivitis is one or two drops instilled into Dibenol
the conjunctival sac(s) every two hours while
awake for two days & one or two drops every Active Ingredient
four hours while awake for the next five days. Glibenclamide.
Ear: For all infections two to three drops every
two to three hours initially. Frequency should Indication
be decreased gradually as warranted by For the management of Diabetes Mellitus.
improvement in clinical signs. Care should be
taken not to discontinue therapy prematurely. Dosage & Administration
Half tablet (2.5 mg) to 3 tablets. Daily doses
Contraindication & Precaution as directed by the physician & depending on
Epithelial herpes simplex keratitis (dendritic blood sugar level.
keratitis), vaccinia, varicella & in many other
viral diseases of the conjunctiva & cornea. Contraindication & Precaution
Mycobacterial infections of the eye, Fungal Glibenclamide is contraindicated in patients
diseases of ocular structures. Hypersensitivity with-Known hypersensitivity to the drug or
to any of the components of the medication. any of its excipients
The possibility of persistent fungal infections Type 1 diabetes or diabetic ketoacidosis, with
of the cornea should be considered after or without coma

D
prolonged corticosteroid dosing. This contraindicated should be treated with
insulin.
Use in Pregnancy & Lactation
US FDA Pregnancy category C. This drug Side Effect
should be used during pregnancy only if the Nausea, vomiting, epigastric pain, dizziness,
potential benefit justifies the potential risk weakness, paraesthesia & headache. Allergic
to the fetus. Caution should be exercised skin reactions & haemopoietic reactions
when Dexamethasone ophthalmic solution is (leukopenia, thrombocytopenia, etc.).
administered to a nursing woman.
Drug Interaction
Use in Children Alcohol, cyclophosphamide, dicoumarol,
Safety & efficacy in pediatric patients have not monoamino oxidase inhibitors,
been established. phenylbutazone, propranolol & other beta-
adrenergic blocking agents.
Side Effect
Adverse reactions seen with Chloramphenicol Use in Pregnancy & Lactation
are transient ocular burning or discomfort. There is no information on the use of
Other reported reactions include stinging, glibenclamide in human pregnancy.
redness, itching, conjunctivitis/keratitis,
periocular/facial edema, foreign body Preparation
sensation, photophobia, blurred vision, 5 mg Tablet.
tearing, dryness & eye pain.

Preparation
(Dexamethasone Sodium Phosphate 1 mg &
Chloramphenicol 5 mg)/ ml sterile solution.
80
Product Guide

Diliner DR Diltizem SR
Active Ingredient Active Ingredient
Duloxetine. Diltiazem.

Indication Indication
Depression, Diabetic Peripheral Neuropathic Angina pectoris, Hypertension with
Pain, Osteoarthritis pain. tachycardia.

Dosage & Administration Dosage & Administration


60 mg/day (given either once a day or as 30 mg 90 - 120 mg twice daily up to 240 mg.
BID) without regard to meals.
Contraindication & Precaution
Contraindication & Precaution Known hypersensitivity, sick sinus syndrome,
Known hypersensitivity to Duloxetine. second or third degree AV block, severe
Concomitant use in patients taking Monoamine hypertension or acute myocardial infarction &
Oxidase Inhibitors (MAOIs) is contraindicated. pulmonary congestion.
Duloxetine use should be avoided in patients
with uncontrolled narrow-angle glaucoma. Side Effect

D
Bradycardia, sino-atrial block, atrioventricular
Side Effect block, hypertension, malaise, headache, hot
In Duloxetine-treated MDD patients: nausea; flushes, GIT disturbances, oedema, hepatitis &
dry mouth; constipation; decreased appetite; depression reported.
fatigue; somnolence; & increased sweating.
In Duloxetine-treated DPN patients: nausea; Drug Interaction
somnolence; dizziness; constipation; dry Caution & careful dosage titration when
mouth; decreased appetite; & asthenia. diltiazem is administered concomitantly with
other drugs that can affect cardiac contractility
Drug Interaction and/ or conduction.
Inhibitors of CYP1A2- Fluvoxamine, quinolone
antibiotics, CYP2D6 inhibitors (e.g., Paroxetine, Use in Pregnancy & Lactation
fluoxetine, quinidine), Thioridazine, alcohol & The drug should be used during pregnancy
other CNS acting drugs. only when the potential benefits justify the
possible risk to the fetus. Women receiving the
Use in Pregnancy & Lactation drug should not breastfeed their infants.
The drug should be used during pregnancy
only when the potential benefits justify the Preparation
possible risk to the fetus. Women receiving the 90 mg SR Tablet.
drug should not breastfeed their infants.

Preparation
30 mg & 60 mg DR (Delayed Release) Capsule.
81
Product Guide

Diprobet Side Effect


The most frequent side effects reported with
Betamethasone Dipropionate are mild to
Active Ingredient moderate transient burning/stinging, dry skin,
Betamethasone Dipropionate. pruritus, irritation & folliculitis. Rarely reported
adverse effects include tingling, prickly skin/
Indication tightening or cracking of skin, warm feeling,
Diprobet (Betamethasone Dipropionate) laminar scaling & perilesional scaling, follicular
cream & ointment are indicated for the relief rash, skin atrophy, erythema, urticaria,
of the inflammatory & pruritic manifestations vesiculation, telangiectasia, acneiform papules
of resistant or severe corticosteroid responsive & hyperaesthesia.
dermatoses. These include- atopic eczema,
nummular eczema, contact dermatitis, Use in Pregnancy & Lactation
neurodermatitis, anogenital & senile pruritus, This medicine should not be used during
lichen planus & psoriasis. pregnancy & during lactation unless considered
essential by your doctor.
Dosage & Administration
Apply a thin film once or twice daily to cover Use in Children
completely the affected area. Patients with Not recommended under one year of age, or
chronic psoriasis who have achieved at least under the nappy, or airtight dressing of an

D
a marked improvement in their psoriatic infant older than one year.
lesion (i.e., approximately 80% improvement)
with Betamethasone Dipropionate may Preparation
be maintained in remission with a pulse 15 gm Cream & Ointment.
dosing regimen consisting of three
consecutive applications of up to 3.5 g each
of Betamethasone Dipropionate cream &
ointment, twelve hours apart (e.g., morning,
evening, following morning) to the previously
affected areas once each week. For this
purpose, Betamethasone Dipropionate cream Dormitol
& ointment should be applied to the lesion
sites previously affected & treated. Patients on Active Ingredient
this pulse dose regimen who relapse should Midazolam.
be reverted back to the conventional dosing
regimen. Indication
Midazolam is used as:
Contraindication & Precaution
Hypersensitivity to Betamethasone
Hypnotic & hence it is used for short term
management of insomnia.
Dipropionate, other corticosteroids. Like
other topical corticosteroids, Betamethasone Sedative & hence it relieves anxiety, tension
Dipropionate is contraindicated in viral & fear
infections of the skin, such as vaccinia, Pre-anaesthetics
varicella & Herpes simplex, also tuberculosis,
acne rosacea, fungal skin infections, perioral Anticonvulsants
dermatitis & ulcerative conditions.
Dosage & Administration
The duration of treatment with oral midazolam
82
Product Guide
should not be more than of 2 weeks. Use in Pregnancy & Lactation
In certain cases extension beyond the . Pregnancy category D
maximum treatment period may be necessary. . Breastfeeding is not recommended during
Insomnia: Adults: -7.5 mg to 15 mg daily. treatment
Elderly: -7.5 mg daily.
Premedication: 7.5 mg to 15 mg, should be Preparation
given 30-60 minutes before the procedure. 7.5 mg & 15 mg tablet; 15 mg/3ml injection.
Endoscopic or Cardiovascular procedures:
Adult: Initial dose is 2.5 mg (IV).
Elderly & debilitated patients: 1-1.5 mg (IV).
Induction of Anesthesia: Adult: 10-15 mg (IV) or
0.07-0.1 mg/Kg body weight, usually 5 mg (IM).
Children: 0.15-0.20 mg/Kg (IM).
Durol
Elderly & debilitated patients
0.025-0.05 mg/Kg (IM). Active Ingredient
Rectal administration in children: for Carvedilol.
preoperative sedation, rectal administration of
the ampoule solution is 0.35-0.45 mg/Kg, 20- Indication
30 min before induction of general anesthesia. Mild or moderate heart failure of ischemic

D
or cardiomyopathic origin, in conjunction
Contraindication & Precaution with digitalis, diuretics & ACE inhibitors,
Known hypersensitivity to Midazolam or Hypertension: Monotherapy or in combination.
other benzodiazepines, severe respiratory,
insufficiency, severe hepatic insufficiency, Dosage & Administration:
sleep apnea syndrome, myasthenia gravis, Heart failure: Start at 3.125 mg twice daily &
patients with a history of alcohol or drug abuse increase to 6.25 & then 25 mg twice daily over
& children. intervals of at least 2 weeks. Maintain lower
CNS depressants, erythromycin, azole type doses if higher doses are not tolerated.
animycotics & cimetidine may interfere the Left ventricular dysfunction following
metabolism of Midazolam. So caution should myocardial infarction: Start at 6.25 mg twice
be taken during the concomitant daily & increase to 12.5 mg then 25 mg twice
treatment with these drugs along with daily after intervals of 3 to 10 days. A lower
Midazolam. Long time use of Midazolam may starting dose or slower titration may be used.
increase dependency. As Midazolam is a strong Hypertension: Start at 6.25 mg twice daily &
sedative, it should not be taken before driving increase if needed for blood pressure control to
or other performance skilled tasks. 12.5 mg then 25 mg twice daily over intervals
of 1 to 2 weeks.
Side Effect
Drowsiness is the most common side Effect. Contraindication
Less common side Effects are CNS depression, Severe chronic cardiac failure requiring
ataxia, confusion, tiredness, muscle weakness, intravenous inotropic therapy, bronchial
fatigue, headache, dizziness & double vision. asthma or related bronchospastic conditions,
These Effects occur predominantly at the start second or third-degree AV block, sick sinus
of treatment & usually disappear with dose syndrome (unless a permanent pacemaker
adjustment or continuation of therapy. is in place), cardiogenic shock, or severe
bradycardia, use in hepatic impairment is not
83
Product Guide
recommended. Carvedilol is contraindicated in Contraindication & Precaution
patients with hypersensitivity to the drug. Acute GI conditions like abdominal pain.

Side Effect Side Effect


Postural hypotension, dizziness, headache, Rectal irritation, potassium loss (thirst,
fatigue, gastro-intestinal disturbances, weakness, nausea & diarrhea).
bradycardia, occasionally diminished
peripheral circulation, peripheral oedema Drug Interaction
& painful extremities, dry mouth, dry eyes, Cimetidine, Diuretics, Famotidine & Ranitidine
eye irritation or disturbed vision, impotence, may cause irritation of stomach or bowel.
disturbances of micturition, influenza like
symptoms, rarely angina. Use inPregnancy & Lactation
Can be given to pregnant women & lactating
Drug Interaction mothers only if physician recommends.
Drug interaction have been seen with co-
administration of carvedilol & digoxin. Use in Children
Safe for children over 03 years. Can be
Use in Pregnancy & Lactation given to children under 03 years if physician
Not recommended. recommends.

Preparation
6.25 mg & 25 mg Tablet.
Preparation
Each 5 ml oral emulsion contains 300 mg D
Magnesium Hydroxide USP & 1.25 ml liquid
paraffin BP.

Duolax
Active ingredient Dyvon TM

Magnesium Hydroxide & Liquid Paraffin.


Active Ingredient
Indication Calcipotriol.
Constipation, Hyperacidity with constipation,
Anorectal disorder, Post-operative Indication
constipation, constipation associated with Calcipotriol ointment is indicated for the
chronic cholecystitis, Hernia. topical treatment of chronic stable plaque type
psoriasis vulgaris in adult patients.
Dosage & Administration
The recommended oral doses are as follows- Dosage & Administration
Adults: 15-30ml before breakfast or at bedtime. Adults: Calcipotriol ointment should be applied
Children: Over 7 years: 7.5ml-15ml at bedtime. topically to the affected area twice daily (i.e. in
3-7 years: 5-10ml at bedtime. The dose may the morning & in the evening). Less frequent
be mixed with milk or half a glass of water if application may be indicated after the
desired. initial period of treatment. After satisfactory
improvement has occurred, treatment should
84
Product Guide
be discontinued. If recurrence takes place children, as there is inadequate experience
after discontinuation, the treatment may be with its use.
reinstituted. Experience is lacking in the use of
Calcipotriol for periods longer than 1 year. Preparation
20 gm Ointment.
Contraindication & Precaution
Betamethasone & Calcipotriol Ointment is
contraindicated in those patients with a history
of hypersensitivity to any of the components
of the preparation. It is also contraindicated
in patients with known disorders of calcium
Dyvon Plus TM

metabolism. Patients with severe renal


Active Ingredient
insufficiency or severe hepatic disorders are
Betamethasone Dipropionate & Calcipotriol.
also contraindicated.
The patient must be instructed on correct use
Indication
of the product to avoid application and/or
Dyvon Plus Topical Suspension is indicated
accidental transfer to the scalp, face, mouth or
for the topical treatment of plaque psoriasis of
eyes. Betamethasone & Calcipotriol Ointment
the scalp & body.
is not recommended for use on the face since
it may give rise to itching & erythema of the

E
Dosage & Administration
facial skin. Treatment of more than 30% of
Apply required quantity of spray of Topical
the body surface should be avoided. Patients
Suspension once daily to the affected areas
should be instructed to wash their hands after
& gently rub in using the tips of the fingers.
using Betamethasone & Calcipotriol Ointment,
Treatment may be continued for up to 8 weeks.
to avoid inadvertent transfer of ointment to the
Treatment may be discontinued earlier, if
face from other body areas.
symptoms are cleared. The maximum weekly
dose should not exceed 100 gm. Shake before
Drug Interaction
use. Dyvon Plus Topical Suspension is not for
There is no experience of concomitant therapy
oral, ophthalmic or intravaginal use.
with other antipsoriatic drugs applied to the
same skin area.
Contraindication & Precaution
Betamethasone & Calcipotriol containing
Use in Pregnancy & Lactation
preparation is contraindicated in those
Pregnancy: Safety for use in pregnancy has
patients with a history of hypersensitivity to
not been established. Therefore Calcipotriol
any of the components of the preparation. It
should not be used during pregnancy unless
is also contraindicated in patients with known
benefits clearly outweigh the risks.
disorders of calcium metabolism. Patients with
Lactation: It is not known whether Calcipotriol
severe renal insufficiency or severe hepatic
is excreted in breast milk, therefore, the drug
disorders are also contraindicated.
should be used during lactation only if the
benefits clearly out weigh the risks. Calcipotriol
Hypercalcemia & hypercalciuria have been
should not be applied to the chest area during
reported. If either occurs, discontinue until
breast feeding to avoid possible ingestion by
parameters of calcium metabolism normalize.
infants.
Topical corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis
Use in Children
suppression, Cushings syndrome & unmask
Calcipotriol Ointment should not be used in
latent diabetes. Rate of adrenal suppression
85
Product Guide
increased with treatment duration. Systemic
Efigrel TM

absorption may require evaluation for HPA axis


suppression. Modify use if HPA axis suppression
develops. Potent corticosteroids, use on large Active Ingredient
areas, prolonged use or occlusive use may Prasugrel Hydrochloride.
increase systemic absorption. Local adverse
reactions may include atrophy, striae, irritation, Indication
acne form eruptions, hypopigmentation, & Efigrel is indicated to reduce the rate of
allergic contact dermatitis & may be more thrombotic cardiovascular (CV) events
likely with occlusive use or more potent (including stent thrombosis) in patients with
corticosteroids. Use is not recommended acute coronary syndrome (ACS) who are to
on face, axillae, groin or where atrophy is be managed with percutaneous coronary
present. Children may be more susceptible intervention (PCI) as follows:
to systemic toxicity when treated with topical Patients with unstable angina (UA) or non-ST-
corticosteroids. elevation myocardial
infarction (NSTEMI).
Side Effect
The most common adverse reactions are Patients with ST-elevation myocardial
folliculitis & burning sensation of skin. infarction (STEMI) when managed with primary
or delayed PCI.
Use in Pregnancy & Lactation
There are no adequate & well-controlled studies Dosage & Administration
Prasugrel should be initiated with a single
E
in pregnant women. Suspension should be used
during pregnancy only if the potential benefit 60 mg loading dose & then continued at
to the patient justifies the potential risk to the 10 mg once a day. Patients taking Prasugrel
fetus. Systemically administered corticosteroids should also take aspirin (75 mg to 325 mg)
appear in human milk & could suppress growth, daily. Prasugrel may be administered with or
interfere with endogenous corticosteroid without food. A treatment of up to 12 months
production, or cause other untoward effects. is recommended, unless the discontinuation of
It is not known whether topically administered Prasugrel is clinically indicated.
calcipotriene or corticosteroids could result In case of patients weighing 60 kg or patients
in sufficient systemic absorption to produce 75 years old, Prasugrel should be given as a
detectable quantities in human milk. Because single 60 mg loading dose & then continued at
many drugs are excreted in human milk, a 5 mg once-daily dose.
caution should be exercised when Calcipotriol
& Betamethasone ointment or suspension is Contraindication & Precaution
administered to a nursing woman. Prasugrel should be avoided in case of
hypersensitivity to the active substance or to any
Use in Children of the excipients, active pathological bleeding,
Dyvon Plus Topical Suspension is not & history of stroke or transient ischaemic attack
recommended for use in children & adolescents (TIA), severe hepatic impairment.
below the age of 18 years.
Side Effect
Preparation Bleeding (non-CABG related & CABG related)
Dyvon Plus Topical Suspension: Each pack has & Thrombotic thrombocytopenic purpura.
an HDPE container containing 25 ml topical Besides this hypertension, headache, back
suspension. pain, dizziness, cough, bradycardia, rash &
86
Product Guide
peripheral edema etc. may happen. nausea, diarrhea, insomnia, vomiting, muscle
cramp, fatigue & anorexia.
Drug Interaction
Coadministration of prasugrel & warfarin Use in Pregnancy & Lactation
increases the risk of bleeding. Coadministration Donepezil should be used during pregnancy
of Prasugrel & NSAIDs (used chronically) may only if the potential benefit justifies the
increase the risk of bleeding. potential risk to the fetus. Donepezil has no
indication for use in nursing mothers.
Use in Pregnancy & Lactation
Pregnancy Category B. There are no adequate Preparation
& well-controlled studies of Prasugrel use in 5 mg Tablet.
pregnant women. Prasugrel should be used
during pregnancy only if the potential benefit
to the mother justifies the potential risk to the
fetus.

Use in Children
Emcil
Safety & Effectiveness in pediatric patients
Active Ingredient
have not been established.
Pivmecillinam.

E Preparation
10 mg Tablet.
Indication
For treatment of infections caused by
mecillinam-sensitive organisms, e.g. acute
cystitis, complicated urinary tract infections,
salmonellosis, shigellosis, enteropathic E. coli

Elzer diarrhoea, Gram-negative septicaemia, billiary


infections.

Active Ingredient Dosage & Administration


Donepezil. Adults: The usual dose is 1-2 tablets 3 times
daily according to severity of the infection.
Indication Children: weighing less than 20 kg should
Indicated for the treatment of mild to moderate be given 20-60 mg/kg divided into 3-4 daily
dementia of the Alzheimers type. doses. Those weighing more than 20 kg should
receive normal adult dose. The tablet should be
Dosage & Administration taken with at least 50-100 ml fluid.
5-10 mg once daily in the evening just prior to
retiring. Treatment with a dose of 10 mg should Contraindication & Precaution
be contemplated until patients have been on a There have been no reports on allergy to
daily dose of 5 mg for 4 to 6 weeks. Pivmecillinam among patients with a known
history of hypersensitivity to penicillins &
Contraindication & Precaution cephalosporins.
Hypersensitivity to Donepezil hydrochloride or
to piperidine derivatives. Side Effect
Generally well tolerated, gastrointestinal
Side Effect disturbances such as nausea, vomiting &
The most common adverse events include diarrhoea or indigestion may occur when a
87
Product Guide
dose has been given on an empty stomach.
Skin rashes have been reported in some cases. Entacyd Plus
Use in Pregnancy & Lactation Active Ingredient
Pivmecillinam in pregnancy should be Aluminum Hydroxide, Magnesium Hydroxide
prescribed when the expected benefits are & Simethicone
considered to be greater than the potential
risk. Mecillinam is not excreted into the milk of Indication
lactating mother. Hyperacidity, peptic ulcer, gastritis, peptic
oesophagitis, gastric hyperacidity, heartburn,
Preparation sour stomach or hiatus hernia.
200 mg Tablet.
Dosage & Administration
1-2 tablets/1-2 teaspoonful suspension 1-3
hours after meal & at bed time.

Contraindication & Precaution


Renal failure or hypophosphatemia, alkalosis,
Entacyd hypermagnesemia.

E
Side Effect
Active Ingredient
Diarrhea, constipation or regurgitation.
Aluminum Hydroxide & Magnesium Hydroxide.
Preparation
Indication
Chewable Tablet & Suspension.
Hyperacidity, peptic ulcer, gastritis, heartburn,
sour stomach & dyspepsia.

Dosage & Administration


Two tablets/two teaspoonful suspension 1-3

Epinal
hours after meal & at bed time.

Contraindication & Precaution


Hypophosphatemia, hypermagnesemia. Active Ingredient
Phenobarbital.
Side Effect
Long term use may cause alkaluria, & Indication
nephrolithiasis. Epinal is indicated as sedative & hence it relieves
anxiety, tension & fear; hypnotic & hence it is
Preparation used for short term insomnia, Pre-anaesthetics,
Chewable tablet & Suspension. Anti-epileptic in epilepsy with Partial seizure
or Generalized Tonic-clonic seizure, Status
epilepticus, anti convulsant.

Dosage & Administration


Insomnia- Adults: 100 to 320 mg.
Sedation- Adults: 30 to 120 mg/day in 2 to 3
divided doses.
88
Product Guide
Epilepsy-Adults: 60 to 250 mg/day. Preoperative & petit mal variant (Lennox-Gastaut syndrome).
Sedation-Children: 1 to 3 mg/kg.
Dosage & Administration
Contraindication & Precaution Children : Infants & children (up to 10 years of
Phenobarbital is contraindicated in patients age or 30 kg of body weight)-Between 0.01 &
with acute intermittent porphyria & who 0.03 mg/kg/day & should not exceed 0.05 mg/
have a natural or idiosyncrasy to barbiturates. kg/day given in 2 or 3 divided doses. Dosage
Phenobarbital is potentially habit forming if should be increased by no more than 0.25 to
taken over an extended period of time. When 0.50 mg every third day until a maintenance
being prescribed to overcome insomnia, the dose of 0.1 to 0.2 mg/kg of body weight has
drug should not be used for a period longer been reached, unless seizures are controlled
than two weeks. Caution should be taken in or side Effects preclude further increase.
patients, who are mentally depressed, have Adults : Initial dose should not exceed 1.5 mg/
hepatic damage, suicidal tendencies or a day divided into three doses. Dosage may
history of drug abuse. be increased in increments of 0.5 to 1 mg
every three days until seizures are adequately
Side-Effect controlled. Maintenance dose for adults is 8 to
Drowsiness is the most common side 10 mg/day in three divided doses.
Effect. Less common side Effects are CNS
depression, nervousness, agitation, psychiatric Contraindication & Precaution

E disturbance, lethargy, mental depression,


ataxia, nightmares, bradycardia, apnea,
Significant liver disease, narrow angle
glaucoma, sensitivity to benzodiazepines.
nausea, vomiting, constipation, restlessness Gradual withdrawal is essential when
& confusion in the elderly & hyperkinesia in discontinuing clonazepam. When used in
children. patients in whom several different types of
seizures co-exist, clonazepam may increase
Use in Pregnancy & Lactation the incidence or precipitate the onset of
Contraindicated during pregnancy & lactation generalized tonic-clonic seizures.

Preparation Use in Pregnancy


30 mg & 100 ml Elixir. The drug should be used during pregnancy
& lactation if potential benefit justifies the
potential risk to the fetus.

Side Effect
Drowsiness, Ataxia, Behaviour problems &
Epitra increased salivation.

Drug Interaction
Active Ingredient Alcohol, narcotics, barbiturates, nonbarbiturate
Clonazepam. hypnotics, antianxiety agents, phenothiazines,
anticonvulsant drugs, mono amino oxidase
Indication inhibitors & tricyclic antidepressants.
Anxiety as well as panic disorder, with or
without agoraphobia. Epilepsy & other Preparation
seizure disorders, alone or as an adjunct in the 0.5 mg Tablet, 1 mg Tablet, 2 mg Tablet & 10 ml
management of myoclonic & akinetic seizures oral drops.
89
Product Guide

Equra pruritic area, morning & evening & after each


stool. For deep application attach applicator/
cannula (supplied) to tube, insert to full extent
Active Ingredient & squeeze tube gently from lower end whilst
Urea. withdrawing.
Indication (2) Suppository: one suppository at morning ,
Ichthyosis & dry skin conditions, eczemas, one at evening & after each stool.
psoriasis.
Contraindication & Precaution
Dosage & Administration
Known hypersensitivity to any of the four
Twice daily.
ingredients, during pregnancy, herpes
Side Effect simplex, vaccinia or varicella, or tuberculous
Burning & irritation, if applied to inflamed, infection of the anal region. Discontinue use
broken or exudative skin eruptions. if sensitization occurs. The possibility, however
Use in Pregnancy & Lactation rare, that prolonged use of this preparation
Equra cream can be used during pregnancy & might produce systemic corticosteroid Effects.
lactation. Equra can be used in all age groups.
Side Effect
Contraindication & Precaution Long-term continuous treatment causes
Local irritation & edema, when applied to atrophic changes in the skin leading to thinning,

E
sensitive skin. If the condition is aggravated or loss of elasticity, dilatation of superficial blood
there is no improvement the doctor should be vessels, telangiectasiae & ecchymoses.
consulted.
Preparation Use in Pregnancy & Lactation
10% Cream. During pregnancy, it should not be used
unnecessarily on extended areas, in large
amounts or for prolonged periods of time.

Drug Interaction
Proper data is not available.

Erian Use in Children


Not recommended.
Active Ingredient
Cinchocaine Hydrochloride + Hydrocortisone Preparation
+ Framycetin Sulphate + Esculin. Ointment.

Indication
Internal & external haemorrhoids;
Haemorrhoids post-partum; Anal pruritus,
Eromycin
peri-anal eczema, anal fissures & proctitis; Post-
Active Ingredient
haemorrhoidectomy application to relieve
Erythromycin.
pain & discomfort.
Indication
Dosage & Administration
Alternative to a penicillin in penicillin-sensitive
(1) Ointment: Apply the ointment in small
patients, penicillin-resistant staphylococcal
quantity with the finger, on the painful or
infections, alternative to a tetracycline in
90
Product Guide
mycoplasma pneumonia, pertussis, diphtheria- areas.
especially in treatment of the carrier state,
rheumatic fever prophylaxis, chronic bronchitis, Contraindication & Precaution
otitis media & chronic prostatitis. Hypersensitivity to any of its ingredients.

Dosage & Administration Side Effect


Adults : 1-2 gm daily in divided doses. Children Erythema, desquamation, burning sensation,
: 30-50 mg/kg/day. eye irritation, tenderness, dryness or oily skin.

Contraindication & Precaution Drug Interaction


Hypersensitivity to Erythromycines, impaired Clindamycin interacts with Erythromycin.
hepatic function.
Use in Pregnancy & Lactation
Side Effect Use with caution.
Nausea, gastrointestinal disturbances & allergy
being the commonest ( 0.5-5%) adverse Effects. Preparation
25 ml Lotion.
Drug Interaction
Theophylline, Carbamazepine, Digoxin,
Warfarin, Ergotamine.

Use in Pregnancy & Lactation


There is no evidence that the use of
Erythromycin is hazardous in pregnancy Esloric
though it does cross the placental barrier.
Active Ingredient
Preparation Allopurinol.
500 mg & 250 mg Tablet, 125 mg/5 ml Dry
Powder for Syrup, 200 mg/5 ml Paediatric Indication
Drops. Primary & secondary gout.

Dosage & Administration


Allopurinol should be introduced at low
dosage e.g. 100mg/day to reduce the risk of
adverse reactions & increased only if the serum

Eromycin Lotion
urate response is unsatisfactory. Extra caution
should be exercised if renal function is poor.
The following dosage schedules are suggested:
Active Ingredient
Erythromycin. 100 to 200 mg daily in mild conditions,
300 to 600 mg daily in moderately severe
Indication conditions,
Acne, pimples & bacterial skin infections
susceptible to Erythromycin.
700 to 900 mg daily in severe conditions.
If dosage on a mg/kg body weight basis is
required, 2 to 10 mg/kg body weight per day
Dosage & Administration should be used.
Apply in morning & evening to the affected Dosage in Children: Children under 15 years:
91
Product Guide
10 to 20 mg/kg body weight per day up to a pressure, Cardiac tamponade, Arterial
maximum of 400 mg daily. hypoxaemia & corpulmonale, Mitral valve
Dosage in the elderly: In the absence of specific prolapse, Glaucoma.
data, the lowest dosage which produces
satisfactory urate reduction should be used. Side Effect
Dosage in renal impairment: In severe renal Nausea, vomiting, urinary & faecal incontinence,
insufficiency, it may be advisable to use less abdominal pain, headache, apprehension,
than 100 mg /day or to use single doses of 100 restlessness & weakness, vertigo & dizziness
mg at longer intervals than one day. are less common. Tachycardia, palpitations
& orthostatic hypotension are common
Side Effect symptoms.
Pruritic maculopapular skin eruptions,
fever, chill, arthralgias, cholestatic jaundice, Drug Interaction
eosinophilia & mild leukocytosis or leukopenia. Calcium channel blockers, antihypertensive
agents, phenothiazines & tricyclic
Drug Interaction antidepressants, alcohol.
Anticoagulant, Diuretic, Cytotoxic agent.
Use in Pregnancy & Lactation
Use in Pregnancy & Lactation Use only when clearly needed.
This drug should be used during pregnancy
only if clearly indicated, caution should be
exercised when Allopurinol is administered to
Preparation
20 mg Tablet. E
a lactating mother.

Preparation
100 mg & 300 mg Tablet. Eslicar
Active ingredient
Eslicarbazepine acetate

Esmo Indication
Eslicar is indicated as an add-on therapy for
Active Ingredient partial seizure with or without secondary
Isosorbide Mononitrate. generalization.

Indication Dosage & Administration


Prophylaxis & treatment of angina, Congestive Eslicar must be added to existing anticonvulsant
heart failure. therapy. The recommended starting dose is
400 mg once daily which should be increased
Dosage & Administration to 800 mg once daily after one or two weeks.
20 mg (1 tablet) twice daily. Based on individual response the dose may be
increased to 1200 mg once daily. Elderly (over
Contraindication & Precaution 65 years of age) Caution should be exercised
Obstructive hypertrophic cardiomyopathy, Low in the treatment of elderly patients as there
cardiac output secondary to hypovolaemia, is limited safety information on the use of
Inferior myocardial infarction with right Eslicarbazepine acetate in these patients.
ventricle involvement, Raised intracranial
92
Product Guide
Contraindication & Precaution a combined oral contraceptive showed an
Hypersensitivity to the active substance, average decrease of 37% & 42% in systemic
to other Carboxamide derivatives (e.g. exposure to Levonorgestrel & Ethinyloestradiol,
Carbamazepine, Oxcarbazepine) or to any respectively. Therefore, women of childbearing
of the excipients. Eslicarbazepine acetate potential must use adequate contraception
may decrease the effectiveness of hormonal during treatment with Eslicarbazepine acetate.
contraceptives. Additional non-hormonal Simvastatin: The dose of Simvastatin shall be
forms of contraception are recommended increased if used with Eslicarbazepine.
when using Eslicarbazepine acetate.As with
other anti-epileptic medicinal products, if Use in Pregnancy & Lactation
Eslicarbazepine acetate is to be discontinued Pregnancy: There are no data from the use of
it is recommended to withdraw it gradually Eslicarbazepine acetate in pregnant women.
to minimize the potential of increased Studies in animals have shown reproductive
seizure frequency. Concomitant use of toxicity. If women receiving Eslicarbazepine
Eslicarbazepine acetate with Oxcarbazepine acetate become pregnant or plan to become
is not recommended because this may cause pregnant, the use of Exalief should be carefully
overexposure to the active metabolites. re-evaluated.
Rash developed as an adverse reaction in 1.1% Lactation: It is unknown whether
of total population treated with Eslicarbazepine Eslicarbazepine acetate is excreted in human
acetate in placebo-controlled add-on studies breast milk.

E in epileptic patients. If signs or symptoms


of hypersensitivity develop, Eslicarbazepine Use in Children
acetate must be discontinued.Hyponatraemia The safety & efficacy of Eslicarbazepine acetate
has been reported as an adverse reaction below 18 years has not yet been established.
in less than 1% of patients treated with No data are available.
Eslicarbazepine acetate
Preparation
Side Effect Tablet.
The use of Eslicarbazepine acetate is associated
with increase in the PR interval. Adverse reactions
associated with PR interval prolongation (e.g.
AV block, syncope, bradycardia) may occur

Drug Interaction
Interaction studies have only been performed Evit
in adults.
Carbamazepine: Based on individual response, Active Ingredient
the dose of Eslicarbazepine acetate may need -Tocopheryl Acetate (Vitamin E)
to be increased if used concomitantly with
Carbamazepine. Indication
Phenytoin: The dose of Eslicarbazepine acetate Vitamin E deficiency.
may need to be increased & the dose of
Phenytoin may need to be decreased. Dosage & Administration
Betterment of Cardiovascular health: 400 mg -
Oral Contraceptives 800 mg / day.
Administration of Eslicarbazepine acetate Deficiency syndrome in adults: 400 mg / day.
1,200 mg once daily to female subjects using Thalassemia: 800 mg / day.
93
Product Guide
Sickle-cell anemia: 400 mg / day.
Betterment of Skin & Hair: 400 mg / day (Topical Ezex
use is also established for beautification).
Active Ingredient
Contraindication & Precaution Clobetasone Butyrate.
No absolute contraindication.
Indication
Side Effect Eczema, dermatitis & otitis externa.
Fatigue, diarrhea or myopathy.
Dosage & Administration
Drug Interaction Up to 4 times daily.
Vitamin A, K & Warfarin.
Contraindication & Precaution
Use in Pregnancy & Lactation Skin lesions caused by infection with viruses
Vitamin E is safe in pregnancy & lactation, when (e.g. Herpes Simplex, chicken pox), fungi (e.g.
used as recommended doses. Higher doses are candidiasis, tinea) or bacteria (e.g. impetigo),
not established. hypersensitivity to the preparations. If applied
to the eyelids, care is needed to ensure that
Preparation the preparation does not enter the eye as
400 mg & 200 mg Licap. glaucoma might result.

Side Effect
Hypersensitivity, transient adrenal suppression,
E
Eyevi local atopic changes, hypertrichosis,
exacerbation of symptoms may occur.

Active Ingredient Use in Pregnancy & Lactation


Vitamin C + Vitamin E + Zinc + Copper + Lutein There is inadequate evidence of safety in
human pregnancy & lactation.
Indication
Age-related Eye Disease. Preparation
25 gm Cream & Ointment.
Dosage & Administration
One Eyevi capsule, one or two times daily or as
directied by the physician.

Contraindication & Precaution


Hyperoxaluria, anticoagulants, estrogens, Facticin TM

vitamin-K.
Active Ingredient
Side Effect Gemifloxacin 320 mg
Diarrhea, abdominal pain, & other
gastrointestinal disturbances, fatigue & Indication
weakness. Acute Exacerbations of chronic bronchitis,
Community-acquired pneumonia.
Preparation
Capsule. Dosage & Administration
In Acute Exacerbations of Chronic Bronchitis
94
Product Guide
(AECB) once daily for 5 days. For Community-
Acquired Pneumonia (CAP) in mild to moderate Famotack
severity once daily for 5 days & in severe cases
once daily for 7 days. Active Ingredient
Famotidine.
Contraindication & Precaution
Known hypersensitivity to Gemifloxacin & Indication
other quinolones, Patients who have previously Duodenal ulcer, Gastric ulcer, Gastro-
suffered tendon damage with fluoroquinolones. oesophageal reflux disease & Zollinger-Ellison
Adequate hydration of patients receiving syndrome, Gastritis.
Gemifloxacin should be maintained to prevent
the formation of a highly concentrated urine & Dosage & Administration
crystalluria. 20 mg twice daily or 40 mg at night. Maintenance
Side Effect: Generally well tolerated. The most therapy as Famotack 20 one tablet at night.
side Effects include abdominal pain, diarrhea,
headache, nausea, rash & vomiting. Contraindication & Precaution
Hypersensitivity
Drug Interaction
Gemifloxacin absorption is significantly reduced Side Effect
Headache, dizziness, constipation & diarrhoea,

F
when aluminium- or magnesium-containing
antacids & iron salts are concomitantly nausea and/or vomiting, abdominal discomfort
administered. Gemifloxacin should be taken or distention, anorexia, fatigue, rash.
at least 2 hours before or 3 hours after these
agents. Gemifloxacin should be taken at least 2 Use in Pregnancy & Lactation
hours before sucralfate administration. Should be prescribed only if clearly needed. It is
best avoided by nursing mothers.

Use in Pregnancy & Lactation Preparation


Gemifloxacin should not be used in pregnant 20 mg Tablet.
or lactating women. The safety & efficacy of
Gemifloxacin in pregnant or lactating women
have not been established.

Use in Children
Not recommended below 18 years of age.
Femastin
Active Ingredient
Preparation Estriol.
Facticin Tablet: Box containing 1x6s Alu-Alu
blister packs. Indication
a. Atrophy of the lower urogenital tract related
to oestrogen deficiency, particularly -
For the treatment of vaginal complaints such
as dyspareunia, dryness & itching.
For the prevention of recurrent infections of
the vagina & lower urinary tract.
95
Product Guide
& vision disturbances are seldom observed.
In the management of micturition complaints In general, most of these adverse reactions
(such as frequency & dysuria) & mild
urinary incontinence. disappear after the 1st week of treatment.
b. Pre-and postoperative therapy in
postmenopausal women undergoing vaginal Drug Interaction
surgery. There are strong indications that estrogens,
estriol included, can increase the pharmacologic
Dosage & Administration Effects of certain corticosteroids. If necessary,
It is important that the total daily dose is taken the dosage of the corticosteroid should be
at one time. It may be taken with or without reduced. There are also some indications,
food. A missed dose should be taken as soon mainly obtained with other estrogens or
as remembered, unless it is more than 12 hours oral contraceptives, that concurrent use of
overdue. In the latter case the missed dose estriol with activated charcoal, barbiturates,
should be skipped & the next dose should be hydantoins & rifampicin may possibly decrease
taken at the normal time. the Effectiveness of estriol.
Atropy of the lower urogenital tract:
4-8 mg/day for the first weeks, followed by a Use in Pregnancy & Lactation
gradual reduction, based on relief of symptoms, Use Femastin in breastfeeding women only if
until a maintenance dosage (e.g. 1-2 mg/day) is really needed, as estriol is excreted in the milk

F
reached. & it may decrease the quality & quantity of the
Pre- & postoperative therapy in postmenopausal milk production.
women undergoing vaginal surgery:
4-8 mg/day in the 2 weeks before surgery; 1-2 Preparation
mg/day in the 2 weeks after surgery. Tablet.

Climacteric complaints such as hot flushes &


night sweating:
4-8 mg/day during the first weeks, followed by
a gradual reduction. For maintenance therapy
the lowest Effective dosage should be used. Fentizol VT 600
A diagnostic aid in case of a doubtful atrophic Active Ingredient
cervical smear: Fenticonazole Nitrate
2-4 mg/day for 7 days before taking the next
smear. Indication
Genital candidiasis (vulvovaginitis, colpitis,
Contraindication & Precaution infectious fluor)
Pregnancy, Known or suspected estrogen- -Trichomoniasis
dependent tumors, undiagnosed vaginal -Vaginal infections sustained by mixed forms of
bleeding, untreated endometrial hyperplasia, Trichomonas vaginalis & Candida albicans.
known or suspected breast cancer.
Dosage & Administration
Side Effect Used in Trichomonas or mixed (Trichomonas &
Breast tension or pain, nausea, spotting, Candida albicans) vaginal infections:
fluid retention & cervical hypersecretion may
occasionally occur & be indicative of too high One 600 mg VT (followed by a second
dosage. Headache, hypertension, leg cramps administration 24 hours later, if necessary).
96
Product Guide
Candida albicans infections: Preparation
1 Tablet in Alu-Alu blister with an applicator.
One single 600 mg VT administration in the
evening. Should the symptoms persist, a
second administration may be repeated after
three days.
The tablet must be introduced deep into
the vagina & pushed well up to the fornix. To
avoid re-infection, it is recommended that the Fe-plus
partner undergoes concurrent treatment with
Fenticonazole Cream or similar Azole Cream. Active Ingredient
Ferrous Fumarate & Folic acid.
Contraindication & Precaution
Contraindicated in case of hypersensitivity Indication
to Fenticonazole & other Imidazoles. As Iron & Folic acid deficiency.
systemic absorption is very low, the possibility
of overdose is rare. In case of accidental Dosage & Administration
swallowing, emesis or gastric lavage should 1 capsule three to four times daily.
be done. After vomiting, active charcoal along In pregnancy, 1 capsule daily.
with water/lemon juice & laxative should be

F given to the patient. Contraindication & Precaution


Pernicious anaemia.
Side Effect
After intravaginal administration slight transient Side Effect
burning (which usually disappears rapidly) Gastric distress, abdominal cramps, diarrhoea,
may occasionally happen. Prolonged topical allergic reaction.
application may cause sensitisation reactions.
Fenticonazole is generally well tolerated by Drug Interaction
the mucous membranes; only exceptionally Antacid, Tetracyclines, Penicillamine & Zinc,
mild & transient erythematous reactions have anticonvulsant drug, Norfloxacin, Ciprofloxacin
been reported. After topical application or & Ofloxacin.
intravaginal administration, a slight burning
sensation may occur, usually subsiding soon. Use in Pregnancy & Lactation
Should more persistent irritation occur or There is no contraindication in pregnancy &
resistant micro-organism develop, suspend the lactation.
treatment & seek the doctors advice. Due to
poor absorption of Fenticonazole, no systemic Preparation
effects should occur, provided the above Capsule.
instructions are carefully observed.

Use in Pregnancy & Lactation


It is not recommended in pregnancy. Safety in
breastfeeding has not been established.

Use in Children
Fenticonazole Nitrate is not recommended for
children.
97
Product Guide

Fexo TM

Active Ingredient
Fexofenadine.

Indication
Seasonal & perennial allergic rhinitis & Chronic idiopathic urticaria.

Dosage & Administration


Patient Fexo Tablet Fexo Oral In case of decreased
Population Suspension renal function

Adults & Children 60 mg twice daily ----- 60 mg once daily is


12 years & older or 120 mg once recommended as
daily or 180 mg the starting dose
once daily
Children 6 to 11 30 mg twice daily 30 mg (5 ml) 30 mg (5 ml) once
years or 60 mg once twice daily daily is recommended

F
daily as the starting dose
Children 2 to 5 years ----- 30 mg (5 ml) 30 mg (5 ml) once
twice daily daily is recommended
as the starting dose
Children 6 months ----- 15 mg (2.5 ml) 15 mg (2.5 ml) once
to less than 2 years twice daily daily is recommended
as the starting dose

Contraindication & Precaution


Fexofenadine is contraindicated in patients with known hypersensitivity to any of the ingredients.

Side Effect
Generally well tolerated.

Use in Pregnancy & Lactation


There are no adequate & well controlled studies in pregnant women. Fexofenadine should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known if Fexofenadine is excreted in human milk. Caution should be exercised when
Fexofenadine is administered to a nursing woman. In case of decreased renal function, care should
be taken in dose selection & it may be useful to monitor renal function.

Preparation
60 mg, 120 mg, 180 mg Tablet & 30 mg / 5 ml Suspension.
98
Product Guide

Fexo Plus TM Use in Children


This drug is not recommended for pediatric
patients under 12 years of age.
Active Ingredient
Fexofenadine HCl + Pseudoephedrine HCl . Preparation
Fexofenadine HCl 60 mg + Pseudoephedrine
Indication HCl 120 mg Bi-layer Tablet.
For the relief of symptoms associated with
seasonal & perennial allergic complications in
adults & children 12 years of age & older.
Symptoms treated Effectively include sneezing,
rhinorrhea, itchy nose/palate/ and/or throat,
itchy/watery/red eyes, & nasal congestion.
It should be administered when both the Filfresh
antihistaminic properties of Fexofenadine
Hydrochloride & the nasal decongestant Active Ingredient
properties of Pseudoephedrine Hydrochloride Melatonin.
are desired.
Indication
Dosage & Administration Insomnia, osteoporosis, in menopause

F
The recommended dose of Fexo Plus Tablet to regulate sleep patterns in peri or
is one tablet twice daily administered on an postmenopausal women, to correct the
empty stomach with water for adults & children symptoms of anorexia, Attention Deficit
12 years of age & older. It is recommended that Hyperactivity Disorder in Children, in
the administration of Fexo Plus Tablet with sarcoidosis & jet lag.
food should be avoided.A dose of one tablet
once daily is recommended as the starting Dosage & Administration
dose in patients with decreased renal function. Adult: Insomnia: 3-6 mg one hour before
bedtime
Contraindication Jet lag: 0.5 to 5 mg one hour prior to bedtime
This drug is contraindicated in patients with at final destination or, 1 to 5 mg 1 hour before
known hypersensitivity to any of its ingredients. bedtime for 2 days prior to departure & for
2 to 3 days upon arrival at final destination.
Side-Effect Eastbound travel - Take a preflight early
The reported side Effects are insomnia, evening treatment followed by treatment at
headache, nausea, dry mouth, bedtime for 4 days after arrival. Westbound
dizziness,agitation, nervousness, anxiety, & travel - Take for 4 days at bedtime when in the
palpitation etc. new time zone.
Sarcoidosis: 20 mg per day for 4 to 12 months.
Use in Pregnancy & Lactation Depression: 0.125 mg twice in the late
Category C. It should be used during afternoon, each dose 4 hours apart.
pregnancy only if the potential benefit justifies Difficulty falling asleep: 5 mg 3 to 4 hours
the potential risk to the fetus. Caution should before an imposed sleep period over a 4-week
be exercised when this drug is administered to period.
nursing women.
Children (6 months to 14 years of age with
sleep disorders): 0.3 mg/day
99
Product Guide
Contraindication & Precaution Contraindication & Precaution
Melatonin should not be used by patients Known hypersensitivity, large dose of vitamin A
who have autoimmune diseases. Caffeine may increase the risk of osteoporosis.
& fluvoxamine may increase the Effects of
melatonin, while melatonin may decrease the Side Effect
antihypertensive Effect of nifedipine. Diarrhorea, skin may assume slightly
yellow discoloration, other gastrointestinal
Side Effect disturbances.
Possible side Effects may include headache &
depression. Drowsiness may be experienced Use in Pregnancy & Lactation
within 30 minutes after taking melatonin & Recommended by the consultation with
may persist for 1 hour & thus may affect driving physician.
skills.
Preparation
Use in Pregnancy & Lactation Tablet.
Information regarding safety & efficacy in
pregnancy & lactation is lacking.

Use in Children
Recommended for the use in children of 6

F

months & above.
Filwel Kids
Preparation
Each tablet contains Melatonin 3 mg. Active Ingredient
Cod Liver Oil, Vitamin A, Vitamin D, Vitamin C,
Vitamin B1, Vitamin B2, Vitamin B6, Vitamin E
& Nicotinamide.

Indication

Filwel Gold
TM Filwel Kids Syrup helps preventing vitamin
deficiencies in children & adult. It stimulates
appetite & improves digestion; promotes
Active Ingredient healthy hair, skin & nails, good vision, strong
Vitamin A, C, D, E, K, Thiamine. Riboflavin, Niacin, bones & healthy teeth; increases resistance
Vitamin B6, Folic acid, Vitamin B12, Biotin, against coughs, colds, chest & bronchial
Pantothenic acid, Calcium, Iron, Phosphorous, troubles; helps maintain healthy muscles
Iodine, Magnesium, Zinc, Selenium, Copper, & nervous system & helps optimizing brain
Manganese, Chromium, Molybdenum, development.
Chloride, Potassium, Boron, Nickel, Silicon, Tin,
Vanadium & Lutein. Dosage & Administration
Infants (<1 year): Half teaspoonful daily.
Indication Children (1 - 4 years): One teaspoonful daily.
Treatment of vitamin & mineral deficiencies. Children (> 4 years): One & half teaspoonful
daily.
Dosage & Administration It can be taken with water or milk if desired.
One tablet daily with food.
100
Product Guide
Contraindication & Precaution Side Effect
The product is contraindicated in patients Diarrhorea, skin may assume slightly
with a known hypersensitivity to any of the yellow discoloration, other gastrointestinal
ingredients of this product. In the long term disturbances.
use, this medicine may accumulate in the
body which may cause hypervitaminosis of the Contraindication & Precaution
related fat soluble vitamins. Then, it should not Known hypersensitivity, large dose of vitamin
be used over dosage or be used continuously A may increase the risk of osteoporosis in
except recommended by the physicians. postmenopausal women.

Side Effect Use in Pregnancy & Lactation


Generally well tolerated. Recommended by the consultation with
physician.
Use in Pregnancy & Lactation
Recommended. Drug Interaction
No drug interactions have been reported.
Use in Children
Recommended. Preparation
Tablet.
Preparation

F 100 ml & 200 ml Syrup.

Flacol
Active Ingredient

Filwel Silver Simethicone.
Indication
Active Ingredient Flatulence, abdominal distention, fullness, gas
Vitamin A, C, D, E, K, Thiamine, Riboflavin, Niacin, & windy colic, large bowel preparation.
Vitamin B6, Folic acid, Vitamin B12, Biotin, Dosage & Administration
Pantothenic acid, Calcium, Phosphorous, Children (<2 years) : 20 mg (0.3 ml) 4 times
Iodine, Magnesium, Zinc, Selenium, Copper, daily; Children (2-12 years) : 40 mg (0.6 ml) 4
Manganese, Chromium, Molybdenum, times daily; Adults: 40-80 mg (0.6 ml - 1.2 ml) 4
Chloride, Potassium, Boron, Nickel, Silicon, times daily. Chewable tablet: Chew 1-3 tabets
Vanadium & Lutein. after meals & at bed time.
Indication Contraindication & Precaution
Treatment of vitamin & mineral deficiencies Do not exceed 12 doses per day without
above the age of 45 years. physicians recommendation.
Side Effect
Dosage & Administration No adverse Effect has been noted after oral
One tablet daily with food. Not formulated for ingestion.
use in children.
Preparation
67 mg/ml Paediatric Drops & 40 mg chewable
tablet.
101
Product Guide

Flexi TM Preparation
100 mg Tablet & 200 mg Sustained Release (SR)
Tablet.
Active Ingredient
Aceclofenac.

Indication
Osteoarthritis, Rheumatoid
Ankylosing Spondylitis.
Arthritis &
Flexilax
Dosage & Administration Active Ingredient
100 mg twice daily. Baclofen.
Indication
Contraindication & Precaution Flexilax is indicated for the treatment of muscle
Peptic ulcer or gastric-intestinal bleeding. It spasm, muscle contraction, spasticity resulting
should not be given to patients with moderate from multiple sclerosis, spinal cord injuries &
to severe renal impairment. Close medical other spinal cord diseases, muscle spasm of
surveillance is also imperative in patients cerebral origin especially infantile cerebral
suffering from severe impairment of hepatic palsy, cerebrovascular accidents or neoplastic
function. It should not be prescribed during or degenerative brain disease, tension-type

F
pregnancy, unless there are compelling headache.
reasons for doing so.
Dosage & Administration
Side Effect Flexilax (Baclofen) should be given in divided
Dyspepsia, abdominal pain, nausea & doses preferably 3 times daily for adults &
diarrhea, dizziness. Dermatological complaints 4 times daily for children. The lowest dose
including pruritus & rash & abnormal hepatic compatible with an optimal response is
enzyme levels & raised serum creatinine have recommended. The dosage shall be started
occasionally been reported. from 5 mg three times a day to a maximum of
20 mg three times a day.
Drug Interaction Contraindication & Precaution
Lithium, digoxin, diuretics, anticoagulants, Baclofen is contraindicated in patients with
methotrexate. previously demonstrated hypersensitivity to
any of the components of the product.
Use in Pregnancy & Lactation Side Effect
The regular use of NSAIDs during the last The most common advarse reactions associated
trimester of pregnancy may increase uterine with Baclofen are transient drowsiness, daytime
tone & contraction. The use of Aceclofenac sedation, dizziness, weakness & fatigue.
should therefore be avoided in pregnancy &
lactation unless the potential benefits to the Use in Pregnancy & Lactation
mother outweigh the possible risks to the fetus Pregnancy category B. Baclofen is excreted
in breast milk however evidence to date
Use in children suggests that the quantities are so small that
No clinical data on the use of Aceclofenac in no undesirable Effects on the infant would be
Children. expected.
Preparation
5 mg & 10 mg Tablet
102
Product Guide

Flonaspray Dosage & Administration


Acute or recurrent vaginal candidiasis - a
single dose of 150 mg. Mucosal candidiasis
Active Ingredient (except vaginal): 50 mg daily (100 mg daily
Fluticasone Propionate. in unusually difficult infections) given for
7-14 days in oropharyngeal candidiasis ; for
Indication 14-30 days in other mucosal infections (e.g.
Prophylaxis & treatment of allergic rhinitis. oesophagitis, candiduria). Systemic candidiasis
& cryptococcal infections (including
Dosage & Administration meningitis) - 400 mg initially then 200 mg
Adults: 02 sprays in each nostril once daily, daily, increased if necessary to 400 mg daily ;
preferably in the morning. Children (4 to 11 treatment continued according to response.
years of age) 01 spray in each nostril once daily. Child over 1 year - superficial candidal infections,
1-2 mg/kg daily; systemic candidiasis &
Contraindication & Precaution cryptococcal infections (including meningitis)
Hypersensitivity to any of its components. Care - 3-6 mg/kg daily (in serious life threatening
must be taken while transferring patients from infections up to 12 mg/kg daily has been given
systemic steroid to Fluticasone nasal spray to children aged 5-13 years - max. 400 mg
if there is any reason to suppose that their daily).
adrenal function is impaired.

F Side Effect
Nasal irritation & stinging. Nasal septum
Contraindication & Precaution
Hypersensitivity, advanced liver disease, renal
impairment, children below the age of one
perforation, dryness of nose & throat, year.
unpleasant taste & smell & epistaxis reported
rarely. Side Effect
Nausea, abdominal discomfort, diarrhoea &
Drug Interaction flatulence, occasionally abnormalities of liver
None is yet known. enzyme, rarely rash, angioedema & anaphylaxis
reported.
Preparation
50 mcg/spray, Nasal Spray. Drug Interaction
Rifampicin , warfarin, phenytoin.

Use in Pregnancy & Lactation


Caution should be taken.

Flugal Preparation
200 mg, 150 mg & 50 mg Capsule, 50 mg/5 ml
Suspension.
Active Ingredient
Fluconazole.

Indication
Candidiasis, cryptococcal infections (including
meningitis), Tinea pedis, corporis, cruris,
versicolor & dermal candidiasis.
103
Product Guide

Flurizin Contraindication & Precaution


Hypersensitivity to Flunarizine. Flunarizine
is contra-indicated in patients with a history
Active Ingredient of depressive illness, or with pre-existing
Flunarizine. symptoms of Parkinsons disease or other
extrapyramidal disorders. Flunarizine may
Indication lead to drowsiness which is aggravated by the
Flurizin is indicated for simultaneous intake of alcohol or other central
Prophylaxis of classic (with aura) or common nervous system depressants. Patients should
(without aura) migraine be cautioned against driving motor vehicles or
Symptomatic treatment of vestibular vertigo performing other potentially hazardous tasks
. Peripheral Vascular Disease (PVD) where a loss of mental alertness may lead to
Motion sickness accidents. Flunarizine is not suited for aborting
Refractory epilepsy resistant to conventional a migraine attack. The possible occurrence of
antiepileptic therapy. an attack is therefore no reason to increase the
dose of Flunarizine. This treatment may give rise
Dosage & Administration to extrapyramidal & depressive symptoms &
Migraine Prophylaxis: reveal Parkinsonism, especially in predisposed
Starting Dose: 10 mg at night in patients patients such as the elderly. Flunarizine should
less than 65 years of age & 5 mg daily in therefore be used with caution in such patients.
patients older than 65 years. If, during this
treatment depressive, extrapyramidal or other Side Effect F
unacceptable symptoms occur, administration Drowsiness and/or fatigue, as well as weight
should be discontinued. If, after 2 months of this gain and/or increased appetite may occur.
initial treatment, no significant improvement is The following advarse experiences have
observed, the patient should be considered been reported during chronic treatment
a non-responder & administration should be with Flunarizine: depression, of which female
discontinued. patients with a history of depressive illness
Maintenance Treatment: If a patient is may be particularly at risk; extrapyramidal
responding satisfactorily & if a maintenance symptoms (such as bradykinesia, rigidity,
treatment is needed, the dose should be akathisia, orofacial dyskinesia, tremor), of
decreased to 5 days treatment at the same which elderly patients seem particularly at
daily dose with two successive medicine free risk.Infrequently reported adverse reaction
days every week. Even if the prophylactic are: heartburn; nausea; gastralgia; insomnia;
maintenance treatment is successful & well anxiety; galactorrhoea; dry mouth; muscle
tolerated, it should be interrupted after 6 ache; skin rash.
months & it should be re-initiated only if the
patient relapses. Use in Pregnancy & Lactation
Peripheral Vascular disease: 10 mg twice daily, Safety in pregnancy & lactation has not been
up to 30 mg per day if required. established.
Vertigo & motion sickness: 10-20 mg daily for
adults & 5 mg daily for children (> 40 kg). Preparation
5 mg & 10 mg Tablet.
Epileptic seizure
15-20 mg daily in adults & 5 to 10 mg daily for
children as an add-on therapy.
104
Product Guide

Fodexil 500 CapsuleTM Creatinine clearance


(ml/min)
Dosing interval

1-10 36 hr.
Active Ingredient 11-25 24 hr.
Cefadroxil 500 mg. 26-50 12 hr.
>50 No need to adjust
Indication
Upper respiratory tract infections caused Cefadroxil can be excreted from body by
by Streptococcus pyogenes (Group A beta- hemodialysis. Prolonged use of Cefadroxil may
hemolytic Streptococci) & Streptococcus result in the overgrowth of nonsusceptible
pneumoniae. organisms. Cefadroxil should be prescribed
with caution in individuals with history of
Urinary tract infections caused by E. coli, gastrointestinal disease, particularly colitis.
Proteus mirabilis, & Klebsiella species.
Skin & soft tissue infections caused by Side Effect
Staphylococci (including penicillinase The most commonly reported side effects are
producing strains) & Streptococci. gastrointestinal disturbances & hypersensitivity
phenomena. Side effects including nausea,
Dosage & Administration vomiting, diarrhoea, dyspepsia, abdominal
discomfort, fever, dizziness, headache,

F
Infections of upper respiratory tract:Adult -
pharyngitis & tonsillitis: 1 g/day in single or arthralgia may also occur.
divided doses for 10 days, Children- 30 mg/kg/
day in equally divided doses every 12 hour for Drug Interaction
at least 10 days. Uncomplicated lower urinary Prothrombin time prolonged; bleeding
tract infections: Adult- 1-2 g daily as a single or may occur when taken with anticoagulants.
2 divided doses, Children- >6 year: 500 mg bid; Decreased elimination with probenecid is also
1-6 year: 250 mg bid; <1 year: 25 mg/kg daily reported.
in divided doses. Skin & soft tissue infections:
Adult- 1 g/day in single or divided doses, Use in Pregnancy & Lactation
Children- 30 mg/kg/day in equally divided Pregnancy category B. But it should be used
doses every 12 hour only if clearly needed. Caution should be
exercised when Cefadroxil is administered to
Contraindication & Precaution nursing mother.
Cefadroxil is contraindicated in patients with
a history of hypersensitivity to any of the Use in Children
ingredients Please see dosage & Administration
Cefadroxil should be used with caution in the
presence of markedly impaired renal function Preparation
(creatinine clearance rate of less than 50 ml/ Capsule.
min). For patients considering creatinine
clearance of ml/min/1.73 sqm, starting dose
1000 mg & maintenance dose 500 mg should
be administered as per following table:
105
Product Guide

Fona Force TM

Active Ingredient Active Ingredient


Adapalene. Cefpirome.

Indication Indication
Acne. Septicemia, bacteremia & infections in
immunosuppressed neutropenic patients
Dosage & Administration with hematological malignancies, pneumonia,
Fona 0.1% Cream: Once daily at night-time. Severe urinary tract infections including
Fona 0.3% Gel: Once daily in the evening. pyelonephritis, Skin & soft tissue infections,
Bone & joint infections, Infections in
Contraindication & Precaution immunocompromised patients.
Hypersensitivity to Adapalene. Adapalene
should not be applied to cuts, abrasions, Dosage & Administration
eczematous or sunburned skin. 1 gm b.i.d. maximum 4 gm daily by IV route
only. Duration depends on response.
Side Effect
Erythema, scaling, dryness, pruritus, burning Contraindication: Known allergy to the

F
sensation, skin irritation, stinging sunburn, Cephalosporin antibiotics.
acne flares.
Side Effect
Drug Interaction Diarrhea, nausea, vomiting,
Concomitant use of other potentially irritating pseudomembraneous colitis, abdominal pain,
topical products (medicated or abrasive Superficial phlebitis, thrombophlebitis &
soaps & cleaners, soaps & cosmetics that infection site reaction.
have a strong drying effect, products with
high concentrations of alcohol, astringents, Pregnancy & Lactation
spices or lime) should be approached with The safety of Cefpirome has not been
caution. Exercise particular caution in using established in pregnancy & it should be
preparations containing sulfur, resorcinol or administered with caution, especially during
salicylic acid in combination with Adapalene. the early months of pregnancy. As Cefpirome
is excreted in human breast milk, either
Use in Pregnancy & Lactation Cefpirome treatment should be discontinued
Use adapalene during pregnancy only if or breast feeding ceased.
the potential benefit justifies the potential
risk to the foetus. Exercise caution when Drug Interaction
administering Adapalene to a nursing mother. Drug interactions have not been observed with
Safety & effectiveness in children below 12 Cefpirome.
years of age have not been established.
Preparation
Preparation 1 gm IV Injection.
10 gm Cream & Gel.
106
Product Guide

Fungidal in the morning, i.e. above the eye tooth, once


daily, for one week. Do not swallow. A second
week of treatment may be indicated. The use
Active Ingredient of Miconazole in children below the age of 7 is
Miconazole Nitrate. not recommended.

Indication Method of Administration


Skin & nail infections due to dermatophytes, Once a tablet is removed from the blister, it
yeasts & other fungi such as: Tinea capitis, should be used immediately.
corporis, manuum, pedis, barbae, cruris,
unguium or onychomycosis. Pityriasis Contraindication & Precaution
versicolor, candidiasis of skin & nails, stomatitis Known hypersensitivity to Miconazole Nitrate
angularis, otitis externa, mycoses secondarily or to any of the other ingredients of the product.
infected with bacteria. Harmful Effects are not expected following
accidental ingestion of the Miconazole buccal
Dosage & Administration tablet. However, reapplication of a new tablet
Twice daily. may be required. In cases of reduced salivary
production, tablet erosion may be prolonged
Contraindication & Precaution or inhibited. A minimal salivary production is
No contraindication is known. required to guarantee complete disintegration

G Side Effect
Topical application of Miconazole Nitrate has
of the tablet & release of the active drug
substance.

almost no side Effect. Side Effect


Nausea & taste perversion are common side
Use in Pregnancy & Lactation effects experienced with Miconazole buccal
Miconazole Nitrate should be used with tablet. Allergic reaction is rarely observed.
caution during pregnancy. Mouth irritation, oral numbness, vomiting,
diarrhoea & dizziness are uncommon side
Preparation effects.
10 gm Cream.
Use in Pregnancy & Lactation
Pregnancy: There are no adequate data from
the use of Miconazole Nitrate in pregnant
women. Caution should be exercised when
Fungidal BT prescribing to pregnant women. Lactation:
No adequate data on excretion of Miconazole
Active Ingredient Nitrate in human milk are available. Caution
Miconazole Nitrate. should be exercised when prescribing to
breastfeeding women.
Indication
For the treatment & prevention of Preparation
Oropharyngeal & Esophageal Candidiasis. 10 mg buccal Tablet.

Dosage & Administration


1 tablet daily (apply in the morning) for 7 days.
Miconazole should be applied to the gingiva
107
Product Guide

Fungidal-HC Dosage & Administration


Tablet : In mild cases, 20 mg daily or 40 mg on
alternate days. In resistant cases, 80 mg/day.
Active Ingredient Children- 1 to 3 mg/kg/day, max. 40 mg/day.
Miconazole Nitrate & Hydrocortisone. Injection : 20-50 mg/day IM/IV. Children- 0.5-
1.5 mg/kg/day. max. 20 mg/day.
Indication
Inflamed dermatoses such as intertrigo & Contraindication & Precaution
infected eczema, primary irritant or contact Anuria, electrolyte deficiency & pre-
allergic eczema or seborrheic eczema including comatose states associated with liver
that associated with acne. perianal & genital cirrhosis. Hypersensitivity to furosemide or
dermatitis. sulphonamides.

Dosage & Administration Side Effect


Two or three times daily. Alkalosis, uric acid retention & may rarely
produce acute gout. Fusid may provoke
Contraindication & Precaution hyperglycemia & glycosuria.
Hypersensitivity. It should be used with caution
when applied to extensive surface areas or Drug Interaction
under occlusive dressings including baby ACE inhibitors, lithium. The toxic Effects of

G
napkins. nephrotoxic antibiotics may be increased by
concomitant administration of potent diuretics
Side Effect such as furosemide.
Local sensitivity may occur. Corticosteroids
can be absorbed sufficient amount to produce Use in Pregnancy & Lactation
systemic Effects. Fusid should be cautiously used in cardiogenic
shock complicated by pulmonary oedema
Drug Interaction & in the first trimester of pregnancy. Blood
Amphotericin antagonises effect of Miconazole. pressure & pulse during rapid diuresis should
be monitored. Should be used with caution
Use in Pregnancy & Lactation during lactation.
Topical steroids should not be extensively used
in pregnancy. Preparation
40 mg Tablet & 20 mg/2 ml Injection.
Preparation
10 gm Cream.

Fusid Plus
Fusid Active Ingredient
Spironolactone + Furosemide.
Active Ingredient
Furosemide.
Indication
Essential hypertension, Chronic
Indication
congestive heart failure, Hepatic cirrhosis with
Cardiac, pulmonary, hepatic & renal oedema,
ascites, Swelling due to excess fluid retention
peripheral oedema & hypertension.
(edema), Hyperaldosteronism, resistant edema
108
Product Guide
associated with secondary hyperaldosteronism. treatment is essential.

Dosage & Administration Preparation


Fusid plus: 1 to 4 tablets daily, Fusid 40 plus: (Spironolactone 50 mg & Furosemide 20 mg)/
one to two tablets daily. Tablet, (Spironolactone 50 mg & Furosemide 40
mg)/ Tablet.
Contraindication & Precaution
Anuria, acute renal insufficiency, rapidly
deteriorating or severe impairment of renal
function (creatinine clearance: < 30 ml/
min), hyperkalaemia, Addisons disease,
& in patients who are hypersensitive to
spironolactone, furosemide or sulphonamides. Gabastar
Caution should be taken in patients liable to
electrolyte deficiency. Used with caution in Active Ingredient
diabetes, enlarged prostate, hypotension & in Gabapentin.
hypovolemia.
Indication
Side Effect Gabastar (Gabapentin) is indicated for
Headache & drowsiness, gastrointestinal . Neuropathic Pain

G distress including cramp & diarrhoea, ataxia, . Adjunctive therapy in partial seizure &
mental confusion, skin rashes, gynaecomastia, secondary generalized seizure
hirsutism, deepening of the voice, menstrual
irregularities, impotence, hyponatremia, Dosage & Administration
hyperkalemia, dehydration & reduction in Neuropathic Pain: The treatment may be
blood volume with circulatory collapse, cardiac initiated as a single 300 mg dose on Day-1, than
arrhythmias. 300 mg twice on Day-2 & 300 mg thrice on Day-
3. The dose can be subsequently be titrated up
Drug Interaction as needed for pain relief to a daily dose of 1800
ACE inhibitors, potassium salts, cardiac mg (divided TID).
glycosides, corticosteroids, indomethacin Epilepsy: Patients over 12 years of age - the
& other non-steroidal anti-inflammatory Effective dose of Gabastar is 900 to 1800 mg/
drugs (NSAIDs), aminoglycoside antibiotics, day given in three divided doses. The starting
sucralfate. dose is 300 mg three times a day.
Paediatric patients age 3-12 years- the starting
Use in Pregnancy dose should range from 10-15 mg/kg/day in 3
Furosemide should only be used in women divided doses, & the Effective dose reached by
in child bearing age when appropriate upward titration over a period of approximately
contraceptive measures are taken or if the three days.
potential benefits justify the potential risks to In case of renal impaired patients Gabapentin
the foetus. doses must be reduced.
Gabapentin can be taken orally with or without
Use in Lactation food.
If use of Spironolactone is considered essential,
an alternative method of infant feeding should Contraindication & Precaution
be instituted. Furosemide is excreted in breast Gabapentin is contraindicated in patients
milk & breast-feeding should be discontinued if who have known hypersensitivity to the drug.
109
Product Guide
Patients should not drive a car or operate Side Effect
complex machinery until they have gained Nausea, vomiting, diarrhoea, allergic reactions.
sufficient experiences about Gabapentin
whether or not it affects their mental and/ or Contraindication & Precaution
motor performance adversely. Known hypersensitivity to the active drug.
If the concomitant use of Miconazole &
Side Effect anticoagulants is envisaged, the anti-
Fatigue, Dizziness, ataxia, weight gain, coagulant Effect should be carefully
peripheral edema, dry mouth & somnolence monitored & titrated. It is advisable to monitor
may occur. Miconazole & phenytoin levels, if they are used
concomitantly. Particularly in infants & young
Use in Pregnancy & Lactation children, caution is required to ensure that the
Pregnancy category C. it should be used during gel does not obstruct the throat.
pregnancy only if potential benefits justifies
the potential risk to the fetus. Drug Interaction
Gabapentin may be secreted through the Terfenadine, astemizole, mizolastine, cisapride,
breast milk. So it should be used during triazolam, oral midazolam, dofetilide, quinidine,
lactation only if potential benefits justifies the pimozide, simvastatin & lovastatin.
potential risk to the baby.
Use in Pregnancy & Lactation
Preparation
100 mg & 300 mg Tablet.
Miconazole Oral Gel should be avoided in
pregnant women if possible. The potential G
hazards should be balanced against the
possible benefits. Caution should be exercised
when prescribing Miconazole Oral Gel to
nursing mothers.

Gelora Preparation
20 mg/gram Oral Gel.

Active Ingredient
Miconazole.

Indication

Genacyn Injection
Treatment & prevention of fungal infections of
the oropharynx & gastrointestinal tract, & of
super infections due to Gram-positive bacteria.
Active Ingredient
Dosage & Administration Gentamicin.
Adults : 1-2 teaspoonfuls of gel four times daily,
Children aged 6 years & over: One tea-spoonful Indication
of gel four times daily, Children aged 2-6 years: Septicaemia & neonatal sepsis, meningitis &
One tea-spoonful of gel twice daily , Infants other CNS infection; biliary tract infection, acute
under 2 years : Half tea-spoonful of gel twice pyelonephritis or prostatitis, endocarditis.
daily.
Dosage & Administration
2-5 mg/kg body wt. daily, in divided doses
110
Product Guide
every 8 hours or as directed by the physician. sycosis barbae, minor surgical wounds, infected
contact dermatitis caused by susceptible
Contraindication & Precaution organisms.
Hypersensitivity, myasthenia gravis, renal
failure. Dosage & Administration
Apply 3-4 times daily. Before application the
Side Effect area should be washed with soap & water
Vestibular damage, reversible nephrotoxicity, & dried thoroughly. The treated area may
auditory ototoxicity may occur. Symptoms be covered with gauze dressing if desired. If
are dizziness, vertigo, tinnitus, roaring in the crusts present, it should be removed before
ears, rarely hearing loss. Also numbness, skin application of ointment to provide maximum
tingling, muscle twitching, convulsions. contact with the infecting organisms.

Drug Interaction Precaution


Concurrent use with other potentially It should not be used to patients with
nephrotoxic or ototoxic drug substances hypersensitivity to Gentamicin.
should be avoided. Frusemide & piretanide
may potentiate the ototoxicity of gentamicin Side Effect
& ethacrynic acid, which is ototoxic in its own Itching, redness, swelling or other signs of
right, should be avoided with gentamicin. irritation.

G Use in Pregnancy & Lactation Preparation


Gentamicin should only be used where the 0.1% Ointment.
seriousness of the mothers condition justifies
the risk.

Preparation
20 mg/2 ml Injection,
80 mg/2 ml Injection.
Genisia TM

Active Ingredient
Thiopental Sodium.

Genacyn Ointment
Indication
Genisia is used for the following cases:

Active Ingredient Induction of general anesthesia


Gentamicin. Anesthesia of short duration
Indication
Reduction of raised intracranial pressure
if ventilation controlled
Burns, eczema, seborrheic dermatitis,
ecthyma, excoriation, folliculitis, furunculosis, Status epilepticus
insect bites & stings, lacerations & abrasions,
paronychia, pyoderma gangrenosum, skin Dosage & Administration
cysts & abscesses, stasis ulcers & infected skin Induction of general anesthesia:
ulcers, bacterial, fungal or viral superinfection, Adults: By intravenous injection usually as a
2.5% (25 mg/ml) solution, initially 100-150
111
Product Guide
mg over 10-15 seconds, followed by further Drug Interaction
quantity if necessary according to response The following drug interactions have been
after 30-60 seconds up to 4 mg/kg (max. 500 reported with Thiopental.
mg).
Child: 2-7 mg/kg body weight. Drug Effect
Raised intracranial pressure: By intravenous Probenecid Prolonged action of Thiopental
injection 1.5-3 mg/kg may be given to reduce Diazoxide Hypotension Zimelidine Thiopental
intraoperative elevations of intracranial antagonism Opioid analgesics Decreased anti
pressure (repeated as required). nociceptive action Aminophylline Thiopental
Status epilepticus (only if other measures fail): antagonism
by intravenous injection as a 2.5% (25 mg/kg) Midazolam Synergism
solution, 75-125 mg as a single dose.
Use in Pregnancy & Lactation
Contraindication & Precaution Pregnancy Category C. Animal reproduction
Absolute Contraindication: studies have not been conducted with
Thiopental. It is also not known whether
Absence of suitable veins for intravenous
Thiopental can cause fetal harm when
administration
administered to a pregnant woman or can
Hypersensitivity (allergy) to barbiturates affect reproduction capacity. Thiopental
should be given to a pregnant woman only

G
Variegate porphyria (South African) or acute if clearly needed. Thiopental sodium readily
intermittent porphyria
crosses the placental barrier & small amounts
Relative Contraindication may appear in the milk of nursing mothers
following administration of large doses.
Severe cardiovascular disease
Hypotension or shock Preparation
Each vial contains Thiopental Sodium USP 500
Conditions in which the hypnotic effect mg.
may be prolonged or potentiated excessive
premedication, Addisons disease, hepatic or
renal dysfunction, myxedema, increased blood
urea, severe anemia, asthma, myasthenia gravis
Status asthmaticus

Side Effect Germisol Hand Rub


Adverse reactions include respiratory
depression, myocardial depression, cardiac Active Ingredient
arrhythmias, prolonged somnolence & Chlorhexidine Gluconate
recovery, sneezing, coughing, bronchospasm,
laryngospasm & shivering. Anaphylactic & Indication
anaphylactoid reactions to Thiopental Sodium For the disinfection of clean & intact skin. For
have been reported. Symptoms, e.g., urticaria, pre-operative surgical h & disinfection, hand
bronchospasm, vasodilation & edema should disinfection on the ward prior to aseptic
be managed by conventional means. Rarely, procedures or after handling contaminated
immune hemolytic anemia with renal failure & materials.
radial nerve palsy have been reported. For disinfection of the patients skin prior to
surgery or other invasive procedures.
112
Product Guide
Dosage & Administration Drug Interaction
For external use only. Chlorhexidine is incompatible with soaps &
Adults: other anionic agents. Hypochlorite bleaches
Pre-operative surgical hand disinfection: may cause brown stains to develop in fabrics
Dispense 5 ml of solution & spread thoroughly which have previously been in contact with
over both hands & forearms, rubbing chlorhexidine solutions.
vigorously. When dry apply a further 5 ml &
repeat the procedure. Use in Pregnancy & Lactation
Antiseptic hand disinfection on the ward: No untoward effects are known.
Dispense 3 ml of solution & spread thoroughly
over the hands & wrists rubbing vigorously Preparation
until dry. 0.5% w/v Chlorhexidine Gluconate in 70% v/v
Disinfection of patients skin: Prior to surgery Isopropyl Alcohol.
apply the solution to a sterile swab & rub
vigorously over the operation site for a
minimum of 2 minutes. Chlorhexidine
Gluconate is also used for preparation of
the skin prior to invasive procedures such as
venepuncture.
Elderly & children: There are no special dosing Geston
G regimes for children & the elderly.
Active Ingredient
Allylestrenol.
Contraindication & Precaution
Chlorhexidine Gluconate is contraindicated
for persons who have previously shown a Indication
hypersensitivity to Chlorhexidine. However, Threatened abortion
such reactions are extremely rare.
Avoid contact with the brain, meninges or Habitual abortion
middle ear. Do not use for injection. Do not use Threatened premature delivery
in body cavities. The solution is irritant to the
eyes & mucous membranes. Keep out of contact Dosage & Administration
with eyes. If chlorhexidine solutions come into Threatened abortion: 1 tablet three times daily
contact with the eyes, wash out promptly until symptoms disappear.
& thoroughly with water. The preparation is Habitual abortion : 1 - 2 tablets daily as soon
flammable due to its alcohol content. When as pregnancy is diagnosed. The administration
use is to be followed by diathermy do not allow should be continued for at least one month
pooling of the fluid to occur, & ensure that the after the end of the critical period.
skin & surrounding drapes are dry. Prolonged Threatened premature delivery : Dosage must
skin contact with alcoholic solutions should be be determined individually. High dosages (up
avoided, allow drying before proceeding. to 40mg daily) have been used.

Side Effect Missed dose: In case of a missed dose it should


Irritative skin reactions can occasionally occur. be taken as soon as the patient remembers
Generalised allergic reactions have also been & she should continue the regular dosing
reported but are extremely rare. schedule. A double dose is not recommended.
113
Product Guide
Contraindication & Precaution Contraindication & Precaution
Hypersensitivity; thrombophleobitis; undiagnosed Sensitivity to the ingredients. Do not use
vaginal bleeding, incomplete abortion, hormone- unless the patient needs to be treated (when
dependent carcinoma, cerebral apoplexy, as a constipated).
diagnostic test for pregnancy; severe hepatic
impairment. Side Effect
Glycerin when used rectally may cause rectal
Side Effect discomfort or a burning sensation.
Treatment with Allylestrenol (especially a long
term treatment with it) is known to cause some Use in Pregnancy & Lactation
gastrointestinal complaints such as vomiting, Pregnancy category C. There are no controlled
nausea, & sometimes epigastric discomfort. data in human pregnancy.

Use in Pregnancy & Lactation Preparation


Specially designed for pregnancy. Should not 1.15 gm & 2.30 gm Suppository
be used during lactation.

Use in Children
It should not be used for children younger than
16 years old.

Preparation Gynepro G
5 mg tablet.
Active Ingredient
Metronidazole, Neomycin Sulphate, Polymyxin
B Sulphate, Nystatin.

Indication

Glysup Suppository
Vaginal trichomoniasis, vaginal leucorrhoeas,
mixed vaginal infections (Fungal or Bacterial).

Active Ingredient Dosage & Administration


Glycerin One suppository in vagina at bedtime for 12 days,
or as directed by the physician.
Indication
For the relief of occasional constipation. Contraindication & Precaution
Contraindicated to the patients who are
Dosage & Administration hypersensitive to Metronidazole, Neomycin
Children under 2 years: Consult with a physician. Sulphate, Polymyxin B Sulphate & Nystatin. Caution
Children (2 to 6 years): Only 1 Glysup 1.15 should be taken in case of renal impairment.
suppository per 24 hours or as directed by the
physician. Side Effect
Adults & Children (From 6 years): only 1 Glysup Skin rash, urticaria may occur rarely.
2.30 suppository per 24 hours or as directed by
the physician. Insert suppository well up into Use in Pregnancy & Lactation
rectum. Suppository needs to melt completely Caution should be practiced in pregnancy &
to produce laxative action. lactation.
114
Product Guide
Preparation to a large surface area or under an occlusive
Each box contains 2 x 6's vaginal suppositories. dressing should be evaluated periodically for
evidence of HPA axis suppression by using
the urinary free cortisol & ACTH stimulation
tests. If HPA axis suppression is noted, an
attempt should be made to withdraw the
drug, to reduce the frequency of application,
Halobet
TM
or to substitute a less potent steroid. Recovery
of HPA axis function is generally prompt &
complete upon discontinuation of the drug.
Active Ingredient Infrequently, signs & symptoms of steroid
Halobetasol Propionate. withdrawal may occur, requiring supplemental
systemic corticosteroids.
Indication
Halobet (Halobetasol Propionate) cream Side Effect
& ointment are a super-high potency In controlled clinical trials, the most frequent
corticosteroid indicated for the relief of the adverse events reported for Halobet included
inflammatory & pruritic manifestations of stinging, burning or itching in 4.4% of the
corticosteroid-responsive dermatoses. patients. Less frequently reported adverse
reactions were dry skin, erythema, skin atrophy,

H
Dosage & Administration leukoderma, vesicles & rash. The following
Apply a thin layer to the affected skin once or additional local adverse reactions are reported
twice daily, as directed by your physician & rub infrequently with topical corticosteroids, & they
in gently & completely. Halobet(Halobetasol may occur more frequently with high potency
Propionate) is a super-high potency topical corticosteroids, such as Halobet.These reactions
corticosteroid; therefore, treatment should are listed in an approximate decreasing order
be discontinued when control is achieved. of occurrence: foluliculitis, hypertrichosis,
If no improvement is seen within 2 weeks, acneiform eruptions,hypopigmentation,
reassessment of diagnosis may be necessary. perioral dermatitis, allergic contact dermatitis,
Halobet should not be used with occlusive seconday infection, striae & miliaria.
dressings.
Drug Interaction
Contraindication & Precaution No such report has been founded.
Halobetasol Propionate is contraindicated in
those patients with a history of hypersensitivity Use in Pregnancy & Lactation
to any of the components of the preparations. Corticosteroids are generally teratogenic
Systemic absorption of topical corticosteroids in laboratory animals when administered
has produced reversible hypothalamic- systemically at relatively low dosage levels.
pituitary-adrenal (HPA) axis suppression, The more potent corticosteroids have
manifestations of Cushings syndrome, been shown to be teratogenic after dermal
hyperglycemia, & glucosuria in some application in laboratory animals. There are
patients. Conditions which augment systemic no adequate & well-controlled studies in
absorption include the application of the more pregnant women on teratogenic effects from
potent steroids, use over large surface areas, topically applied corticosteroids. Therefore,
prolonged use, & the addition of occlusive topical corticosteroids should be used during
dressings. Therefore, patients receiving a pregnancy only if the potential benefit justifies
large dose of a potent topical steroid applied the potential risk to the fetus. Drugs of this class
115
Product Guide
should not be used extensively on pregnant increased depending on severity.
patients, in large amounts, or for prolonged
periods of time.
It is not known whether topical administration Side Effect
of corticosteroids could result in sufficient Gastric disorder & neurovegetative disorders
systemic absorption to produce detectable (feeling of discomfort).
quantities in breast milk. Systemically
administered corticosteroids are secreted into Use in Pregnancy & Lactation
breast milk in quantities not likely to have a Experimental studies in animal have not
deleterious effect on the infant. Nevertheless, demonstrated any teratogenic effects & no
caution should be exercised when topical harmful effect have been reported in women
corticosteroids are administered to a nursing to date.
woman. breast feeding is not recommended during
treatment.
Use in Children
Not recommended for use in children. Preparation
(Diosmin 450 mg + Hesperidin 50 mg)/Tablet.
Preparation
Halobet 0.05% Cream - Each pack has a
laminated tube containing 10 gm cream.
Halobet 0.05% Ointment - Each pack has a
laminated tube containing 10 gm ointment. H
Hepavir
Active Ingredient
Lamivudine.

Hemorif Indication
Chronic hepatitis B with evidence of hepatitis
Active Ingredient B viral replication & active liver inflammation.
Micronised Diosmin & Hesperidin
Dosage & Administration
Indication 100 mg once daily.
Acute hemorrhoidal attacks, Chronic
hemorrhoidal disease, Organic & functional
chronic venous insufficiency of the lower limbs Contraindication & Precaution
with the following symptoms: heavy legs, pain, Known hypersensitivity.
nocturnal cramps.
Side Effect
Dosage & Administration Lactic acidosis & severe hepatomegaly with
Acute hemorrhoidal attacks: 3 tablets twice daily steatosis, post treatment exacerbations of
for 4 days, then 2 tablets twice daily for three hepatitis B, pancreatitis, & emergence of viral
days & if required then 1 tablet twice daily. mutants malaise, fatigue, fever, ENT infections,
Chronic hemorrhoids : 1 tablet twice daily, sore throat, nausea, vomiting, abdominal
Chronic venous insufficiency : 1 tablet twice discomfort, pain, diarrhea, myalgia, arthralgia,
daily initially for seven days. Duration may be headache, skin rashes may occur.
116
Product Guide
Drug Interaction Use in Pregnancy & Lactation
Trimethoprim /Sulfamethoxazole. Although studies in animal did not demonstrate
any teratogenic Effect of loperamide, it should
Use in Pregnancy & Lactation not be administered during pregnancy. The
Lamivudine should be used during pregnancy fraction of loperamide secreted in the human
only if the potential benefits outweigh the milk is very low, but caution is advised if it is to
risks. Mothers should be instructed not to be administered to nursing mothers.
breast feed if they are receiving Lamivudine.
Preparation
Preparation 2 mg Capsule.
100 mg Tablet.

Inflagic
Imotil
Active Ingredient
Active Ingredient

I
Loperamide. Prednisolone.

Indication Indication
Acute & chronic diarrhoea, IBS (Diarrhoea Endocrine Disorders, Rheumatic disorders,
predominant). Collagen Diseases, Dermatologic Diseases,
Allergic States, Ophthalmic Diseases,
Dosage & Administration Respiratory Diseases, Hematologic Disorders,
Acute diarrhoea: The initial dose is 2 capsules Neoplastic Diseases, Edematous States,
for adults & 1 capsule for children older than Gastrointestinal Diseases
eight; in addition 1 capsule should be taken
at any subsequent loose stool. The daily dose, Dosage & Administration
however should not exceed 8 capsules for The initial dose may vary from 5 mg to 60 mg
adults, for children 4-6 capsules according to per day depending on the specific disease.
age. Chronic diarrhoea Initial dose: Adults: 2 After a favorable response is noted, the proper
capsules daily. Children: Older than eight: 1 maintenance dosage should be determined
capsule daily. by decreasing the initial drug dosage in small
decrements at appropriate time intervals
Contraindication & Precaution until the lowest dosage which will maintain
It should not be used in children less than 4 an adequate clinical response is reached.
years of age. Constant monitoring is needed in regard to
drug dosage. If after long-term therapy the
Side Effect drug is to be stopped, it is recommended that
Paralytic ileus, abdominal cramps & bloating it should be withdrawn gradually rather than
urticaria, nausea, vomiting, constipation, abruptly. Multiple Sclerosis: In the treatment of
tiredness, drowsiness, dizziness & dry mouth. acute exacerbations of multiple sclerosis daily
doses of 200 mg of prednisolone for a week
followed by 80 mg every other day for 1 month
have been shown to be effective.
117
Product Guide
Contraindication & Precaution Use in Pregnancy & Lactation
Systemic fungal infections & known Since adequate human reproduction studies
hypersensitivity to components. have not been done with corticosteroids,
the use of these drugs in pregnancy, nursing
Side Effect mothers or women of childbearing potential
Fluid & Electrolyte Disturbance: Sodium requires that the possible benefits of the drug
retention, Fluid retention, Congestive heart be weighed against the potential hazards to
failure in susceptible patients, Potassium the mother & embryo or fetus. Infants born
loss, Hypokalemic alkalosis, Hypertension. of mothers, who have received substantial
Musculoskeletal: Muscle weakness, Steroid doses of corticosteroids during pregnancy,
myopathy, Loss of muscle mass, Osteoporosis, should be carefully observed for signs of
Tendon rupture, particularly of the Achilles hypoadrenalism. Dietary salt restriction &
tendon, Vertebral compression fractures, potassium supplementation may be necessary.
Aseptic necrosis of femoral & humeral All corticosteroids increase calcium excretion.
heads, Pathologic fracture of long bones.
Gastrointestinal: Peptic ulcer with possible Preparation
perforation & hemorrhage, Pancreatitis, 5 mg & 20 mg tablet.
Abdominal distention, Ulcerative esophagitis,
Increases in alanine transaminase (ALT,
SGPT), aspartate transaminase (AST, SGOT)
& alkalinephosphatase have been observed
following corticosteroid treatment. These I
changes are usually small, not associated
with any clinical syndrome & are reversible
Intimate TM

upon discontinuation.Dermatologic:
Impaired wound healing, thin fragile skin, Active Ingredient
Petechiae & ecchymoses, Facial erythema, Tadalafil.
increased sweating, & may suppress
reactions to skin tests. Metabolic: Negative Indication
nitrogen balance due to protein catabolism. Erectile Dysfunction (ED) & the signs &
Neurological: Increased intracranial pressure symptoms of Benign Prostatic Hyperplasia
with papilledema, (pseudo-tumor cerebri) (BPH).
usually after treatment, Convulsions Vertigo,
Headache. Endocrine: Menstrual irregularities, Dosage & Administration
Development of Cushingoid state, Secondary Erectile Dysfunction
adrenocortical & pituitary unresponsiveness, For Use as Needed
particularly in times of stress, as in trauma, The recommended starting dose of Tadalafil
surgery or illness, Suppression of growth in for use as needed in most patients is 10 mg,
children, Decreased carbohydrate tolerance, taken prior to anticipated sexual activity.
Manifestations of latent diabetes mellitus,
Increased requirements for insulin or oral The dose may be increased to 20 mg or
hypoglycemic agentsin diabetics. Ophthalmic: decreased to 5 mg, based on individual efficacy
Posterior subcapsular cataracts, increased & tolerability. The maximum recommended
intraocular pressure, Glaucoma, Exophthalmos. dosing frequency is once per day in most
Additional Reactions: Urticaria & other allergic, patients.
anaphylactic or hypersensitivity reactions.
118
Product Guide
For Once Daily Use prescribed to these patients.
The recommended starting dose of Tadalafil for Severe : The use of Tadalafil is not
once daily use is 2.5 mg, taken at approximately recommended.
the same time every day, without regard to
timing of sexual activity. Geriatrics
The Tadalafil dose for once daily use may be
increased to 5 mg, based on individual efficacy No dose adjustment is required in patients >65
& tolerability. years of age.
Use with Food
Tadalafil may be taken without regard to food. Contraindication
ild (creatinine clearance 51 to 80 mL/min): No Nitrates
dose adjustment is required. Administration of Intimate to patients
Moderate (creatinine clearance 31 to 50 mL/ who are using any form of organic nitrate,
min): A starting dose of 5 mg not more than either regularly and/or intermittently, is
once per day is recommended, & the, maximum contraindicated. In clinical pharmacology
dose should be limited to 10 mg not more than studies, Intimate was shown to potentiate the
once in every 48 hours. hypotensive effect of nitrates.
Severe (creatinine clearance <30 mL/min & on
hemodialysis): The maximum recommended Hypersensitivity Reactions
dose is 5 mg not more than once in every 72 Intimate is contraindicated in patients with

I hours a known serious hypersensitivity to tadalafil.


Hypersensitivity reactions have been reported,
Tadalafil for Once Daily Use including Stevens-Johnson syndrome &
Mild (creatinine clearance 51 to 80 mL/min): exfoliative dermatitis.
No dose adjustment is required.
Moderate (creatinine clearance 31 to 50 mL/ Side Effect
min): No dose adjustment is required. Body as a whole: hypersensitivity reactions
Severe (creatinine clearance <30 mL/min & on including rash, urticaria, facial edema, Stevens-
hemodialysis): Tadalafil for once daily use is not Johnson syndrome, & exfoliative dermatitis.
recommended. Cardiovascular & cerebrovascular: Serious
cardiovascular events, including myocardial
Hepatic Impairment infarction, sudden cardiac death, unstable
angina pectoris, ventricular arrhythmia,
Tadalafil for Use as Needed stroke, transient ischemic attacks, chest pain,
Mild or moderate : The dose of Tadalafil should palpitations, & tachycardia, may occur. Most of
not exceed 10 mg once per day. The use of the patients in whom these events have been
Tadalafil once per day has not been extensively reported had pre-existing cardiovascular risk
evaluated in patients with hepatic insufficiency factors. However, it is not possible to definitively
& therefore, caution is advised. determine whether these events are related
Severe : The use of Tadalafil is not recommended directly to these risk factors, to Tadalafil, to
sexual activity, or to a combination of these or
Tadalafil for Once Daily Use other factors. Hypotension (more commonly
reported when tadalafil is given to patients
Mild or moderate : Tadalafil for once daily use who are already taking antihypertensive
has not been extensively evaluated in patients agents), hypertension, & syncope.
with hepatic insufficiency. Therefore, caution
is advised if Tadalafil for once daily use is Skin & subcutaneous tissues: hyperhidrosis
119
Product Guide
(sweating).
Gastrointestinal: abdominal pain & Iprex TM
HFA Inhaler
gastroesophageal reflux.
Nervous system: migraine, transient global Active Ingredient
amnesia Ipratropium.
Respiratory system: epistaxis (nose bleed)
Special senses: blurred vision, nonarteritic Indication
anterior ischemic optic neuropathy, retinal vein Asthma & Chronic Obstructive Pulmonary
occlusion, visual field defect. Diseases including chronic bronchitis &
Otologic: Cases of sudden decrease or loss of emphysema.
hearing have been reported.
Dosage & Administration
Pregnancy & Lactation Adults :1-2 puffs (20 mg/puff) 3-4 times daily.
Intimate is not indicated for use in newborn, Children: 1-2 puffs 2-3 times daily.
children or women.
Contraindication & Precaution
Precaution Known hypersensitivity.
Evaluation of erectile dysfunction & BPH should
include an appropriate medical assessment Side Effect
to identify potential underlying causes, as Dryness of the mouth, oropharynx, cough,

I
well as treatment options. Before prescribing exacerbation of symptoms, & imitation from
Intimate, it is important to note the following: aerosol, headache, nausea, dizziness, blurred
Cardiovascular status of the patient, Interaction vision/difficulty in accommodation & drying
with other medicines (Nitrates, alpha-blocker, of secretions. Less frequently tachycardia,
anti-hypertensive & potent inhibitors of nervousness, paresthesias, drowsiness, co-
CYP3A4) & with substantial consumption of ordination difficulty, itching, flushing, alopecia,
alcohol, sudden loss of vision, sudden hearing constipation, tremor & mucosal ulceration.
loss, renal insufficiency & hepatic impairment.
Preparation
Overdosage 20 mcg/puff, 200 puffs.
Adverse events were similar to those seen at
lower doses. In case of overdose, standard
supportive measure should be adopted as
required. Hemodialysis contributes negligible
to tadalafil elimination

Preparation
Iprex TM
Respirator Solution
5, 10 & 20 mg Tablet.
Active Ingredient
Ipratropium.

Indication
Maintenance treatment of bronchospasm
associated with chronic obstructive pulmonary
disease, including chronic bronchitis &
emphysema.
120
Product Guide
Dosage & Administration Preparation
Adults - 0.4-2 ml (100-500 mcg) of Ipratropium 250 mcg/ml Respirator Solution.
bromide should be diluted to a final volume of
2.0-4.0 ml with normal saline 0.9% administered
four times daily. Children (over 3 years) - The
same mode of administration is applicable
to children. 0.4-2 ml of the prepared solution
administered 3 times daily.
Iracet TM

Contraindication & Precaution Active Ingredient


Contraindicated in patients with a history of Levetiracetam
hypersensitivity to soya lecithin or related
food products such as soybean & peanut, Indication
known or suspected cases of hypersensitivity Iracet (Levetiracetam) is indicated as an
to ipratropium bromide, or to atropine & its adjunctive therapy for Partial Onset Seizures,
derivatives. Ipratropium bromide should be Myoclonic Seizures in Patients with Juvenile
used with caution in patients with narrow- Myoclonic Epilepsy, Primary Generalized Tonic-
angle glaucoma, prostatic hypertrophy or Clonic Seizures
bladder-neck obstruction.

I
Dosage & Administration
Side Effect Iracet (Levetiracetam) can be initiated with
Dry mouth through inhibition of salivary either intravenous or oral administration.
flow, dryness of the oropharynx; cough, For tablet & oral solution: Treatment should
exacerbation of symptoms, & irritation from be initiated with a daily dose of 1000 mg/day,
aerosol; headache; nausea, dizziness, blurred given as twice-daily dosing (500 mg twice
vision/difficulty in accommodation & drying daily). Additional dosing increments may be
of secretions, tachycardia, nervousness, given (1000 mg/day additional every 2 weeks)
paresthesias, drowsiness, coordination to a maximum recommended daily dose of
difficulty, itching, hives, flushing, alopecia, 3000 mg.
constipation, tremor & mucosal ulceration,
worsening of narrow-angle glaucoma, acute Use in Pediatric Patients
eye pain, hypotension, Allergic-type reactions Age/weight Initial dose Incremental
(Daily) dose (Daily)
such as skin rash, angio-oedema of tongue,
1 Month To < 6 7 mg/kg twice 21 mg/kg twice
lips & face, urticaria (including giant urticaria), Months daily daily
laryngospasm & anaphylactic reaction.
6 Months To < 4 10 mg/kg twice 25 mg/kg twice
Years daily daily
Drug Interaction 4 Years To < 16 10 mg/kg twice 30 mg/kg twice
There are no studies fully evaluating the Years daily daily
interaction Effects of Ipratropium. Adolescent with 250 mg twice 750 mg twice
20- 40 kg body daily daily
weight
Use in Pregnancy & Lactation
*The daily dose should be increased every 2
Pregnancy Category B., Ipratropium bromide
weeks.
should be used during pregnancy only if clearly

needed. It is not known whether ipratropium
Weight-Based Dosing Calculation For Pediatric
bromide is excreted in human milk.
Patients:
Total daily dose (mL/day) = Daily dose
121
Product Guide
(mg/kg/day) x patient weight (kg)/100 mg/mL Side Effect
Injection: Dizziness, drowsiness, irritability, sore throat,
Iracet (Levetiracetam) injection is for tiredness, weakness are some common
intravenous use only & must be diluted prior adverse effects. In rare cases severe allergic
to administration. Iracet (Levetiracetam) reaction may happen.
injection (500 mg/5 mL) should be diluted
in 100 mL of compatible diluents & Drug interaction
administered intravenously as a 15-minute IV No potential drug interaction has been
infusion. Product with particulate matter or reported
discoloration should not be used.
Use in Pregnancy & Lactation
Dosing Instructions Pregnancy category C.
Preparation & Administration
Dose Withdraw Volume Infusion Lactation: No data on the use of Levetiracetam
Volume of Diluent Time in breast-feeding women are available. Data
500 mg 5 ml (one 100 ml 15 from animals indicate that Levetiracetam is
5 ml minutes secreted into milk. Therefore Levetiracetam is
ampoule) contraindicated during breast-feeding
1000 mg 10 ml 100 ml 15
(two 5 ml minutes Use in Children

I
ampoules)
The safety & effectiveness of Levetiracetam
1500 mg 15 ml 100 ml 15 in the adjunctive treatment of partial onset
(three minutes
5 ml
seizures in pediatric patients age 1 month to 16
ampoules) years old with epilepsy have been established.

For example, to prepare a 1000 mg dose, dilute Preparation


10 ml of Iracet (Levetiracetam) injection in Iracet 250 mg & 500 mg Tablet, Injection: 50 ml
100 ml of a compatible diluents & administer oral solution.
intravenously as a 15-minute infusion.
Compatibility & Stability
Levetiracetam injection was found to be
physically compatible & chemically stable
when mixed with the following diluents &
antiepileptic drugs for at least 24 hours & stored
in polyvinyl chloride (PVC) bags at controlled
Isovent
room temperature 15-30C (59-86F).
Active Ingredient
Diluents
Misoprostol.
Sodium chloride (0.9%) injection, USP
Lactated Ringers injection
Indication
Dextrose 5% injection, USP
Antiulcerant Indication: Indicated for
Other Antiepileptic Drugs
reducing the risk of NSAID (nonsteroidal
Lorazepam
anti-inflammatory drugs, including aspirin)-
Diazepam
induced gastric ulcers in patients at high risk of
Valproate sodium
complications from gastric ulcer, eg, the elderly
& patients with concomitant debilitating
Contraindication & Precaution
disease, as well as patients at high risk of
None
122
Product Guide
developing gastric ulceration, such as patients between Misoprostol & cardiac, pulmonary
with a history of ulcer. & CNS drugs & NSAIDs. Bioavailability of
Gynecological Indication: Labor induction Misoprostol is decreased with high doses of
(in unfavorable cervical conditions) & in antacid.
the prevention & treatment of Post Partum
Hemorrhage (PPH) Use in Pregnancy & Lactation
Because of the abortifacient property of the
Dosage & Administration Misoprostol component, it is contraindicated
Antiulcerant Dosage & Administration: 200 in women who are pregnant. It should not
mcg four times daily with food. If this dose be used in women of childbearing potential
cannot be tolerated, a dose of 100 mcg can unless the patient requires nonsteroidal anti-
be used. Misoprostol should be taken for the inflammatory drug (NSAID) therapy & is at
duration of NSAID therapy as prescribed by the high risk of developing gastric or duodenal
physician. Misoprostol should be taken with a ulceration or for developing complications
meal, & the last dose of the day should be at from gastric or duodenal ulcers associated with
bedtime. the use of the NSAID. Because of the potential
Gynecological dosage & administration: for serious adverse reactions in nursing infants,
Induction of Labor: 25 mcg vaginally 6 hourly it is not recommended for use by nursing
or, 50 mcg orally 4 hourly. mothers.
Postpartum Hemorrhage (PPH) prophylaxis:

I 400 mcg to 600 mcg orally or rectally


immediately following delivery of the child.
Preparation
100 mcg, 200 mcg & 600 mcg Tablet.
Postpartum Hemorrhage (PPH) treatment:
1000 mcg rectally or, 200 mcg orally with 400
mcg sublingually.

Side Effect
Gastrointestinal: Abdominal pain, diarrhea &
other GI symptoms. Gynecological: Spotting, Itra
cramps, hypermenorrhea, menstrual disorder
& dysmenorrhea. Postmenopausal vaginal Active Ingredient
bleeding may be related to Misoprostol Itraconazole.
administration.
Indication
Contraindication & Precaution Candidiasis, pityriasis versicolor, tinea,
Misoprostol should not be taken by pregnant histoplasmosis. It is indicated in the treatment
women to reduce the risk of ulcers induced by of systemic candidiasis, aspergillosis,
nonsteroidal anti-inflammatory drugs (NSAIDs). cryptococcosis, in AIDS patients to prevent
Misoprostol should not be taken by anyone relapse of underlying fungal infections & in
with a history of allergy to prostaglandins. the prevention of fungal infection during
Precaution should be taken in conditions prolonged neutropenia.
where hypertension might precipitate
severe complications (e.g. Cerebrovascular & Dosage & Administration
cardiovascular disease). 100 mg -200 mg daily.

Drug Interaction Side Effect


No evidence of clinically significant interaction Nausea, abdominal pain, dyspepsia,
123
Product Guide
constipation, headache, dizziness, raised blocker dose & whose heart rate is > 60 bpm.
liver enzymes, menstrual disorders, allergic
reactions (including pruritus, rash, urticaria &
angioedema), hepatitis & cholestatic jaundice, Dosage & Administration
peripheral neuropathy & Stevens-Johnson The usual recommended starting dose of
syndrome reported. On prolonged use Ivabradine is 5 mg twice daily which may be
hypokalaemia, oedema & hair loss reported. increased after 3-4 weeks of treatment to 7.5
mg twice daily, depending on therapeutic
Contraindication & Precaution response. Usual dose is 1 tablet in the morning
Known hypersensitivity, severe hepatic disease. & 1 tablet in the evening during meals.

Drug Interaction Contraindication & Precaution


The drugs like terfenadine, astemizole, History of hypersensitivity to Ivabradine or
cisapride, HMG-CoA reductase inhibitors such any of the excipients, resting heart rate below
as simvastatin, oral midazolam or triazolam 60 bpm before treatment, cardiogenic shock,
should not be given concurrently with acute myocardial infarction, severe hypotension
Itraconazole. Significant interactions also (<90/50 mmHg), severe hepatic insufficiency,
observed during co-administration of rifampin, sick sinus syndrome, sino-atrial block, heart
phenytoin, phenobarbital, digoxin, & calcium failure, pacemaker dependent, unstable angina,
channel blockers. 3rd degree AV block, combination with strong

Use in Pregnancy & Lactation


cytochrome P450 3A4 inhibitors (such as azole
antifungals, macrolide antibiotics, HIV protease I
Itraconazole is contraindicated in pregnancy. inhibitors).
Breast feeding while receiving Itraconazole is Mild to moderate hypotension, Atrial fibrillation,
not recommended. Patients with congenital QT syndrome or
treated with QT wave prolonging medicinal
Preparation products, Moderate hepatic insufficiency,
100 mg Capsule. Severe renal insufficiency.

Side Effect
Visual symptoms, blurred vision, bradycardia,
1st degree AV block, ventricular extrasystoles,
Ivanor TM
headaches, & dizziness.

Drug Interaction
Active Ingredient
QT wave prolonging medicinal products is not
Ivabradine Hydrochloride.
recommended.
Indication Cardiovascular QT wave prolonging medicinal
Symptomatic treatment of chronic stable products (e.g. quinidine, disopyramide,
angina pectoris in coronary artery disease bepridil, sotalol, ibutilide, amiodarone). Non
patients with normal sinus rhythm. IvanorTM is cardiovascular QT wave prolonging medicinal
indicated: products (e.g. pimozide, ziprasidone, sertindole,
mefloquine, halofantrine, pentamidine,
In patients unable to tolerate or with a contra- cisapride, intravenous erythromycin).
indication to the use of beta-blockers, or
In combination with beta-blockers in patients &
The concomitant use of cardiovascular
non cardiovascular QT wave prolonging
inadequately controlled with an optimal beta-
124
Product Guide
medicinal products with Ivabradine should may result in overgrowth of non-susceptible
be avoided since QT wave prolongation may organisms, including fungi. If superinfection
be exacerbated by heart rate reduction. If the occurs, discontinue use & institute alternative
combination appears necessary, close cardiac therapy. Patients should be advised not to wear
monitoring is needed. contact lenses if they have signs & symptoms of
bacterial conjunctivitis.
Use in Pregnancy & Lactation
Fertility: Studies in rats have shown no Effect on Drug Interaction
fertility in males & females Drug-drug interaction studies have not been
Pregnancy: There are no or limited amount of conducted with Moxifloxacin Hydrochloride
data from the use of Ivabradine in pregnant ophthalmic solution.
women. Therefore, Ivabradine is contra-
indicated during pregnancy. Side Effect
Breast-feeding: Animal studies indicate that Ocular: Conjunctivitis, decreased visual acuity,
Ivabradine is excreted in milk. Therefore, dry eye, keratitis, ocular discomfort, ocular
Ivabradine is contra-indicated during breast- hyperemia, ocular pain, ocular pruritus,
feeding. subconjunctival hemorrhage, & tearing. Non-
ocular: fever, increased cough, infection, otitis
Use in Children media, pharyngitis, rash, & rhinitis.
Not recommended.

I Preparation
Use in Pregnancy & Lactation
Moxifloxacin Hydrochloride ophthalmic
5 mg & 7.5 mg Tablet. solution should be used during pregnancy only
if the potential benefit justifies the potential
risk to the fetus. Caution should be exercised
when Moxifloxacin hydrochloride ophthalmic
solution is administered to a nursing mother.

Preparation

Iventi Eye Drops 0.5% Eye Drops.

Active Ingredient
Moxifloxacin.

Indication Iventi 400 IV


Bacterial conjunctivitis.
Active Ingredient
Dosage & Administration Moxifloxacin
One drop in the affected eye 3 times a day for
7 days. Indication
Acute Bacterial Sinusitis, Acute Bacterial
Contraindication & Precaution Exacerbation of Chronic Community Acquired
In patients with a history of hypersensitivity Pneumonia, Uncomplicated Skin & Skin
to Moxifloxacin, to other quinolones, or to Structure Infection.
any of the components in this medication.
As with other anti-infectives, prolonged use
125
Product Guide
Dosage & Administration
Infection Dose Duration
Ketoral
Acute Bacterial 400 mg 10 days Active Ingredient
Sinusitis OD Ketoconazole.
Acute Bacterial 400 mg 5 days
Exacerbation of OD Indication
Chronic Bronchitis Superficial & deep mycoses.
C o m m u n i t y 400 mg 10 days
Dosage & Administration
A c q u i r e d OD
200 mg one tablet once daily.
Pneumonia
Uncomplicated Skin 400 mg 7 days Contraindication & Precaution
& Skin Structure OD Pregnancy & patients with acute liver
Infection pathology. In patients with a previous history
of liver disease, liver enzyme levels should be
monitored during treatment.

Side Effect
Contraindication & Precaution Nausea, itching, an idiosyncratic liver reaction

I
Moxifloxacin is contraindicated in persons with may occur (incidence 1:10,000).
a history of hypersensitivity to Moxifloxacin
or any member of the quinolone class of Drug Interaction
antimicrobial agents. Acyclovir have shown dose-dependent,
synergistic, antiviral activity against herpes
Side Effect simplex virus type 1 & 2 in
Iventi is generally well tolerated. The most in-vitro replication studies. Ketoconazole &
common side effects caused by Iventi, which vidarabine showed interference, indifference
are usually mild, include nausea, vomiting, or antagonism in vitro against these viruses.
stomach pain, diarrhea, dizziness & headache.
You should be careful about driving or Use in Pregnancy & Lactation
operating machinery until you are sure Iventi Ketoconazole is contraindicated in pregnancy.
is not causing dizziness. Breast-feeding is contraindicated in patients
taking this drug.
Pregnancy & Lactation
The safety & effectiveness of Moxifloxacin in Preparation
pregnant women, & lactating women have not 200 mg Tablet.
been established.

Preparation
Iventi 400 IV: Each box contains 1 bag of 250 ml
solution for intravenous infusion.
126
Product Guide

K-one MM by the baby during birth process), obstructive


jaundice, inability to swallow, maternal use
of anticoagulants or anti-epileptics]: 1 mg
Active Ingredient intramuscularly or intravenously at birth or
Phytomenadione. shortly after birth if the oral route is unsuitable.

Indication Intramuscular & intravenous doses should


not exceed 0.4 mg/kg in premature infants
Prophylaxis & treatment of haemorrhagic weighing less than 2.5 kg. The size &
disease in the newborn. frequency of further doses should be based on
Haemorrhage or risk of haemorrhage as a coagulation status.
result of severe hypoprothrombinemia (i.e.
deficiency of clotting factors II, VII, IX & X) Side Effect
of various etiologies, including over dosage There are isolated unconfirmed reports on the
possible occurrence of anaphylactoid reactions
of courmarin-type anticoagulants, their
& venous irritation or phlebitis after parenteral
combination with phenylbutazone, & other
use of Phytomenadione injections.
forms of hypovitaminosis K (e.g. in obstructive
jaundice as well as liver & intestinal disorders, Precaution & Contraindication
& after prolonged treatment with antibiotics, Careful monitoring of the coagulation
sulphonamides or salicylates). parameters is necessary for patients with

K
severely impaired liver function after
Prevention & treatment of bleeding due to administration of Phytomenadione. It is
vitamin K deficiency.
contraindicated in patients with known
hypersensitivity to any of its constituents.
Dosage & Administration
Prophylaxis: Mild Hemorrhage or hemorrhagic
Use in Pregnancy & Lactation
tendency: The usual dose for neonates is 2 mg Though Vitamin K1 does not readily cross
orally at or just after birth. Then 2 mg on 4th the placental barrier & only a small fraction
- 5th day & another 2 mg on 28th - 30th day of administered Vitamin K1 enters into
orally. the breast milk, it is not recommended for
If the oral route is unsuitable then 2 mg of Phytomenadione to be given to expectant
drug can be administered by IM or IV route. mothers as prophylaxis of hemorrhagic disease
Children over 1 year of age are could be given in the newborn. Vitamin K1 should be given
5-10 mg orally. A single 1 mg (0.1ml) dose IM is to pregnant women only if the benefit to the
recommended in children who are not assured mother outweighs the risk to the fetus.
of receiving a second oral dose or, in the case
of breast-fed children, who are not assured of Preparation
receiving a third oral dose. Phytomenadione 2 mg / 0.2 ml Oral / IM / IV
To ensure a total protection of the newborns,
3 prophylactic doses of Vitamin K should be
administered orally following the dosing
schedule mentioned above.

Therapy: Initially, 1 mg by intravenous injection,


with further doses as required, based on the
clinical picture & coagulation status.
Neonates with special risk factors (Pre-maturity,
birth asphyxia (inadequate intake of oxygen
127
Product Guide

Kop TM Drug Interaction


Anticoagulant or thrombolytic agent,
hydrochlorothiazide, salicylates, methotrexate.
Active Ingredient
Ketoprofen. Use in Pregnancy & Lactation
It is recommended to avoid medication during
Indication pregnancy, should not be used during breast
Ankylosing Spondylitis, Osteoarthritis, & feeding unless unavoidable.
Rheumatoid Arthritis, Bursitis & Tendinitis,
Dysmenorrhoea or postoperative pain & acute Preparation
gout or soft-tissue disorders. 50 mg Tablet, 100 mg & 200 mg SR Capsule, 25
mg/gm Gel & 100 mg/2 ml IM Injection.
Dosage & Administration
Tablet: 50-100 mg daily, taken with food
to minimize gastrointestinal disturbance.
For rheumatic disease, 100-200 mg daily
in 2-4 divided doses with food. For pain &
dysmenorrhoea, 50 mg up to 3 times daily. SR
Capsule: 100-200 mg once daily. IM injection: Lanso
Adults: 50 to 100 mg every four hours, repeated

L
up to a maximum of 200 mg in twenty-four Active Ingredient
hours for up to 3 days. Elderly: As with other Lansoprazole.
medications it is generally advisable in the
elderly to begin ketoprofen therapy at the Indication
lower end of the dose range. Paediatric dosage: Duodenal ulcer, gastric ulcers, erosive
Not established for intramuscular use. Gel: To esophagitis, Zollinger-Ellison Syndrome, H.
be applied to the painful area twice daily. pylori eradication.

Contraindication & Precaution Dosage & Administration


Ketoprofen is contraindicated in patients with 30 mg daily dose.
known hypersensitivity to the drug. Ketoprofen
is contraindicated in patients in whom Contraindication & Precaution
asthma, urticaria, or other sensitivity reaction Known hypersensitivity.
is precipitated by aspirins or other NSAIDs.
Adverse GI Effects should be considered in Side Effect
patients receiving Ketoprofen. Gastrointestinal disturbances, headache,
dizziness, malaise, dry or sour mouth or throat.
Side Effect
Dyspepsia, nausea, abdominal pain, diarrhoea, Use in Pregnancy & Lactation
constipation, flatulence, anorexia, vomiting, USFDA Pregnancy category B.
stomatitis, headache, dizziness, malaise,
depression, nervousness, dreams, tinnitus, Preparation
visual disturbance, rash, impairment of renal 30 mg Capsule.
function, signs or symptoms of urinary-tract
irritation.
128
Product Guide

Laxyl Lebac TM

Active Ingredient Active Ingredient


Bromazepam. Cephradine

Indication Indication
Laxyl is indicated for the treatment of anxiety Pharyngitis, sinusitis, otitis media, tonsilitis,
& anxiety related disorders like emotional laryngotracheo-bronchitis, acute & chronic
disturbance, functional disturbance in the bronchitis, lobar & bronchopneumonia, cystitis,
gastrointestinal system, functional disturbance urethritis, pyelonephritis, abscess, cellulitis,
in the genitourinary system, psychosomatic furunculosis, impetigo, bacillary dysentery,
disorders. enteritis, peritonitis. bone & joint infection,
surgical prophylaxis.
Dosage & Administration
3 mg to 18 mg daily in divided doses. Dosage & Administration
1-2 gm daily in 2 to 4 divided doses.
Contraindication & Precaution
Patients with known hypersensitivity Contraindication & Precaution
to benzodiazepines; acute pulmonary Hypersensitivity to any Cephalosporin

L
insufficiency; respiratory depression; phobic or antibiotic.
obsessional states; chronic psychosis.
In patients with chronic pulmonary Side Effect
insufficiency, & in patients with chronic renal Nausea, vomiting, diarrhoea & abdominal
or hepatic disease, dosage may need to be discomfort, allergic reactions, skin rashes,
reduced. urticaria, eosinophilia, angioedema &
anaphylaxis, elevation of hepatic enzyme
Use in Pregnancy & Lactation values, neutropenia, Super-infection with
Not recommended. resistant microorganisms, particularly candida,
pseudomembranous colitis. Thrombophlebitis.
Side Effect
Common adverse Effects include drowsiness, Use in Pregnancy & Lactation
sedation, unsteadiness & ataxia. The drug should be used during pregnancy
only when clearly indicated, the drug should
Preparation be used with caution in nursing mother.
3 mg Tablet.
Preparation
250 mg & 500 mg Capsule, 125 mg/5 ml
Powder for Suspension, 250 mg/5 ml Forte
Powder for Suspension, 125 mg/1.25 ml
Powder for Paediatric Drops, 500 mg & 1 gm
IM/IV Injection.
129
Product Guide

Lerozol Syndrome, Male infertility & Hyperthyroidism.

Dosage & Administration


Active Ingredient Adults: 1 to 2 gm per day in divided doses.
Letrozole. Infants & children: Between 50 & 100 mg/kg/
day in divided doses, with a maximum of 3 g/
Indication day. Dosage should begin at 50 mg/kg/day. The
Infertility, ER positive breast cancer. exact dosage will depend on clinical response.

Precaution Contraindication & Precaution


Since fatigue & dizziness have been observed No known contraindication.
with the use of letrozole & somnolence was
uncommonly reported, caution is advised Side Effect
when driving or using machinery. Generally well tolerated.

Drug Interaction Use in Pregnancy & Lactation


Co-administration of letrozole & tamoxifen 20 Pregnancy Category B. It is not known whether
mg daily results reduction of plasma levels of Levocarnitine is excreted in human milk.
Letrozole. Supplemental Levocarnitine is not advised for
nursing mothers.

L
Pregnancy
Pregnancy Category D. Preparation
330 mg Tablet & 500 mg/ 5 ml Solution.
Nursing Mothers: Caution should be exercised
when letrozole is administered to a nursing
woman.

Pediatric Use
Not recommended
Levostar TM

Preparation
2.5 mg Tablet. Active Ingredient
Levosalbutamol

Indication
Treatment or prevention of bronchospasm in
adults, adolescents, & children 6 years of age

Levocar & older with reversible obstructive airway


disease.

Active Ingredient Dosage & Administration


Levocarnitine. Levostar 1 & 2 mg Tablets: Adults & adolescents
above 12 years: 1-2 mg three times daily,
Indication Children (upto 11 years): 1 mg three times
Heart Diseases , Congestive Heart Failure, daily. Levostar Syrup: Adults: 5-10 ml three
Kidney Disease, Chronic Fatigue Syndrome, times daily, Children (upto 11 years): 5 ml three
High Cholesterol, Intermittent Claudication, times daily.
Dementia & memory impairment, Down
130
Product Guide
Contraindication & Precaution adolescents & children 4 years of age & older
Hypersensitivity to any of the components with reversible obstructive airway disease.
of the formulation.. Potentially serious
hypokalemia may result from 2 agonist Dosage & Administration
therapy. Particular caution is advised in acute Adults & children above the age of 4 yrs : 1 or 2
severe asthma as this Effect may be potentiated puffs as necessary.
by hypoxia & by concomitant treatment with
Xanthine derivatives, steroids & diuretics. Oral Contraindication & Precaution
Levosalbutamol should be used with caution Hypersensitivity to any of the components of
in patients with cardiovascular disorders, the formulation. Particular caution is advised
especially coronary insufficiency, cardiac in acute severe asthma as this Effect may be
arrhythmias or hypertension. potentiated by hypoxia & by concomitant
treatment with Xanthine derivatives, steroids
Drug Interaction & diuretics. Serum potassium levels should be
Short-acting sympathomimetic monitored in such situations.
bronchodilators or epinephrine & If additional
adrenergic drugs are to be administered by Drug Interaction
any route, they should be used with caution to Other short-acting sympathomimetic
avoid deleterious cardiovascular Effects. bronchodilators or epinephrine should be used
with caution with levosalbutamol.

L Side Effect
Hypokalaemia, palpitation, fine tremors of the Side Effect
skeletal muscle (particularly the hand), muscle Potentially serious hypokalaemia may result
cramps, nausea, vomiting, burning substernal from 2 agonist therapy.
or epigastric pain, diarrhoea, nervousness,
headache, dizziness, fatigue & sleeplessness. Uses in Pregnancy & Lactation
Administration of the drug during pregnancy
Use in Pregnancy & Lactation should be considered only if the expected
Use of oral Levosalbutamol in pregnant or benefit to the mother is greater than any
nursing mothers should be considered only if possible risk to the foetus.
the expected benefit to the mother is greater
than any possible risk to the foetus or the infant. Preparation
50 mcg/puff, 200 puffs.
Preparation
1 mg, 2 mg Tablet, 1 mg/5 ml Syrup.

Levostar TM
Inhaler Lido Spray TM

Active Ingredient Active Ingredient


Levosalbutamol Lidocaine BP

Indication Indication
Levostar is indicated for the treatment or
Prevents pain associated with minor surgical
prevention of bronchospasm in adults,
131
Product Guide
procedures in the ear, nose & throat amount is insignificant to cause any harm. Still
Prevents pain or discomfort during dental it should be used upon physicians judgment.
procedures (e.g., prior to an injection)
Prevents coughing during general anesthesia Use in children
Prevents pain during the final stages of Dosages in children should be reduced,
childbirth, before the cutting or stitching of commensurate with age & body weight.
the perineum
Preparation
Dosage & Administration 30 ml (Each spray delivers 10 mg of Lidocaine)
In dentistry, the normal dose is 1-5 sprays.
Two sprays per quarter of the mouth is
recommended, with a maximum of 3 sprays
per quarter of the mouth over 30 minutes
In sinus procedures 3 sprays are used
Up to 20 sprays may be necessary in childbirth Linita TM

& procedures of the throat & windpipe


Active Ingredient
Contraindication & Precaution Linagliptin INN
Should not be given to patients with myasthenia

L
gravis, epilepsy, impaired cardiac condition or Indication
liver damage. Patient should be careful driving LinitaTM is indicated as an adjunct to diet
or operating machinery after use of Lidocaine & exercise to improve glycemic control in
Spray. Patient may be drowsy & reflexes may be patients with type 2 diabetes mellitus.
slow. Patient should not eat or drink anything
for at least 1 hour after using Lidocaine Spray Dosage & Administration
in the mouth or throat area. Should be careful The recommended dose of LinitaTM is 5 mg
not to spray Lidocaine Spray near the eyes. If once daily. No dosage adjustment is required
any of the spray does go in the eye, should rinse for hepatic or kidney impaired patients.
immediately with lots of water for at least 15 Contraindication & precaution: History of a
minutes. serious hypersensitivity reaction to Linagliptin,
such as anaphylaxis or angioedema. When
Side Effect used with an insulin secretagogue (e.g.
Skin rash or irritation, drowsiness, wheezing or sulfonylurea), consider lowering the dose of
difficulty breathing, chest pain, severe rash or the insulin secretagogue to reduce the risk of
itching, increased sweating, numbness. hypoglycemia.

Drug Interaction Side Effect


Many drugs besides lidocaine may affect Side effects includes: Hypoglycemia, headache,
the heart rhythm (QT prolongation), drowsiness, weakness, dizziness, confusion,
including amiodarone, dofetilide, pimozide, irritability, hunger, fast heartbeat, sweating,
procainamide, quinidine, sotalol, macrolide stuffy or runny nose & sore throat.
antibiotics (such as Erythromycin).
Drug Interaction
Use in Pregnancy & Lactation P-glycoprotein/CYP3A4 inducer: The
Pregnancy category B. Small amount of efficacy of Linagliptin may be reduced when
Lidocaine may pass to a lactating baby, but the administered in combination (e.g., with
132
Product Guide
rifampin). Use of alternative treatments is rhabdomyolysis, photosensitivity, eczema,
strongly recommended. peripheral edema, angina, palpitations,
tachycardia, & migraine.
Use in Pregnancy & Lactation
Pregnancy: Pregnancy Category-B. There Drug Interaction
are no adequate & well-controlled studies in Oral Anticoagulants, Resins, Cyclosporine.
pregnant women. Linagliptin tablets should be
used during pregnancy only if clearly needed. Preparation
Nursing Mothers:It is not known if whether 200 mg Capsule & 160 mg Tablet.
Linagliptin passes into breast milk or not.
Caution should be exercised when Linitagliptin
is administered to a nursing woman

Use in Children
Livwel
Safety & effectiveness of Linagliptin in pediatric
Active Ingredient
patients under 18 years of age have not been
Vitamin A (as Retinol Palmitate & Beta
established.
Carotene), C, D3, E, B1, B6, B12, Riboflavin,
Niacin, Folic acid, Biotin, Pantothenic Acid,
Preparation
Calcium, Iodine, Magnesium, Zinc, Selenium,
Tablet

L
Manganese, Chromium, Potassium, Para-
Amino Benzoic Acid, Inositol, Choline

Indication
Livwel Syrup is indicated in multivitamin &
multimineral deficiencies in:
Lipired
TM
.Adults (especially who cannot intake
supplements in solid dosage forms e.g. tablet
Active Ingredient & who suffer gastrointestinal side Effects after
Fenofibrate. taking solid dosage forms).
.Children of all ages & infants.
Indication
Hyperlipidemias of Type IIa, IIb, III, IV & V. Dosage & Administration
For adults: 3 - 4 teaspoonful daily;
Dosage & Administration For children of 4 - 12 years: 2 - 3 teaspoonful
One 200 mg capsule or 160 mg tablet daily. daily;
For children of 1 - 4 years: 1-2 teaspoonful daily:
Contraindication For infants up to 1 year: 1 teaspoonful daily, or
Hepatic or severe renal dysfunction, as directed by the physician.
including primary biliary cirrhosis, & patients
with unexplained persistent liver function Contraindication & Precaution
abnormality. Preexisting gallbladder disease. Supplement should not be used in over dosage
Hypersensitivity to fenofibrate. or should not be used long time without the
recommendation by a physician.
Side Effect
Hepatitis, cholelithiasis, cholecystitis, Side-Effect
hepatomegaly, myalgia, myasthenia, Generally the product is well tolerated.
133
Product Guide
Use in Pregnancy & Lactation follicles, ocular allergic reactions, ocular pruritus,
The specific information is not available in this corneal staining/erosion, photophobia, eyelid
respect. erythema, ocular ache/pain, ocular dryness,
tearing, upper respiratory symptoms, eyelid
Preparation edema, conjunctival edema, dizziness,
100 ml & 200 ml Syrup. blepharitis, ocular irritation, gastrointestinal
symptoms, asthenia, conjunctival blanching,
abnormal vision & muscular pain, lid crusting,
conjunctival hemorrhage.
Locular Eye Drops Use in Pregnancy & Lactation
Active Ingredient Brimonidine Tartrate ophthalmic solution 0.2%
Brimonidine. should be used during pregnancy only if the
potential benefit to the mother justifies the
Indication potential risk to the fetus. A decision should
For lowering intraocular pressure in patients be made whether to discontinue nursing or to
with open-angle glaucoma or ocular discontinue the drug, taking into account the
hypertension. importance of the drug to the mother.

Dosage & Administration Preparation

L
One drop in the affected eye(s) three times 0.2% Eye Drops.
daily, approximately 8 hours apart.

Locular Plus Eye Drops


Contraindication & Precaution
In patients with hypersensitivity to Brimonidine
Tartrate & also in patients receiving monoamine
oxidase (MAO) inhibitor therapy. Caution Active ingredient
should be exercised in treating patients with Brimonidine Tartrate + Timolol
severe cardiovascular disease, in patients with
depression, cerebral or coronary insufficiency, Indication
Raynauds phenomenon, or thostatic For the reduction of elevated intraocular
hypotension or thromboangiitis obliterans. pressure (IOP) in patients with glaucoma or
ocular hypertension who require adjunctive
Drug Interaction or replacement therapy due to inadequately
Although specific drug interaction studies have controlled IOP.
not been conducted with Brimonidine Tartrate
ophthalmic solution 0.2%, the possibility of Dosage & Administration
an additive or potentiating effect with CNS The recommended daily dose is one drop in
depressants should be considered. Caution the affected eye(s) twice daily approximately
in using concomitant drugs such as systemic 12 hours apart. If more than one topical
beta-blockers, antihypertensives, Tricyclic ophthalmic product is to be used, the different
antidepressants and/or cardiac glycosides are products should be instilled at least 5 minutes
advised. apart.

Side Effect Contraindication & Precaution


Oral dryness, ocular hyperemia, burning & Contraindicated in patients with
stinging, headache, blurring, foreign body hypersensitivity to any component of this
sensation, fatigue/drowsiness, conjunctival product. Cautions should be exercised in
134
Product Guide
treating patients with severe or unstable & Use in children
uncontrolled cardiovascular or pulmonary It is not recommended for use in children under
diseases. It should be used with caution the age of 2 years.
in patients with depression, orthostatic
hypotension. Preparation
Each 5 ml container contains Brimonidine
Side Effect tartrate 0.2% & Timolol 0.5% sterile solution.
Most common side effects are asthenia,
blepharitis, corneal erosion, depression,
epiphora, eye dryness, eye irritation, eye

Loracef
pain, eyelid edema, eyelid erythema, eyelid TM
pruritus, headache, hypertension, oral dryness,
somnolence, superficial punctate keratitis, &
visual disturbance. Active Ingredient
Cefaclor.
Drug Interaction
Concomitant use of two topical beta- Indication
adrenergic blocking agents may potentiate Pneumonia, bronchitis, pharyngitis, tonsillitis
systemic beta-blockade. Potentiated systemic sinusitis, otitis media, Skin & soft tissue
beta-blockade (e.g. Decreased heart rate, infections, urinary tract infections including

L
depression) has been reported during pyelonephritis & cystitis.
combined treatment with CYP2D6 inhibitors
(e.g. Quinidine, SSRIs) & Timolol. Monoamine Dosage & Administration
oxidase (MAO) inhibitors may theoretically 250 mg every eight hours. Children : 20 mg/kg/
interfere with the metabolism of Brimonidine & day in divided doses every 8 hours.
potentially result in an increased systemic side-
effect such as hypotension. Concomitant use Contraindication & Precaution
with CNS depressants may result an additives Hypersensitivity, caution in the presence of
or potentiating effect. markedly impaired renal function, overgrowth
of non-susceptible organisms.
Use in Pregnancy & Lactation
Pregnancy: Pregnancy Category C: There Side Effect
are no adequate & well-controlled studies in Diarrhoea, nausea & vomiting, eruptions,
women; however, it should be used during pruritis & urticaria, Serum sickness, Eosinophilia,
pregnancy only if the potential benefit to the thrombocytopenia, transient lymphocytosis &
mother justifies the potential risk to the fetus. leucopenia. Transient hepatitis & cholestatic
Nursing mother: Timolol has been detected jaundice, slight elevation in AST, ALT or alkaline
in human milk following oral & ophthalmic phosphate. Reversible interstitial nephritis,
drug administration. It is not known whether Reversible hyperactivity, nervousness,
Brimonidine tartrate is excreted in human milk, confusion, hypertonia, dizziness, hallucinations
although in animal studies Brimonidine tartrate & somnolence have been reported rarely.
has been shown to be excreted in breast milk.
Because of the potential for serious adverse Drug Interaction
reactions in nursing infants, a decision should The nephrotoxicity of aminoglycoside
be made whether to discontinue nursing or to antibiotics such as gentamicin & tobramycin
discontinue nursing or to discontinue the drug, may enhanced by any Cephalosporin.
taking into account the importance of the drug
to the mother.
135
Product Guide
Use in Pregnancy & Lactation
Caution is recommended in the use of the Loratin Fast
drug in early pregnancy. Caution should be
exercised when Cefaclor is administered to a Active Ingredient
nursing women. Loratadine.

Indication
Preparation
Seasonal allergic rhinitis, Perennial allergic
500 mg Capsule, 125 mg/5 ml Suspension, 125
rhinitis, Skin allergies including Chronic
mg/1.25 ml Paediatric Drops.
Idiopathic Urticaria (CIU).

Dosage & Administration

Loratin Adult & children over 6 years: One tablet daily.


Children aged 2-5 years : 1/2 tablet daily. Not
recommended for children under 2 years of age.
Active Ingredient
Loratadine. Contraindication
Hypersensitivity to its ingredients or
Indication idiosyncrasy.
Allergic rhinitis, Skin allergies including Chronic
Idiopathic Urticaria (CIU). Side Effect

Dosage & Administration


Adult & child over 6 years: One Loratin 10
Fatigue, nausea, headache, tachycardia &
syncope. L
mg tablet or two teaspoonful (10 ml) Loratin Use in Pregnancy & Lactation
suspension once daily. Children aged 2-5 Loratadine should be used during pregnancy
years: 5 ml or 1 teaspoonful (5 mg) suspension only if clearly needed. Loratadine should not be
once daily. Loratadine is not recommended for administered to lactating mother.
children under 2 years of age.
Preparation
Contraindication 10 mg Orally Dispersible Tablet.
Loratadine is contraindicated in patients who
have shown hypersensitivity to its ingredients
or idiosyncrasy.

Side Effect
Loratin Plus TM

Anticholinergic Effects, fatigue, nausea, Active Ingredient


headache, tachycardia & syncope. Loratadine & Pseudoephedrine Sulfate

Use in Pregnancy & Lactation Indication


Loratadine should be used during pregnancy Loratin Plus is indicated for the relief of
only if clearly needed. Loratadine should not be symptoms of seasonal & perennial allergic
administered to lactating mother. rhinitis. Loratin Plus tablet should be
administered when both the antihistaminic
Preparation properties of Loratadine & the nasal
10 mg Tablet & 5 mg/5 ml Suspension. decongestant activity of Pseudoephedrine
Sulfate are desired in patients 12 years of age
& older. Loratin Plus tablet also temporarily
relieves runny nose, sneezing, itching, watery
136
Product Guide
eyes, nasal congestion, itching of the nose or administered alone passes into breast milk,
throat due to allergic rhinitis or other upper therefore a decision should be made whether
respiratory allergies, symptoms of common to discontinue nursing or to discontinue Loratin
cold, & nasal congestion & sinus pressure Plus, taking into account the importance of
associated with sinusitis. the drug to the mother.

Dosage & Administration Preparation


In adults & children 12 years of age & over, Loratadine 10 mg & Pseudoephedrine Sulfate
the recommended dose of Loratin Plus 240 mg Tablet.
tablet is once daily. As Loratin Plus contains
Pseudoephedrine Sulfate which may cause
agitation & insomnia as side Effects, it is
best recommended that Pseudoephedrine
Sulfate should be administered in once daily
formulation & be taken in the morning instead
Lubtear Eye Drops
of night. Active Ingredient
Dextran 70 & Hypromellose.
Contraindication & Precaution
Loratadine/Pseudoephedrine Sulfate Indication
combination is contraindicated in patients As a lubricant & artificial tear in dry eye &
who are hypersensitive to this medication or other ocular irritation syndromes associated

L
to any of its ingredients. This product, due to with deficient tear or mucous secretion.
its Pseudoephedrine Sulfate component, is This combination also prevents cornea to
contraindicated in patients with narrow angle damage in patients with keratoconjunctivitis
glaucoma or urinary retention, & in patients & for ocular lubrication. It is also used for the
receiving monoamine oxidase (MAO) inhibitor temporary relief of burning & irritation due to
therapy or within fourteen days of stopping dryness of the eye & for use as the protectant
such treatment. It is also contraindication in against further irritation.
patients with severe hypertension, severe
coronary artery disease & in those who have Dosage & Administration
shown hypersensitivity or idiosyncrasy to its Adults & children: One or two drops three
components to adrenergic agents, or to other times daily or as directed by the physician.
drugs of similar chemical structures.
Loratadine/Pseudoephedrine Sulfate Contraindication & Precaution
combination tablets should be used with This product contains Benzalkonium Chloride
caution in patients with hypertension, diabetes BP & should not be used when soft contact
mellitus, ischemic heart disease, increased lenses are being worn.
intraocular pressure, hyperthyroidism,
renal impairment or prostatic hypertrophy. Side Effect
Central nervous system stimulation with There are no known side effects with the use
convulsions or cardiovascular collapse with of it, however, if the patient experiences any
accompanying hypotension may be produced reaction in eye or other part of the body after
by sympathomimetic amines. using this medication then consult with doctor.
Side Effect Use in Pregnancy & Lactation
Generally well tolerated. There is insufficient evidence as to the safety in
pregnancy & lactation. Therefore, this product
Use in Pregnancy & Lactation should only be used in pregnancy & lactation if
It is not known if this combination product
it is considered essential by the physician.
is excreted in human milk. However, both
Loratadine & Pseudoephedrine when
137
Product Guide
Preparation carbamazepine, phenytoin) with Roflumilast
Each LDPE container contains 10 ml of Dextran is not recommended. The co-administration
70 0.1% & Hypromellose 0.3%. of Roflumilast with CYP3A4 inhibitors or
dual inhibitors that inhibit both CYP3A4 &
CYP1A2 simultaneously (e.g., erythromycin,
ketoconazole, fluvoxamine, enoxacin,
cimetidine) may increase Roflumilast systemic
exposure & may result in increased adverse
reactions.
LumastTM Use in Pregnancy & Lactation
Active Ingredient Pregnancy Category C. Roflumilast and/or its
Roflumilast 0.5 mg tablet. metabolites should not be used during breast-
feeding.
Indication
As add-on therapy to bronchodilator treatment Use in Children
for the maintenance treatment of severe Safety & effectiveness of Roflumilast in
chronic obstructive pulmonary disease (COPD) children & adolescents below 18 years of age
associated with chronic bronchitis (i.e. patients have not been established. Roflumilast is not
with a history of chronic cough & sputum) recommended in this population.
in adult patients with a history of frequent

L
exacerbations. Preparation
Each box contains 30 tablets in blister pack.
Dosage & Administration
The recommended dosage for patients with
COPD is one 0.5 mg (500 mcg) tablet daily, with
or without food. de g
ori in
Flu ntain
Co
Contraindication & Precaution
Hypersensitivity to Roflumilast or to any
of the excipients. Moderate to severe liver
Antiseptic & Anticavity Mouthwash
impairment.
A complete mouthwash
Side Effect
General disorders: Fatigue Al co
Metabolism & nutrition disorders: Decreased ho
appetite, Weight decreased. Fr
ee
l

Musculoskeletal & connective tissue disorders:


Back pain, muscle spasms
Nervous system disorders: Dizziness, Headache, Fluoride Containing

Tremor.
Psychiatric disorders: Anxiety, Depression, Fluoride Containing

Insomnia.

Drug Interaction
A major step in Roflumilast metabolism is Also available
Orostar
the N-oxidation of Roflumilast to roflumilast TM

N-oxide by CYP3A4 & CYP1A2. Therefore, 250 ml & 120 ml

&
the use of strong cytochrome P450 enzyme
inducers (e.g. rifampicin, phenobarbital, Antiseptic Mouthwash 250 ml & 120 ml
138
Product Guide

Lumertam
Active Ingredient
Artemether & Lumefantrine.

Indication
Lumertam is indicated in the treatment & standby emergency treatment of acute uncomplicated
Plasmodium falciparum malaria including mixed P. falciparum infection of adults, children & infants
weighing from 5 kg & above.

Dosage & Administration


Body Day 1 Day 2 Day 3
Weight 0 hour 8 hours later Morning Evening Morning Evening

5-15 kg 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet


15-25 kg 2 Tablet 2 Tablet 2 Tablet 2 Tablet 2 Tablet 2 Tablet
20-35 kg 3 Tablet 3 Tablet 3 Tablet 3 Tablet 3 Tablet 3 Tablet

L
35kg & 4 Tablet 4 Tablet 4 Tablet 4 Tablet 4 Tablet 4 Tablet
above

Contraindication & Precaution


Hypersensitivity to any of the ingredients, patients with family history of bradycardia or severe
cardiac disease & patients with known electrolyte imbalance.

It is not evaluated for prophylaxis of malaria, cerebral malaria or other severe manifestation of
severe malaria including pulmonary oedema or renal failure. Hence, should not be used in those
conditions.

Side Effect
Generally well tolerated & most side effects are of mild to moderate in severity & duration.

Use in Pregnancy & Lactation


Not recommended.

Preparation
(Artemether 20 mg + Lumefantrine 120 mg)/Tablet.
139
Product Guide

Maganta Plus TM

Active Ingredient
Magaldrate & Simethicone.

Indication
Hyperacidity, gastric & duodenal ulcer, gastritis, heartburn, dyspepsia, gastroesophageal reflux.

It is also indicated for the relief of flatulence, abdominal distention & windy colic.

Dosage & Administration


Chewable tablet: 1-4 chewable tablets, 20 to 60 minutes after meals & at bedtime, or as directed
by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals & at bedtime,
or as directed by the physician.

Contraindication & Precaution


intestinal obstruction, renal function impairment, appendicitis, chronic diarrhea, sensitivity to
aluminium, magnesium & simethicone.

M
Should be cautious, if allergic to any ingredient to Magaldrate & Simethicone, with a history of
kidney problems or taking citrate salts (found in some calcium supplements, antacids & laxative).
Do not take with tetracycline antibiotics. Antacids can interfere with the absorption of iron
preparation.

Side Effect
Constipation, diarrhea, intestinal pain.

Use in Pregnancy & Lactation


Thought to be safe antacid during pregnancy & lactation.

Preparation
Chewable tablet: Each chewable tablet contains Magaldrate USP 480 mg & Simethicone USP 20
mg.
Suspension: Each 5 ml contains Magaldrate USP 480 mg & Simethicone USP 20 mg.

Malacide
Active Ingredient
Sulphadoxine & Pyrimethamine.

Indication
Malaria, suppressive or prophylactic management.
140
Product Guide
Dosage & Administration
Curative : Adults : 2-3 tablets, Children under 4 years : 1/2 tablet, 4-8 years: 1 tablet, 9-14 years :
2 tablets. Prophylactic : First dose 1 or 2 days befroe arrival in an endemic area; dose should be
continued during stay & for 4-6 weeks after return.

Prophylactic dose: for chart

Once weekly Once every 2 weeks

Adults 1 tablets 2 tablets

Pediatric patients
(>2 months to 18 years) The dosage for prevention of
malaria in children is based upon
body weight:
Weight (kg) Number of Tablets Taken Once
Weekly
>45 1
M 31 to 45 1
21 to 30
11 to 20
5 to 10

Side Effect
Drug rash, pruritus & slight hair loss have been observed. Feeling of fullness, nausea, rarely
vomiting, stomatitis, In rare cases, leukopenia, thrombocytopenia, megaloblastic anemia Fatigue,
headache, fever, polyneuritis may occasionally occur.

Drug Interaction
Folate antagonists (e.g. cotrimoxazole, methotrexate, anticonvulsants).

Use in Pregnancy & Lactation


Malacide is contraindicated during pregnancy, premature & newborn infants.

Preparation
(Sulfadoxine 500 mg + Pyrimethamine 25 mg)/Tablet.
141
Product Guide

Maxcef
Active Ingredient
Cefotaxime.

Indication
Acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess & post-
operative chest infections, acute & chronic pyelonephritis, cystitis & asymptomatic bacteriuria,
cellulitis, peritonitis & wound infections, osteomyelitis, septic arthritis, pelvic inflammatory disease,
gonorrhoea, meningitis & other sensitive infections suitable for parenteral antibiotic therapy.

Prophylaxis
The administration of Cefotaxime prophylactically may reduce the incidence of certain post
operative infections in patients undergoing surgical procedures.

Dosage & Administration


1gm every 12 hourly. In severe infections dosage may be increased up to 12 gm daily given in 3
or 4 divided doses. Children : 100-150 mg/kg/day in 2 to 4 divided doses. In very severe infections
doses up to 200 mg/kg/day may be required. Neonates : 50 mg/kg/day in 2-4 divided doses. In
severe infections 150-200 mg/kg/day in divided doses.

Contraindication & Precaution


Hypersensitivity, in renal insufficiency. M
Side Effect
Mild & transient candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline
phosphatase & diarrhoea. pseudomembranous colitis, changes in renal function, skin rashes, drug
fever & very rarely anaphylaxis. Administration of high doses of cephalosporins particularly in
patients with renal insufficiency may result in encephalopathy.

Drug Interaction
Increased nephrotoxicity has been reported following concomitant administration of
cephalosporins & aminoglycoside antibiotics.

Pregnancy & lactation


Pregnancy Category B.
Cefotaxime is excreted in the milk. Caution should be exercised when Cefotaxime is administered
to a nursing women.

Preparation
250 mg, 500 mg & 1gm IM/IV Injection.
142
Product Guide

Maxpime
Active Ingredient
Cefepime.

Indication, Dosage & Administration


The recommended adult & pediatric dosages & routes of administration are outlined in the
following table. Cefepime should be administered intravenously over approximately 30 minutes.
Before administration ensure that the powder has been fully dissolved in the solution.

Site & Type of Infection Dose Frequency Duration (Days)

Moderate to severe Pneumonia 1-2 gm Every 12 10


due to S. pneumoniae*, P. IV hours
aeruginosa, K. pneumoniae, or
Enterobacter species

Mild to moderate 0.5-1 gm Every 12 7-10


Uncomplicated or Complicated IV/IM hours

M
Urinary Tract Infections,
including pyelonephritis,
due to E. coli, K. pneumoniae, or
P. mirabilis*

Severe Uncomplicated 2 gm IV Every 12 10


or Complicated Urinary hours
Tract infections, including
pyelonephritis, due to E- coli or
K. pneumoniae*

Moderate to Severe 2 gm IV Every 12 10


Uncomplicated Skin & skin hours
structure infections due to S.
aureus or S. pyogenes

Complicated intra-abdominal 2 gm IV Every 12 7-10


infections (used in combination hours
with metronidazole) caused
by E.coli, viridans group
streptococci, P. aeruginosa,
K. pneumoniae, Enterobacter
species, or B. fragilis
143
Product Guide
Pediatric patients (2 months up to 16 years)
The maximum dose for pediatric patients should Maxrin TM

not exceed the recommended adult dose.


The usual recommended dosage in pediatric Active Ingredient
patients up to 40 kg in weight for uncomplicated Tamsulosin Hydrochloride.
& complicated urinary tract infections (including
pyelonephritis), uncomplicated skin & skin Indication
structure infections, & pneumonia is 50 mg/ Treatment of the signs and symptoms of
kg/dose, administered every 12 hours (50 mg/ Benign Prostatic Hyperplasia (BPH).
kg/dose, every 8 hours for febrile neutropenic
patients), for durations as given above. Dosage & Administration
1(one) capsule once daily.
Contraindication & Precaution
Cefepime is contraindicated in patients who Contraindication & Precaution
have shown immediate hypersensitivity Hypersensitivity, orthostatic hypotension;
reactions to Cefepime or the cephalosporin severe hepatic insufficiency, syncope,
class of antibiotics, penicillins or other beta- dizziness, weakness. The treatment of
lactam antibiotics. severely renal impaired patients should be
approached with caution.
Side Effect

M
As with some other drugs in this class, Side Effect
encephalopathy (disturbance of Dizziness, abnormal ejaculation, less
consciousness including confusion, frequently headache, asthenia, postural
hallucinations, stupor & coma), myoclonus & hypotension, palpitations, rhinitis,
seizures have been reported. nausea, vomiting, diarrhoea, constipation,
Hypersensitivity reactions such as rash,
Drug Interaction pruritus, urticaria, drowsiness, blurred
Renal function should be monitored carefully vision, dry mouth, edema, syncope,
if high doses of aminoglycosides are to be angioedema and priapism.
administered with Cefepime because of
the increased potential of nephrotoxicity & Drug Interaction
ototoxicity of aminoglycoside antibiotics. Atenolol, enalapril, nifedipine or
Nephrotoxicity has been reported following theophylline, cimetidine, frusemide.
concomitant administration of other
cephalosporins with potent Use in Pregnancy & Children
diuretics such as furosemide. Tamsulosin Hydrochloride capsules are not
indicated for use in women and children.
Use in Pregnancy & Lactation
Pregnancy Category B. Preparation
Nursing Mothers 0.4 mg Capsule.
Cefepime is excreted in human breast milk in
very low concentrations (0.5
ug/mL). Caution should be exercised when
Cefepime is administered to a nursing woman.

Preparation
500 mg & 1 gm IM/IV injection.
144
Product Guide

Melcam Melixol
Active Ingredient Active Ingredient
Meloxicam. Flupenthixol & Melitracen.
Indication
Indication
Osteoarthritis, Rheumatoid arthritis,
Anxiety along with depression.
Ankylosing spondylitis.
Dosage & Administration
Dosage & Administration
2 tablets in a day, 1 in morning & another at
7.5-15 mg/day.
mid day.
Contraindication & Precaution
Hypersensitivity, asthma, nasal polyps, Contraindication
angioneurotic oedema or urticaria, active Hypersensitivity to Melitracen & Flupenthixol,
peptic ulcer, severe hepatic failure, non- depression of the CNS (e.g. at the time of
dialysed severe renal failure, gastrointestinal acute intoxications to alcohol, barbiturates or
bleeding, cerebrovascular bleeding or other opiates), state of coma, pheochromocytoma,
bleeding disorders. blood dyscrasy, immediately consecutive
recovery to a myocardial infarction, at the

M Side Effect time of a cardiac block of any rank, disorders


Nausea, vomiting, abdominal pain, dyspepsia, of cardiac conduction as well as coronary
constipation or diarrhoea, ulcers or insufficiency. The concomitant administration
gastrointestinal bleeding, skin rash, urticaria, of inhibitors of the MAOIs are contra-indicated.
oedema of the lower limbs, asthma, headache,
vertigo or drowsiness may occur. Precaution & Warning
The administration of this requires prudence
Drug Interaction among patients presenting an organic
Other NSAIDs, including high doses of cerebral lesion, convulsions, urinary retention,
salicylates, Oral anticoagulants, heparin & hyperthyroid, parkinsons syndrome, serious
ticlopidine, Lithium, Methotrexate, Intrauterine myasthenia, advanced hepatic affection as well
contraceptive devices. as cardiovascular disorders. Among depressive
patients, the risk of suicide remains during
Use in Pregnancy & Lactation the treatment. As for all nerve sedatives, a
It is advisable to avoid the administration of syndrome nerve sedative (potentially fatal) can
Meloxicam during pregnancy. Meloxicam seldom occur. Extrapyramidal disorders can
should not be given to nursing mothers. occur in very rare cases.

Preparation Side Effect


15 mg Tablet. Side Effects are rare. These could be transient
restlessness & insomnia.

Preparation
Flupenthixol 10 mg & Melitracen 0.5 mg in each
tablet.
145
Product Guide

Menoral anti-diabetics or Insulin may be changed.

Use in Pregnancy & Lactation


Active Ingredient: The use of Menoral during pregnancy is contra-
Norethisterone. indicated. Menoral should not be used during
lactation.
Indication
Dysfunctional uterine bleeding Use in Children
Relief of primary & secondary amenorrhea The safety & Effectiveness of bromocriptine for
Timing of menstruation the treatment of prolactin-secreting pituitary
Endometriosis adenomas have been established in patients
age 16 to adult. No data are available for
Dosage & Administration
bromocriptine use in pediatric patients under
DUB: 1 tablet 3 times daily
the age of 8 years.
PMS: One tablet 1-3 times daily during the
luteal phase of the cycle
Preparation
Timing of menstruation: One tablet 2-3 times
Norethisterone 5 mg.
daily for no longer than 10-14 days
Endometriosis: 1 tablet twice daily, should be
started between 1-5th day of the cycle

M
Menorrhagia: 1 tablet 3 times daily from day
5-25 of the cycle

Contraindication & Precaution


Known or suspected pregnancy MetasprayNasal Spray
Lactation
Active thromboembolic processes or a history Active Ingredient
thereof Mometasone Furoate.
Diabetes mellitus with vascular involvement
Presence or history of severe hepatic disease, Indication
as long as liver function values have not Metaspray Nasal Spray is indicated for the
returned to normal treatment of the nasal symptoms of seasonal &
Presence or history of liver tumors (benign or perennial allergic rhinitis, in adults & pediatric
malignant) patients 2 years of age & older. It is indicated
Known or suspected sex hormone-dependent for the prophylaxis of the nasal symptoms of
malignancies seasonal allergic rhinitis in adult & adolescent
Hypersensitivity to the active substance or to patients 12 years & older. It is also indicated for
any of the excipients the treatment of nasal polyps in patients 18
years & older.
Side Effect
Visual disturbance, nausea, headache, Dosage & Administration
migraine, edema, dyspnea, hypersensitivity Adults & Children 12 Years of Age & Older:
reactions (urticaria, rash). The recommended dose for prophylaxis &
treatment of the nasal symptoms of seasonal
Drug Interaction allergic rhinitis & treatment of the nasal
Phenytoin, barbiturates, primidone, symptoms of perennial allergic rhinitis is two
carbamazepine, rifampicin may decrease sprays (50 mcg of Mometasone Furoate in each
therapeutic efficacy. The requirement of Oral spray) in each nostril once daily (total daily dose
146
Product Guide
of 100 mcg). In patients with a known seasonal Preparation
allergen that precipitates nasal symptoms 120 Nasal Sprays (50 mcg in each spray)
of seasonal allergic rhinitis, prophylaxis with
Metaspray Nasal Spray, 50 mcg (200 mcg/
day) is recommended 2 to 4 weeks prior to the
anticipated start of the pollen season.
Children 2 to 11 Years of Age: The recommended
dose for treatment of the nasal symptoms of
seasonal & perennial allergic rhinitis is one Methicol
spray (50 mcg of Mometasone Furoate in each
spray) in each nostril once daily (total daily Active Ingredien
dose of 100 mcg). Mecobalamin.

Nasal Polyps: Adults 18 years of Age & Older: Indication


The recommended dose for nasal polyps is For both tablet & injection: Peripheral
two sprays (50 mcg of Mometasone Furoate neuropathies observed in - Diabetic
in each spray) in each nostril twice daily (total neuropathy, Diabetic retinopathy, Entrapment
daily dose of 400 mcg). A dose of two sprays (50 neuropathy, Amyotrophic lateral sclerosis,
mcg of mometasone furoate in each spray) in Parkinsons disease, Alzheimers disease,
each nostril once daily (total daily dose of 200 Lumbago, Drug induced neuropathy, Multiple

M mcg) is also Effective in some patients. sclerosis, Intercostal neuralgia, Vertebral


syndrome, Nerve Compression Syndrome. For
Contraindication & Precaution injection only: Megaloblastic anemia due to
Hypersensitivity to any of the ingredients of Vitamin B12 deficiency.
this preparation contraindicates its use. While
using nasal corticosteroids, caution is required
in patients with active or dormant tuberculous Dosage & Administration
infection, or in untreated fungal, bacterial, Methicol Tablet: Adults 3 tablets, equivalent
systemic viral infections, or ocular herpes to a total of 1500 mcg of Mecobalamin,
simplex. administered orally in 3 divided doses.

Side-Effect Methicol Injection: Peripheral neuropathy:


Side Effects are generally mild & included Adults 1 ampoule, administered intramuscularly
headache, viral infection, sore throat, or intravenously 3 times a week. Megaloblastic
nosebleeds, & coughing. anemia: Adults 1 ampoule administered
intramuscularly or intravenously 3 times a
Pregnancy & Lactation week. After two months of administration,
There are no adequate & well-controlled dosage should be changed to 1 ampoule in
studies in pregnant women. Mometasone every one to three months as maintenance
Furoate, like other corticosteroids, should be therapy.
used during pregnancy only if the potential
benefits justify the potential risk to the fetus. It Contraindication & Precaution
is not known if Mometasone Furoate is excreted Hypersensitivity to Mecobalamin or to any
in human milk. Because other corticosteroids of the excipients used in the preparations.
are excreted in human milk, caution should be Mecobalamin should not be administered for
used when Mometasone is administered to extensive period (months) to patients who
nursing women. do not show clinical response. Prolonged
147
Product Guide
use of larger doses of Mecobalamin is not of this group.
recommended for patients whose occupation
requires handling mercury or its compounds. Side Effect
Generally Mebeverine is well tolerated.
Side Effect However, few side-effects like skin rash,
Gastrointestinal symptoms (e.g. anorexia, urticaria & angioedema may appear.
nausea or diarrhea) & skin rash may occur.
Use in Pregnancy & Lactation
Drug Interaction No teratogenicity has been shown in animal
No significant drug interaction reported. experiments. However, the usual precautions
concerning the administration of any drug
Use in Pregnancy & Lactation during pregnancy should be exercised.
Not recommended during pregnancy & Mebeverine does not excrete in the breast milk
lactation. after administering the therapeutic dose.

Preparation Use in Children


500 mcg Tablet, 500 mcg/1 ml Ampoule Mebeverine is not recommended in children
Injection. under 10 years.

Preparation
200 mg SR Capsule & 135 mg Tablet.
M
Mevin TM

Active Ingradient
Mebeverine Hydrochloride

Indication Mexlo Eye Drops


Symptomatic treatment of IBS
Chronic irritable colon Active Ingredient
Spastic constipation Lomefloxacin.
Mucous colitis
Colicky abdominal pain Indication
Persistent non-specific diarrhoea Conjunctivitis, blepharitis, blepharo-
conjunctivitis, Staphylococcus aureus - induced
Dosage & Administration corneal ulcers.
Adults, elderly & children over 10 years: MevinTM
Tablet: 1 tablet three times daily. MevinTM 200 Dosage & Administration
SR Capsule: 1 capsule 2 times daily. MevinTM is At the beginning of therapy on Day 1 instill
most effective when taken 20 minutes before 5 drops into the conjunctival sac within 20
meals. After several weeks when the desired minutes. There after, until Day 7-9 instill 1 drop
effect has been obtained, the dosage may be 2 times daily into the conjunctival sac.
gradually reduced.
Contraindication & Precaution
Precaution Hypersensitivity to lomefloxacin. Long term
Caution should be exercised in porphyria or treatment may enhance development
allergic reaction to this or any other medicine
148
Product Guide
of secondary fungal infections, phototoxicity, Contraindication & Precaution
exposure to sunlight or UV-radiation should In patients with hypersensitivity to Diclofenac
be avoided. or to Misoprostol or other prostaglandins.
It should not be given to patients who have
Side Effect experienced asthma, urticaria, or other allergic-
Slight & transient burning, allergic reactions, type reactions after taking aspirin or other
asthma, dyspnoea, urticaria, erythema, NSAIDs.
pruritus, & hypersensitization.
Side Effect
Drug Interaction Abdominal pain, diarrhea & other GI symptoms.
Preparations containing heavy metals, The incidence of diarrhea can be minimized by
such as Zinc, should not be used during 15 administering this preparation with food & by
minutes preceding & following application of avoiding coadministration with magnesium-
Lomefloxacin. containing antacids.

Use in Pregnancy & Lactation Drug Interaction


The drug should only be used when the benefit Aspirin, Digoxin, Antihypertensive agents,
outweighs the potential risk for the foetus or Warfarin, oral hypoglycemic agents,
the infant. Methotrexate, Cyclosporine, Lithium, Antacids,
Diuretics.

M Preparation
0.3% Eye Drops. Use in Pregnancy & Lactation
Misoprostol component is contraindicated
in women who are pregnant. Because of the
potential for serious adverse reactions in
nursing infants, it is not recommended for use
by nursing mothers.

Miclofenac Preparation
(Diclofenac Sodium 50 mg & Misoprostol 200
Active Ingredient mcg)/Tablet, (Diclofenac Sodium 75 mg &
Diclofenac & Misoprostol. Misoprostol 200 mcg)/Tablet.

Indication
Osteoarthritis or Rheumatoid Arthritis in
patients at high risk of developing NSAID-
induced gastric & duodenal ulcers & their
complications. Migranil
Dosage & Administration Active Ingredient
Osteoarthritis: Miclofenac 50 TID. For patients Pizotifen.
who experience intolerance, Miclofenac 50 BID
or Miclofenac 75 BID can be used. Rheumatoid Indication
Arthritis: Miclofenac 50 TID or QID. For patients Prophylactic treatment of recurrent vascular
who experience intolerance, Miclofenac 50 BID headaches including classical migraine
or Miclofenac 75 BID can be used. common migraine & cluster headache.
149
Product Guide
Dosage & Administration Adolescents: 15 ml 4 times daily. Children (6-12
1.5 mg daily at bed time as a single dose or in years): 10 ml 3 times daily. (3-6 years): 5 ml 3
three divided doses. times daily.

Contraindication & Precaution Contraindication & Precaution


Hypersensitivity, narrow-angle glaucoma or Hypersensitivity to the active ingredient.
prostate hypertrophy. Dosage adjustment
may be necessary in patients with kidney Side-Effect
insufficiency. Rash, nausea, diarrhoea & vertigo have been
observed in a few rare cases, resolving after
Side Effect dose reduction or treatment withdrawal.
Drowsiness, dizziness, dry mouth, nausea &
constipation Use in Pregnancy & Lactation
Butamirate Citrate should not be used during
Use in Pregnancy the first trimester of pregnancy. During the
Clinical data with pizotifen in pregnancy remainder of pregnancy, it can be used if
are very limited; it should be administered indicated by a physician but with caution. The
in pregnancy only if the expected benefits benefits of Butamirate Citrate administration
outweigh the potential risks. during breast feeding should be carefully
weighed against the risks.
Drug Interaction
Alcohol, tranquilizers, hypnotics, Preparation M
antidepressants & MAO inhibitors. 50 mg Sustained Release Tablet & 7.5 mg/ml
Syrup (100 ml)
Preparation
0.5 mg & 1.5 mg Tablet.

Montene TM

Mirakof Active Ingredient


Montelukast.
Active Ingredient
Butamirate Citrate. Indication
For the prophylaxis & chronic treatment of
Indication asthma in adults & pediatric patients 2 years of
Dry (non-productive) cough & also used in pre- age & older.
& post-operative cough sedation.
Dosage & Administration
Dosage & Administration Adolescents & adults 15 years of age & older:
Mirakof Tablet Adolescents over 12 years old: One 10 mg tablet daily to be taken in the
1-2 tablets daily evening. Patients 6-14 years of age: 5 mg daily
Adults: 2-3 tablets daily at 8 to 12 hours to be taken in the evening. Patients 2-5 years
intervals. of age: 4 mg daily to be taken in the evening.
Mirakof Syrup: Adults: 15 ml 4 times daily.
150
Product Guide
Contraindication & Precaution 1-2 tablet every 6-8 hours daily 15-30 minutes
Hypersensitivity to the active ingradient. before meals.

Side Effect Contraindication & Precaution


The common adverse Effect are headache, Known hypersensitivity to this drug, in case
rash, dyspepsia, dizziness & abdominal pain. of neonates, gastro-intestinal hemorrhage,
Pediatric patients have experienced diarrhea, mechanical obstruction or perforation,
sinusitis, & otitis media during montelukast prolactinoma. Domperidone should be used
clinical trials. with absolute caution in case of children
because there may be increased risk of extra-
Drug Interaction pyramidal reactions. It should be used with
Patients with known aspirin sensitivity should caution in patient with hepatic impairment.
continue avoidance of aspirin or nonsteroidal
anti-inflammatory agents while taking
montelukast. Side Effect
Hyperprolactinemia, galactorrhea, breast
Use in Pregnancy enlargement, soreness, reduced libido,
There have been no reports of its use in dry mouth, thirst, headache, nervousness,
pregnant women. Caution should be used drowsiness, diarrhea, skin rash, itching & extra-
prior to initiating montelukast therapy in pyramidal reactions.

M nursing mothers.
Drug Interaction
Preparation Bromocriptine, MAO (monoamine oxidase)
10 mg Tablet, 5 mg Chewable Tablet & 4 mg inhibitors , anti-muscarinics & opioid analgesics
Chewable Tablet.
Use in Pregnancy & Lactation
Pregnant women: Not recommended during
pregnancy. Lactating mother: Domperidone
may precipitate galactorrhea & improve post-
natal lactation. It is secreted in breast milk

Motifast but in very small quantities insufficient to be


considered harmful.

Active Ingredient Preparation


Domperidone. 10 mg Tablet.

Indication
Dyspeptic symptom complex, acute nausea
& vomiting of functional, organic, infectious,
dietetic origin or induced by radiotherapy or
drug therapy or induced in migraine.
Motigut
Parkinsons disease: In dopamine-agonist Active Ingredient
induced nausea & vomiting, Radiological Domperidone.
studies: Speeding barium transit in follow-
through radiological studies. Indication
Nausea & vomiting: Acute nausea & vomiting
Dosage & Administration of functional, organic, infectious, dietetic origin
151
Product Guide
or induced by radiotherapy or drug therapy or
induced in migraine. Moxacil
Dosage & Administration Active Ingredient
1-2 tablet or 10-20 ml suspension every 6-8 Amoxicillin.
hours daily before meals. Children: 2 ml-4 ml
suspension/10 kg or 0.4 ml-0.8 ml Paed. drops/ Indication
10 kg 6-8 hours daily. Infections of the ear, nose, & throat, genitourinary
tract, skin & skin structure, lower respiratory
Contraindication & Precaution tract; gonorrhea, acute uncomplicated
Known hypersensitivity, gastro-intestinal (ano-genital & urethral infections). H. pylori
stimulation, gastro-intestinal hemorrhage, eradication to reduce the risk of duodenal ulcer
mechanical obstruction or perforation, recurrence in combination with clarithromycin
prolactinoma, increased risk of extra-pyramidal plus lansoprazol as triple therapy. Prophylactic
reactions, should be used with caution in cover for patients at risk of developing
patient with hepatic impairment. endocarditis when undergoing dental surgery.

Side Effect Dosage & Administration


Hyperprolactinemia, galactorrhea, breast Adult : Mild/Moderate-500 mg every 12
enlargement, & soreness & reduced libido. hours or 250 mg every 8 hours, Severe-875

M
Dry mouth, thirst, headache, nervousness, mg every 12 hours or 500 mg every 8 hours.
drowsiness, diarrhea, skin rash & itching. Children: Mild/Moderate-25 mg/kg/day in
divided doses every 12 hours or 20mg/kg/
Drug Interaction day in divided doses every 8 hours, Severe-45
Bromocriptine, anti-muscarinics & opioid mg/kg/day in divided doses every 12 hours or
analgesics. MAO (monoamine oxidase) 40 mg/kg/day in divided doses every 8 hours.
inhibitors. Gonorrhea, Acute, uncomplicated ano-genital,
& urethral infections in males & females 3 g
Use in Pregnancy & Lactation as single oral dose. Prepubertal children 50
Not recommended during pregnancy. It mg/Kg Amoxicillin, combined with 25 mg/kg
is secreted in breast milk but in very small Probenecid as a single dose
quantities insufficient to be considered
harmful. Contraindication & Precaution
It is contraindicated for patients hypersensitive
Preparation to penicillin. In renal impairment the excretion
10 mg Tablet, 5 mg/5 ml Suspension, 5 mg/ml of antibiotic will be delayed & depending on
Paediatric Drops. the degree of impairment it may be necessary
to reduce the total daily dose. Caution should
also be exercised in case of erythematous
rashes, glandular fever, history of allergy etc.

Adverse Effect
Mild, rare & infrequent. Diarrhoea, indigestion
or skin rashes.

Use in Pregnancy & Lactation


Can be used safely throughout pregnancy
152
Product Guide
at the normal adult dose. Can be used safely hours, Children up to 3 months: 30 mg/kg every
during lactation in most instances. 8 hours (every 12 hours in the perinatal period
& in premature infants); child 3 months-12
Drug Interaction years, 30 mg/kg every 6-8 hours.
Concurrent administration of probenecid
delays the excretion of Amoxicillin. Precaution & Warning
Co-amoxiclav should be used with care in
Preparation patients on anti-coagulation therapy or with
250 mg, & 500 mg Capsule, 250 mg DT severe hepatic dysfunction. In patients with
(Dispersible Tablet), 875 mg Tablet, 125 mg/5 ml moderate or severe renal impairment, dosage
Suspension, 250 mg/5 ml Forte Suspension,125 should be adjusted.
mg/1.25 ml Paediatric Drops, 500 mg Injection.
Contraindication
History of Penicillin hypersensitivity. Patients
with previous history of Co-amoxiclav or
penicillin associated cholestatic jaundice.

Side Effect

Moxaclav TM Mild & transitory nature. Diarrhoea,


pseudomembranous colitis, indigestion,

M Active Ingredient
Co-Amoxiclav (Amoxicillin + Clavulanic Acid)
nausea, vomiting & candidiasis.

Drug interactions
Oral contraceptives.
Indication
Upper respiratory tract infections; Lower Use in Pregnancy & Lactation
respiratory tract infections; Genito-urinary Use of Co-amoxiclav in pregnancy is not
tract infections; Skin & soft tissue infections; recommended unless considered essential by
Bone & joint infections e.g. osteomyelitis; the physician. During lactation, trace quantities
Other infections e.g. septic abortion, puerperal of Amoxicillin can be detected in breast milk.
sepsis, intra-abdominal sepsis, etc.
Preparation
Dosage & Administration 375 Tablet (Amoxicillin 250 mg & Clavulanic
Adults & children over 12 years: One Moxaclav Acid 125 mg); 625 Tablet (Amoxicillin 500
375 mg tablet three times a day. In severe mg & Clavulanic Acid 125 mg); 1gm Tablet
infection one Moxaclav 625mg tablet three (Amoxicillin 875 mg & Clavulanic Acid 125
times a day or one Moxaclav 1gm tablet two mg); 60 ml & 100 ml Powder for Suspension
times a day. Children of 6-12 years: 2 teaspoonful (Amoxicillin 125 mg & Clavulanic Acid 31.25
of Moxaclav Powder for Suspension every 8 mg/ 5 ml); 35 ml Forte Powder for Suspension
hours. Children of 1-6 years: 1 teaspoonful of (Amoxicillin 400 mg & Clavulanic Acid 57.5
Moxaclav Powder for Suspension every 8 hours. mg/ 5 ml); 0.6 gm IV Inj. (Amoxicillin 0.5 gm
Children below 1 year: 25 mg/kg/day in divided & Clavulanic Acid 0.1gm),1.2 gm IV Injection
doses every 8 hours. Moxaclav Forte Powder (Amoxicillin 1gm & Clavulanic Acid 0.2 gm).
for Suspension: Children of 2-12 years: to
2 teaspoonful b.i.d. Children of 2 months to 2
years: 25/3.6 mg/kg/day to 45/6.4 mg/kg/day
b.i.d. Moxaclav 1.2 IV Injection: 1.2 g every 6-8
153
Product Guide

Mucospel Preparation
8 mg Tablet, 4 mg/5 ml Syrup (100 ml).

Active Ingredient
Bromhexine.

Indication
Treatment of respiratory disorder s associated
with viscid or excessive mucus and/or
productive cough.

Dosage & Administration


Multivit Plus
Mucospel Syrup: Adults & Children over 10 years Active Ingredient
: 2 to 4 teaspoonfuls 3 times daily, Children 5-10 Vitamin A, D, B1, B2, B6, C, E, Nicotinamide,
years : 1 teaspoonful 3 times daily, Children 2-5 Cyanocobalamin, Folic acid, Calcium
years : 1/2 teaspoonful 3 times daily, Children pantothenate, Iron, Copper, Manganese,
below 2 years : 1/4 teaspoonful 3 times daily. Iodine, Potassium & Zinc.
Mucospel Tablet: Adults & Children over 10
years : 1-2 tablets 3 times daily, Children 5-10 Indication
years : 1/2 tablet 3 times daily. Vitamin & mineral deficiencies.

Contraindication & Precaution


known hypersensitivity or idiosyncratic
Dosage & Administration M
Orally one Multivit Plus tablet daily for adult &
reaction to bromhexine hydrochloride (or any children over 5 years of age or as directed by
of the other ingredients in the product). Since the physicians.
mucolytics may disrupt the gastric mucosal
barrier, bromhexine should be used with Contraindication & Precaution
caution in patients with a history of gastric Hypersensitivity, severe specific deficiencies
ulceration. of vitamins or minerals, treatment with
levodopa as pyridoxine decreases the efficacy
Use in Pregnancy & Lactation of levodopa. During the first trimester of
Category B. Bromhexine has been taken by a pregnancy, larger doses of vitamin A (more
large number of pregnant women & women of than 10 tablets per day) may be teratogenic,
child bearing age without any proven increase pernicious anemia or other megaloblastic
in the frequency of malformations or other anemia where vitamin B12 is deficient.
direct or indirect harmful Effects on the foetus.
It is not recommended for breastfeeding Side Effect
mothers unless the potential benefits to the Iron has been associated with gastrointestinal
patient are weighed against the possible risk intolerance.
to the infant.
Use in Pregnancy & Lactation
Side Effect During the first trimester of pregnancy,
Gastrointestinal side Effects, transient rise in recommended daily dose should not be
serum aminotransferase values, headache, exceeded.
vertigo (dizziness), sweating & allergic
reactions. Preparation
Tablet.
154
Product Guide

Myonil Nacromin Nasal Drops


Active Ingredient Active Ingredient
Eperisone. Sodium Cromoglycate

Indication Indication
Improvement of muscular hypertonic Symptomatic prevention & treatment
symptoms in the following diseases- Cervical of seasonal or perennial allergic rhinitis,
syndrome, periarthritis of the shoulder, rhinorrhea, nasal congestion, sneezing &
lumbago. Spastic paralysis in the following postnasal drip.
disease: Cerebrovascular disease, spastic spinal
paralysis, cervical spondylosis, postoperative Dosage & Administration
sequelae (including cerebrospinal tumor), Adults (including the elderly) & children: Initial
sequelae to trauma (spinal trauma, head injury), two drops into each nostril 4-6 times daily.
amyotrophic lateral sclerosis, cerebral palsy,
spinocerebellar degeneration, spinal vascular Contraindication & Precaution
diseases & other encephalomyelopathies. Contraindicated in individuals who have shown
hypersensitivity to the drug or any ingredient
Dosage & Administration of the preparation. Use of Nacromin 2% Nasal

N
For adults: Usually 3 tablets per day in three Drops is not recommended in children younger
divided doses after each meal. than 6 years of age.

Contraindication & Precaution Side Effect


In patients with a history of hypersensitivity to Irritation of nasal mucosa , wheezing or
Eperisone Hydrochloride. tightness of the chest.

Use in Pregnancy & Lactation Preparation


Eperisone Hydrochloride should only be used 2% Nasal Drops.
in pregnant women if the expected therapeutic
benefits are evaluated to outweigh the possible
risks of treatment. The drug should not be used
during lactation.

Side Effect
Excessive relaxation, stomachache, nausea, Nalid
vertigo, anorexia, drowsiness, skin rashes,
diarrhea, vomiting, indigestion, GI disturbances, Active Ingredient
insomnia, headache, constipation, etc. Nalidixic Acid.

Preparation Indication
50 mg Tablet. Urinary tract infection.

Dosage & Administration


Infants & children 3 months of age & over.
Initial: Oral 13.75 mg per kg body weight every
six hours for one or two weeks. Maintenance:
Oral 8.25 mg per kg body weight every six
155
Product Guide
hours. Usual adult dose initially is 1 g every 6 including high dose cisplatin. Prevention &
hours for 7 days reducing to 500 mg every 6 treatment of postoperative nausea & vomiting.
hours or as prescribed by the physician. Naurif Tablet: Nausea & vomiting associated
with initial & repeat courses of emetogenic
Contraindication & Precaution cancer therapy, including high dose of cisplatin.
Risk-benefit must be considered during the first Nausea & vomiting associated with radiation,
trimester of pregnancy & during breast feeding, including total body irradiation & fractionated
impaired renal or hepatic function. Nalidixic abdominal radiation.
acid is contraindicated in the following cases -
Infants under 3 months, epilepsy, CNS lesions. Dosage & Administration
Naurif Injection: Chemotherapy Induced
Side Effect Nausea & Vomiting: Adults: 10 mcg/kg
Gastro-intestinal disturbances including administered intravenously within 30 minutes
nausea, vomiting, diarrhoea, allergic reaction before initiation of chemotherapy, & only on
including urticaria, rashes, fever, arthralgia, the day(s) chemotherapy is given. Paediatric
muscle weakness, phototoxicity. patients 2 to 16 years of age: 10 mcg/kg.
Treatment of Postoperative Nausea & Vomiting:
Drug Interaction Adults: Single dose of 1 mg of Naurif should
This drug should not be used with the following be diluted to 5 ml & administered as a slow
medications because very serious interactions intravenous injection (over 30 seconds). Naurif
may occur: certain cancer chemotherapy
(alkylating agents such as melphalan).
Tablet: Emetogenic chemotherapy: 2 mg once
daily or 1 mg twice daily. Administered only on N
the days(s) chemotherapy is given. Radiation:
Use in Pregnancy & Lactation 2 mg once daily. Two 1 mg tablets are taken
This drug should be used in pregnancy only if within one hour of irradiation.
clearly needed. Nalidxic acid excreted into milk
in small amounts. It is compatible with breast Contraindication
feeding. Known hypersensitivity to granisetron.

Preparation Side Effect


500 mg Tablet & 300 mg/5 ml Powder for Headache, constipation, asthenia, diarrhea,
Suspension. abdominal pain, dyspepsia, nausea, vomiting,
dizziness, insomnia, anxiety.

Pregnancy
Pregnancy category B. This drug may be used in
pregnancy only if clearly needed.
Naurif Nursing Mother
Caution should be exercised when granisetron
Active Ingredient is administered to a nursing mother.
Granisetron.
Preparation
Indication 1 mg/ml Injection, 1 mg Tablet.
Naurif Injection: Prevention of nausea &
vomiting associated with initial & repeat courses
of emetogenic cancer chemotherapy, therapy
156
Product Guide

Nebanol Dosage & Administration


A thin film to be applied one to three times
Active Ingredient daily.
Neomycin Sulphate & Bacitracin Zinc.
Contraindication & Precaution
Indication Hypersensitivity reaction, ototoxicity. Not
Topical bacterial infections, atopic or contact
recommended for neonates.
stasis & infections, eczematoid dermatitis,
neurodermatitis, eczema, anogenital pruritus
etc. Use in Pregnancy & Lactation
Not recommended in pregnancy & lactation.
Dosage & Administration
A thin film to be applied 2 to 4 times daily.
Preparation
Contraindication & Precaution (3.5 mg + 400 I.U. + 5000 I.U.)/gm Ointment.
Hypersensitivity, nephrotoxicity, overgrowth
of non-susceptible organisms including fungi.

Adverse Reaction

N
Allergic reaction. Nebita TM

Preparation
(5 mg + 250 I.U.)/gm Powder, (5 mg + 500 I.U.)/ Active Ingredient
gm Ointment. Nebivolol HCl

Indication
Hypertension, Heart Failure
Dosage & administration: Heat Failure: Initially
1.25 mg once daily, then if tolerated increased
Nebanol Plus at intervals of 12 weeks to 2.5 mg once daily,
then to 5 mg once daily, then to max. 10 mg
once daily. Hypertension: Starting dose is 5
Active Ingredient mg once daily. The dose can be increased at 2
Neomycin Sulphate, Bacitracin Zinc & weeks interval up to 40 mg once daily.
Polymyxin B Sulphate.
Contraindication & Precaution
Indication Nebivolol is contraindicated in the following
Infected wounds, burns or skin grafts, chronic conditions: severe bradycardia, heart block
varicose or other indolent ulcers, furuncles, greater than first degree, patients with
carbuncles, pyoderma, sycosis barbae, cardiogenic shock, decompensated cardiac
impetigo & acne, secondary infected skin failure, sick sinus syndrome, patients with
lesions of scabies, pediculosis, tinea pedis & severe hepatic impairment, patients who
contact & allergic dermatitis. are hypersensitive to any component of this
product.
157
Product Guide
Side Effect
The most common side effects are headache,
Nectar
nausea & bradycardia. Active Ingredient
Glycerol, liquid sugar (67.5%).
Drug Interaction
Use caution when Nebivolol is co-administered Indication
with CYP2D6 inhibitors (quinidine, Relief of dry, irritating coughs & sore throats. It
propafenone, fluoxetine, paroxetine, etc.). also assists in relieving productive cough.
Do not use Nebivolol with other -blockers,
Dosage & Administration
both digitalis glycosides & -blockers slow
Adults including the elderly & children over 5
atrioventricular conduction & decrease heart years: Two 5 ml spoonfuls.
rate. Concomitant use can increase the risk Children 1-5 years: One 5 ml spoonful.
of bradycardia, Nebivolol can exacerbate Children 3 month-under 1 year:2.5 - 5 ml (1/2 - 1
the effects of myocardial depressants or spoonful).
The dose should be repeated three or four
inhibitors of AV conduction, such as certain
times a day as required.
calcium antagonists (verapamil & diltiazem), or
antiarrhythmic agents, such as disopyramide. Contraindication & Precaution

N
Hypersensitivity to any of the ingredients
Use in Pregnancy & Lactation or hereditary fructose intolerance, glucose-
-blockers may cause intra-uterine growth galactose malabsorption syndrome, or sucrase-
restriction, neonatal hypoglycaemia, & isomaltase deficiency.
Diabetics should take note of the carbohydrate
bradycardia; the risk is greater in severe
content of this product. Not recommended for
hypertension. If beta-blockers are used close to children below three months.
delivery, infants should be monitored for signs
of -blockade. Nebivolol is advised to avoid Side Effect
during breast-feeding due to possible risk of This medicine is unlikely to cause side Effects
unless the patient is allergic to the ingredients.
toxicity due to -blockade.
Use in Pregnancy & Lactation
Use in Children The safety of this product during pregnancy
Safety & effectiveness of Nebivolol in pediatric & lactation has not been established, but is
patients have not been established. not considered to constitute a hazard during
these periods & used widely without any ill
consequence.
Preparation
2.5 mg/Tablet, 5 mg/ Tablet. Preparation
100 ml linctus.
158
Product Guide

Neotack or Toxic neuropathies, Neuritis, Neuralgia,


Cervical Syndrome, Shoulder-arm syndrome,
Lumbago, Sciatica, Mayalgia, Intercostal
Active Ingredient neuralgia, Herpes Zoster, Trigeminal Neuralgia
Ranitidine. Supportive treatment in facial paresis.

Indication Dosage & Administration


Duodenal ulcer, Gastric ulcer, Reflux Tablet : 1 to 3 tablets daily or as directed by
oesophagitis, Zollinger-Ellison syndrome, post the physician. Injection : Preferably injected
operative ulcer, Mendelsons syndrome intramuscularly (deep intragluteal). In severe
cases 1 ampoule daily until the acute symptoms
Dosage & Administration subside. For milder cases & follow-up therapy, 2
150 mg twice daily. Maintenance therapy: 150 or 3 ampoules per week.
mg at night. Injection: 50 mg, slow IV every
six to eight hourly. Children: 2 mg/kg-4 mg/ Contraindication & Precaution
kg twice daily to a maximum 300 mg/day. Patients on Levodopa therapy & hypersensitivity
Injection is not indicated for children. to any of the active ingredients. Cyanocobalamin
should not be given before a diagnosis has been
Contraindication & Precaution fully established because of the possibility of
Hypersensitivity. masking symptoms of subacute degeneration

N Side Effect
Infrequent Rash, mental confusion &
of the spinal cord. Cyanocobalamin is not a
suitable form of Vitamin B12 for the treatment
of optic neuropathies associated with raised
hallucination. plasma concentrations of cyanocobalamin.

Use in Pregnancy & Lactation Side Effect


Should be prescribed only if clearly needed. It is Well tolerated. Few allergic responses may be
best avoided by nursing mothers. seen in rare cases.

Preparation Use in Pregnancy & Lactation


150 mg Tablet, 75 mg/5 ml Syrup & 50 mg/2 ml Sufficient data yet not availalble in this respect.
Injection.
Drug Interaction
No drug interactions have yet been reported.

Preparation
(Thiamine Mononitrate 100 mg, Pyridoxine
Neuro-B Hydrochloride 200 mg, Cyanocobalamin
200 mcg)/ Tablet, (Thiamine Mononitrate
100 mg, Pyridoxine Hydrochloride 100 mg,
Active Ingredient
Cyanocobalamin 1000 mcg)/ 3 ml Injection.
Thiamine (Vit-B1), Pyridoxine (Vit-B6),
Cyanocobalamin (Vit-B12).

Indication
Indicated in low back pain & in the deficiency of
the relevant vitamins including Polyneuropathy
of any origin such as- Diabetic, Alcoholic
159
Product Guide

Neurolep neuropathic pain associated with diabetic


peripheral neuropathy & management of
post herpetic neuralgia. It is also indicated for
Active Ingredient the adjunctive therapy for adult patients with
Piracetam. partial onset seizures. It can be used for the
management of fibromyalgia & Neuropathic
Indication pain associated with spinal cord injury.
Cerebral vascular accidents & cerebral
insufficiencies, mental retardation in children, Dosage & Administration
behaviour & psychotic problems in old age, Neuropathic pain associated with diabetic
memory deficits. peripheral neuropathy: The maximum
recommended dose of Pregabalin (Neurolin)
Dosage & Administration is 100 mg three times a day (300 mg/day) in
Adults: One tablet (800 mg) 3 times a day. patients with creatinine clearance of at least 60
Children: 50 mg/kg of body weight in 3 divided mL/min. Dosing should begin at 50 mg three
doses. times a day (150 mg/day) & may be increased
to 300 mg/day within 1 week based on efficacy
Contraindication & Precaution & tolerability.
Severe renal insufficiency (creatinine clearance Post herpetic neuralgia: The recommended dose
< 20 ml/min), hepatic impairment & those of Pregabalin (Neurolin) is 75 to 150 mg two

N
under 16 years of age. times a day, or 50 to 100 mg three times a day
(150 to 300 mg/day) in patients with creatinine
Side Effect clearance of at least 60 mL/min. Dosing should
Nervousness, agitation, irritability, anxiety & begin at 75 mg two times a day, or 50 mg three
sleep disturbances. Nausea, vomiting, diarrhea times a day (150 mg/day) & may be increased
& stomachache, vertigo, headache, trembling to 300 mg/day within 1 week based on efficacy
& sexual stimulation have occasionally been & tolerability.
reported. Adjunctive therapy for adult patients with partial
onset seizures: Pregabalin (Neurolin) at doses
Drug Interaction of 150 to 600 mg/day has been shown to be
Thyroid extract, clonazepam, carbamazepine, Effective as adjunctive therapy in the treatment
phenyton, phenobarbitone & sodium of partial onset seizures in adults. The total
valporate. daily dose should be divided & given either two
or three times daily.
Preparation In general, it is recommended that patients be
800 mg Tablet & 500 mg/5ml Solution. started on a total daily dose no greater than
150 mg/day (75 mg two times a day, or 50 mg
three times a day). Based on individual patient
response & tolerability, the dose may be
increased to a maximum dose of 600 mg/day.
Neurolin Management of Fibromyalgia:
recommended dose of Pregabalin for
The

Active Ingredient fibromyalgia is 300 to 450 mg/day. Dosing


Pregabalin. should begin at 75 mg two times a day (150
mg/day) & may be increased to 150 mg two
Indication times a day (300 mg/day) within 1 week based
Neurolin is indicated for the management of on efficacy & tolerability. Patients who do not
160
Product Guide
experience sufficient benefit with 300 mg/day
may be further increased to 225 mg two times a
day (450 mg/day).
Neuropathic pain associated with spinal cord
injury: The recommended dose range is 150 to
600 mg/day. The recommended starting dose is
75 mg two times a day (150 mg/day). The dose
may be increased to 150 mg two times a day
(300 mg/day) within 1 week based on efficacy
& tolerability. Patients who do not experience
sufficient pain relief after treatment with 300 mg/
day & who tolerate Pregabalin may be treated
with up to 300 mg two times a day.

Contraindication & Precaution


Pregabalin (Neurolin) is contraindicated in patients
with known hypersensitivity to Pregabalin or any
of its components. Discontinuation of Pregabalin
without tapering may produce insomnia, nausea,
headache & diarrhea. So it should be tapered

N gradually over a minimum of 1 week rather than


discontinued abruptly. Creatinine kinase may be
elevated if treated with Pregabalin. It should be
discontinued rapidly if myopathy is diagnosed
or suspected or if creatinine kinase is elevated
markedly.

Side Effect
The most common side Effects include dizziness,
somnolence, dry mouth, edema, blurred vision,
weight gain, & abnormal thinking.

Use in Pregnancy & Lactation


Pregnancy: Pregnancy category C. So it should
only used if potential benefit justifies the
potential risks to the fetus.
Nursing mother: It is not known if pregabalin is
excreted in human milk; it is, however, present in
the milk of rats. So it should be used in nursing
mother only if there is a clear benefit over the risk.
Use in Children
The safety & efficacy of pregabalin in paediatric
patients have not been established.

Preparation
25 mg, 50 mg, 75 mg Capsule.
161
Product Guide

Nexum
Active Ingredient
Esomeprazole.

Indication
Nexum is indicated for the treatment of - Gastroesophageal Reflux Disease (GERD), Healing of
Erosive Esophagitis, Maintenance of healing of Erosive Esophagitis, Symptomatic Gastroesophageal
Reflux Disease (GERD), Risk Reduction of NSAID-associated gastric ulcer & H. pylori eradication
(Triple therapy).

Dosage & Administration


Tablet & capsule: Recommended adult dosage schedule of Esomeprazole is -

Indications Dose Frequency

Gastroesophageal Reflux Disease (GERD)


20 mg or 40 mg Once daily for

N
Healing of erosive esophagitis
4 to 8 weeks*

Maintenance of healing of 20 mg Once daily**


erosive esophagitis

Symptomatic GERD 20 mg Once daily for 4 weeks ***


Risk Reduction of NSAID- 20 mg or 40 mg Once daily for up to
associated gastric ulcer 6 months**
H. pylori eradication (Triple therapy)
Esomeprazole 20 mg Twice daily for 10 days
Amoxicillin 1000 mg Twice daily for 10 days
Clarithromycin 500 mg Twice daily for 10 days

Paediatric use (12 years & older)


Short term treatment of GERD: 20 mg or 40 mg once daily for up to 8 weeks.
The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8
weeks, an additional 4-8 weeks treatment may be considered.
Controlled studies did not extend beyond 6 months.
If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may
be considered.
162
Product Guide
Injection
Duodenal ulcer, gastric ulcer, gastrointestinal 40 mg per day
lesions refractory to H2 blockers, intravenously
Zollinger-Ellison syndrome
Reflux esophagitis 20-40 mg per day
intravenously

Direction for use of IV Injection


Esomeprazole lyophilized powder & 0.9% Sodium Chloride Injection is for intravenous
administration only & must not be given by any other route. Esomeprazole injection 40 mg should
be given as a slow intravenous injection. The solution for IV injection is obtained by adding 5 ml
0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection
should be given slowly over a period of at least 3 minutes. Use only freshly prepared solution. The
o
reconstituted solution may be stored at room temperature (up to 30 c) for a maximum 12 hours.
Half of the IV injection should be used when 20 mg to be administered.

Direction for use of IV Infusion


Esomeprazole IV 40 mg should be given as an intravenous infusion over a period of 10 to 30
minutes. Esomeprazole IV should be reconstituted with 5 ml of 0.9% Sodium Chloride Injection &

N further diluted (admixed) with 5% Dextrose Injection or 0.9% Sodium Chloride Injection or Lactated
Ringers Injection to a final volume of 50 ml. The reconstituted solution may be stored at room
temperature (up to 30oc) for a maximum 12 hours prior to dilution. The admixed solution may be
stored at room temperature (up to 30oc) & must be used within 12 hours when reconstituted with
0.9% Sodium Chloride Injection or Lactated Ringers Injection & within 6 hours when reconstituted
with 5% Dextrose Injection.

Contraindication & Precaution


Esomeprazole is contraindicated in those patients who have known hypersensitivity to any
other components of the formulation. Exclude the possibility of malignancy when gastric ulcer is
suspected & before treatment for dyspepsia.

Side-Effect
Side Effects reported with Esomeprazole include headache, diarrhea & abdominal pain.

Use in Pregnancy & Lactation


US FDA Pregnancy Category - C. This drug should be used during pregnancy only if clearly
needed. Because Esomeprazole is likely to be excreted in human milk, a decision should be made
whether to discontinue nursing or to discontinue the drug, taking into account the importance
of the drug to the mother.

Preparation
20 mg Tablet & Capsule, 40 mg Tablet & Capsule & 40 mg IV Injection.
163
Product Guide

Nidipine SR Nidipro
Active Ingredient Active Ingredient
Nifedipine. Nifedipine + Atenolol.

Indication Indication
Hypertension, Angina. Management of hypertension & chronic stable
angina pectoris where therapy with either a
Dosage & Administration calcium channel blocker or a beta-blocking
20 mg twice daily with food. drug proves inadequate.

Contraindication & Precaution Dosage & Administration


Cardiogenic shock, advanced aortic stenosis, Adult: Hypertension: One capsule daily
nursing mothers, GI obstruction, inflammatory swallowed with water. If necessary, the dosage
bowel disease, hypotension, should be may be increased to 1 capsule every 12 hours.
swallowed whole & should not be bitten, Angina: One capsule every 12 hours swallowed
chewed or broken up. It should be used with with water. Where additional efficacy is
caution in patient whose cardiac reserve is necessary, prophylactic nitrate therapy or
poor. additional nifedipine may be of benefit.

N
Elderly: Dosage should not exceed 1 capsule
Side Effect daily in hypertension or 1 capsule twice daily
Headache, flushing, lethargy, gravitational in angina.
oedema, rash, nausea, increased frequency
of micturition, eye pain, gum hyperplasia, Contraindication & Precaution
depression, tremor, photosensitivity & few Known hypersensitivity to either active
cases of jaundice have been reported. component or any other excipient or other
dihydropyridines. Bradycardia; cardiogenic
Drug Interaction shock; hypotension; metabolic acidosis; severe
ACE inhibitors, Anti-arrhythmics, Anti- peripheral arterial circulatory disturbances;
bacterials, Anti-epileptics, Antipsychotics, second or third degree heart block; sick sinus
Enhanced, hypotensive effect, beta-blockers, syndrome; untreated pheochromocytoma;
Cyclosporin, Muscle relaxants, Ulcer healing uncontrolled heart failure; women capable
drugs. of childbearing or during pregnancy or during
lactation; patients with clinically significant
Use in Pregnancy aortic stenosis; patients with marked
It should be used during pregnancy only if the renal impairment, secondary prevention
potential benefit justifies the potential risk to of myocardial infarction, patients with
the fetus. Prinzmetals angina & first degree heart block.

Preparation Side Effect


20 mg SR Tablet. Flushing, edema, dizziness, headache,
gastrointestinal disturbance, purpura,
impotence, fatigue.

Use in Pregnancy & Lactation


Contraindicated in women capable of
164
Product Guide
childbearing or during pregnancy or during Use in Pregnancy & Lactation
lactation. Large doses of nimodipine have been shown to
cause birth defects in animals. Human studies
Use in Children have not been done. Nimodipine may pass into
Safety & effectiveness in pediatric patients breast milk but has not been reported to cause
have not been established. problems; caution is advised.

Preparation Preparation
Nifedipine 20 mg + Atenolol 50 mg Capsule 30 mg Tablet.

Nimocal Nixalo
Active Ingredient Active Ingredient
Nimodipine. Alprazolam

N
Indication Indication
For the improvement of neurological outcome Anxiety disorder
by reducing the incidence & severity of Generalized Anxiety Disorder (GAD)
ischemic deficits in patients with subarachnoid Panic disorder with or without agoraphobia
hemorrhage from ruptured intracranial berry
aneurysms regardless of their post-ictus
neurological condition. Dosage & Administration
For Adults : Initially 0.25 mg (250 mcg) given
Dosage & Administration 2 or 3 times daily. if required, increases may
Initial dose is 60 mg in every four hours be made in 0.25 mg (250 mcg) increments
interval for 21 consecutive days. Oral therapy according to the severity of symptoms &
should be commence within 96 hours of the patient response.
subarachnoid hemorrhage.
Contraindication & Precaution
Side Effect Hypersensitivity to Alprazolam or other
Headache, dizziness, flushing, heartburn, fast benzodiazepines. Alprazolam is also
heartbeat, slow heartbeat, upset stomach, contraindicated in pregnancy. Elderly &
stomach pain, constipation, depression etc. debilitated patients, or those with organic brain
syndrome, have been found to be prone to the
Precaution CNS depressant activity of benzodiazepines
Blood pressure should be carefully monitored even after low doses.
during treatment with nimodipine based on
its known pharmacology & the known Effects Drug Interaction
of calcium channel blockers. The metabolism AIprazolam produces additive CNS depressant
of nimodipine is decreased in patients with Effects when co-administered with other
impaired hepatic function. psychotropic medications, anticonvulsants,
antihistaminics, ethanol & other drugs which
165
Product Guide
themselves produce CNS depression. The Side Effect
most frequently reported are drowsiness, Not serious, nausea; dizziness; somnolence;
coordination difficulties with dizziness. warm sensation; asthenia; dry mouth,
heaviness, tightness or pressure may occur
Uses in Pregnancy & Lactation in the throat, neck, limbs & chest (with no
Safety in pregnancy has not been established, evidence of ischaemic changes on ECG), &
therefore its use is not recommended. myalgia, muscle weakness, paraesthesia &
dysaesthesia.
Preparation
0.25 mg Tablet. Preparation
2.5 mg Tablet.

Nomi
Norpill 1
TM
Active Ingredient
Zolmitriptan.
Active Ingredient

N
Indication Levonorgestrel.
Acute treatement of Migraine with or without
aura. Indication
Norpill 1 is an emergency contraceptive that
Dosage & Administration can be used to prevent pregnancy following
2.5 mg if symptoms persist or return within unprotected intercourse or a known or
24 hours, a second dose has been shown to suspected contraceptive failure.
be effective within 2 hours of the initial dose,
subsequent attacks can be treated with 5 mg Dosage & Administration
doses of Nomi (Zolmitriptan). One Norpill 1 tablet should be taken orally
as soon as possible within 72 hours after
Contraindication unprotected intercourse.
Known hypersensitivity, uncontrolled
hypertension. Contraindication & Precaution
Levonorgestrel should not be given to pregnant
Precaution & Warning women. If menstrual bleeding is overdue, if the
Wolff-Parkinson-White syndrome or last menstrual period was abnormal in timing or
arrhythmias associated with other cardiac character, or if pregnancy is suspected for any
accessory conduction pathways. other reason, pregnancy should be excluded
before treatment is given. Levonorgestrel,
Drug Interaction like progestin-only contraceptives, does not
It is recommended that patients should leave protect against HIV infection (AIDS) & other
at least 6 hours between taking an ergotamine sexually transmitted diseases.
preparation & starting Zolmitriptan, & vice
versa. Concomitant administration of other Side Effect
5HT1D agonists within 12 hours of Zolmitriptan Nausea/vomiting, abdominal pain, tiredness,
treatment should be avoided. dizziness, changes in vaginal bleeding, breast
166
Product Guide
tenderness, diarrhea, or headache may occur.
Norvent TM

Tell your doctor immediately if any of these Inhaler


rare but very serious side Effects occur: lower
abdominal pain. A very serious allergic reaction Active Ingredient
to this drug is rare. Symptoms of a serious Tiotropium.
allergic reaction: rash, itching, swelling, severe
dizziness, trouble breathing. Indication
Norvent is indicated for the long-term, once-
Drug Interaction daily, maintenance treatment of bronchospasm
The metabolism of levonorgestrel is enhanced associated with Chronic Obstructive Pulmonary
by concomitant use of liver enzyme inducers. Disease (COPD), including chronic bronchitis &
Drugs suspected of having the capacity emphysema.
to reduce the efficacy of levonorgestrel-
containing medication includes: barbiturates, Dosage & Administration
primidone, phenytoin, carbamazepine, herbal Adults & adolescents 12 years & older : The
medicines containing Hypericum perforatum recommended dosage of Tiotropium bromide
(St Johns Wort), rifampicin, ritonavir, rifabutin is the inhalation of 2 puffs of Norvent Inhaler
& griseofulvin. Levonorgestrel may increase once daily.
the risk of cyclosporin toxicity due to possible
inhibition of cyclosporin metabolism. Contraindication & Precaution

N
Tiotropium is contraindicated in patients with
Use in Pregnancy & Lactation
a history of hypersensitivity to atropine or its
It should not be given to pregnant women & it
derivatives, including ipratropium, or to any
will not interrupt the pregnancy. Levonorgestrel
component of this product. As an anticholinergic
is secreted into breast milk. The potential
drug, Tiotropium may potentially worsen
exposure of an infant to levonorgestrel can
symptoms & signs associated with narrow-
be reduced if the breastfeeding woman takes
angle glaucoma, prostatic hyperplasia or
the tablets immediately after feeding & avoids
bladder-neck obstruction & should be used
nursing following each tablet administration.
with caution in patients with any of these
Use in Children conditions.
This product is not intended for use in pediatric
populations, & pharmacokinetic data are not Drug Interaction
available for this population. Tiotropium has been used concomitantly
with other drugs commonly used in COPD
Preparation without increase in adverse drug reactions.
1.5 mg Tablet. The co-administration of Tiotropium with
other anticholinergic-containing drugs
(e.g., ipratropium) has not been studied & is
therefore not recommended.

Side Effect
The most commonly reported adverse drug
reaction was dry mouth, Other reactions,
included constipation, increased heart rate,
blurred vision, glaucoma, urinary difficulty, &
urinary retention.
167
Product Guide
Uses in Pregnancy & Lactation May be used in lactating mother only if it
Pregnancy Category C : Tiotropium should be is clearly needed by the assessment of risk
used during pregnancy only if the potential benefit ratio.
benefit justifies the potential risk to the fetus.
Preparation
Preparation 50 mg Tablet, 5 mg/2 ml Injection, 10 mg/5 ml
Inhaler : Tiotropium 9 mcg/puff, 120 puffs. syrup & 20 mg suppository.

Norvis Ocubrom TM
Eye Drops

Active Ingredient Active Ingredient


Tiemonium Methylsulphate. Bromfenac.

Indication Indication
Pain in gastrointestinal, biliary, urinary & OcubromTM 0.09% Eye Drops is indicated for

N
gynaecological disease such as gastroenteritis, the treatment of postoperative inflammation
diarrhoea, dysentery, biliary colic, enterocolitis, & the reduction of ocular pain in patients who
cholecystytis, colonopathyes, mild cystitis, & have undergone cataract extraction.
spasmodic dysmenorrhoea.
Dosage & Administration
Dosage & Administration Adults: 1 drop to the problem eye 2 times a day;
Tablet: 2-6 tablets (100-300 mg) daily in divided treatment should start 24 hours after surgery &
doses. should continue for 2 weeks
Injection: 1 ampoule (5 mg) three times Children: Use & dose must be determined by the
daily, through Intravenous route slowly or doctor.
Intramuscular route.
Syrup: 3 mg-6mg/body weight/day or 1.5 ml-3 Contraindication & Precaution
ml, 3 times a day. Bromfenac ophthalmic solution is
Suppository: 01 Suppository 02 to 03 times contraindicated in patients with known
daily through rectal route. hypersensitivity to any ingredient in the
formulation.
Side Effect
Very rare. Side Effect
The most commonly reported adverse
Contraindication experiences are: abnormal sensation in
Glucoma or where acute pain of eyeball with eye, conjunctival hyperemia, eye irritation
vision disturbance, disorder of prostate or (including burning/stinging), eye pain, eye
urinary bladder. pruritus, eye redness, headache, & iritis.

Use in Pregnancy & Lactation Use in Pregnancy & Lactation


May be used in pregnancy only if it is clearly US FDA Pregnancy Category C.
needed by the assessment of risk benefit ratio. This drug should be used during pregnancy
168
Product Guide
only if the potential benefit justifies the & the lack of pharmacological activity, this
potential risk to the fetus. medication can be used during pregnancy.
Caution should be exercised when Bromfenac Nursing Mothers: It is not known whether this
ophthalmic solution is administered to a medication is excreted in human milk. Because
nursing woman. many drugs are excreted in human milk,
caution should be exercised when this product
Use in Children is applied to a nursing woman.
Safety & efficacy in pediatric patients have not
been established yet. Use in Children
Safety & efficacy in pediatric patients have not
Preparation been established.
0.09% Eye drops.
Preparation
Each plastic dropper bottle contains 10 ml of
Polyethylene Glycol 400 BP 0.4% & Propylene
Glycol BP 0.3% sterile solution.

Oculant TM
Eye Drops

O
Active Ingredient
Polyethylene Glycol 400 BP 0.4% & Propylene
Glycol BP 0.3% Ofkof
Indication
Oculant Eye Drops is indicated of the temporary Active Ingredient
relief of burning & irritation due to dryness of Dextromethorphan, Pseudoephedrine &
the eye. Triprolidine.

Dosage & Administration Indication


Instill 1 or 2 drops in the affected eye(s) as Symptomatic relief of upper respiratory tract
needed or as directed by the physician. disorders accompanied by non-productive
Children under 6 years of age: ask a doctor. cough which benefits from the administration
of a nasal decongestant, a histamine H1 receptor
Contraindication & Precaution antagonist & an antitussive combination.
Hypersensitivity to any of the components of
the medication. This product may temporarily Dosage & Administration
cause blurred vision right after being placed Adults : 2 teaspoonful three times a day.
in the eye(s). Never touch tip of container with Children : over 12 years: 2 teaspoonful three
any surface to avoid contamination & replace times a day. 6-12 years: 1 teaspoonful three
cap after each use. times a day. 2-6 years : 1/2 teaspoonful three
times daily or as directed by the physician.
Side Effect
Generally well tolerated. It should not be used Contraindication & Precaution
if allergic condition occurs to any ingredients Known hypersensitivity to Dextromethorphan,
of the product. Pseudoephedrine or Triprolidine, in persons
under treatment with monoamine oxidase,
Use in Pregnancy & Lactation within 2 weeks of stopping such treatment,
Due to the negligible systemic exposure
169
Product Guide
severe hypertension or severe coronary
artery disease. This combination may
Prevention of nausea & vomiting associated
with radiotherapy
cause drowsiness & impair performance in
tests of auditory vigilance. As with other
Prevention of post operative nausea &
vomiting
sympathomimetic agents caution should be
exercised in patients with hypertension, heart Dosage & Administration
disease, diabetes, hyperthyroidism, elevated Prevention of chemotherapy induced nausea &
intraocular pressure & prostatic enlargement. vomiting (CINV):
Adult- The recommended adult oral dosage of
Side Effect Ofran (Ondansetron) is 24 mg given as three 8 mg
Dizziness, gastro-intestinal disturbances, tablets in highly emetogenic chemotherapy. In
Central nervous system (CNS) depression or case of moderately emetogenic chemotherapy
excitation, Sleep disturbance, hallucination, the oral dose is one 8 mg Ofran (Ondansetron)
Skin rashes with or without irritation, tablet or 10 ml of Ofran (Ondansetron) oral
tachycardia, dryness of mouth, nose & throat, solution given twice daily
urinary retention. Pediatric patients- for pediatric patients 4
through 11 years of age the dosage is one 4mg
Drug Interaction Ofran tablet or 5ml of Ofran solution should be
Decongestants, tricyclic antidepressants, administered 3 times a day for 1 to 2 days after
appetite suppressants & amphetamine like

O
completion of chemotherapy.
psychostimulants or with monoamine oxidase Radiotherapy induced nausea & vomiting:
inhibitors, guanethidine, methyldopa, alpha- Adult- the recommended oral dosage is one
adrenergic blocking agents. 8mg Ofran tablet or 10ml of Ofran oral solution
given 3times daily.
Use in Pregnancy & Lactation Post operative nausea & vomiting (PONV):
Caution should therefore be exercised by Adult- the recommended dosage is 16 mg
balancing the potential benefits of treatment given as two 8mg Ofran tablets or 20 ml of
of the mother against any possible hazards to Ofran oral solution 1hour before induction of
the developing fetus. anesthesia.
Dosage adjustment for patients with impaired
Preparation hepatic function-
(Dextromethorphan Hydrobromide 10 mg, The total daily dose of 8mg should not be
Pseudoephedrine Hydrochloride 30 mg & exceeded.
Triprolidine Hydrochloride 1.25 mg)/5 ml
Syrup. Contraindication & Precaution
Ondansetron is contraindicated in patients
with known hypersensitivity to the drug.
Hypersensitivity reactions have been reported in
Ofran patients who have exhibited hyper sensitivity to
other 5-HT3 receptor antagonists.
Active Ingredient Ondansetron is not a drug that stimulates
Ondansetron gastric or intestinal peristalsis. It should not be
used instead of nasogastric suction. The use of
Indication Ondansetron in patients following abdominal
Ofran is indicated for surgery or in patients with chemotherapy-
Prevention of nausea & vomiting associated induced nausea & vomiting may mask a
with highly emetogenic cancer chemotherapy progressive ileus and/or gastric distension.
170
Product Guide
Use in Pregnancy & Lactation Patients should be strongly encouraged to take
In pregnancy: Pregnancy category B. So the a multivitamin supplement that contains fat-
drug should be used in pregnancy only if soluble vitamins to ensure adequate nutrition
clearly needed. because Orlistat has been shown to reduce
In lactation: Ondansetron excretes in milk of the absorption of some fat-soluble vitamins
lactating animals. Caution should be exercised & beta-carotene. In addition, the levels of
when Ondansetron is administered to nursing vitamin D & betacarotene may be low in obese
mother. patients compared with non-obese subjects.
The supplement should be taken once a day at
Preparation least 2 hours before or after the administration
8 mg Tablet, 4 mg/5 ml (50 ml) solution, 8 of Orlistat, such as at bedtime. Liver Injury:
mg/4ml Injection. Patients should be instructed to report any
symptoms of hepatic dysfunction (anorexia,
pruritus, jaundice, dark urine, light-colored
stools, or right upper quadrant pain) while
taking Orlistat. When these symptoms occur,
Orlistat & other suspect medications should be
OlistatTM discontinued immediately & liver function tests
& ALT & AST levels obtained. Increases in Urinary
Oxalate: Some patients may develop increased

O
Active Ingredient levels of urinary oxalate following treatment
Orlistat with Orlistat. Cases of oxalate nephrolithiasis
& oxalate nephropathy with renal failure have
Indication been reported. Monitor renal function when
Obesity management prescribing ORLISTAT to patients at risk for renal
impairment & use with caution in those with
a history of hyperoxaluria or calcium oxalate
Dosage & Administration nephrolithiasis. Cholelithiasis: Substantial
120 mg capsule 3 times daily with each main weight loss can increase the risk of cholelithiasis.
meal containing fat during or within 1 hour of Miscellaneous: Organic causes of obesity (eg,
meal. hypothyroidism) should be excluded before
prescribing Orlistat. Patients should be advised
Contraindication & Precaution to adhere to dietary guidelines Gastrointestinal
Orlistatis contraindicated in: Pregnancy, events may increase when Orlistat is taken with
Patients with chronic malabsorption a diet high in fat (>30% total daily calories from
syndrome, Patients with cholestasis, Patients fat). The daily intake of fat should be distributed
with known hypersensitivity to Orlistat or to over three main meals. If Orlistat is taken with
any component of this product. Precautions any one meal very high in fat, the possibility of
should be taken during: Concomitant Drug & gastrointestinal effects increases.
Vitamin Use: Orlistat & cyclosporine should
not be simultaneously coadministered. To Side Effect
reduce the chance of a drug-drug interaction, Commonly-observed adverse events
cyclosporine should be taken at least 3 hours associated with the use of Orlistat include oily
before or after Orlistat in patients taking both spotting, flatus with discharge, fecal urgency,
drugs. In addition, in those patients whose fatty/oily stool, oily evacuation, increased
cyclosporine levels are being measured, more defecation, fecal incontinence.
frequent monitoring should be considered.
171
Product Guide
Drug Interaction
Olmecar TM

Cyclosporine: Data from a Orlistat & cyclosporine


drug interaction study indicate a reduction in
cyclosporine plasma levels when Orlistat was Active Ingredient
coadministered with cyclosporine. Orlistat & Olmesartan Medoxomil.
cyclosporine should not be simultaneously
coadministered. Cyclosporine should be Indication
administered 3 hours after the administration For the treatment of hypertension. It may
of Orlistat. Fat-soluble Vitamin Supplements be used alone or in combination with other
& Analogues: Data from a pharmacokinetic antihypertensive agents.
interaction study showed that the absorption
of beta-carotene supplement is reduced when Dosage & Administration
concomitantly administered with Orlistat. Dosage must be individualized. The usual
Orlistat inhibited absorption of a vitamin E recommended starting dose of Olmesartan is
acetate supplement. The effect of Orlistat 20 mg once daily when used as monotherapy
on the absorption of supplemental vitamin in patients who are not volume-contracted. For
D, vitamin A, & nutritionally-derived vitamin patients requiring further reduction in blood
K is not known at this time. Levothyroxine: pressure after 2 weeks of therapy, the dose of
Hypothyroidism has been reported in Olmesartan may be increased to 40 mg.
patients treated concomitantly with Orlistat & Doses above 40 mg do not appear to have

O
levothyroxine postmarketing. Patients treated greater effect. Twice-daily dosing offers no
concomitantly with Orlistat & levothyroxine advantage over the same total dose given once
should be monitored for changes in thyroid daily.
function. Administer levothyroxine & Orlistat
at least 4 hours apart. Warfarin: Vitamin K Contraindication & Precaution
absorption may be decreased with Orlistat. Olmesartan is contraindicated in patients who
Patients on chronic stable doses of warfarin are hypersensitive to any component of this
who are prescribed Orlistat should be product.
monitored closely for changes in coagulation
parameters. Side Effect
Treatment with Olmesartan was well tolerated,
Use in Pregnancy & Lactation with an incidence of adverse events similar
Pregnancy Category X. Orlistat is to placebo. The following adverse events
contraindicated during pregnancy, because occurred in placebo controlled clinical trials
weight loss offers no potential benefit to a at an incidence of more than 1% of patients
pregnant woman & may result in fetal harm.It is treated with Olmesartan, but also occurred
not known if Orlistat is present in human milk. at about the same or greater incidence
Caution should be exercised when Orlistat is in patients receiving placebo: back pain,
administered to a nursing woman. bronchitis, creatine phosphokinase increased,
diarrhea, headache, hematuria, hyperglycemia,
Use in Children hypertriglyceridemia, influenzalike symptoms,
Safety & effectiveness in pediatric patients pharyngitis, rhinitis & sinusitis.
below the age of 12 have not been established.
Use in Pregnancy & Lactation
Preparation Pregnancy Categories: C (first trimester) & D
120 mg Capsule. (second & third trimesters).
Nursing Mothers: It is not known whether
172
Product Guide
Olmesartan is excreted in human milk, but mg, for inadequate blood pressure control. If
Olmesartan is secreted at low concentration large doses of hydrochlorothiazide have been
in the milk of lactating rats. Because of the used as monotherapy & volume depletion or
potential for adverse Effects on the nursing hyponatremia is present, caution should be
infant, a decision should be made whether to used when adding Olmesartan or switching
discontinue nursing or discontinue the drug, to Olmecar Plus tablet, as marked decreases
taking into account the importance of the drug in blood pressure may occur. Consideration
to the mother. should be given to reducing the dose of
Use in Children: Safety & Effectiveness in Hydrochlorothiazide to 12.5 mg before adding
pediatric patients have not been established. Olmesartan. The antihypertensive effect of
Olmecar Plus tablet is related to the dose of
Preparation both components over the range of 10 mg/12.5
20 mg & 40 mg Tablet. mg to 40 mg/25 mg.

Contraindication & Precaution


This combination tablet is contraindicated
in patients who are hypersensitive to any
component of this product. Because of the

Olmecar Plus Hydrochlorothiazide component, this product


TM

is contraindicated in patients with anuria or

O Active Ingredient
Olmesartan Medoxomil + Hydrochlorothiazide.
hypersensitivity to other sulfonamide-derived
drugs.

Side Effect
Indication Some common side Effects include: headache,
Indicated for the treatment of hypertension. urinary tract infection, chest pain, back pain,
This fixed dose combination is not indicated peripheral edema, vertigo, abdominal pain,
for initial therapy. dyspepsia, gastroenteritis, diarrhoea, SGOT
increased, GGT increased, SGPT increased,
Dosage & Administration hyperlipemia, creatine phosphokinase
The dose of Olmecar Plus tablet is one tablet increased, hyperglycemia, arthritis, arthralgia,
once daily. Olmecar Plus tablet may be myalgia, coughing, rash etc.
administered with other antihypertensive
agents. A patient whose blood pressure is Use in Pregnancy & Lactation
inadequately controlled by Olmesartan or Pregnancy: Pregnancy Categories C (first
Hydrochlorothiazide alone may be switched trimester) & D (second & third trimesters). This
to once daily Olmecar Plus tablet. Dosing combination drug should not be used during
should be individualized. Depending on the pregnancy.
blood pressure response, the dose may be Nursing Mothers: It is not known whether
titrated at intervals of 2-4 weeks. If blood Olmesartan is excreted in human milk, but
pressure is not controlled by Olmesartan alone, Olmesartan is secreted at low concentration
Hydrochlorothiazide may be added starting in the milk of lactating rats. Thiazides appear
with a dose of 12.5 mg & later titrated to 25 mg in human milk. Because of the potential for
once daily. adverse Effects on the nursing infant, a decision
If a patient is taking Hydrochlorothiazide, should be made whether to discontinue nursing
Olmesartan may be added starting with a or discontinue the drug, taking into account the
dose of 20 mg once daily & titrated to 40 importance of the drug to the mother.
173
Product Guide
Use in Children
Orogel TM

Safety & Effectiveness in pediatric patients


have not been established.
Active Ingredient
Preparation Benzocaine.
Olmesartan Medoxomil 20 mg +
Hydrochlorothiazide 12.5 mg. Indication
For the temporary relief of pain due to minor
injury or irritation of the mouth & gums like-
toothache, sore gums, canker sores, braces,
minor dental procedures, dentures.
Oni Dosage & Administration
Active Ingredient Apply to the affected area up to 4 times daily or
Betamethasone Dipropionate & Clotrimazole. as directed by a doctor/dentist. Children under
12 years of age should be supervised in the use
Indication of this product.
Inflammatory dermal infections like tinea
pedis, tinea cruris, tinea corporis etc. Contraindication & Precaution
In patients who are hyper-sensitive to this

O
Dosage & Administration medication or to any of its ingredients, or to
Twice a day for 2-4 weeks. other caine anesthetics. The product should
not be used more than 7 days unless directed
Contraindication & Precaution by a doctor/dentist. If condition persists or
Hypersensitivity, facial rosacea, acne vulgaris, irritation develops, use of the product should
perioral dermatits, perianal & genital pruritus, be discontinued.
napkin eruptions & bacterial or viral infections.
systemic absorption produces HPA axis Drug Interaction
suppression, Pediatric patients may be more Information regarding drug interaction is not
susceptible to systemic toxicity from equivalent known.
doses due to their large skin surface to body
mass ratios. Side Effect
Allergies, swelling in the mouth or throat etc.
Side Effect
Paresthesia, rash, edema & secondary infection, Pregnancy & Lactation
burning & dry skin. Benzocaine has not been reported to cause
birth defects or other problems in pregnant
Use in Pregnancy & Lactation women, as well as, in nursing babies.
The cream should only be used in pregnancy,
if the benefit justifies the potential risk to Preparation
the fetus caution should be exercised when 5 gm Dental Gel.
treating nursing mothers.

Use in Children
Not recommended under 12 years.

Preparation
10 gm Cream.
174
Product Guide

Orostar TM & then spit out. Do not swallow. Children under


6 years of age should use according to the
consultancy of dentist or physician.
Active Ingredient
Menthol + Thymol + Eucalyptol + Methyl Precaution
Salicylate Should not eat or drink for 30 minutes after
rinsing. Children under 12 years of age
Indication should be instructed in good rinsing habits
Dental Plaque, Gingivitis & Bad breath to minimize swallowing. Children have to be
supervised in rinsing as necessary until they are
Dosage & Administration capable of using without supervision. If more
Rinse with 20 ml Orostar Antiseptic Mouthwash than amount used for rinsing is accidentally
for 30 seconds, twice daily (morning & evening). swallowed, physicians help should be taken
Then rinse with water. Do not swallow. immediately.

Contraindication & Precaution Drug Interaction


If more than used for rinsing is accidentally No drug interaction has been reported.
swallowed, please consult with a doctor.
Use in Pregnancy & Lactation
Use in Children It is safe to use during pregnancy.

O
Not indicated below 12 years of age.
Use in Children
Preparation According to the consultancy of dentist or
Orostar Cool Mint: 120 ml & 250 ml in PET physician.
container.
Orostar Original: 120 ml & 250 ml in PET Preparation
container. Orostar Plus 250 ml: Each PET bottle contains
250 ml mouthwash with a measuring cup.
Orostar Plus 120 ml: Each PET bottle contains
120 ml mouthwash with a measuring cup.

Orostar Plus TM

Active Ingredient
Eucalyptol+Menthol+Methyl
Salicylate+Thymol+Sodium Fluoride
Osmolax TM

Active Ingredient
Indication Lactulose.
Dental cavities/Tooth decay
Bad breath , Dental plaque , Gingivitis Indication
Constipation, hepatic encephalopathy.
Dosage & Administration
Adults & children of 6 years & older should use Dosage & Administration
once a day after brushing teeth with toothpaste Constipation: Initially Osmolax solution may
by vigorously swishing 10ml ( as indicated be given twice daily. In due course the dose
inside cap) or rinse between teeth for 1 minute
175
Product Guide
should be adjusted according to the needs of
Ostel -D TM

the individual, but the following serves as a


guide line:-
Starting dose: Active Ingredient
Adults: (including the elderly) - 15 ml twice Sodium Alendronate + Vitamin D3
daily. (Colecalciferol)
Children: 5 to 10 years - 10 ml twice daily.
Children under 5 years - 5 ml twice daily. Indication
Children under 1 year - 2.5 ml twice daily. 1.Treatment of Osteoporosis in Postmenopausal
Osmolax solution may, if necessary, be taken Women: For the treatment of osteoporosis
with water, fruit juice etc. Ostel-D increases bone mass & reduce the
incidence of fractures, including those of the
Hepatic encephalopathy: Adults (including the hip & spine. 2. Treatment to Increase Bone Mass
elderly): Initially 30-50 ml three times a day. in Men with Osteoporosis
Subsequently adjust the dose to produce two
or three soft stools each day. Dosage & Administration
Children: No dosage recommended for this Treatment of osteoporosis in post-menopausal
indication. women: Ostel-D 70/2800 tablet once weekly or
Because of Lactuloses physiological mode of Ostel-D 10/400 tablet once daily.
action it may take up to 48 hours before Effects Treatment to increase bone mass in men with

P
are obtained. However, clinical experience osteoporosis: Ostel-D 70/2800 tablet once
has shown that this medicament does exhibit weekly or Ostel-D 10/400 tablet once daily.
a carry-over Effect, which may enable the To permit adequate absorption, Ostel-D must
patient to reduce the dose gradually over be taken at least 30 minutes before the first
a period of time. A maintenance dose of 15 food, beverage or medication of the day with
ml per day provides only 14 kilocalories & is plain water only. Other beverages (including
therefore, unlikely to adversely affect diabetic mineral water), food & some medications are
patients. likely to reduce the absorption of Alendronate.
To facilitate delivery to the stomach & thus to
reduce the potential for esophageal irritation,
Contraindication & Precaution Ostel-D tablet should only be swallowed upon
Galactosaemia. gastro-intestinal obstruction, rising for the day with a full glass of water.
lactose intolerance. Patients should not lie down for at least 30
minutes after taking Alendronate until after
Side Effect their first food of the day. Patients should not
Meteorism & increased flatulence, diarrhoea. chew or suck on the tablet Ostel-D should not
be taken at bed time.
Use in Pregnancy
If laxative therapy is needed in pregnancy, use Contraindication & Precaution
of this drug is acceptable. Abnormalities of the esophagus which delay
esophageal emptying, such as stricture or
Preparation achalasia
3.4 gm/5 ml Solution.
Inability to stand or sit upright for at least 30
minutes
Hypersensitivity to any component of this
product
176
Product Guide
Hypocalcaemia
Hypocalcaemia & other disturbances of
Oxapro
mineral metabolism should be corrected
Active Ingredient
before initiation of therapy.
Escitalopram.
Alendronate can cause local irritation of the
upper gastro-intestinal mucosa. Caution
Indication
should be used when Alendronate is given
Major depressive disorder & maintenance
to patients with active upper gastrointestinal
therapy to prevent people with depression
problems such as dysphagia, esophageal
from suffering a relapse.
disease, gastritis, duodenitis or ulcers. Patients
should stop taking medicine & consult their
Dosage & Administration
physician if they develop esophageal diseases.
Adults : 1 tablet once daily.
No dosage adjustment is necessary for the
elderly or for patients with mild-to-moderate
Contraindication & Precaution
renal insufficiency (creatinine clearance 35 to
Known hypersensitivity to escitalopram. If a
60 ml/min). Ostel-D is not recommended for
patient enters a manic phase, Escitalopram
patients with more severe renal insufficiency
Oxalate should be discontinued. As with all
(creatinine clearance < 35 ml/min).
drugs effective in the treatment of major
depressive disorder, Escitalopram should be

O
Side Effect
used cautiously in patients with a history of
Usually mild & generally do not require
mania. A combination of symptoms, possibly
discontinuation of therapy. Side Effects
including agitation, confusion, tremor,
include esophageal reactions, abdominal
myoclonus & hyperthermia, may indicate the
pain & distension, diarrhoea or constipation,
development of this condition.
flatulence, musculoskeletal pain, headache,
rash, erythema & transient decreases in serum
Side Effect
calcium & phosphate.
Agitation or restlessness, blurred vision,
diarrhea, indigestion, nausea, increased or
Use in Pregnancy & Lactation
decreased appetite, increased sweating, sexual
Alendronate Sodium is pregnancy category
difficulties (decreased sexual ability or desire,
C. Overdoses of vitamin-D have shown
ejaculatory delay), taste alterations, tremor
teratogenic Effects in pregnant animals. Ostel-D
(shaking), weight changes.
should be used during pregnancy only if the
potential benefit justifies the potential risk to
Use in Pregnancy & Lactation
the mother & fetus. Colecalciferol & some of its
The drug should be used during pregnancy
active metabolites pass into breast milk. It is
& lactation if potential benefit justifies the
not known whether alendronate is excreted in
potential risk to the fetus.
human milk. Caution should be exercised when
Ostel-D is administered to lactating women.
Preparation
5 mg & 10 mg Tablet.
Preparation
10/400 Tablet & 70/2800 Tablet.
177
Product Guide

Oxat 20 Oxifun
TM

Active Ingredient Active Ingredient


Paroxetine. Oxiconazole.

Indication Indication
Major Depressive Disorder, Obsessive Indicated for the topical treatment of the
Compulsive Disorder, Panic Disorder, Social following dermal infections: tinea pedis, tinea
Anxiety Disorder, Generalized Anxiety Disorder, cruris, & tinea corporis due to Trichophyton
Post-traumatic Stress Disorder. rubrum, Trichophyton mentagrophytes, or
Epidermophyton floccosum. Oxifun Cream
Dosage & Administration
is indicated for the topical treatment of tinea
20 mg as a single daily dose.
(pityriasis) versicolor due to Malassezia furfur.
Contraindication
MAOIs or thioridazine, hypersensitivity. Dosage & Administration
Oxifun Cream should be applied to affected
Precaution
& immediately surrounding areas once to
Cardiac conditions, epilepsy. Patients should
twice daily in patients with tinea pedis, tinea
be cautioned about their ability to drive a car
corporis, or tineacruris.

O
& operate machinery.
Oxifun Cream should be applied once daily
in the treatment of tinea (pityriasis) versicolor.
Drug Interaction
Tinea corporis, tinea cruris, & tinea (pityriasis)
Tryptophan, Alcohol, Warfarin.
versicolor should be treated for 2 weeks & tinea
pedis for 1 month to reduce the possibility of
Side Effect
recurrence.
Asthenia, sweating, nausea, decreased
appetite, somnolence, dizziness, insomnia,
Side Effect
tremor, nervousness, ejaculatory disturbance
Pruritus, burning, irritation & allergic contact
& other male genital disorders, nausea, dry
dermatitis, folliculitis, erythema, & papules,
mouth, constipation, dizziness, somnolence,
fissure, maceration, rash, stinging & nodules.
impotence, female genital disorders.
Drug Interaction
Use in Pregnancy & Lactation
Potential drug interactions between
The drug should be used during pregnancy
Oxiconazole & other drugs have not been
& lactation if potential benefit justifies the
systematically evaluated.
potential risk to the fetus.
Preparation
Preparation
10 mg Cream.
20 mg Tablet.
178
Product Guide

Oxifyl CR should be made whether to discontinue


nursing or discontinue the drug, taking into
account the importance of the drug to the
Active Ingredient mother.
Pentoxifylline.
Preparation
Indication 400 mg CR (Controlled Release) Tablet.
Treatment of peripheral vascular disease
evident as intermittent claudication, venous
leg ulcers.

Dosage & Administration


One tablet two to three times a day with meals
Paloset TM
for at least 8 weeks.

Contraindication & Precaution Active Ingredient


Recent cerebral and/or retinal hemorrhage Palonosetron
or in patients who have previously exhibited
intolerance to this product or methylxanthines Indication
such as caffeine, theophylline, & theobromine. Chemotherapy Induced Nausea &

O
Patients on warfarin should have frequent Vomiting: Moderately emetogenic cancer
monitoring of prothrombin times, while chemotherapy prevention of acute & delayed
patients with other risk factors complicated nausea & vomiting associated with initial &
by hemorrhage (e.g., recent surgery, peptic repeat courses. Highly emetogenic cancer
ulceration, cerebral and/or retinal bleeding) chemotherapy prevention of acute nausea
should have periodic examinations for bleeding & vomiting associated with initial & repeat
including, hematocrit and/or hemoglobin. courses.
Postoperative Nausea & Vomiting: Prevention
Side Effect of postoperative nausea & vomiting (PONV) for
Dyspnea, edema, hypotension, anorexia, up to 24 hours following surgery.
cholecystitis, constipation, dry mouth/thirst,
anxiety, confusion, depression, seizures, Dosage & Administration
epistaxis, flu-like symptoms, laryngitis, nasal Chemotherapy Induced Nausea & Vomiting.
congestion, brittle fingernails, pruritus, Adults: A single 0.25 mg I.V. dose administered
rash, urticaria, angioedema, blurred vision, over 30 seconds approximately 30 minutes
conjunctivitis, earache, scotoma, bad taste, before the start of chemotherapy. Children
excessive salivation, leukopenia, malaise, sore (1 Month 17 yrs) : A single 20 micrograms/
throat/swollen neck glands, weight change. kg I.V. dose administered over 15 minutes
approximately 30 minutes before the start of
Drug Interaction chemotherapy.
Warfarin, Theophylline.
Postoperative Nausea & Vomiting: Adults: A
Use in Pregnancy & Lactation single 0.075 mg I.V. dose administered over 10
Used during pregnancy only if the potential seconds immediately before the inductionof
benefit justifies the potential risk to the fetus. anesthesia. Children (1 Month 17 yrs): Not
Because of the potential for tumorigenicity recommended.
shown for Pentoxifylline in rats, a decision
179
Product Guide
Contraindication & Precaution Dosage & Administration
Palonosetron is contraindicated in patients Adults: One tablet daily, The safety of doses
known to have hypersensitivity to the in excess of 600 mg per day has not been
drug or any of its components. Precaution: established. Elderly: No change in initial dosage
Hypersensitivity reactions, including is generally required in the elderly. Children:
anaphylaxis, have been reported with or Not recommended.
without known. Hypersensitivity to other
selective 5-HT3 receptor antagonists. Contraindication & Precaution
Etodolac should not be used in patients who
Side Effect have previously shown hypersensitivity to it.
The most common side effects of Palonosetron Etodolac should not be used in patients with
in chemotherapy-induced nausea & vomiting active peptic ulceration or a history of peptic
are headache & constipation. The most common ulcer disease. Due to possible cross-reactivity,
side effects of Palonosetron in postoperative Etodolac should not be administered to
nausea & vomiting are QT prolongation, patients who experience asthma, rhinitis
bradycardia, headache, & constipation. or urticaria during therapy with aspirin or
other non-steroidal anti-inflammatory drugs.
Drug Interaction Etodolac should be used with caution in
No potential or clinically significant drug patients with fluid retention, hypertension or
interaction with Palonosetron was found. heart failure.

Side Effect P
Use in pregnancy & lactation Reported side Effects include nausea,
Pregnancy Category-B. epigastric pain, diarrhoea, indigestion,
There are no adequate & well-controlled studies heartburn, flatulence, abdominal pain,
in pregnant women. Palonosetron should be constipation, vomiting, ulcerative stomatitis,
used during pregnancy only if clearly needed. It dyspepsia, gastritis, haematemesis, melaena,
is not known whether Palonosetron is excreted rectal bleeding, colitis, vasculitis, headaches,
in human milk. dizziness, abnormal vision, pyrexia, drowsiness,
tinnitus, rash, pruritus, fatigue, depression,
Use in Children insomnia, confusion, paraesthesia, tremor,
Can be used in children from 1 month. weakness/malaise, dyspnoea, oedema,
palpitations, bilirubinuria, hepatic function
Preparation abnormalities & jaundice, urinary frequency,
0.075 mg & 0.25 mg IV Injection dysuria, angioedema, anaphylactoid reaction,
photosensitivity, urticaria & Stevens-Johnson
syndrome.

Use in Pregnancy & Lactation


Panodin SR Safety in human pregnancy has not been
established & Etodolac should not be used
during pregnancy. Safety of Etodolac use
Active Ingredient
during lactation has not been established &
Etodolac.
as such its use in nursing mothers should be
avoided.
Indication
Etodolac is indicated for acute or long-term use
in Rheumatoid Arthritis & Osteoarthritis.
180
Product Guide
Drug Interaction
Pentadol TM

Since Etodolac is extensively protein-bound, it


may be necessary to modify the dosage of other
highly protein-bound drugs. Concomitant Active Ingredient
use of cyclosporin, methotrexate, digoxin, or Tapentadol.
lithium with NSAIDs may cause an increase in
serum levels of these compounds & associated Indication
toxicities. Pentadol tablet is indicated for the relief of
moderate to severe acute pain in patients 18
Preparation years of age or older.
600 mg SR Tablet.
Dosage & Administration
The dose is 50 mg, 75 mg, or 100 mg every 4 to
6 hours depending upon pain intensity.
On the first day of dosing, the second dose may
be administered as soon as one hour after the
first dose, if adequate pain relief is not attained
with the first dose. Subsequent dosing is 50 mg,

Penrif 75 mg, or 100 mg every 4 to 6 hours & should be


adjusted to maintain adequate analgesia with

P
acceptable tolerability.
Active Ingredient Daily doses greater than 700 mg on the first day
Methyl salicylate (Oil of Wintergreen) & of therapy & 600 mg on subsequent days have
Menthol. not been studied & are not recommended.
Use in renal disease
Indication In patients with severe renal impairment, the
Joint pain & inflammation, muscle pain, safety & Effectiveness of Tapentadol has not
backache, minor arthritis. been established.
Use in hepatic disease
Dosage & Administration Tapentadol should be used with caution in
It is applied to affected areas not more than 3 patients with moderate hepatic impairment.
to 4 times daily. Tapentadol has not been studied in patients
with severe hepatic impairment, therefore,
Warnings use of Tapentadol is not recommended in this
For external use only. Do not use with a heating population
pad. Do not swallow. Do not bandage tightly.
Keep away from eyes, mucous membranes, Contraindication & Precaution
broken or irritated skin. If skin redness or This drug is contraindicated in patients
excessive irritation develops, pain lasts for more with impaired Pulmonary Function, It is
than 10 days, or with arthritis-like conditions in also contraindicated in patients with acute
children under 12, do not use & call a physician. or severe bronchial asthma or hypercapnia
in unmonitored settings or the absence
Preparation of resuscitative equipment. This drug is
Methyl salicylate (Oil of Wintergreen) 15% & contraindicated in any patient who has or is
Menthol 10% Cream, Methyl salicylate (Oil of suspected of having paralytic ileus.
Wintergreen) 30% & Menthol 8% Cream. Tapentadol should be administered
with caution to patients with conditions
181
Product Guide
accompanied by hypoxia, hypercapnia or
respiratory problems such as: asthma, chronic Penvik
obstructive pulmonary disease etc. In case of
patient with sleep apnea syndrome, myxedema, Active Ingredient
kyphoscoliosis, central nervous system (CNS) Phenoxymethyl Penicillin.
depression should have to be cautious prior
administration of Tapentadol. Alternative Indication
non-mu-opioid agonist analgesics should be Streptococcal infections, scarlet fever, mild
considered & Tapentadol should be employed erysipelas, bacterial endocarditis, lobar
only under careful medical supervision at the pneumonia.
lowest Effective dose in such patients.
Dosage & Administration
Side Effect 250 to 500 mg 6 hourly.
The following treatment-emergent adverse
events may happen: Contraindication & Precaution
heart rate increased, heart rate decreased, Known to be hypersensitive, severe acute
visual disturbance, abdominal discomfort, infections.
impaired gastric emptying, irritability, edema,
drug withdrawal syndrome, hypersensitivity, Side Effect
involuntary muscle contractions, sensation Diarrhoea, abdominal discomfort, nausea,

P
of heaviness, hypoesthesia, paresthesia, vomiting, spontaneous petechial hemorrhages,
disturbance in attention, sedation, dysarthria, serum sickness.
memory impairment, ataxia, presyncope,
syncope, coordination abnormal, seizure, Drug Interaction
urticaria, blood pressure decreased etc. Zinc oxide, Magnesium oxide, Magnesium
carbonate, Calamine etc. Aspirin,
Drug Interaction sulphamethoxypyrida- zinc & sulphaethidole,
Patients receiving other mu-opioid aminoglycosides.
agonist analgesics, general anesthetics,
phenothiazines, other tranquilizers, sedatives, Use in Pregnancy & Lactation
hypnotics, or other CNS depressants (including There are no contraindications to the use of
alcohol) concomitantly with Tapentadol may penicillin in pregnancy.
exhibit additive CNS depression.
Preparation
Use in Pregnancy & Lactation 250 mg Tablet, 500 mg DS Tablet, 100 ml (125
Pregnancy Category C. There are no adequate mg/5 ml) Powder for Suspension, 100 ml (250
& well-controlled studies in pregnant women. mg/5 ml) Forte Powder for Suspension.
This combination preparation should be used
during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Neonates whose mothers have been taking
Tapentadol should be monitored for respiratory
depression.

Preparation
50 mg, 75 mg & 100 mg Tablet.
182
Product Guide

Peridol Co-administration of antidopaminergic


antiemetics increases the risk of extrapyramidal
adverse Effects.
Active Ingredient
Haloperidol. Use in Pregnancy & Lactation
There is no proven harmful Effect in the first
Indication trimester.
Adult: Schizophrenia: Other psychoses,
especially paranoid (oral & IM), Mania & Preparation
hypomania (oral & IM), Mental or behavioral 5 mg Tablet.
problems such as aggression, hyperactivity
& self- mutilations in the mentally retarded &
in patients with organic brain damage, severe
psychomotor agitation, excitement, violent
or dangerously impulsive behavior (oral & Perkinil
IM), Intractable hiccup (oral), Restlessness
& agitation in the elderly (oral), Gilles de la Active Ingredient
Tourette syndrome & severe tics (oral), Nausea Procyclidine.
& vomiting (IM), Children (Oral administration
only) : Childhood behavioral disorders Indication

P
especially when associated with hyperactivity Parkinsonism of arteriosclerotic, idiopathic &
& aggression, Gilles de la Tourette syndrome, post-encephalitic origin,
Childhood schizophrenia.
Control of neuroleptic drug-induced
Dosage & Administration ectrapyramidal symptoms, such as pseudo-
Initial dosage: Moderate symptomatology 1.5- parkinsonism, akathisia & acute dystonic reactions.
3.0 mg bd or tds.
Dosage & Administration
Contraindication & Precaution 2.5 mg 3 times a day, then 5 mg 3 times a day &
CNS depression; Parkinsons disease; known occasionally 5 mg at night.
hypersensitivity to haloperidol; lesions of the
basal ganglia. Contraindication & Precaution
Caution in children & geriatric patients. It is
Side Effect advisable to be cautious in giving Perkinil to
Extrapyramidal symptoms, acute dystonia, patients with diarrhea & cardiovascular disease,
parkinsonian rigidity, tremor, oculogyric crises glaucoma, urinary retention, hepatic or renal
& laryngeal dystonia, confusional states or impairment.
epileptic fits, depression, sedation, agitation,
drowsiness, insomnia, headache, vertigo & Side Effect
apparent exacerbation of psychotic symptoms, Dryness of the mouth , Mydriasis, blurred
nausea, loss of appetite, constipation & vision & adverse G.I. effects (nausea, vomiting,
dyspepsia, dry mouth, blurred vision, urinary epigastric distress, constipation), an allergic
retention. reaction (rash) or muscular weakness, vertigo,
confusion & hallucination.
Drug Interaction
Haloperidol with lithium may predispose Preparation
to the neuroleptic malignant syndrome. 5 mg Tablet & 10 mg/2 ml Injection.
183
Product Guide

Perkirol Use in Pregnancy & Lactation


TM

Ropinirole should not be used during


pregnancy & in nursing mothers.
Active Ingredient
Ropinirole. Preparation
0.25 mg & 2 mg Tablet.
Indication
Parkinsons Disease, Restless Legs Syndrome.

Dosage & Administration


Parkinsons Disease: Starting dose is 0.25 mg
3 times daily. After week 4, if necessary, daily
dosage may be increased by 1.5 mg/day on a Pevitin
weekly basis up to a dose of 9 mg/day, & then
by up to 3 mg/day weekly to a total dose of Active Ingredient
24 mg/day. Restless Legs Syndrome: Starting Econazole Nitrate & Triamcinolone Acetonide.
dosage is 0.25 mg once daily, 1 to 3 hours
before bedtime. After 2 days, the dosage can Indication
be increased to 0.5 mg once daily & to 1 mg Inflammatory dermatomycoses & inflammatory
once daily at the end of the first week of dosing. skin conditions which can be complicated by or

P
threatened by bacterial or fungal skin infection.
Contraindication & Precaution
Hypersensitivity to Ropinirole, patients with Dosage & Administration
severe cardiovascular disease should be treated Apply by gently rubbing onto the skin twice
with caution. As with other dopaminergic daily for 14 days.
drugs, caution should be exercised when
these compounds are given concomitantly Contraindication & Precaution
with Ropinirole because of the unknown Tubercular or luetic skin infections or
potential for the occurrence of hypotension, in viral diseases (e.g. herpes, vaccinia,
bradycardias or other arrhythmias. Patients varicella). Hypersensitivity to imidazoles or
should be informed & advised to exercise corticosteroids, adrenal suppression. Long
caution while driving or operating machines term therapy with corticosteroids can cause
during treatment with Ropinirole. skin lesions such as atrophy, telangiectasia &
striae.
Side Effect
Nausea, somnolence, leg edema, abdominal Side Effect
pain, vomiting, syncope, decreases in systolic Local mild irritation & Hypersensitivity.
blood pressure, symptomatic hypotension,
bradycardia, excessive daytime somnolence & Drug Interaction
sudden sleep onset episodes. No information is available.

Drug Interaction Preparation


Neuroleptics & other centrally acting (10 mg + 1 mg)/gm cream.
dopamine antagonists, such as sulpiride or
metoclopramide, theophylline, ciprofloxacin,
fluvoxamine & cimetidine, oestrogens.
184
Product Guide

Phylopen TM
Pivalo TM

Active Ingredient Active Ingredient


Flucloxacillin Pitavastatin.

Indication Indication
Boils, abscesses, carbuncles, furunculosis, Pitavastatin is indicated as an adjunctive
cellulitis; infected skin conditions, e.g. ulcer, therapy to diet to reduce elevated total
eczema & acne; infected wounds, infected cholesterol (TC), low-density lipoprotein
burns, protection for skin grafts, otitis media cholesterol (LDL-C), apolipoprotein B (Apo B),
& externa, impetigo, pneumonia, lung abscess, triglycerides (TG) & to increase HDL-C in adult
empyema, sinusitis, pharyngitis, tonsillitis, & patients with primary hyperlipidemia or mixed
quinsy, osteomyelitis, enteritis, endocarditis, dyslipidemia.
urinary tract infections, meningitis,
septicaemia, prophylactic agent during major Dosage & Administration
surgical procedures for example, cardiothoracic The dose range for Pitavastatin is 1 to 4 mg
& orthopaedic surgery. orally once daily at any time of the day with or
without food. The recommended starting dose
Dosage & Administration is 2 mg & the maximum dose is 4 mg.

P
Adult : 500 mg six hourly, 2-10 years : half of
the adult dose, Under 2 years : quarter of the Contraindication & Precaution
adult dose. Patients with a known hypersensitivity to any
component of this product. Hypersensitivity
Contraindication reactions including rash, pruritus & urticaria
Penicillin hypersensitivity. have been reported with Pitavastatin.

Side Effect Side Effect


Uncommon, nausea, diarrhoea, skin rashes. Rhabdomyolysis, myopathy & Liver Enzyme
Abnormalities
Drug Interaction
Gentamicin sulphate, streptomycin sulphate, Use in Pregnancy & Lactation
vitamin mixtures, lipids, blood products & Pregnancy Category X. It is not known
protein hydrolysates or other proteinaceous whether pitavastatin is excreted in human
fluids. milk, however, it has been shown that a small
amount of another drug in this class passes into
Use in Pregnancy & Lactation human milk.
The use of Flucloxacillin in pregnancy should
be reserved for cases considered essential by Preparation
the clinician. 2 mg & 4 mg tablet

Preparation
250 mg Capsule, 500 mg DS Capsule, 125 mg/5
ml Powder for Suspension, 250 mg/5 ml Forte
Powder for Suspension.
185
Product Guide

Prolert Promtil TM

Active Ingredient Active Ingredient


Fluoxetine. Prochlorperazine.

Indication Indication
Depressive illness, Bulimia nervosa & anorexia, For control of severe nausea & vomiting caused
Obsessive compulsive disorders, Pre-menstrual by radiation therapy, cancer chemotherapy,
syndrome. surgery, & other conditions. Relieving
nausea, vomiting & attacks of dizziness or
Dosage & Administration spinning sensations (vertigo) associated with
A dose of 20 mg/day to 60 mg/day is Menieres disease & other inner ear disorders,
recommended. for the treatment Psychotic illness such as
schizophrenia (hallucinations & hostility),
Contraindication & Precaution acute mania, for the short-term treatment of
Monoamine Oxidase inhibitors (MAOIs) generalized non-psychotic anxiety.
Severe renal failure, Usage in nursing mothers,
Hypersensitivity to Fluoxetine. Dosage & Administration
Children (not recommended in children <10 kg

P
Side Effect or <2 years): 10-14 kg: 2.5 mg every 12-24 hours
Anxiety, nervousness & insomnia; drowsiness as needed; maximum: 7.5 mg/day
& fatigue or asthenia; tremor; sweating; 15-18 kg: 2.5 mg every 8-12 hours as needed;
gastrointestinal complaints, including maximum: 10 mg/day
anorexia, nausea & diarrhea ; & dizziness or 19-39 kg: 5 mg every 12 hours as needed;
light headedness. Other side Effects include maximum: 15 mg/day
angioedema, urticaria, or other allergic Adults: Oral: 5-10 mg 3-4 times/day; usual
reactions. maximum: 40 mg/day

Drug Interaction Contraindication & Precaution


MAO inhibitors: Serious sometimes fatal Hypersensitivity to prochlorperazine or any
reactions have been reported with concomitant component of the formulation, severe CNS
use. Tryptophan: Patients experience adverse depression; coma; should not be used in children
reactions including agitation, restlessness, <2 years of age or <10 kg. Very high or very low
& GI distress. Other Antidepressants: There blood pressure, liver or heart disease, Reyes
have been greater than two fold increases syndrome, alcohol or drug dependencies, nervous
of previously stable plasma levels of other system problems, blood disorders, allergies
antidepressants. Lithium: There have been (especially drug allergies). Caution should
reports of increased or decreased lithium levels be taken while performing tasks that require
when used concomitantly with fluoxetine. alertness, such as driving or using machinery. Use
of alcohol can cause extreme drowsiness. This
Use in Pregnancy & Lactation medication may increase sensitivity to sunlight.
Should not be prescribed in pregnancy & Prolonged sun exposure should be avoided &
lactation. a sunscreen & protective clothing should be
taken when anybody is exposed to the sun. This
Preparation medication can reduce sweating making more
20 mg Capsule. susceptible to heat stroke.
186
Product Guide
Side-Effect Drug Interaction
Drowsiness, jaw, neck, & back muscle spasms, No clinically important drug interactions
fine worm-like tongue movements, rhythmic have been identified. Pronor does not appear
face, mouth, or jaw movements, slow or difficult to significantly affect the cytochrome P450-
speech, difficulty swallowing, restlessness link drug metabolizing enzyme system.
& pacing, tremors, shuffling walk, skin rash, Compounds which have been tested in man
yellowing of the skin or eyes. include propanolol, digoxin, glibenclamide,
warfarin, theophylline & antipyrine.
Use in Pregnancy & Lactation
No evidence of adverse Effects of this drug has Although specific interaction studies were
been reported during pregnancy & lactation. not performed in clinical studies, Pronor
was used concomitantly with ACE inhibitors,
Preparation alpha blockers, beta blocker, calcium
5 mg Tablet. channel blockers, cardiac nitrates, diuretics,
H2 antagonists, NSAIDs, quinilones &
benzodiazepines without evidence of clinically
significant adverse interactions.

Use in Pregnancy & Lactation

Pronor Pronor is contra-indicated in women who are

P
TM
or may become pregnant. It is not known
whether finasteride is excreted in human milk.
Active Ingredient
Finasteride. Preparation
5 mg Tablet.
Indication
Treatment & control of benign prostatic
hyperplasia (BPH).

Dosage & Administration

Prosalic Lotion
Pronor one 5 mg tablet daily with or without TM
food.

Contraindication & Precaution Active Ingredient


Hypersensitivity to any component of this Betamethasone + Salicylic Acid
product; women who are or may become
pregnant; children, people with severely Indication
diminished urinary flow. Indicated for the treatment of hyperkeratotic
& dry corticosteroid-responsive dermatoses
Side Effect where the cornified epithelium may resist
Pronor is well tolerated. The most frequently penetration of the steroid. The Salicylic Acid
reported side-effects have been related to constituent of Prosalic Lotion, as a result of its
sexual function. In clinical studies the following descaling action, allows access of the dermis
effects have been reported in 1% of patient more rapidly than by applying steroid alone.
treated for 12 months with 5mg a day of Pronor
: impotence (3.7%), decreased libido (3.3%) Dosage & Administration
decreased volume of ejaculate (2.8%). Apply required quantity of spray of Prosalic
187
Product Guide
Lotion to the affected areas & massage gently & importance of the drug to the mother.
thoroughly. The usual frequency of application
is twice daily, in the morning & night. Use in Children
Pediatric patients may demonstrate greater
Contraindication & Precaution susceptibility to topical corticosteroid-
Betamethasone & Salicylic Acid lotion is induced HPA axis suppression & to exogenous
contraindicated in viral diseases including corticosteroid effects than mature patients
vaccinia, varicella, Herpes simplex & fungal because of a greater absorption due to a larger
infection; also tuberculosis of the skin. It is skin surface area to body weight ratio. Use of
contraindicated in those patients with a history topical corticosteroids in children should be
of sensitivity reactions to any of its components. limited to the least amount compatible with
If irritation & sensitization develops with the an effective therapeutic regimen. Chronic
use of Betamethasone & Salicylic Acid lotion, corticosteroid therapy may interfere with
treatment should be discontinued. Systemic growth & development of children.
absorption of topical corticosteroids or
Salicylic Acid may be increased if extensive Preparation
body surface areas are treated. Application of Each container contains 25 ml Lotion.
Salicylic Acid to open wounds or damaged skin
should be avoided.

Side Effect
Side effects that have been reported with the P
application of topical corticosteroids include:
burning, itching, irritation, dryness, folliculitis,
hypertrichosis, hypopigmentation, perioral Proxivir TM

dermatitis, & allergic contact dermatitis.


Active Ingredient
Drug Interaction Tenofovir Disoproxil Fumarate.
Drug interaction may be observed with
other potential corticosteroid containing Indication
preparation. Chronic hepatitis B virus infection in adults
HIV infected adults in combination with other
Use in Pregnancy & Lactation anti retroviral agents.
Since safety of topical corticosteroid use in
pregnant women has not been established, Dosage & Administration
drugs of this class should be used during The recommended dose of Tenofovir in chronic
pregnancy only if the potential benefit justifies hepatitis B virus infection in adults 18 years of
the potential risk to the fetus. Drugs of this age & older with adequate renal function is 300
class should not be used extensively in large mg once daily with or without food.
amounts or for prolonged periods of time in Dose adjustment in renal impairment:
pregnant patients. Tenofovir is eliminated by renal excretion, so
Since it is not known whether topical the exposure to Tenofovir increases in patients
administration of corticosteroids can result with renal dysfunction. Dosing interval should
in sufficient systemic absorption to produce be adjusted in all patients with creatinine
detectable quantities in breast milk, a decision clearance <50 ml/min, as detailed below -
should be made to discontinue nursing or to
discontinue the drug, taking into account the
188
Product Guide
Dosing interval adjustment of Tenofovir in patients with renal impairment
Creatinine Clearance (ml/ 50 30 to 49 10 t0 29 Haemodialysis patients
min)
Recommended (300mg) Every 24 Every 48 Every Every 7 days or after
dosing Interval hours hours 72 to 96 approximately 12 hours
hours of dialysis

Dose adjustment in hepatic impairment: No dose adjustment is required in patients with hepatic
impairment.

Contraindication & Precaution


Tenofovir is contraindicated in patients with known hypersensitivity to Tenofovir or any component
of the product.
Co-administration with other drugs: Tenofovir should not be administered concurrently with
Emtricitabine & Tenofovir combination or Adefovir Dipivoxil.
Lactic Acidosis & Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis
is low for Tenofovir, treatment should be suspended in any patient who develops lactic acidosis
or hepatotoxicity.

P
Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir therapy
may be associated with severe acute exacerbation of hepatitis.

Side Effect
The most common side effects are nausea, vomiting, diarrhea & flatulence.

Drug Interaction
Co-administration of Tenofovir with anti-retroviral, Entecavir, Lamivudine, Methadone, oral
contraceptives, Ribavirin & Tacrolimus did not result in significant drug interactions. The Effects of
co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect
renal function have not been evaluated.

Use in Pregnancy & Lactation


Pregnancy category B. It should be used during pregnancy only if clearly needed. It is not known
whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are
taking Tenofovir.

Use in Children
Safety & Effectiveness of Tenofovir in pediatric patients below the age of 18 years have not been
established.

Preparation
300 mg Tablet.
189
Product Guide

Purotrol Pylotrip
TM

Active Ingredient Active Ingredient


Levocetirizine Dihydrochloride. Lansoprazole Capsule, Amoxicillin Capsule &
Clarithromycin Tablet.
Indication
It is indicated in the treatment of seasonal Indication
allergic rhinitis (two years & above) perennial Eradication of H. pylori in active chronic gastric,
& chronic idiopathic urticaria (six months & duodenal & gastric ulcers.
above) along with other allergic complications.
Dosage & Administration
Dosage & Administration One strip twice daily for 7-14 days or as per the
Adult & children above 12 years of age physicians advice.
Purotrol Tablet: 1 tablet (5 mg) daily
Contraindication & Precaution
Side-Effect Hypersensitivity.
Generally Levocetirizine is well tolerated. But in
rare cases, somnolence, dry mouth, headache, Side Effect
fatigue & asthenia are reported. Nausea, vomiting, diarrhoea, dark stools, dry

P
mouth, glossitis, oral moniliasis, stomatitis,
Contraindication tongue discoloration, myalgia, confusion,
Hypersensitivity to Levocetirizine, Cetirizine headache, dizziness, skin reactions, vaginitis,
or its parent compound Hydroxyzine. vaginal moniliasis.
Patients with severe renal impairment (< 10
ml/min creatinine clearance) should not be Use in Pregnancy & Lactation
administered such medicine. Use only if the potential benefit justifies the
potential risk of the mother.
Pregnancy & Lactation
The safety of Levocetirizine in pregnancy has
not been established. Therefore, it should be Preparation
used with caution during pregnancy & only if (30 mg + 1 gm + 500 mg)/Strip.
the benefits to the mother outweigh any risk
to the fetus. Since Levocitirizine is excreted in
breast milk, it is not recommended for use by
the nursing mothers.

Preparation
5 mg Tablet.
Rabeca TM

Active Ingredient
Rabeprazole Sodium.

Indication
Short-term treatment in healing & symptomatic
relief of duodenal ulcers & erosive or ulcerative
Gastroesophageal Reflux Disease (GERD).
Maintaining healing & reducing relapse rates
190
Product Guide
of heartburn symptoms in patients with GERD. doses. Doses up to 100 mg QD & 60 mg BID
Treatment of daytime & nighttime heartburn & have been administered. Some patients with
other symptoms associated with GERD. .Long- Zollinger-Ellision syndrome have been treated
term treatment of pathological hypersecretory continuously with Rabeprazole Sodium for up
conditions, including Zollinger-Ellison to one year.
Syndrome. In combination with Amoxicillin &
Clarithromycin to eradicate Helicobacter pylori. Contraindication
Rabeprazole Sodium is contraindicated
Dosage & Administration in patient with known hypersensitivity to
Can be taken with or without food. Healing of Rabeprazole or to any component in the
Erosive or Ulcerative Gastroesophageal Reflux product.
Disease (GERD): 20 mg to be taken once daily
for 4 to 8 weeks. For those patients who have Precaution
not healed after 8 weeks of treatment, an Administration of Rabeprazole Sodium to
additional 8 week course may be considered. patients with mild to moderate liver impairment
Maintenance of Healing of Erosive or Ulcerative resulted in increased exposure & decreased
Gastroesophageal Reflux Disease (GERD elimination. Caution should be exercised in
Maintenance): The recommended adult patients with severe hepatic impairment.
oral dose is 20 mg once daily. Treatment of
Symptomatic Gastroesophageal Reflux Disease Drug Intaraction

P (GERD): The recommended adult oral dose is 20


mg once daily for 4 weeks. If symptoms do not
Rabeprazole is metabolized by the non
enzymatic pathway. Rabeprazole does not
resolve completely after 4 weeks, an additional have clinically significant interactions with
course of treatment may be considered. Healing drugs metabolized by the CYP-450 system,
of Duodenal Ulcers: The recommended adult such as Warfarin & Theophylline given
oral dose is 20 mg once daily after the morning as single oral dose, Diazepam as a single
meal for a period up to four weeks. Most intravenous dose, & Phenytoin given as a
patients with Duodenal Ulcer heal within four single intravenous dose. In normal subjects,
weeks. A few patients may require additional co-administration of Rabeprazole 20 mg QD
therapy to achieve healing. Helicobacter pylori resulted in an approximately 30% decrease in
Eradication to Reduce the Risk of Duodenal the bioavailability of Ketoconazole & increase
Ulcer Recurrence: Rabeprazole Sodium 20 in the AUC & Cmax for digoxin of 90% & 29%
mg Twice Daily for 7 Days Amoxicillin 1000 mg respectively.
Twice Daily for 7 Days Clarithromycin 500
mg Twice Daily for 7 Days. All three medications Use in Pregnancy & Lactation
should be taken twice daily with the morning Rabeprazole is FDA Pregnancy Category C.
& evening meals. It is important that patients No data is available on administration of
comply with the full 7-day regimen. Treatment Rabeprazole to pregnant women. However
of Pathological Hypersecretory Conditions this drug should be used during pregnancy,
Including Zollinger-Ellison Syndrome: The only if clearly needed. There are no data on
dosage of Rabeprazole Sodium in patients with the excretion of Rabeprazole into the breast
pathologic hypersecretory conditions varies milk. A decision should be made whether to
with the individual patient. The recommended discontinue nursing or to discontinue the drug,
adult oral starting dose is 60 mg once a day. taking into account the benefit of the drug to
Doses should be adjusted to individual patient the mother.
needs & should continue for as long as clinically
indicated. Some patients may require divided
191
Product Guide
Use in Children Myocardial infarction: By slow intravenous
The safety & effectiveness of Rabeprazole in injection 10-20 mg, repeated after 30 minutes
pediatric patients have not been established. if necessary. Larger dose is required when used
as supplement of anesthesia than that required
Preparation for analgesia.
20 mg Tablet. Children from 18 months to 15 years old: usually
0.2 mg/ kg body-weight, given preferably
by intravenous or intramuscular injection.
Maintenance doses may be given at intervals
of 4 to 6 hours or the dose must be determined
by the physician.

Radirif Contraindication & Precaution
Known hypersensitivity to Nalbuphine
Active Ingredient Hydrochloride. Caution should be taken in
Nalbuphine. the following conditions: impaired respiration,
impaired renal or hepatic function, billiary tract
Indication surgery, myocardial infarction & hypotension.
Moderate to severe pain, moderate to severe
pain associated with myocardial infarction (MI),

R
as a supplement to balanced anesthesia, for Side Effect
preoperative & postoperative analgesia, & for Generally Nalbuphine is well tolerated.
obstetrical analgesia during labor & delivery. However, few side Effects like sedation,
sweating, nausea, vomiting, dizziness, vertigo,
Dosage & Administration dry mouth, headache, respiratory depression,
The usual recommended adult dose is 10 mg for a dyspnea & asthma may be seen.
70 kg individual, administered subcutaneously,
intramuscularly or intravenously; this dose may Use in Pregnancy & Lactation
be repeated every 3 to 6 hours as necessary. Nalbuphine is pregnancy category B. Caution
Dosage should be adjusted according to the should be exercised when Nalbuphine
severity of the pain, physical status of the Hydrochloride is administered to a nursing
patient, & other medications which the patient woman.
may be receiving.
Moderate to severe pain: by intravenous or Preparation
intramuscular injection 10 - 20 mg for 70 kg 20 mg/2 ml (IM/IV) injection.
patient, adjusted as required; child up to 0.3
mg/kg repeated once or twice as necessary.
Preoperative anesthesia: by intravenous or
intramuscular injection 0.1-0.2 mg/kg.
Obstetrical analgesia during labor & delivery:
by intravenous injection 0.3-1 mg/kg over 10- Ranolin XR TM

15 minutes with maintenance doses of 0.25-0.5


mg/ kg in single intravenous administration as Active ingredient
required. Ranolazine
Intraoperative analgesia: by intravenous
injection 0.25-0.5 mg/ kg at 30 minutes Indication
intervals. Ranolazine is indicated for the treatment of
chronic angina. Ranolazine may be used with
192
Product Guide
-blockers, Nitrates, Calcium channel Blockers, when co-administering Ranolazine with P-gp
Anti-platelet therapy, lipid-lowering therapy, inhibitors such as Ritonavir or Cyclosporine.
ACE inhibitors, & angiotensin receptor blockers.
It has been shown to decrease angina episodes Side Effect
in patients with coronary artery disease Cardiac Disorders bradycardia, palpitations;
on maximal doses of amlodipine. Because Ear & Labyrinth Disorders tinnitus, vertigo;
Ranolazine prolongs the QT interval, it should Gastrointestinal Disorders abdominal pain,
be reserved for patients who have not achieved dry mouth, vomiting; General Disorders &
an adequate response with other antianginal Administrative Site Adverse Events peripheral
drugs.The effect on angina rate or exercise edema; Respiratory, Thoracic, & Mediastinal
tolerance appeared to be smaller in women Disorders dyspnea; Vascular Disorders
than men. hypotension, orthostatic hypotension.

Dosage & Administration Drug Interaction
Initiate Ranolazine dosing at 500 mg twice daily CYP 3A Inhibitors: Do not use Ranolazine with
& increase to 1 gm twice daily, as needed, based strong CYP3A inhibitors. With moderate
on clinical symptoms. Take Ranolazine with or CYP 3A inhibitors (e.g., Diltiazem, Verapamil,
without meals. Ranolazine tablets whole; do Erythromycin) limit maximum dose of
not crush, break or chew. Ranolazine to 500 mg twice daily.
The maximum recommended daily dose of CYP3A Inducers: Do not use Ranolazine with

P Ranolazine is 1 gm twice daily. If a dose of


Ranolazine is missed, take the prescribed dose
inducers.
P-gp Inhibitors (e.g., Cyclosporin): May need
at the next scheduled time; do not double the to lower the Ranolazine dose based on clinical
next dose. dose.
Drugs transported by P-gp or metabolized
Contraindication & Precaution by CYP2D6 (e.g., Digoxin, TCA): May need
Ranolazine is contraindicated in patients: reduced doses of these drugs when used with
With pre-existing QT prolongation Ranolazine.
With hepatic impairment
Taking QT prolonging drugs Use in pregnancy & Lactation
Taking potent & moderately potent CYP3A Pregnancy Category C. There are no adequate
inhibitors such as Ketoconazole, Itraconazole, studies assessing the effect of Ranolazine on
Clarithromycin, Nefazodone, Nelfinavir, the developing fetus. There are no adequate
Ritonavir, Indinavir, & Saquinavir, including well-controlled studies in pregnant women.
Diltiazem Ranolazine should be used during pregnancy
Ranolazine blocks Ikr & prolongs the QTc interval only when the potential benefit to the patient
in a dose-related manner. Clinical experience justifies the potential risk to the fetus. It is
in an acute coronary syndrome population did not known whether Ranolazine is excreted
not show an increased risk of proarrhythmia or in human milk. Because of the potentiality
sudden death. for serious adverse reactions from ranolazine
Co-administration of Ranolazine with Digoxin in nursing infants, a decision should be
increases the plasma concentrations of made whether to discontinue nursing or to
digoxin by approximately 1.5 fold & the dose discontinue Ranolazine, taking into account
of digoxin may have to be reduced accordingly. the importance of the drug to the mother.
The dose of other P-gp substrates may have
to be reduced as well when Ranolazine is co-
administered. Caution should be exercised
193
Product Guide
Use in children pregnancy & lactation.
Safety & effectiveness in pediatric patients
have not been established. Pediatric Use
Not recommend below 18 years of age.
Preparation
Ranolin XR 500 tablet: Each box containing 20 Preparation
extended release tablets in PVC blister pack. Each pack contains a tube of 15 gm ointment
& an applicator.

Rectocare
Remac TM

Active Ingredient
Nitroglycerin. Active Ingredient
Clarithromycin.

Indication Indication

R
For relief of pain associated with chronic anal Pharyngitis, sinusitis, chronic bronchitis,
fissure. pneumonia, skin & soft tissue infection,
duodenal ulcers for eradication of H. pylori.
Dosage & Administration
Nitroglycerin 0.4% ointment should be Dosage & Administration
inserted into the anal cavity with an applicator. Adults : Remac 250 - 500 mg for 7-14 days.
The ointment must be inserted at least 1cm Children: 7.5 mg/kg twice daily.
into the anus. The dose is twice daily up to a
maximum of 8 weeks. Contraindication & Precaution
Hypersensitivity, caution should be taken in
Contraindication & Precaution administering this antibiotic to patients with
Nitroglycerin 0.4% ointment is contraindicated impaired hepatic & renal function. Prolonged
in patients with known hypersensitivity to or repeated use of Clarithromycin may result in
Nitroglycerin or other ingredients of the an overgrowth of non-susceptible bacteria or
formulation. Nitroglycerin 0.4% ointment fungi.
should be used with caution in patients who
have severe hepatic or renal disease. It should Drug Interaction
not be used if patient suffers from severe Theophylline,Terfenadine, Carbamazepine.
anemia, glaucoma, hypotension, increased
intracranial pressure. Use in Pregnancy & Lactation
Clarithromycin is not recommended.
Side Effect
Headache & dizziness is a common side effect Preparation
experienced with Nitroglycerin 0.4% ointment. 500 mg Tablet.

Use in Pregnancy & Lactation


This ointment should not be used during
194
Product Guide

Remus osteoporosis in women who have gone


through the menopause & are at high risk of
fractures, but cannot take other medicines
Active Ingredient used to prevent osteoporosis.
Tacrolimus.
Dosage & Administration
Indication Treatment of symptoms resulting from the
Moderate to severe atopic dermatitis. natural or surgical menopause.
Prevention of post-menopausal bone mineral
Dosage & Administration density loss: The recommended dose is 2.5 mg
Twice daily for one week until clearing of signs once daily.
& symptoms of atopic dermatitis. Improvement of symptoms generally occurs
within a few weeks, but optimal results are
Contraindication & Precaution obtained when therapy is continued for at
Hypersensitivity, Nethertons Syndroms, least 3 months. Women experiencing a natural
generalized erythroderma. menopause should commence treatment with
tibolone at least 12 months after their last
Side Effect natural bleed. In case of a surgical menopause,
Skin Burning, pruritus, allergic reaction, treatment with tibolone may commence
anaphylactoid reaction, angioedema, anorexia, immediately.

R
anxiety.
Contraindication & Precaution
Drug Interaction Contraindicated in - pregnancy & lactation;
Erythromycin, itraconazole, ketoconazole, known, past or suspected breast cancer;
fleoconazole, calcium channel blockers & known or suspected estrogen dependent
cimetidine. malignant tumors (e.g. endometrial cancer);
undiagnosed genital bleeding; untreated
Use in Pregnancy & Lactation endometrial hyperplasia; previous idiopathic
Caution should be taken during pregnancy & or current venous thromboembolism (deep
lactation. venous thrombosis, pulmonary embolism);
arterial thromboembolic disease (e.g. angina,
Preparation myocardial infarction, stroke or TIA); acute
0.03% & 0.1% Ointment. liver disease or a history of liver disease as long
as liver function tests have failed to return to
normal; porphyria
Precautions should be taken in - uterine fibroids
or endometriosis, thromboembolic disorders,
estrogen dependent tumors, hypertension,
Renorma liver disorders (e.g. liver adenoma), diabetes,
asthma, epilepsy etc.
Active Ingredient
Side-Effect
Tibolone.
Gastrointestinal disorders like abdominal
pain, skin & subcutaneous tissue disorders
Indication
like abnormal hair growth, acne, reproductive
Treatment of symptoms resulting from
system & breast disorders like vaginal discharge,
the natural or surgical menopause in
genital pruritus, vaginal candidiasis etc.
post menopausal women. Prevention of
195
Product Guide
Use in Pregnancy & Lactation Use in Pregnancy & Lactation
US FDA pregnancy category D. Tibolone is In pregnant women Indapamide is not
contraindicated in lactating women. recommended. Mothers taking Indapamide
should not breast feed.
Preparation
2.5 mg Tablet. Preparation
1.5 mg SR (Sustained Release) Tablet.

Repres SR
ResQ
TM

Active Ingredient
Indapamide. Active Ingredient
Coenzyme Q10
Indication
Essential hypertension, hypertension in Indication
patients with renal function impairment, salt HMG CoA reductase inhibitors mediated

S
& fluid retention associated with congestive decreased level of Coenzyme Q10, Drug
heart failure. induced Myopathy, Protects body against free
radial damage with its antioxidant property,
Dosage & Administration Adjuvant therapy in cardiovascular disease
One tablet daily, preferably in the morning. especially in angina & congestive heart failure,
Immune system depression, Cognitive decline,
Contraindication & Precaution Useful in the management of Periodontal
Known allergy to this drug or to sulphonamides, Disease.
Renal failure, Serious liver disease,
Hypokalemia, Disturbed water/electrolyte Dosage & Administration
balance, diabetes, gout & kidney problems. Daily doses of Coenzyme Q10 range from 5 to
Monitoring of Potassium & Uric acid serum 300 milligrams. Effectiveness is thought to be
levels is recommended. obtained with doses of 50 to 200 milligrams
daily.
Side Effect
Dizziness, headache, anorexia, nausea, Side Effect
vomiting, constipation, diarrhea & postural This product usually has very few side effects.
hypotension. Electrolyte imbalances include Nausea, loss of appetite, upset stomach, or
hypochloremic alkalosis, hyponatremia, diarrhoea may infrequently occur.
hypokalemia, hyperuricemia; hypersensitivity
reactions which include skin rashes, cholestatic Contraindication & Precaution
jaundice & blood dyscrasias including Patients with a known hypersensitivity to any
thrombocytopenia, leucopenia, aplastic component of this product.
anemia. Supplemental Coenzyme Q10 may improve
beta-cell function & glycemic control in type
Drug Interaction II diabetics. Therefore, those diabetics who
Other Antihypertensives, Norepinephrine. do use supplemental Coenzyme Q10 should
196
Product Guide
determine by appropriate monitoring if they within 48 hours of the onset of zoster rash.
need to make any adjustments in their diabetic Genital Herpes: Initial Episodes: The
medications. recommended dosage for treatment of initial
genital herpes is 1 gram twice daily for 10 days.
Drug Interaction Recurrent Episodes: The recommended dosage
Warfarin: Supplemental Coenzyme Q10 may for the treatment of recurrent genital herpes
decrease the effectiveness of Warfarin. Statins: is 500 mg twice daily for 3 days. Suppressive
The statin drugs are known to decrease Therapy: The recommended dosage for chronic
Coenzyme Q10 levels in humans. Doxorubicin: suppressive therapy of recurrent genital herpes
Coenzyme Q10 may help to decrease the is 1 gram once daily in patients with normal
cardiotoxicity of doxorubicin. Antidiabetic immune function. In patients with a history of
medications: Coenzyme Q10 may improve 9 or fewer recurrences per year, an alternative
glycemic control in some type II diabetics. If this dose is 500 mg once daily.
were to occur, anti-diabetic medications might In HIV-infected patients with CD4 cell count
need appropriate adjusting. 100 cells/mm3, the recommended dosage
for chronic suppressive therapy of recurrent
Use in Pregnancy & Lactation genital herpes is 500 mg twice daily. Reduction
Because of lack of information on long-term of Transmission: The recommended dosage for
safety, pregnant women & nursing mothers reduction of transmission of genital herpes in
should avoid Coenzyme Q10. patients with a history of 9 or fewer recurrences

R Preparation
per year is 500 mg once daily for the source
partner.
30 mg & 60 mg Licap Cold Sores (Herpes Labialis): The recommended
dosage for the treatment of cold sores is 2
grams twice daily for 1 day taken about 12
hours apart.
Patients with Acute or Chronic Renal
Impairment: In patients with reduced renal

Revira function, reduction in dosage is recommended.

Contraindication & Precaution


Active Ingredient Valaciclovir is contraindicated in patients with
Valaciclovir. a known hypersensitivity or intolerance to
Valaciclovir, Aciclovir or any component of the
Indication formulation.
Revira is indicated for cold sore of adult &
children, genital herpes, chicken pox & herpes Side-Effect
zoster. Nausea, headache, vomiting, dizziness &
abdominal pain may occur. In rare cases
Dosage & Administration following adverse reactions reported:
Revira tablets may be given without regard to General: Facial edema, hypertension,
meals. tachycardia.
Herpes Zoster: The recommended dosage Allergic: Acute hypersensitivity reactions
for the treatment of herpes zoster is 1 gram including anaphylaxis, angioedema, dyspnea,
orally 3 times daily for 7 days. Therapy should pruritus, rash, & urticaria.
be initiated at the earliest sign or symptom of CNS Symptoms: Aggressive behavior;
herpes zoster & is most effective when started agitation; ataxia; coma; confusion; decreased
197
Product Guide
consciousness; dysarthria; encephalopathy; Side Effect
mania; & psychosis, including auditory & visual Loose stools, yellow discoloration of skin,
hallucinations; seizures, tremors. chronic overdosage can lead to peeling &
Eye: Visual abnormalities. redness of the skin, loss of appetite, diarrhoea
Gastrointestinal: Diarrhea. & other gastro-intestinal disturbances. It has
Hepatobiliary Tract & Pancreas: Liver enzyme also been stated abdominal pain, fatigue &
abnormalities, hepatitis. weakness.
Renal: Elevated creatinine, renal failure.
Hematologic: Thrombocytopenia, aplastic Drug Interaction
anemia, leukocytoclastic vasculitis, TTP/HUS. Neomycin, bleomycin, aminophylline,
nitrofurantoin sodium, conjugated
Use in Pregnancy & Lactation oestrogens, sulphafurazole diethanolamine,
Pregnancy Category B. Valaciclovir should be chloramphenicol sodium succinate,
used during pregnancy only if the potential chlorothiazide sodium & hydrocortisone
benefit justifies the potential risk to the fetus. sodium succinate.
Valaciclovir should be administered to a nursing
mother with caution & only when indicated. Use in Pregnancy & Lactation
High doses should not be given in pregnancy
Use in Children & lactation.
Safety & effectiveness of Valaciclovir in pre-
pubertal pediatric patients have not been
established.
Preparation
(6 mg + 200 mg + 50 mg)/Tablet. R
Preparation
500 mg & 1 gm Tablet.

Rezulin TM

Rex Active Ingredient


Pioglitazone & Metformin.
Active Ingredient
Beta Carotene , Vitamin C , & Vitamin E. Indication
Type 2 diabetes.
Indication
Reduces risks of cardiovascular diseases in Dosage & Administration
human, reduces risks of cataract, combat Starting dose for patients inadequately
infection & chronic diseases, trend toward controlled on Metformin monotherapy based
decreased age-related degenerative changes, on the usual starting dose of Pioglitazone
defense against infection. (15-30 mg daily), Rezulin may be initiated at
either the 15 mg/500 mg or 15 mg/850 mg
Dosage & Administration tablet strength once or twice daily, & gradually
1 tablet daily. titrated after assessing adequacy of therapeutic
response. Based on the usual starting doses
Contraindication & Precaution of Metformin (500 mg twice daily or 850 mg
Hypersensitivity , hyperoxaluria. daily), Rezulin may be initiated at either the
198
Product Guide
15 mg/500 mg twice daily or 15 mg/850 mg
tablet strength once daily, & gradually titrated Rice ORS
after assessing adequacy of therapeutic
response. Starting dose for patients switching Active Ingredient
from combination therapy of Pioglitazone plus Rice ORS for 500 ml Water: Each sachet contains
Sodium Chloride BP 1.30 gm, Potassium
Metformin as separate tablets Rezulin may be
Chloride BP 0.75 gm, Tri-Sodium Citrate
initiated with either the 15 mg/500 mg or 15
Dihydrate BP 1.45 gm & Processed Rice Powder
mg/850 mg tablet strengths based on the dose Pharma Grade 25 gm.
of Pioglitazone & Metformin already being Rice ORS for 250 ml Water: Each sachet contains
taken. The maximum recommended dose for Sodium chloride BP 0.650 gm, Potassium
Pioglitazone is 45 mg daily. The maximum chloride BP 0.375 gm, Tri-Sodium Citrate
recommended daily dose for Metformin is 2550 Dihydrate BP 0.725 gm & Processed Rice
mg in adults. Powder Pharma Grade 12.500 gm

Indication
Contraindication
Rice ORS is indicated in -
Renal disease or renal dysfunction which
Acute fluid & electrolyte loss conditions such
may also result from conditions such as as cholera, acute diarrhea & vomiting
cardiovascular collapse (shock), acute Dehydration
R Severely low concentrations of salts in the
myocardial infarction, & septicemia, Known
hypersensitivity to Pioglitazone, Metformin blood (severe electrolyte depletion)
or any other component of combination of
Pioglitazone & Metformin, Acute or chronic Dosage & Administration
metabolic acidosis, including diabetic Dose of Rice ORS depends on the severity of
the dehydrating conditions of the patients. The
ketoacidosis, with or without coma.
following is a guideline:

Use in Pregnancy & Lactation Age Recommended Dose


Pregnancy category C. Should not be used during after each watery
stool
pregnancy unless the potential benefit justifies
the potential risk to the fetus. Combination 6 months to 2 50 ml to 100 ml (10 to
of Pioglitazone & Metformin should not be years 20 Teaspoonfuls)
administered to a breastfeeding woman. 2 years to 9 100 ml to 200 ml (20
years to 40 teaspoonfuls)
Drug Interaction 10 years & 250 ml to 500 ml (1 to
Metformin hydrochloride: Furosemide, above 2 glassfuls)
Nifedipine, Cationic drugs (e.g., amiloride,
digoxin, morphine, procainamide, quinidine, Contraindication & Precaution
quinine, ranitidine, triamterene, trimethoprim, Not to be used in -
& vancomycin).
Kidney failure resulting in diminished
production of urine
Kidney failure, preventing production of urine
Preparation Obstruction of the stomach or intestines
(Pioglitazone 15 mg & Metformin Hydrochloride Reduced blood flow to vital internal organs
500 mg)/Tablet, (Pioglitazone 15 mg & (shock)
Metformin Hydrochloride 850 mg)/Tablet. Severe & continuous vomiting (intractable
199
Product Guide
vomiting) Maintenance dosage in adult is 2.5-20 mg daily
Severe dehydration as single or in 2 divided doses.
Severe diarrhea in infants
Contraindication
Precautions should be taken in case of Hypersensitivity, angioedema.
significant overdose, especially for the
following patients - Side Effect
Children less than 1 year of age Dizziness, headache, fatigue & asthenia,
Patients with imbalance of salt concentrations hypotension, cough, nausea, vomiting,
in the blood (electrolyte imbalance) diarrhoea, rash, urticaria, oliguria, anxiety,
Patients with severely decreased kidney amnesia, angioneurotic edema, anaphylactic
function reactions & hyperkalemia.
Patients with severely decreased liver function
Use in Pregnancy & Lactation
Drug Interaction Not recommended.
There is no known drug interaction reported.
Preparation
Use in Pregnancy & Lactation 1.25 mg, 2.5 mg & 5 mg Tablet.
Rice ORS is recommended in pregnancy &
lactation, as there is no known harmful Effect
when this medicine is used.
R
Use in Children
Safety & effectiveness of Rice ORS in pediatric
patients below the age of 6 months have not Risedon 150 TM

been established.
Active Ingredient
Preparation Risedronate Sodium 150 mg INN tablet.
Rice ORS for 250 ml Water: Each box contains
10 sachets. Rice ORS for 500 ml Water: Each box Indication
contains 10 sachets. Osteoporosis in postmenopausal women,
osteoporosis in men, osteoporosis in men
& women that is caused by treatment with
steroid medicines such as prednisone, Pagets
disease of bone in men & women.

Ripril TM Dosage & Administration


One tablet orally, taken once a month. To
permit adequate absorption, tablet must be
Active Ingredient taken at least 30 minutes before the first food,
Ramipril. beverage or medication of the day with plain
water only.
Indication
Mild to severe hypertension. Contraindication & Precaution
Risedronate may cause upper gastrointestinal
Dosage & Administration disorders such as dysphagia, esophagitis,
Initial dose is 1.25-2.5 mg once daily. & esophageal or gastric ulcers. It should be
200
Product Guide
taken according to the dosing instructions
to minimize the risk of these events. Patients Risedon Plus TM

should discontinue use if new or worsening


symptoms occur. Active Ingredient
Risedronate Sodium & Calcium
Side Effect
Usually mild & generally do not require Indication
discontinuation of therapy. Side Effects include to prevent & treat osteoporosis in
esophagus or stomach problems, including postmenopausal women.
ulcers, pain, or trouble swallowing, low calcium to increase bone mass in men with
& other mineral disturbances, pain in bones, osteoporosis.
joints or muscles, sometimes severe, jaw-bone to prevent & treat osteoporosis in men &
problems in some people, which may include women that is caused by treatment with
infection & slower healing after teeth are steroid medicines such as prednisolone.
pulled & short-lasting, mild flu-like symptoms, to treat Pagets disease of bone in men &
& usually get better after the first dose. women.

Drug Interaction Dosage & Administration


Calcium supplement, antacids & some oral One Risedon tablet should be taken orally
medications will interfere with absorption once a week (Day 1 of the 7-day treatment

R of Risedronate if taken at the same time. cycle). One calcium 500 mg tablet should be
Intravenous ranitidine makes the bioavailability taken orally with food daily on each of the
of oral Risedronate double. Incidence of upper remaining six days (Days 2 through 7 of the
gastro-intestinal adverse events associated 7-day treatment cycle).
with NSAID & aspirin appears to be greater with The following instructions are applicable to all
concomitant administration of Alendronate. patients taking Risedon tablet:
Take Risedon tablet exactly as prescribed by
Use in Pregnancy & Lactation your healthcare provider
Pregnancy Category C. It is only intended for At first take Risedon tablet in the morning
use in postmenopausal women. It is not known before you eat or drink anything except plain
whether Risedronate is excreted in human water.
milk. It should not be given to nursing women. Take Risedon tablet while you are sitting up
or standing.
Use in Children Take a Risedon tablet with 1 glass of plain
Safety & Effectiveness in pediatric patients water. Do not take it with any other drink
have not been established. besides plain water.
Swallow whole Risedon tablet. Do not chew
Preparation the tablet or keep it in your mouth to melt or
Risedon 150 Tablet: Each box containing 1X1 dissolve.
tablet in alu alu blister pack. After taking Risedon tablet you must wait at
least 30 minutes before:
1. lying down. You may sit, stand, or do normal
activities.
2. eating or drinking anything except plain
water.
3. taking vitamins, calcium, or antacids.
4. Take vitamins, calcium, & antacids at a
201
Product Guide
different time of the day from when you take
Risedon tablet. Robic
5. Keep taking Risedon tablet for as long as your
healthcare provider tells you. Active Ingredient
Ornidazole.
Precaution
Take special care with if you: Indication
have low blood calcium (hypocalcemia). Amoebiasis (Intestinal & hepatic), Giardiasis,
cannot sit or stand up for 30 minutes. Trichomoniasis, Bacterial vaginosis, Treatment
have kidneys that work poorly. of susceptible anaerobic infections.
have an allergy to Risedronate Sodium.
are pregnant or may become pregnant. Dosage & Administration
are breast-feeding or plan to breast-feed. Amoebiasis : Adults: 500 mg twice a day for 5
have kidney problems, Risedronate Sodium days. Children: 10-25 mg/kg body weight in 2
may not be right for you. divided doses. Amoebic dysentery : Adults : 1.5
Please tell your doctor if you are taking or have gm once a day for 3 days. Children: 40 mg/kg
recently taken any other medicines, including body weight once a day for 3 days. Giardiasis:
medicines obtained without a prescription Adults : 1.5 gm once daily for 1-2 days.
specially aspirin or other NSAIDs. Antacids, Children: 40 mg/kg body weight for 2 days.

R
supplements, or medicines that contain Trichomoniasis : 1.5 gm once or 500 mg twice
aluminum, calcium, magnesium, or other a day for 5 days. Sexual partner should also be
minerals can interfere with the absorption of treated at the same time. Bacterial vaginosis : 3
Risedronate Sodium. If you use these other tablets of 500 mg each as a single dose or one
medicines, do not take these for at least 30 tablet of 500 mg once daily for 5-7 days.
minutes after taking a Risedronate Sodium
tablet. Contraindication & Precaution
Hypersensitivity, epilepsy, peripheral
For Renal Impaired Patients neuropathy. In patient with ataxia, vertigo,
Risedronate Sodium is not recommended for & mental confusion, Ornidazole should be
use in patients with severe renal impairment prescribed with caution.
(creatinine clearance <30 ml/min). No dosage
adjustment is necessary in patients with a Side Effect
creatinine clearance >30 ml/min or in the Nausea, vomiting, epigastric pain,
elderly. dizziness, headache, lassitude. Unlike other
nitroimidazoles, Ornidazole does not interact
Side Effect with alcohol, Leukopenia has been described
Chest pain, difficulty or pain when swallowing, occasionally.
pain or burning under the ribs or in the back,
new or worsening heartburn, severe joint, Drug Interaction
bone, or muscle pain, jaw pain, numbness, or Disulfiram-like reactions. Concomitant
swelling, mild heartburn or stomach upset, administration of oral anticoagulants may
diarrhea, gas, or constipation, mild joint or back increase the risk of haemorrhage due to
pain, headache. diminished hepatic metabolism. Ornidazole
has been reported to decrease the clearance of
Preparation 5-fluorouracil.
Risedronate Sodium 35 mg & Calcium 500 mg.
202
Product Guide
Use in Pregnancy & Lactation administered concomitantly with these drug
Ornidazole should be prescribed only if the substances & other inhibitors of the isozyme
potential benefit justifies the potential risk to CYP3A4.
foetus/neonate.
Use in Pregnancy & Lactation
Preparation No adequate data available. Caution should
500 mg Tablet. be exercised when prescribing rupatadine to
pregnant or lactating women; it is unknown
whether rupatadine is excreted into breast
milk.

Preparation

Rupatrol 10 mg Tablet.

Active Ingredient
Rupatadine.

Rosuva
Indication TM
Rupatadine is indicated for the symptomatic

R
treatment of Seasonal & Perennial Allergic
Rhinitis & Urticaria. Active Ingredient
Rosuvastatin.
Dosage & Administration
Adults & adolescents (above 12 years) - The Indication
recommended dose is 10 mg once daily, with Hypercholesterolemia.
or without food.
Dosage & Administration
Contraindication & Precaution 5-40 mg once daily.
Hypersensitivity to Rupatadine or to any of the
excipients. Rupatadine should be used with Contraindication
caution in elderly patients (65 years & older) Hypersensitivity to Rosuvastatin on any of
due to little clinical data. As there is no clinical its components, active liver disease or with
experience in patients with impaired kidney unexplained persistent elevations of serum
or liver function, the use of rupatadine 10 mg transaminases.
tablets is at present not recommended in these
patients. Side Effect
Generally well tolerated. Myalgia, constipation,
Side Effect asthenia, abdominal pain, & nausea.
Sleepiness, headache, dizziness, dry mouth,
fatigue, asthenia etc. Use in Pregnancy & Lactation
Not recommended. Should be administered
Drug Interaction to women of childbearing age only when such
The concomitant administration of rupatadine patients are highly unlikely to conceive.
20 mg & ketoconazole or erythromycin
increases the systemic exposure. rupatadine Preparation
should be used with caution when it is 5mg, 10 mg & 20 mg Tablet.
203
Product Guide

Rutix Saga
Active Ingredient Active Ingredient
Ofloxacin. Sparfloxacin.

Indication Indication
Chronic bronchitis lung abscess, pneumonia, Community acquired pneumonia, Chronic
Enteric fever, shigellosis. Multi-drug-resistant Bronchitis.
Tuberculosis, uncomplicated skin & skin
structure infections, acute, gonorrhoea. Dosage & Administration
Nongonococcal urethritis & cervicitis. Urinary Two Saga tablets on first day as loading dose,
Tract Infections. thereafter one tablet of Saga every 24 hours for
a total of 10 days therapy.
Dosage & Administration
200 mg to 800 mg daily from 5-7 days. For Contraindication & Precaution
children 15 mg/kg/day in two divided doses. Hypersensitivity or photosensitivity reactions.
Acute or chronic prostatitis: 200 mg twice daily Adjustment of the dosage regimen is necessary
for 28 days. for the patients with impaired renal function
creatinine clearance (< 50 ml/min).

S
Contraindication & Precaution
Hypersensitivity, epilepsy, children or growing Side Effect
adolescents & in pregnant or breast feeding Photosensitivity reaction, diarrhoea, nausea,
women. headache, dyspepsia, dizziness, insomnia,
abdominal pain & QTc interval prolongation.
Side Effect
Nausea, rash, vomiting, abdominal pain, Drug Interaction
diarrhoea, dizziness & insomnia. Antacids & Sucralfate, Zinc/iron salts.

Drug Interaction Use in Pregnancy & Lactation & Children


Antacids containing magnesium, aluminium or Should be used during pregnancy only if the
calcium may decrease absorption of ofloxacin. potential benefit justifies the potential risk to
Iron or Zinc may decrease oral absorption of the fetus. Safety & Effectiveness have not been
ofloxacin. established in patients below the age of 18
years.
Preparation
200 & 400 mg Tablet. Preparation
200 mg Tablet.
204
Product Guide

Salmate HFA Inhaler Dosage & Administration


One tablet three times daily.

Active Ingredient Contraindication & Precaution


Salmeterol. Epilepsy or brain damage, blood dyscrasias,
severe cardiac insufficiency, renal or liver
Indication damage.
Asthma & Chronic Obstructive Pulmonary
Diseases including chronic bronchitis & Side Effect
emphysema. Tardive dyskinesias, dryness of mouth,
drowsiness, faintness & constipation.
Dosage & Administration Occasionally tachycardia, nasal congestion,
For inhalation only .Two puffs (50g) twice blurred vision & excitement are seen.
daily.
Drug Interaction
Barbiturates, alcohol & narcotic drugs.
Contraindication & Precaution
Hypersensitivity, hypokalamia. Use in Pregnancy & Lactation
The drug should be used during pregnancy
Side Effect & lactation if potential benefit justifies the
Dose related tremor, subjective palpitations & potential risk to the fetus.

S
headaches are usually mild & transient. Skin
reactions, muscle cramps, non-specific chest Preparation
pain, local irritation & arthralgia have been Nortriptyline 10 mg & Fluphenazine 0.5 mg on
reported. each Tablet.

Drug Interaction
As with all the other beta2-agonists there may
be interaction with beta-blocking agents at
the receptor site when given concomitantly.
Monoamino Oxidase Inhibitors & Tricyclic
Antidepressants : These agent should be used Scabex
with caution because Salmeterol may be
potentiated by these agents. Active Ingredient
Permethrin.
Preparation Indication
Inhaler : Salmeterol 25 mcg/puff, 200 puffs. Scabies

Dosage & Administration


Adults: two full tube (15 gm) or one full tube
Sanit (30 gm), Children: 1/4 (15 gm) to 1/8 (30 gm) of
a tube. How to use: Patients >2 months of age
can use the dermal cream. It should be applied
Active Ingredient to the whole body excluding head.
Nortriptyline & Fluphenazine.
Contraindication & Precaution
Indication Hypersensitivity.
Mild to moderate anxiety, tension and/or
agitation with or without co-existing depression. Side Effect
205
Product Guide
Skin discomfort, burning, stinging or tingling erythema, edema, eczema, rash & pruritus.

Drug Interaction
The treatment of eczematous-like reactions with corticosteroids should be withheld prior to
treatment with Permethrin.

Use in Pregnancy & Lactation


Permethrin is suggested not to use during pregnancy & lactation.

Preparation
15 & 30 gm Cream.

Seclo
Active Ingredient
Omeprazole.

Indication
Seclo capsule & tablet is indicated for gastroesophageal reflux disease including reflux esophagitis, S
acid reflux disease, duodenal & benign gastric ulcers, Helicobacter pylori eradication regimens in
peptic ulcer disease, prophylaxis of acid aspiration, Zollinger-Ellison Syndrome & for the treatment
of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions.
Seclo IV is indicated primarily for the treatment of Zollinger-Ellison syndrome, & may also be used
for the treatment of gastric ulcer, duodenal ulcer & reflux esophagitis.

Dosage & Administration


Capsule & Tablet: Omeprazole should be taken 30 minutes before meal.

Disease Dosage & Administration


Gastroesophageal The usual dosage is 20 mg Omeprazole once daily. The majority
reflux disease of patients are healed after 4 weeks. For those patients not fully
including reflux healed after the initial course, healing usually occurs during a
esophagitis further 4-8 weeks treatment. Omeprazole has also been used in
a dose of 40 mg once daily in patients with reflux esophagitis
refractory to other therapy. Healing usually occurred within 8
weeks. Patients can be continued at a dosage of 20 mg once daily.
Acid reflux disease For long-term management Omeprazole 10 mg once daily is
recommended, increasing to 20 mg if symptoms return.
206
Product Guide
Duodenal and The usual dose is 20 mg Omeprazole once daily. The majority of
benign gastric patients with duodenal ulcer are healed after 4 weeks. The majority
ulcers of patients with benign gastric ulcer are healed after 8 weeks. In
severe or recurrent cases the dose may be increased to 40 mg
Omeprazole daily. Long-term therapy for patients with a history
of recurrent duodenal ulcer is recommended at a dosage of 20 mg
Omeprazole once daily. For prevention of relapse in patients with
duodenal ulcer the recommended dose is Omeprazole 10 mg once
daily, increasing to 20 mg once daily, if symptoms return.
Helicobacter pylori Omeprazole is recommended at a dose of 40 mg once daily or 20
eradication mg twice daily in association with antimicrobial agents Amoxicillin
regimens in peptic 1 g & Clarithromycin 500 mg both twice a day for 7 to 14 days.
ulcer disease
Prophylaxis of acid For patients considered to be at risk of aspiration of the gastric
aspiration contents during general anaesthesia, the recommended dosage
is Omeprazole 40 mg on the evening before surgery followed by
Omeprazole 40 mg 2-6 hours prior to surgery.
Zollinger-Ellison The recommended initial dosage is 60 mg Omeprazole once daily.
syndrome The dosage should be adjusted individually & treatment continued

S
as long as clinically indicated. More than 90% of patients with
severe disease & inadequate response to other therapies have
been effectively controlled on doses of 20-120 mg daily. With doses
above 80 mg daily, the dose should be divided & given twice daily.
For the treatment The recommended dosage of Omeprazole is 20 mg once daily.
of NSAID associated Symptom resolution is rapid & in most patients healing occurs
gastric ulcers, within 4 weeks. For those patients who may not be fully healed after
duodenal ulcers or the initial course, healing usually occurs during a further 4 weeks
gastroduodenal treatment. For the prophylaxis of NSAID-associated gastric ulcers,
erosions duodenal ulcers, gastroduodenal erosions & dyspeptic symptoms
in patients with a previous history of gastroduodenal lesions who
require continued NSAID treatment, the recommended dosage of
Omeprazole is 20 mg once daily.

Children
GERD or other The recommended dose for pediatric patients 1 years of age &
acid-related older is as follows:
disorders Age Dose
Body Weight

> 1 year 10 - 20 kg 10 mg once daily, if needed,


20 mg once daily
> 2 year > 20 kg 20 mg once daily, if needed,
40 mg once daily
IV Injection
207
Product Guide
Duodenal ulcer, In patients with duodenal ulcer, gastric ulcer or reflux esophagitis
gastric ulcer or where oral medication is inappropriate, Omeprazole IV 40 mg once
reflux esophagitis daily is recommended.
Zollinger-Ellison In patients with Zollinger-Ellison syndrome the recommended
Syndrome (ZES) initial dose of Omeprazole given intravenously is 60 mg daily.
Higher daily doses may be required & the dose should be adjusted
individually. When doses exceed 60 mg daily, the dose should be
divided & given twice daily.

Direction For Use Of IV Injection


Omeprazole lyophilized powder & water for injection is for intravenous administration only &
must not be given by any other route. Omeprazole injection 40 mg should be given as a slow
intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection
to the vial containing powder. After reconstitution the injection should be given slowly over a
period of at least 2-5 minutes at a maximum rate of 4 ml per minute. Use only freshly prepared
solution. The solution should be used within 4 hours of reconstitution.
Direction For Use Of IV Infusion
Omeprazole IV infusion 40 mg should be given as an intravenous infusion over a period of 20-30
minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100

S
ml 5% dextrose for infusion. The solution should be used within 12 hours when Omeprazole is
dissolved in saline & within 6 hours when dissolved in 5% dextrose. The reconstituted solution
should not be mixed or co-administered in the same infusion set with any other drug.

Contraindication & Precaution


There are no known contraindications to the use of Omeprazole. When gastric ulcer is suspected,
the possibility of malignancy should be excluded before treatment with Omeprazole is instituted
as treatment may alleviate symptoms & delay diagnosis.

Side-Effect
Omeprazole is well tolerated. Nausea, diarrhoea, abdominal colic, paresthesia, dizziness &
headache have been stated to be generally mild & transient & not requiring a reduction in dosage.

Use in Pregnancy & Lactation


US FDA pregnancy category C. Omeprazole is excreted in breast milk but is not likely to influence
the child when therapeutic doses are used.

Preparation
20 mg Capsule & DR Tablet, 40 mg Capsule & 40 mg IV Injection.
208
Product Guide

Secnid below:
Children of 10 to 15 kg body weight: 1 bottle of
Secnid 500 Suspension. Children of 16 to 25 kg
Active Ingredient of body weight: 1 & half bottles of Secnid 500
Secnidazole. Suspension. Children of 26 kg or more body
weight: 2 bottles of Secnid 500 Suspension.
Indication
Intestinal Amoebiasis, Hepatic Amoebiasis, Contraindication & Precaution
Urethritis & Vaginitis due to Trichomonas Hypersensitivity, Patients should be advised
vaginalis, Giardiasis. not to take alcohol during treatment with
secnidazole, should be avoided to patients with
Dosage & Administration a history of blood dyscrasia.
DS tablet: (Secnidazole INN) DS tablet should
be administered orally. The dosage schedule of Side Effect
is mentioned below: Nausea, epigastric pain, metallic taste, glossitis,
Acute Intestinal Amoebiasis: & stomatitis, Urticaria, moderate leukopenia
Adults: 2 gm single dose, taken preferably just (reversible), Rare Side-Effect: Vertigo, ataxia &
before meal. motor incoordination, paresthesia, & peripheral
Children: 30 mg/kg single dose, taken neuropathy.
preferably just before meal.

S
Asymptomatic Amoebiasis (minute & cystic Drug Interaction
form): Disulfiram, Warfarin.
Adults: 2 gm once daily for only 3 days, taken
preferably just before meal. Use in Pregnancy & Lactation
Children: 30 mg/kg once daily for only 3 days, Secnidazole may be prescribed in pregnancy
taken preferably just before meal. after the first trimester, should not be used
Hepatic Amoebiasis: during lactation.
Adults: 1.50 gm/day in a single or divided doses,
just before meal, for 5 days. Children: 30 mg/ Preparation
kg/day, in a single or divided dose, just before 1 gm DS Tablet & 500 mg Granules for oral
meal, for 5 days. N. B. Evacuation of pus must Suspension.
be performed simultaneously with Secnid
(Secnidazole INN) treatment at the suppurative
stage of hepatic amoebiasis.
Giardiasis:
Adults: 2 gm single dose, taken preferably just
before meal.
Children: 35-50 mg/kg single dose, taken Secrin TM

preferably just before meal.


Trichomoniasis: Active Ingredient
Adults: 2 gm single dose, taken preferably just Glimepiride
before meal.
The partner should also receive the same Indication
treatment concomitantly. Type 2 diabetes.
Secnid 500 Suspension: SecnidSuspension
should be administered orally. The dosage Dosage & Administration
schedule of Secnid suspension is mentioned 1 mg once daily. If necessary, the daily dose
209
Product Guide
can be increased. Any increase can be based
on regular blood sugar monitoring, & should Sedil
be gradual. maximum recommended dose of
Secrin is 8 mg daily. Active Ingredient
Diazepam.
Contraindication & Precaution
Type-I diabetes mellitus, diabetic precoma Indication
or coma, hypersensitivity to Glimepiride, Anxiety pain from apprehension & depression,
other sulphonylureas, other sulphonamides. acute & chronic stress of life, skeletal muscle
In the initial weeks of treatment, the risk of spasm & strychnine poisoning. For surgical
hypoglycemia may be increased & necessitates measures, Sedil is a useful premedication (I.M.
careful monitoring. route recommended).

Side Effect Dosage & Administration


Hypoglycemia, temporary visual impairment, Sedil 15 to 30 mg daily in divided doses.
nausea, vomiting, diarrhea, abdominal pain,
urticaria, fall in blood pressure. Contraindication & Precaution
Sedil is contraindicated in patients with known
Drug Interaction history of hypersensitivity to it. Porphyria or a
Potentiation of the blood-sugar-lowering family history of porphyria contraindicates the

S
Effect : Insulin & other oral , antidiabetics, use of Sedil.
ACE inhibitors, allopurinol, anabolic steroids
& male sex hormones, chloramphenicol, Side Effect
coumarin derivatives, fluoxetine, MAO Infrequent & mild. Drowsiness, headedness,
inhibitors, miconazole, para-aminosalicylic ataxia, vertigo, dry mouth, inattentiveness,
acid, pentoxifylline, phenylbutazone, hypotension, gastro-intestinal & visual
oxyphenbutazone, quinolones, salicylates, disturbances.
sulfonamides, tetracyclines, beta blockers.
Weakening of the blood-sugar-lowering Effect: Drug Interaction
Acetazolamide, barbiturates, corticosteroids, If diazepam is given concomitantly with
diazoxide, diuretics, epinephrine & other centrally acting drugs such as neuroleptics,
sympathomimetic agents, laxatives, oestrogens tranquillizers, antidepressants, hypnotics,
& progestogens, phenothiazines, phenytoin, analgesics & anaesthetics, the sedative Effects
rifampicin, thyroid hormones. H2-receptors are likely to be intensified.
antagonists, clonidine & reserpine. Both acute
& chronic alcohol intake may potentiate or Preparation
weaken the blood- sugar- lowering action of 5 mg Tablet & 10 mg/2 ml Injection.
glimepiride unpredictably.

Use in Pregnancy & Lactation


Glimepiride must not be taken during
pregnancy. Glimepiride must not be taken by
breast-feeding women.

Preparation
1 mg, 2 mg, 3 mg & 4 mg Tablet.
210
Product Guide

Sedno Use in Pregnancy & Lactation


Category C. Desloratadine should be used
during pregnancy only if clearly needed. A
Active Ingredient decision should be made whether to discontinue
Desloratadine. nursing or to discontinue Desloratadine, taking
into account the importance of the drug to the
Indication mother.
Allergic Rhinitis, Chronic Idiopathic Urticaria.
Preparation
Dosage & Administration 5 mg Tablet & 2.5 mg/5 ml Syrup.
Adult & over 12 years: Syrup: 10 ml (2
teaspoonful) once daily. Tablet : One tablet (5
mg) once daily. Children 6-11 years : Syrup: 5
ml (1 teaspoonful) daily. Tablet : 2.5 mg (half of
one 5 mg tablet) once daily. Children 1-5 years:
Syrup: 2.5 ml (1/2 teaspoonful) daily. Children
Sensimet TM
6-11 months : Syrup: 2 ml (1.0 mg) once daily
or as directed by the physician. Patients with
liver or renal Impairment: A starting dose of Active Ingredient
one Sedno Tablet (Desloratadine 5 mg) every Rosiglitazone & Metformin

S
other day is recommended.
Indication
Contraindication & Precaution Type 2 diabetes mellitus.
Hypersensitive to this medication or to any
of its ingredients, or to Loratadine. In general, Dosage & Administration
dose selection for an elderly patient should be For initial therapy: The recommended starting
cautious, reflecting the greater frequency of dose of sensimet is 2 mg/500 mg administered
decreased hepatic, renal or cardiac function, & once or twice daily.For patients inadequately
of concomitant disease or other drug therapy. controlled on Metformin monotherapy:
Starting dose is 4 mg Rosiglitazone (total daily
Side Effect dose) plus the dose of Metformin already being
In general it is well tolerated. Clinical trials taken. For patients inadequately controlled on
suggest a very low rate of adverse effects Rosiglitazone monotherapy: Starting dose is
associated with Desloratadine administration. 1,000 mg Metformin (total daily dose) plus the
among the very few adverse effects commonly dose of Rosiglitazone already being taken.
reported by small percentage of patients are dry
mouth, fatigue, myalgia, & somnolence. Less Adverse Reactions
common side effects may include headache, Diarrhea, nausea, vomiting, flatulence,
nausea, dizziness, dyspepsia, pharyngitis etc. asthenia, indigestion, abdominal discomfort,
headache.
Drug Interaction
Concomitant administration of Erythromycin, Precaution
Ketoconazole, Azithromycin, Fluoxetine & When a patient stabilized on any diabetic
Cimetidine with Desloratadine increased the regimen is exposed to stress such as fever,
plasma concentration of Desloratadine. But trauma, infection, or surgery, a temporary
there were no clinically relevant changes in the loss of glycemic control may occur. At such
safety profile of Desloratadine. times, it may be necessary to withhold
211
Product Guide
combination of Rosiglitazone & Metformin & while not exceeding the maximum
temporarily administer insulin. Combination of recommended daily dose of 100 mg sitagliptin
Rosiglitazone & Metformin should be used with & 2000 mg metformin. Sitagliptin/Metformin
caution in patients with edema. combination should generally be given twice
daily with meals, with gradual dose escalation,
Drug Interaction to reduce the gastrointestinal (GI) side
Gemfibrozil, rifampin, cationic drugs (e.g., Effects due to metformin. The recommended
amiloride, digoxin, morphine, procainamide, starting dose in patients not currently treated
quinidine, quinine, ranitidine, triamterene, with metformin is 50 mg sitagliptin/500 mg
trimethoprim, & vancomycin). metformin hydrochloride twice daily, with
gradual dose escalation recommended to
Use in Pregnancy & Lactation reduce gastrointestinal side Effects associated
Pregnancy Category C: Combination of with metformin. The starting dose in patients
Rosiglitazone & Metformin should not be already treated with metformin should provide
used during pregnancy unless the potential sitagliptin dosed as 50 mg twice daily (100 mg
benefit justifies the potential risk to the fetus. total daily dose) & the dose of metformin already
Combination of Rosiglitazone & Metformin being taken. For patients taking metformin 850
should not be administered to a nursing mg twice daily, the recommended starting dose
woman. of this combination is 50 mg sitagliptin/1000
mg metformin hydrochloride twice daily.
Preparation
(Rosiglitazone 1 mg & Metformin Hydrochloride
Patients treated with an insulin secretagogue or
insulin Co-administration of the combination S
500 mg)/Tablet, (Rosiglitazone 2 mg & with an insulin secretagogue (e.g., sulfonylurea)
Metformin Hydrochloride 500 mg)/Tablet. or insulin may require lower doses of the insulin
secretagogue or insulin to reduce the risk of
hypoglycemia.

Contraindication & Precaution


Combination (sitagliptin/metformin HCl) is
Siglimet contraindicated in patients with:
TM

Renal disease or renal dysfunction, e.g., as


suggested by serum creatinine levels 1.5 mg/
Active Ingredient dL [males], 1.4 mg/dL [females]
Sitagliptin Phosphate Monohydrate &
Metformin HCl.
Acute or chronic metabolic acidosis, including
diabetic ketoacidosis, with or without coma.

Indication
History of a serious hypersensitivity reaction
to the combination or sitagliptin, such as
SiglimetTM is indicated as an adjunct to diet anaphylaxis or angioedema.
& exercise to improve glycemic control in
adults with type 2 diabetes mellitus when Side Effect
treatment with both Sitagliptin & Metformin The most common (>5%) adverse reactions due
is appropriate to initiation of metformin therapy are diarrhea,
nausea/vomiting, flatulence, abdominal
Dosage & Administration discomfort, indigestion, asthenia, & headache
Dose of this combination should be
individualized on the basis of the patients Drug Interaction
current regimen, Effectiveness, & tolerability Cationic drugs (e.g., amiloride, digoxin,
212
Product Guide
morphine, procainamide, quinidine, quinine,
Siglita TM

ranitidine,triamterene, trimethoprim, or
vancomycin) that are eliminated by renal
tubular secretion theoretically have the Active Ingredient
potential for interaction with metformin by Sitagliptin Phosphate Monohydrate.
competing for common renal tubular transport
systems. Indication
Co-administration of Digoxin & Sitagliptin For the Management of Type 2 Diabetes
may slightly increase the mean peak drug
concentration of Digoxin. But no dosage Dosage & Administration
adjustment of digoxin or Sitagliptin is The recommended dose of SiglitaTM is 100
recommended. mg once daily. Siglita can be taken with or
without food.
Use in Pregnancy & Lactation For patients with mild renal insufficiency
Pregnancy Category B. There are no adequate (creatinine clearance [CrCl] 50 mL/min) no
& well-controlled studies in pregnant women dosage adjustment for Siglita is required.
with the combination of Metformin/Sitagliptin For patients with moderate renal insufficiency
or its individual components; therefore, the (CrCl 30 to <50 mL/min), the dose of Siglita is
safety of the combination in pregnant women 50 mg once daily.
is not known. The combination of sitagliptin & For patients with severe renal insufficiency
S metformin should be used during pregnancy (CrCl <30 mL/min) or with end-stage renal
only if clearly needed. disease (ESRD) requiring hemodialysis or
peritoneal dialysis, the dose of Siglita is 25
Nursing Mothers mg once daily. Siglita may be administered
It is not known whether sitagliptin is excreted in without regard to the timing of hemodialysis.
human milk. Because many drugs are excreted
in human milk, caution should be exercised Contraindication & Precaution
when SiglimetTM is administered to a nursing History of a serious hypersensitivity reaction to
woman. sitagliptin, such as anaphylaxis or angioedema.

Use in Children Side Effect


Safety & Effectiveness of Sitagliptin/Metformin The most common adverse reactions are; upper
in pediatric patients under 18 years of age have respiratory tract infection, nasopharyngitis &
not been established headache. Hypoglycemia may occur in patients
treated with the combination of Sitagliptin &
Preparation sulfonylurea & add-on to insulin.
SiglimetTM 50/500 Tablet: Each box contains
20 tablets in blister pack. SiglimetTM 50/1000 Drug Interaction
Tablet: Each box contains 20 tablets in blister Co-administration of Digoxin & Sitagliptin
pack. SiglimetTM XR 50/500 Tablet: Each box may slightly increase the mean peak drug
contains 18 tablets in blister pack. SiglimetTM concentration of Digoxin. But no dosage
XR 50/1000 Tablet: Each box contains 18 tablets adjustment of digoxin or Sitagliptin is
in blister pack. recommended.

Use in Pregnancy & Lactation


Pregnancy Category B
Safety of Sitagliptin in pregnant women has
213
Product Guide
not been established. Sitagliptin should be
Solo TM

used during pregnancy only if the potential


benefit justifies the potential risk of the fetus.
Nursing Mothers: It is not known whether Active Ingredient
sitagliptin is excreted in human milk. Because Sodium Chloride 0.9%.
many drugs are excreted in human milk,
caution should be exercised when Sitagliptin is Indication
administered to a nursing woman. Solo Nasal Drops is indicated for dry nasal
membranes including dry nose resulting
Use in Children from cold & allergy medications. It moistens
Safety & Effectiveness of Sitagliptin in pediatric dry nasal passages from dry climates or from
patients under 18 years of age have not been
airplane travel, may help dissolve mucus from
established.
stuffy noses & clears the nose after surgery. This
Preparation sterile saline solution is also used to cleanse
Siglita 50 mg & 100 mg Tablet. various parts of the body (wounds, body
cavities) & medical equipment (e.g., bandages,
catheters, drainage tubes). It is also used as a
mixing solution (diluent) for other medications

Simacor S
used to irrigate the body (e.g., bacitracin,
polymyxin).

Active Ingredient Dosage & Administration


Simvastatin.
Infants, children & adults : 2-6 drops into each
nostril as needed daily.
Indication
Primary hypercholesterolemia, Fredickson
Type IIa & IIb dyslipidemia. Contraindication & Precaution
Tell your doctor about your medical history,
Dosage & Administration especially of heart problems (e.g., congestive
Simacor tablet 10 mg/day. heart failure), lung problems (pulmonary
edema), kidney problems, low levels of
Contraindication & Precaution potassium (hypokalemia), high levels of
Hypersensitivity, Active liver disease or un-
sodium (hypernatremia), & any allergies.
explained persistent elevations of serum
transaminases, Porphyria, Pregnancy & breast-
feeding, Women of child-bearing potential Side Effect
unless adequately protected by barrier No side Effects are expected to occur. However
contraceptive methods. stinging, sneezing, increased nasal discharge,
or salty taste may occur in some cases.
Preparation
10 mg Tablet. Use in Pregnancy & Lactation
It is unknown if this medication passes into
breast milk. Consult with your doctor before
breast-feeding.
214
Product Guide
Use in Children attacks of asthma, angioedema, urticaria or
Safe for pediatrics rhinitis have been precipitated by aspirin or
any other NSAID. Naproxen suppository in
Preparation contraindicated in children under 12 years of
age. The suppository is contraindicated also
Each box contains 10 dropper bottle of 10 ml
in patients with any inflammatory lesions of
each.
rectum or anus & in patients with recent history
of rectal or anal bleeding.

Sonap TM Side Effect


Nausea, diarrhoea, occasionally bleeding
& ulceration. Hypersensitivity reactions :
Active Ingredient bronchospasm, rashes & angioedema. CNS
Naproxen Sodium. side Effects : drowsiness, headache, fluid
retention, vertigo, tinnitus, & photosensitivity.
Indication A few instances of jaundice, impairment
Rheumatoid Arthritis, Degenerative Arthritis, of renal function, thrombocytopenia, &
Ankylosing Spondylitis, Juvenile Rheumatoid agranulocytosis.
Arthritis, Tendinitis, Bursitis, acute gout,
acute musculoskeletal disorders (such as Drug Interaction

S sprains, direct trauma & fibrositis), migraine &


dysmenorrhoea.
ACE inhibitors, coumarin-type anticoagulants,
sulfonylureas, propranolol & other beta-
blockers, probenecid, methotrexate.
Dosage & Administration
Tablet & Suppository - Rheumatoid Arthritis, Use in Pregnancy & Lactation
Osteoarthritis, Ankylosing Spondylitis: 250 to The drug should not be used during pregnancy
500 mg twice daily. May be increased to 1.50 unless clearly needed. Use in nursing mothers
gm for limiting periods. Mild to moderate must be avoided.
pain, primary dysmenorrhoea, acute tendinitis,
bursitis, & dysmenorrhoea: 500 mg initially, Preparation
followed by every 250 mg every 6 to 8 hours as 250 mg & 500 mg Tablet, 500 mg Suppository.
required. Do not exceed a 1.375 gm total daily
dose. Acute gout: 750 mg, then 250 mg every6
8 hours until attack subsides. Juvenile arthritis
(Children over 5 years): 10 gm/kg daily in two
Specbac TM
divided doses is recommended. Gel - Is to be
applied 2-6 times a day as required & is not
recommended for use in children.
Active Ingredient
Meropenem.
Contraindication & Precaution
Naproxen should be used with caution
Indication
in patients with cardiac, hepatic & renal
Pneumonias & Nosocomial Pneumonias,
impairment, coagulation defect, & previous
Urinary Tract Infections, Intra-abdominal
history of gastro-intestinal ulceration. The
Infections, Gynaecological Infections such as
drug is contraindicated in patients with a
endometritis, Skin & Skin Structure Infections,
history of hypersensitivity to aspirin or any
Meningitis, Septicaemia, Empiric treatment
other NSAID - which includes those in whom
for presumed infections in adult patients with
215
Product Guide
febrile neutropenia & other polymicrobial
Splendora TM

infections.

Dosage & Administration Active Ingredient


Adults : In the treatment of pneumonia, UTI, Minoxidil
gynaecological infections such as endometritis,
skin & skin structure infections- 500 mg IV Indication
every 8 hours. In the treatment of nosocomial For the treatment of alopecia androgenetica
pneumonias, peritonitis, presumed infections (hair loss) in males & females between 18 to 65
in neutropenic patients, septicaemia- 1 g IV years of age.
every 8 hours, In cystic fibrosis- doses up to 2
gm every 8 hours, In meningitis- 2 gm every 8 Dosage & Administration
hours. Children : Over 3 months to 12 years - 10 Apply 1 ml (7 sprays) of Splendora topical
to 20 mg/kg every 8 hours, Children over 50 kg solution twice daily at 12-hour intervals to the
weight, adult dosage should be used, 4 years scalp, beginning at the centre of the affected
to 18 years with cystic fibrosis - 25 to 40 mg/kg area & spreading the solution out to cover the
every 8 hours, In meningitis - 40 mg/kg every entire affected area. The total daily application
8 hours dose should not exceed 2 ml. For the best results,
Splendora topical solution should be allowed
Contraindication to remain on the scalp for about 4 hours before

S
Hypersensitivity to this product. washing. The night-time application should be
done 24 hours before going to bed to allow
Adverse Effect the solution to dry out. Splendora topical
Inflammation, thrombophlebitis, pain at the site solution should not be massaged into the scalp,
of injection, Skin reactions like rash, pruritus, but applied lightly. A hair dryer should not be
urticaria etc, abdominal pain, nausea, vomiting, used to speed up the drying of the solution as
diarrhoea,headache, paraesthesiae. it may decrease the effectiveness. Splendora
topical solution should not be mixed with any
Precaution hair oil. The drug should not be used more than
As with all beta-lactam antibiotics, rare two times a day, or be taken orally or applied
hypersensitivity reactions have been reported. to any other part of the body to avoid the risk
Before initiating therapy with meropenem, of adverse effects & unwanted hair growth.
careful inquiry should be made concerning More frequent use or longer application
previous hypersensitivity reactions to beta- time have no effect on hair growth. In case of
lactam antibiotics. The co-administration of missing any daily applications of Splendora
Specbac with potentially nephrotoxic drugs topical solution, the patient should continue
should be considered with caution. with the next application. Hands should
be washed immediately if Minoxidil topical
Use in Pregnancy & Lactation solution is applied with the fingertips. Clinical
Specbac should not be used in pregnancy unless experience with Splendora indicates that
the potential benefit justifies the potential risk twice-daily applications for 4 months or more
to the foetus. Specbac should not be used in may be required before there is evidence of hair
breastfeeding women unless the potential growth. To arrest hair fall, Splendora topical
benefit justifies the potential risk to the baby. solution should be used for not less than 45
days. Depending upon the severity of hair loss
Preparation or type & extent of baldness, particular strength
500 mg & 1 gm IV Injection. of Splendora topical solution may be selected.
216
Product Guide
Contraindication Contraindication & Precaution
Patients with cardiac abnormalities Hypersensitivity or toxic reactions.
Children below 18 years of age Blood dyscrasias (granulocytopenia,
Patients using occlusive dressings or other thrombocytopenia & moderate anaemia) may
medicines on the scalp occur after prolonged ophthalmic use.
Patients with red, inflamed infection, or
irritated or painful scalp (including psoriasis & Side Effect
sunburn) Bone marrow hypoplasia. Rarely optic atrophy
in children, stinging & burning of the eye,
Side Effect vesicular or maculopapular dermatitis, sore
Dermatitis or hypertrichosis may occur. These throat & angioedema.
incidences may occur in 0.15% of patients.
Drug Interaction
Drug Interaction Chymotryptin will be inhibited if given
Minoxidil topical solution should not be used simultaneously with Chloramphenicol.
along with other topical agents known to Use in Pregnancy & Lactation
alter the stratum corneum barrier such as Use only when considered essential by the
tretinoin or dithranol, due to the enhanced physicians.
absorption of Minoxidil. Although there is no
clinical evidence, there exists the theoretical Preparation

S possibility of absorbed Minoxidil potentiating


orthostatic hypotension caused by peripheral
0.5% Eye/Ear Drops.

vasodilators.

Use In Pregnancy & Lactation


Minoxidil topical solution should not be used
during pregnancy & lactation.
Square Zinc
Preparation
Active Ingredient
Minoxidil 2% & 5% topical solution.
Zinc Sulfate Monohydrate USP.

Indication
Square Zinc (Zinc Sulfate Monohydrate) is
indicated for the treatment of diarrhoea,
SQ-Mycetin Eye/Ear Drops especially for the children from 2 months to 5
years of age along with Oral Rehydration Salts
Active Ingredient (ORS). Square Zinc (Zinc Sulfate Monohydrate)
Chloramphenicol is also indicated for the treatment of other Zinc
deficiency (Loss of appetite, Severe growth
Indication retardation, Deformed bone formation,
Bacterial infection involving conjunctiva or Impaired immunological response, Recurrent
cornea & otitis externa. respiratory tract Infections, Acrodermatitis
enteropathica, Parakeratatic skin lesions,
Dosage & Administration Defective & delayed wound healing, Anaemia,
Eye : 2 drops every 1-4 hours depending upon Night blindness, Mental disturbances).
the severity. Ear : 2-3 drops every 3-4 hours.
217
Product Guide
Dosage & Administration Children & adolescents over 70 kg body weight
In the treatment of Diarrhoea Zinc should be & adults - Initiated at a total daily dose of 40
given as soon as diarrhoea starts. mg & increased after a minimum of 3 days to
For infants between 2 to 6 months of age: 10 a target total daily dose of approximately 80
mg Zinc once daily for 10-14 days. mg administered either as a single daily dose
For children between 6 months to 5 years of in the morning or as evenly divided doses in
age: 20 mg Zinc once daily for 10-14 days. the morning & late afternoon/early evening.
For other indications After 2 to 4 additional weeks, the dose may be
The recommended dose for children is 2 - 2.5 increased to a maximum of 100 mg in patients
mg/kg/day. Children under 10 kg: 10 mg Zinc who have not achieved an optimal response.
2 times daily. Children within 10 to 30 kg: 20 There are no data that support increased
mg Zinc 1-3 times daily. Adults & children over effectiveness at higher doses.
30 kg body weight: 40 mg Zinc 1-3 times daily. Maintenance treatment
There is no evidence available from controlled
Contraindication trials to indicate how long the patient with
It is contraindicated in patients with ADHD should be treated with Atomoxetine.
hypersensitivity to Zinc. It is generally agreed, however, that
pharmacological treatment of ADHD may be
Preparation needed for extended periods. The physicians
20 mg dispersible tablet who choose to use SuevTM 10 (Atomoxetine)
for extended periods should periodically re-
evaluate the long-term usefulness of the drug S
for the individual patient.

Contraindication & Precaution


Suev This is contraindicated in patients known to be
TM

hypersensitive to Atomoxetine & also in case


of-
Active ingredient 1) Monoamine Oxidase Inhibitors (MAOIs)
Atomoxetin 2) Effects on blood pressure & heart rate
3) Severe liver injury
Indication
Attention Deficit Hyperactivity Disorder Side Effect
(ADHD). Common side effects in children & teenagers
include upset stomach, decreased appetite,
Dosage & Administration nausea or vomiting, dizziness, tiredness, &
Initial treatment mood swings.
Children & adolescents up to 70 kg body Common side effects in adults include
weight- Initiated at a total daily dose of constipation, dry mouth, nausea, decreased
approximately 0.5 mg/kg & increased after a appetite, dizziness, trouble sleeping, sexual
minimum of 3 days to a target total daily dose side effects, menstrual cramps, & problems
of approximately 1.2 mg/kg administered passing urine.
either as a single daily dose in the morning or
as evenly divided doses in the morning & late Drug Interaction
afternoon/early evening. The total daily dose in Albuterol, CYP2D6 inhibitors & antihypertensive
children & adolescents should not exceed 1.4 agents interact with Atomoxetine.
mg/kg or 100 mg, whichever is less.
218
Product Guide
Use in Pregnancy & Lactation diarrhea, dry mouth, dyspepsia, vomiting,
Should not be used during pregnancy unless arrhythmia, palpitation, tachycardia, arthralgia,
the potential benefit justifies the potential risk angina, increased sputum, taste perversion, &
to the foetus.It is not known if atomoxetine is urinary tract infection/dysuria.
excreted in human milk. Because of the lack of
data, atomoxetine should be avoided during Preparation
breast-feeding. Sulprex HFA Inhaler : Each puff delivers 20
mcg of Ipratropium bromide & 100 mcg of
Preparation Salbutamol, 200 puffs.
10 mg capsule.

Sulprex TM
Nebuliser Solution
Sulprex TM
HFA Inhaler
Active Ingredient
Active Ingredient lpratropium + Salbutamol.
lpratropium + Salbutamol.

T
Indication
Indication The management of bronchospasm in patients
Sulprex HFA Inhaler is indicated for use in suffering from chronic obstructive pulmonary
patients with chronic obstructive pulmonary disease.
disease (COPD) & asthma on a regular aerosol
bronchodilator who continue to have evidence Dosage & Administration
of bronchospasm & who require a second Sulprex Nebuliser Solution may be
bronchodilator. administered from a suitable nebuliser or an
intermittent positive pressure ventilator. Adults
Dosage & Administration (including elderly patients & children over 12
The dose of Sulprex Inhalation Aerosol is two years): 1 ampoule three or four times daily.
inhalations four times a day. Patients may take
additional inhalations as required; however, Contraindication & Precaution
the total number of Inhalations should not It is contraindicated in patients with
exceed 12 in 24 hours. hypertrophic obstructive cardio- myopathy
or tachyarrhythmia & in patients with
Contraindication & Precaution hypersensitivity to ipratropium bromide,
Salbutamol & Ipratropium Bromide salbutamol sulphate or to atropine or its
combination Inhalation Aerosol is derivatives.
contraindicated in patients with a history of
hypersensitivity to soya lecithin or related food Side Effect
products such as soybean & peanut. Dry mouth, Nervousness, Dizziness, Tremor,
headache, Palpitations, Tachycardia, Cough,
Side Effect Dysphonia, Nausea, Arrhythmia, Atrial
Adverse reactions, includes edema, fatigue, fibrillation, Myocardial ischaemia.
hypertension, dizziness, nervousness,
paresthesia tremor, dysphonia, insomnia,
219
Product Guide
Use in Pregnancy & Lactation dizziness, & chest discomfort.
It should not be used in pregnancy, especially
the first trimester, unless the expected benefit Drug Interaction
is thought to outweigh any possible risk to the Other oral sympathomimetic agents should
foetus. Similarly, it should not be administered not be used concommitently. Cautions to
to breast-feeding mothers unless the expected patients being treated with monoamine
benefit is thought to outweigh any possible oxidase inhibitors or tricyclic antidepressants.
risk to the neonate.
Preparation
Preparation 4 mg Tablet, 8 mg SR Tablet, 2 mg/5 ml Syrup,
(lpratropium 500 mcg + Salbutamol 2.5 HFA Inhaler (100 g/puff), 200 g DPI Capsule.
mg)/2.5 ml, 10 ampoule.

Sultolin Respirator Solution


Sultolin Active Ingredient
Salbutamol

T
Active Ingredient
Indication
Salbutamol.
Treatment of severe acute asthma (status
asthmaticus) & also forms of bronchospasm in
Indication
adults & children. It is also Effective in children
Bronchial asthma, Chronic bronchitis,
>18 months.
Emphysema.
Dosage & Administration
Dosage & Administration
By Intermittent Administration : Adult : Sultolin
Sultolin tablet: 2-4 mg tablet 3-4 times daily.
Respirator Solution 0.5-1.0 ml should be diluted
SultolinSR tablet: 8 mg tablet twice daily,
to final volume of 2.0-4.0 ml with normal saline
Sultolin syrup: 1-2 mg 3 to 4 times daily. Not
for injection. The resulting solution is inhaled
recommended below 2 years of age. Sultolin
from a suitably driven nebulizer until aerosol
100 HFA Inhaler : 2 puffs 3-4 tomes daily. Sultolin
generation ceases. Should take about 10
Cozycap: 1-2 Cozycap may be administered
minutes. Sultolin Respirator Solution may be
as a single dosage. The usual recommended
used undiluted for intermittent administration.
dosage of Sultolin Cozycap for inhalation for
For this 2.0 ml of the solution is placed in the
adults for maintenance or prophylactic therapy
nebulizer & the patient allowed to inhale until
is the contents of one 200 mg capsule every 4
bronchodilatation is achieved. This usually
to 6 hours using a revolizer device.
takes 3-5 minutes. Children under 12 years
age: 0.5 ml of the solution diluted to 2.0-4.0 ml
Contraindication & Precaution
with normal saline. Intermittent treatment may
Hypersensitivity to the active ingradient.
be repeated four times a day. By Continuous
Administration : Sultolin Respirator Solution is
Side Effect
diluted with normal saline for injection, 1-2 ml
Nervousness, tremor, headache, tachycardia, &
solution made upto 100 ml with diluent. The
palpitation. Less frequent adverse reactions are
diluted solution is administered as an aerosol
muscle cramps, insomnia, nausea, weakness,
by a suitably driven nebulizer. The usual rate of
220
Product Guide
administration is 1-2 mg/hour. Contraindication & Precaution
A proper balance between fat, protein & starch
Contraindication & Precaution intake must be maintained to avoid temporary
History of hypersensitivity to any of its indigestion.
components. It should be used with care
in patients known to have received large Side Effect
doses of other sympathomimetic drugs & in Pancreatin may cause buccal & perianal
thyrotoxicosis. soreness, particularly in infants. Hypersensitivity
reactions have been reported; these may be
Side Effect sneezing, lacrimation or skin rashes.
Small increase in heart rate, peripheral
vasodilation & fine tremor of skeletal muscle. Drug Interaction
Alkaline media will rupture the enteric coating.
Use in Pregnancy As such to prevent bursting out of the content
Unnecessary administration of drugs during in the stomach Pancreatin should not be used
the first trimester of pregnancy is undesirable. concurrently with antacid.

Preparation Use in Pregnancy & Lactation


5 mg Salbutamol/ml, 20 ml Respirator Solution. Pregnancy category C. Not known whether
Pancreatin is distributed into milk. Caution

S advised if Pancreatin is used.

Preparation
Film coated tablet.
Suzyme
Active ingredient
Pancreatin

Indication Tazid
Children: - Reduced or absence of pancreatic
exocrine secretion Active Ingredient
-Cystic fibrosis Ceftazidime.
Adults: In the conditions with deficient
pancreatic exocrine function such as Indication
-Following pancreatectomy Single infections, Mixed infections, Severe
-Following total gastrectomy infections in general, Respiratory tract
-Chronic pancreatitis infections, Ear, nose & throat infections, Skin &
-Steatorrhea soft tissue infections, Gastrointestinal, biliary &
-Somatostatinoma abdominal infections, Bone & joint infections,
-Celiac disease Infections associated with hemo & peritoneal
dialysis & with continuous ambulatory
Dosage & Administration peritoneal dialysis (CAPD).
1-3 tablets daily with meal or as per direction of
the physician. Dosage & Administration
1 to 6 gram per day 8 or 12 hourly (IM/IV) in the
221
Product Guide
majority of infections, Infants & Children: The Nosocomial pneumonia (moderate to severe)
usual dosage range for children aged over two Community-acquired pneumonia (moderate
months is 30 to 100 mg/kg/day, given as two or severity only)
three divided doses. Neonates & children up to Uncomplicated & complicated skin & skin
2 months: The usual dosage range is 25 to 60 structure infections, including cellulitis,
mg/kg/ day as two divided doses. cutaneous abscesses & ischemic/diabetic foot
infections
Pregnancy & Lactation Postpartum endometritis or pelvic
Pregnancy Category B. inflammatory disease
Ceftazidime is excreted in human breast Appendicitis (complicated by rupture or
milk & caution should be exercised when abscess) & peritonitis
administered to a nursing woman. Tazocilin 4.5 IV Infusion may also be used in the
management of neutropenic patients (adults,
Side Effect adolescents & children) with fever suspected to
Local: phlebitis or thrombophlebitis with IV be due to bacterial infections.
administration; pain and/or inflammation
after IM injection. Hypersensitivity: Urticarial Dosage & Administration
rash, fever, pruritus, & very rarely angioedema Piperacillin/Tazobactam may be given by slow
& anaphylaxis (bronchospasm and/or intravenous infusion (over 20-30 minutes).
hypotension), diarrhea, nausea, vomiting, The usual dosage for adults & children over
abdominal pain, & very rarely oral thrush
or colitis, candidiasis, vaginitis, headache,
12 years is Tazocilin 4.5 IV infusion given every
eight hours. The total daily dose of Piperacillin/ T
dizziness, paraesthesia & bad taste. Tazobactam depends on the severity &
localization of the infection & can vary from
Contraindication 2.25 gm to 4.50 gm administered every six or
Known hypersensitivity to Cephalosporin eight hours. In neutropenia the recommended
antibiotics. dose is Piperacillin/Tazobactam 4.5 gm
given every six hours in combination with an
Drug Interaction aminoglycoside.
Increased nephrotoxicity has been reported
following concomitant administration of Contraindication & Precaution
cephalosporins & aminoglycoside antibiotics. Hypersensitivity to Piperacillin or any of the
beta-lactam antibiotics & to Tazobactam or any
Preparation other beta-lactamase inhibitor.
250 mg, 500 mg & 1 gm IM/IV Injection.
Side Effect
Nausea, vomiting, diarrhoea; less commonly
stomatitis, dyspepsia, constipation, jaundice,
Tazocilin 4.5 IV Infusion hypotension, headache, insomnia, & injection-
site reactions; rarely abdominal pain, hepatitis,
oedema, fatigue, & eosinophilia; very rarely
Active ingredient
hypoglycemia, hypokalemia, pancytopenia, Stevens-
Piperacillin & Tazobactam
Johnson syndrome, & toxic epidermal necrolysis.
Indication
Drug Interaction
Tazocilin 4.5 IV infusion is indicated for the
Probenecid, anticoagulants, vecuronium,
treatment of the following systemic and/or
methotrexate
local bacterial infections:
222
Product Guide
Use in Pregnancy & Lactation reported side effects include abdominal pain,
Piperacillin/Tazobactam should only be dyspepsia, nausea & insomnia.
used during pregnancy if clearly indicated.
Piperacillin is excreted in low concentrations Drug Interaction
in breast milk. Women who are breast-feeding Concomitant use of Ketoconazole, Itraconazole,
should be treated only if clearly indicated. Clarithromycin or Erythromycin may increase
plasma levels of Ebastine & cause QTc interval
Use in Children prolongation.
Children under 2 years: Piperacillin/Tazobactam
is not recommended for use in children below Use in Pregnancy & Lactation
2 years old due to insufficient data on safety. The safety of ebastine during pregnancy &
Hepatic Impairment: No dose adjustment is lactation has not been established
necessary.
Preparation
Preparation 10 mg tablet
4.5 gm IV Infusion

T Tetrax
Tebast TM

Active Ingredient
Active Ingredient Tetracycline.
Ebastine.
Indication
Indication Ricketsial infection, Mycoplasma pneumoniae
Ebastine is indicated for the symptomatic infections, Chlamydial Infections, Non-
treatment of: gonococcal or non specific urethritis, Lyme
Seasonal & perennial allergic rhinitis disease, Brucellosis, Miscellaneous infections
Chronic Idiopathic Urticaria including granuloma inguinale, cholera,
Allergic skin disorders glanders, relapsing fever & V. vulnifians, urinary
tract infections, bronchitis, PID, STD, travelers
Dosage & Administration diarrhoea, acne vulgaris, prostatitis, syphilis,
Adults (more than 12 years of age): 10 mg (one anaerobic infections.
tablet) once daily, Children (6-12 years of age):
5 mg (half tablet) once daily, Ebastine may be Dosage & Administration
taken with or without food. 1-2 g daily given in 2-4 divided doses, children
: 25-50 mg/kg daily.
Contraindication
Patients with a known hypersensitivity to Contraindication & Precaution
Ebastine or any of its ingredients. Hypersensitivity, systemic lupus erythematosus,
renal impairment, in impaired liver function
Side Effect high doses should be avoided. Potentiality
The most common side-Effects are headache, hepatotoxic drugs (including erythromycin,
dry mouth & drowsiness. Less commonly
223
Product Guide
chloramphenicol, isoniazide & sulphonamides) primary hypothyroidism is clinically euthyroid
should not be given concomitantly. & the serum TSH has normalized.
In patients with severe hypothyroidism: 12.5-
Side Effect 25 mcg/day with gradual increment of 25 mcg/
Depression of bone growth, discoloration of the day every 2-4 weeks.
teeth when given during tooth development In patients with secondary (pituitary) or tertiary
(i.e. during the later half of pregnancy, during (hypothalamic) hypothyroidism: The dose
infancy & in childhood) anaphylaxis, urticaria should be titrated until the patient is clinically
& rashes are uncommon. Photosensitivity euthyroid & the serum free- T4 level is restored
reactions, epigastric distress & nausea . to the upper half of the normal range.
Vomiting can occur, appears to aggravate pre- For patients older than 50 years or for patients
existing renal failure, candidiasis, Esophageal under 50 years of age with underlying cardiac
ulcerations. disease: 1.7 mcg/kg/day.
b) Pediatric Dosage
Use in Pregnancy & Lactation & Children Newborns
Tetracycline should not be used during The recommended starting dose is 10-15 mcg/
pregnancy, lactation & in children. kg/day. In infants with very low (< 5 mcg/dL)
or undetectable serum T4 concentrations, the
Preparation recommended initial starting dose is 50 mcg/
500 mg Capsule. day.
Infants & Children
Initial dose is 25 mcg/day with increments of T
25 mcg every 2-4 weeks until the desired effect
is achieved.

Thyrin c) Daily dose per Kg body weight


0-3 months : 10-15 mcg/kg/day
3-6 months : 8-10 mcg/kg/day
Active Ingredient 6-12 months : 6-8 mcg/kg/day
Levothyroxine Sodium. 1-5 years : 5-6 mcg/kg/day
6-12 years : 4-5 mcg/kg/day
Indication >12 years but growth & puberty incomplete:
Hypothyroidism - Primary (thyroidal), 2-3 mcg/kg/day
secondary (pituitary), & tertiary (hypothalamic) Growth & puberty complete: 1.7 mcg/kg/day
hypothyroidism & subclinical hypothyroidism.
Pituitary TSH Suppression Contraindication & Precaution
Contraindicated in the following conditions:
Dosage & Administration Untreated subclinical or overt thyrotoxicosis
Dosing must be individualized & adjustments of any etiology & acute myocardial infarction,
made based on periodic assessment of
the patients clinical response & laboratory
Uncorrected adrenal Levothyroxine has a
narrow therapeutic index. So, careful dosage
parameters.
titration is necessary to avoid the consequences
a) Adult Dosage
of over- or under-treatment.
Initial starting dose: 25-50 mcg/day, with
gradual increments in dose at 6-8 week intervals
Side-Effect
as needed. The dose is generally adjusted in
Adverse reactions associated with
12.5-25 mcg increments until the patient with
Levothyroxine therapy are primarily those of
224
Product Guide
hyperthyroidism due to therapeutic overdose. Dosage & Administration
They include the following: fatigue, increased In order to avoid irregular absorption, Thyrin
appetite, weight loss, heat intolerance, fever, 25 tablets should be taken preferably at a
excessive sweating, headache, nervousness, fixed time on an empty stomach. Concomitant
anxiety, irritability, tremors, muscle weakness, intake of food may decrease the absorption of
palpitations etc. Levothyroxine. Dosing must be individualized
& adjustments to be made based on periodic
Use in Pregnancy & Lactation assessment of the patients clinical response &
US FDA Pregnancy Category A. Pregnancy may laboratory parameters.
increase Levothyroxine requirements. Thyroid Adult Dosage: Initial starting dose: 25-50
hormones are excreted minimally in human mcg/day, with gradual increments in dose
milk; caution should be exercised when it is at 6-8 week intervals, as needed. The dose is
administered to a nursing woman. generally adjusted in 12.5-25 mcg increments
until the patient with primary hypothyroidism
Pediatric Use is clinically euthyroid & the serum TSH has
Can be used. normalized.
In patients with severe hypothyroidism: Initial
Preparation dose is 12.5-25 mcg/day with increases of 25
50 mcg Tablet. mcg/day every 2-4 weeks, accompanied by
clinical & laboratory assessment, until the TSH

T level is normalized.
In patients with secondary (pituitary) or tertiary
(hypothalamic) hypothyroidism: The dose
should be titrated until the patient is clinically

Thyrin 25 euthyroid & the serum free - T4 level is restored


to the upper half of the normal range.
For patients older than 50 years or for patients
Active Ingredient under 50 years of age with underlying cardiac
Levothyroxine Sodium disease: 1.7 mcg/kg/day. Pediatric Dosage:
Newborns: The recommended starting dose is
Indication 10-15 mcg/kg/day. A lower starting dose should
Hypothyroidism-As replacement or be considered in infants at risk for cardiac failure,
supplemental therapy in congenital or & the dose should be increased in 4-6 weeks as
acquired hypothyroidism of any etiology, needed based on clinical & laboratory response
except transient hypothyroidism during the to treatment. In infants with very low (< 5 mcg/
recovery phase of subacute-thyroiditis. dL) or undetectable serum T4 concentrations,
Specific indications: Primary (thyroidal), the recommended initial starting dose is 50
secondary (pituitary), & tertiary (hypothalamic) mcg/day of Levothyroxine Sodium.
hypothyroidism & subclinical hypothyroidism. Infants & Children: In children with chronic or
Pituitary TSH Suppression- In the treatment or severe hypothyroidism, initial dose of 25 mcg/
prevention of various types of euthyroid goiters, day with increments of 25 mcg every 2-4 weeks
subacute or chronic lymphocytic thyroiditis until the desired effect is achieved.
(Hashimotos thyroiditis), multinodular goiter Hyperactivity in an older child can be
and, as an adjunct to surgery & radioiodine minimized if the starting dose is one-fourth
therapy in the management of thyrotropin- of the recommended full replacement dose,
dependent well-differentiated thyroid cancer. & the dose is then increased on a weekly basis
by an amount equal to one-fourth the full-
225
Product Guide
recommended replacement dose until the full Drug Interaction
recommended replacement dose is reached. Concurrent use of tri/tetracyclic
antidepressants & Levothyroxine may increase
Daily dose per kg body weight: the therapeutic & toxic effects of both drugs,
0-3 months: 10-15 mcg/kg/day possibly due to increased receptor sensitivity
3-6 months: 8-10 mcg/kg/day to catecholamines. Toxic effects may include
6-12 months: 6-8 mcg/kg/day increased risk of cardiac arrhythmias & CNS
1-5 years: 5-6 mcg/kg/day stimulation; onset of action of tricyclics may
6-12 years: 4-5 mcg/kg/day be accelerated. Administration of sertraline in
>12 years but growth & puberty incomplete: patients stabilized on Levothyroxine may result
2-3 mcg/kg/day in increased Levothyroxine requirements.
Growth & puberty complete: 1.7 mcg/kg/day Addition of Levothyroxine to antidiabetic
The dose should be adjusted based on clinical or insulin therapy may result in increased
response & laboratory parameters. antidiabetic agent or insulin requirements.
Careful monitoring of diabetic control is
Contraindications & Precaution recommended, especially when thyroid
Untreated subclinical or overt thyrotoxicosis of therapy is started, changed, or discontinued.
any etiology & acute myocardial infarction. Serum digitalis glycoside levels may be reduced
Levothyroxine has a narrow therapeutic index. in hyperthyroidism or when the hypothyroid
So, careful dosage titration is necessary to avoid patient is converted to the euthyroid state.
the consequences of over or under-treatment.
Caution is needed when administering
Therapeutic effect of digitalis glycosides may
be reduced. T
Levothyroxine to patients with cardiovascular
disorders, to the elderly in whom there is Use in Pregnancy & Lactation
an increased risk of occult cardiac disease & Pregnancy - Category A. Pregnancy may
for patients with nontoxic diffuse goiter or increase Levothyroxine requirements.
nodular thyroid disease in order to prevent Nursing Mother - Although thyroid hormones
precipitation of thyrotoxicosis. are excreted only minimally in human milk,
caution should be exercised when it is
Side Effect administered to a nursing woman. However,
Adverse reactions associated with adequate replacement doses of Levothyroxine
Levothyroxine therapy are primarily those of are generally needed to maintain normal
hyperthyroidism due to therapeutic overdose. lactation.
They include the following:
General: Fatigue, increased appetite, weight Preparation
loss, heat intolerance, fever, excessive sweating; 25 mcg Tablet
Central nervous system: headache,
hyperactivity, nervousness, anxiety, irritability,
emotional lability, insomnia.
Musculoskeletal: Tremors, muscle weakness.
Ticamet TM
Cardiovascular: Palpitations, tachycardia, Cozycap
arrhythmias, increased pulse & blood pressure,
Respiratory: Dyspnea. Active Ingredient
Gastrointestinal: Diarrhea, vomiting, abdominal Salmeterol & Fluticasone
cramps
Dermatologic: Hair loss, flushing Indication
It is indicated for the long term maintenance
226
Product Guide
treatment of asthma in patient 12 years of age
Ticamet TM

& older. HFA Inhaler

Dosage & Administration Active Ingredient


One dry powder capsule inhalation twice daily Salmeterol & Fluticasone
approximately 12 hours apart.
Indication
Contraindication & Precaution Ticamet is indicated in the regular treatment of
Ticamet 100 & 250 Cozycap is contraindicated asthma, where use of a combination (LABA +
in the primary treatment of status asthmaticus Steroid) has been found to be appropriate. It is
or other acute episodes of asthma where also Effective for COPD patients.
intensive measures are required. The CVS & CNS
Effects seen with all sympathomimetic drugs Dosage & Administration
(e.g., increased blood pressure, heart rate, Adults & adolescents 12 years & older: 2 puffs
excitement) can occur, significant hypokalamia twice daily.
in some patients, systemic eosinophilic
conditions, with some patients presenting with Contraindication & Precaution
clinical features of vasculitis consistent with Hypersensitivity to any of the ingredients.
Churg-Strauss syndrome. Physicians should be
alert to eosiniphilia, vasculitic rash, worsening Precaution

T pulmonary symptoms, cardiac complications, Ticamet HFA Inhaler should not be used to
and/or neuropathy presenting in their patients. treat acute asthma symptoms for which a fast
& short acting bronchodilator (Salbutamol) is
Side Effect required.
Respiratory tract infection, Pharyngitis, Sinusitis,
Hoarseness/dysphonia, Oral candidiasis, Side Effect
Bronchitis, Headache, Nausea & vomiting, GI The pharmacological side Effects of beta2
discomfort & pain, Diarrhoea & Musculoskeletal agonist treatment are tremor, palpitations &
pain, hypersensitivity reactions, including rash, headache. Due to the fluticasone propionate
angioedema & bronchospasm. component, hoarseness & candidiasis (thrush)
of the mouth & throat can occur in some
Use in Pregnancy & Lactation patients.
The drug should be used in pregnancy only if
the potential benefit justifies the potential risk Use in Pregnancy & Lactation
to the fetus. Administration of Ticamet HFA Inhaler to
pregnant women should only considered if the
Preparation expected benefit to the mother is greater than
100 mcg (50 mcg + 100 mcg)/DPI & 250 mcg any possible risk to the foetus.
(50 mcg + 250 mcg)/DPI Capsule.
Preparation
50 Inhaler (25 mcg of Salmeterol & 50 mcg of
Fluticasone propionate/puff, 120 puffs), 125
Inhaler (25 mcg of Salmeterol & 125 mcg of
Fluticasone propionate/puff, 120 puffs), & 250
HFA Inhaler (25 mcg of Salmeterol & 250 mcg of
Fluticasone propionate/puffs, 120 puffs).
227
Product Guide

Ticas Timotor TM

Active Ingredient Active Ingredient


Fluticasone Propionate. Trimebutine Maleate.

Indication Indication
Inflammatory & pruritic manifestations of Treatment & relief of symptoms associated
corticosteroid-responsive eczema/dermatitis. with irritable bowel syndrome (spastic colon)
Postoperative paralytic ileus in order to
Dosage & Administration accelerate the resumption of the intestinal
Once or twice daily. transit following abdominal surgery.

Contraindication & Precaution


Rosacea, Acne vulgaris, Peri-oral dermatitis, Dosage & Administration
Primary cutaneous viral infections (e.g., Herpes For adults: 100mg-200mg, 3 times per day
Simplex, chicken pox), Perianal & genital before meals.
pruritus, etc.The use of Fluticasone Propionate
is not indicated in the treatment of primarily Adverse Reaction
infected skin lesions caused by infection with Trimebutine maleate is generally well

T
fungi or bacteria & dermatoses in children tolerated. The infrequently reported adverse
under one year of age, including dermatitis & effects are as follows: dry mouth, foul taste,
napkin eruptions. diarrhea, dyspepsia, epigastric pain, nausea,
constipation, drowsiness, fatigue, dizziness,
Side Effect hot/cold sensations, headache etc.
Local burning & pruritus, hypersensitivity
appear, atrophic changes in the skin Contraindication
such as thinning, striae, dilatation of the Patients with known hypersensitivity to
superficial blood vessels, hypertrichosis & trimebutine maleate or any excipient.
hypopigmentation, secondary infection,
hypercorticism. Use in Pregnancy & Lactation
The use of trimebutine maleate in pregnant
Use in Pregnancy & Lactation women is recommended. It is not known if
Administration of Fluticasone Propionate trimebutine maleate passes into breast milk.
during pregnancy & lactation should only This medication should be used while breast
be considered if the expected benefit to the feeding only if the potential benefits outweigh
mother is greater than any possible risk to the risks to the nursing infants.
fetus.
Drug Interaction
Preparation Trimebutine maleate increases the duration of
0.05% Cream & 0.005% Ointment. d-tubocurarine-induced curarization. No other
drug interactions have been observed during
clinical trials or otherwise reported.

Preparation
100 mg Tablet.
228
Product Guide

Togent of diphenhydramine to nursing mothers, levels


in breast milk following topical application are
 likely to be very low.
Active Ingredient
Diphenhydramine HCl & Zinc acetate. Preparation
Diphenhydramine HCl 2% + Zinc acetate 0.1%
Indication Cream.
Togent cream is used to temporarily relieve
pain & itching associated with: insect bites,
minor burns, sunburn, minor skin irritations,
minor cuts, scrapes, rashes due to poison ivy,
poison oak, & poison sumac, dries the oozing
& weeping of poison ivy, poison oak, & poison
sumac. Topicort
Dosage & Administration Active Ingredient
Adults & children above 2 years: Apply to Hydrocortisone Acetate.
the affected area 3 to 4 times daily. Before
application of cream, the skin should be clean, Indication
cool & dry. Should not have a hot shower or Irritant dermatitis, Allergic dermatitis, Eczema,

T
bath before applying. Apply the cream lightly Seborrheic dermatitis, Lichen simplex &
on the skin until the cream disappears. It is Pruritus ani, Flexural
important to include all skin surfaces, such as Psoriasis, Itching & rashes, caused by insect
between the fingers & toes, under the nails & bites, minor thermal burns, sunburn, etc.
on the soles of the feet.
Dosage & Administration
Contraindication & Precaution 2 or 3 times daily.
Use of cream is contraindicated in individuals
with a known allergy to its components, other Contraindication & Precaution
pyrethroids or pyrethrins. Do not use on large Infections - bacterial; viral; fungal, skin ulcers,
areas of the body with any other product hypersensitivity. In infants & children: Long
containing diphenhydramine, even once taken term topical therapy should be avoided, where
by mouth. Consult with the physician before possible as adrenal suppression can occur.
use on chicken pox, on measles. When using
this product, avoid contact of eyes. Side Effect
Hypersensitivity.
Side Effect
Contact dermatitis with mild erythematous Use in Pregnancy & Lactation
vesicular lesions & papules has occasionally It is recommended that topical corticosteroids
been reported. should not be used extensively during
pregnancy.
Use in Pregnancy & Lactation
In the absence of specific studies in pregnant Preparation
women its use in pregnancy should only 10 gm Cream.
follow medical advice. However, teratogenic
effects would not be anticipated. Although
caution should be exercised in administration
229
Product Guide

Torax excessive thirst, inability to concentrate,


TM

insomnia, malaise, fatigue, pruritus, urticaria,


skin photosensitivity, Lyells syndrome,
Active Ingredient Stevens-Johnson syndrome, flushing,
Ketorolac Tromethamine. bradycardia, hypertension, palpitations, chest
pain, infertility in female, dyspnoea, asthma,
Indication pulmonary oedema, fever, injection site pain.
Short-term management of moderate to
severe acute post-operative pain & acute pain Drug Interaction
of other origins. Should not be used with other NSAIDs or aspirin.
Anti-coagulants may cause an enhanced anti-
Dosage & Administration coagulant Effect.
Injecetion: For adults (65 years): Initial dose is
60 mg IM (Single). Maintenance dose is 30 mg Use in Pregnancy & Lactation
IM/IV 6 hourly. Maximum dose is 120 mg/day. Contraindicated during pregnancy, labour or
For elderly patients (>65 years), Initial dose is delivery, or in mothers who are breast feeding.
30 mg IM. Maintenance dose is 10-15 mg IM/
IV 6 hourly. Maximum dose is 60 mg/day. The Preparation
maximum duration of treatment should not 10 mg Tablet, 30 mg & 60 mg Injection.
exceed two days. Tablets: 10 mg every 6 hours

T
as required up to 7 days.

Contraindication
Patients having hypersensitivity to this drug
or other NSAIDs & those patients in whom
aspirin or other prostaglandin synthesis
inhibitors induce allergic reactions. It is also Tory
contraindicated in a history of peptic ulcer or
gastro-intestinal bleeding, moderate or severe Active Ingredient
renal impairment, a history of asthma. Ketorolac Etoricoxib.
tromethamine can cause gastro-intestinal
irritation, ulcers or bleeding in patients with or Indication
without a history of previous symptoms. Since Relief of pain & inflammation in - osteoarthritis,
ketorolac tromethamine & its metabolites are rheumatoid arthritis, other chronic
excreted primarily by the kidney, patients musculoskeletal disorders, acute gout,
with moderate to severe impairment of renal dysmenorrhoea, & following dental surgery.
function (serum creatinine greater than 160
micromol/l) should not receive. Dosage & Administration
Adult & adolescent over 16 years: osteoarthritis,
Drug Interaction chronic musculoskeletal disorders &
NSAIDs, aspirin, anti-coagulants, methotrexate, dysmenorrhoea: 60 mg, once daily, rheumatoid
Probenecid. arthritis: 90 mg, once daily, pain following
dental surgery & acute gout: 120 mg, once
Side Effect daily.
Nausea, vomiting, gastrointestinal bleeding,
melaena, peptic ulcer, pancreatitis, anxiety, Contraindication & Precaution
drowsiness, dizziness, headache, hallucinations, Known hypersensitivity to Etoricoxib, patients
230
Product Guide
with active peptic ulceration or gastro-
intestinal (GI) bleeding, patients who have Trevox
developed signs of asthma, acute rhinitis, nasal
polyps, angioneurotic oedema or urticaria Active Ingredient
following the administration of acetylsalicylic Levofloxacin.
acid or other Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs), patient having inflammatory Indication
bowel disease, severe congestive heart failure, Acute maxillary sinusitis, Acute bacterial
to children & adolescents under 16 years of age. exacerbation of Chronic bronchitis,
Community-acquired pneumonia,
Side Effect Nosocomial Pneumonia, Complicated urinary
Dry mouth, taste disturbance, mouth ulcers, tract infections, Uncomplicated UTI, Acute
flatulence, constipation, appetite & weight pyelonephritis, Chronic bacterial prostatitis,
changes, chest pain, fatigue, paraesthesia, Uncomplicated & complicated skin & soft
influenza-like syndrome & myalgia. tissue infections including abscesses, cellulitis,
furuncles, impetigo, pyoderma, wound
Drug Interaction infections.
Oral anticoagulants, diuretics & ACE inhibitors, Inhalation anthrax (post-exposure): To prevent
Acetylsalicylic acid, Cyclosporin & Tacrolimus, the development of inhalational anthrax
Lithium, Methotrexate, oral contraceptives, following exposure to Bacillus anthracis.

T Prednisone/Prednisolone, Digoxin, drugs


metabolized by sulfotransferases (Ethinyl Dosage & Administration
Acute sinusitis, 500 mg once daily for 10-14 days,
Estradiol), drugs metabolized by CYP
isoenzymes, Ketoconazole, Rifampicin, & Exacerbation of chronic bronchitis, 250-500
Antacids. mg once daily for 7 days, Community-acquired
pneumonia, 500 mg once daily for 7-14 days,
Use in Pregnancy & Lactation Community-acquired pneumonia, 750 mg once
It should be avoided in late pregnancy because daily for 5 days, Nosocomial Pneumonia, 750 mg
it may cause premature closure of the ductus once daily for 7-14 days, Complicated urinary-tract
arteriosus. It should be used during the first two infections & acute pyelonephritis, 250 mg daily for
trimesters of pregnancy only if the potential 7-10 days, Uncomplicated UTI, 250 mg once daily
benefit justifies the potential risk to the foetus. for 3 days, Acute pyelonephritis, 250 mg once
It is not known whether this drug is excreted in daily for 10 days, Chronic bacterial prostatitis, 500
human milk. mg once daily for 28 days, Uncomplicated skin &
soft-tissue infections, 500 mg once daily for 7-10
Preparation days, Complicated skin & soft-tissue infections,
60 mg, 90 mg & 120 mg Tablet. 750 mg once daily for 7-14 days.
Inhalation anthrax (post-exposure): Adult-500 mg
once daily for 60 days.

Contraindication & Precaution


Hypersensitivity, While taking Levofloxacin,
adequate amount of water should be taken to
avoid concentrated form of urine. Dose adjustment
should be exercised during Levofloxacin ingestion
in presence of renal insufficiency.
231
Product Guide
Side Effect tested in humans for post-exposure prevention
Nausea, vomiting, diarrhea, abdominal pain, of inhalational anthrax; plasma concentrations
flatulence, phototoxicity, tremors, depression, are likely to predict efficacy.
confusion etc.
Contraindication & Precaution
Drug Interaction Levofloxacin is contraindicated in persons with
Antacids, Iron, NSAID, Warfarin. known hypersensitivity to levofloxacin or other
quinolone antibacterials.
Use in Pregnancy & Lactation
Side Effect
Not recommended for use during pregnancy
Headache, nausea, vomiting, diarrhea,
or nursing, as the Effects on the unborn child constipation, abdominal pain, dyspepsia,
or infant are unknown. edema & injection site reaction. Less common
(0.1 to 1%) side Effects include allergic reaction,
Preparation hyperglycemia, hypoglycemia, anxiety,
500 mg & 750 mg Tablet, 125 mg/5 ml Oral agitation, tremor, palpitation, abnormal
Solution. hepatic function, tendonitis etc.

Drug Interaction
There are no data concerning an interaction
of intravenous fluoroquinolones with oral

T
antacids, sucralfate, multivitamins, didanosine,
or metal cations. However, no fluoroquinolone
should be co-administered with any
solution containing multivalent cations, e.g.,
magnesium, through the same intravenous
Trevox 500 IV line. Levofloxacin may enhance the Effect
of warfarin. Elevations of the prothrombin
Active Ingredient time in the setting of concurrent warfarin
& Levofloxacin use have been associated
Levofloxacin 500 mg as Levofloxacin
with episodes of bleeding. Disturbances of
Hemihydrate INN.
blood glucose, including hyperglycemia &
hypoglycemia, have been reported in patients
Indication treated concomitantly with fluoroquinolones
Levofloxacin infusion is indicated for the & an anti-diabetic agent. The concomitant
treatment of mild, moderate & severe infections administration of a non-steroidal anti-
caused by susceptible strains of the designated inflammatory drug with a fluoroquinolone,
microorganisms in the conditions listed below- including Levofloxacin, may increase the risk of
Pneumonia: Nosocomial & community CNS stimulation & convulsive seizures.
acquired
Acute bacterial sinusitis Use in Pregnancy & Lactation
Acute bacterial exacerbation of chronic There are no adequate & well-controlled studies
bronchitis
in pregnant women. Levofloxacin should be
Skin & skin structure infections: Complicated used during pregnancy only if the potential
& uncomplicated benefit justifies the potential risk to the fetus.
Chronic bacterial prostatitis Based on data on other fluoroquinolones &
Urinary tract infections: Complicated & very limited data on Levofloxacin, it can be
uncomplicated presumed that levofloxacin will be excreted
Acute pyelonephritis in human milk. Because of the potential for
In halational anthrax, post-exposure. Not serious adverse reactions from Levofloxacin in
232
Product Guide
nursing infants, a decision should be made whether to discontinue nursing or to discontinue the
drug, taking into account the importance of the drug to the mother.

Dosage & Administration


Type of Infection Dosed Every Duration (days)
24 hours

Nosocomial Pneumonia 750 mg 7-14


Community Acquired Pneumonia 500 mg 7-14
or
750 mg 5

Acute Bacterial Sinusitis 500 mg 7-14


or
750 mg 5

T Acute Bacterial Exacerbation of Chronic 500 mg


Bronchitis
7

Complicated Skin & Skin Structure Infections 750 mg 7-14


Uncomplicated SSSI 500 mg 7-10
Chronic Bacterial Prostatitis 500 mg 28
Complicated Urinary Tract Infection or 250 mg 10
Acute Pyelonephritis or
750 mg 5

Uncomplicated Urinary Tract Infection 250 mg 3

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the
physician.

Use in Children
Except for inhalational anthrax (postexposure), safety & efficacy have not been established in
children in children younger than 6 mo of age.

Preparation
Trevox 500 IV: Each box contains 1 bag of 100 ml solution for intravenous infusion.
233
Product Guide

Trispray Trupan
Active Ingredient Active Ingredient
Triamcinolone Acetonide. Pantoprazole.
Indication
Indication
Treatment & prophylaxis of the nasal symptoms
Trupan is indicated for the treatment of - Benign
of seasonal & perennial allergic rhinitis from 6
gastric ulcer, duodenal ulcer, gastroesophageal
years of age to adults.
reflux disease (GERD), NSAID-induced peptic
Dosage & Administration ulcer, acid hypersecretory conditions including
Adults & children 12 years & older : The Zollinger-Ellison Syndrome, eradication of
recommended dose is 2 sprays in each nostril Helicobacter pylori (in combination with
once daily. 6-12 years: 1 spray in each nostril Antibiotics), ulcer resistant to H2 receptor
once daily. Below 6 years: Not recommended. antagonists.

Contraindication Contraindication & Precaution


No contraindication. Pantoprazole is contraindicated in patients
with known hypersensitivity to the active drug
Adverse Reactions or any other components of the formulation.

T
Rhinitis, headache, pharyngitis, epistaxis, nasal Patients should be cautioned that Pantoprazole
irritation, dry mucous membrane, naso-sinus tablet should not be split, crushed or chewed.
congestion, sneezing, nasal septal perforation
has been reported. Side Effect
Pantoprazole is well tolerated in both short
Drug Interaction term & long term treatment. Headache &
None is known. diarrhoea are the most common side effects
& rarely included abdominal pain, flatulence,
Precaution rash, insomnia & hyperglycemia.
If there is any reason to suppose that adrenal
function is impaired, care must be taken while Use in Pregnancy & Lactation
transferring patients from systemic steroid USFDA Pregnancy category B. Pantoprazole should
treatment to Triamcinolone. be used during pregnancy only if clearly needed. A
decision should be made whether to discontinue
Preparation nursing or to discontinue the drug, taking into
55 mcg/spray, Nasal Spray. account the benefit of the drug to the mother.

Dosage & Administration


Tablet
Disease Dosage &
administration
Benign gastric ulcer 40 mg daily in
the morning for 4
weeks, continued
for further 4 weeks
if not fully healed
234
Product Guide
Duodenal ulcer 40 mg daily in Gastroesophageal 40 mg once daily
the morning for 2 reflux disease for 7-10 days
weeks, continued associated with a
for further 2 weeks history of erosive
if not fully healed esophagitis
Prevention of IV 80 mg, followed
GERD 20-40 mg daily in
rebleeding in peptic by 8 mg/hour
the morning for 4
ulcer infusion for 72
weeks, continued
hours
for further 4 weeks
if not fully healed Prophylaxis of acid 80 mg IV every 12
aspiration h for 24 h, followed
NSAIDs induced 20 mg daily by 40 mg every 12 h
peptic ulcer
Long-term 80 mg IV every
Acid hypersecretory Initially 80 mg management of 12 hours, may
conditions including once daily adjusted Zollinger-Ellison increase to 80
Zollinger-Ellison according to response Syndrome & other mg every 8 hours
Syndrome (Elderly - maximum 40 pathological if needed, may
mg daily), daily doses hypersecretory titrate to higher

T above 80 mg given in conditions doses depending


two divided doses on acid output.

Eradication of 40 mg twice daily by Intravenous Pantoprazole should be replaced


Helicobacter triple therapy with with oral therapy as soon as possible.
pylori Antibiotics
Direction For Use Of IV Injection: Pantoprazole
Ulcer resistant to H2 40 mg once daily
lyophilized powder & 0.9% Sodium Chloride
receptor antagonists for 8 weeks. 20
Injection is for intravenous administration
mg daily as a
only & must not be given by any other route.
maintenance
Pantoprazole injection 40 mg should be
therapy, increased
given as a slow intravenous injection. The
to 40 mg daily if
solution for IV injection is obtained by adding
symptoms return.
10 ml 0.9% Sodium Chloride Injection to the
vial containing powder. After reconstitution
Children: Safety & effectiveness have not been the injection should be given slowly over a
established period of at least 2-5 minutes. Use only freshly
prepared solution. The reconstituted solution
o
may be stored at room temperature (up to 30 c)
Injection for a maximum 4 hours.
Duodenal ulcer & 40 mg once daily Direction For Use Of IV Infusion: Pantoprazole IV 40
gastric ulcer for 7-10 days mg should be given as an intravenous infusion
over a period of approximately 15 minutes.
Pantoprazole IV should be reconstituted with
10 ml of 0.9% Sodium Chloride Injection &
further diluted (admixed) with 5% Dextrose
235
Product Guide
or 0.9% Sodium Chloride Injection or Lactated Drug Interaction
Ringers Injection. The reconstituted solution This drug should not be used with other
o
may be stored at room temperature (up to 30 c) medicine containing Almitrine. Due to the
for a maximum 4 hours prior to further dilution. presence of lactose, this drug should not
The admixed solution may be stored at room be used in case galactosemia, glucose or
o
temperature (up to 30 c) & must be used within galactose mal-absorption syndrome or in
24 hours from the time of initial reconstitution. lactose deficiency.

Preparation Use in pregnancy & lactation


20 mg Tablet, 40 mg Tablet & 40 mg IV Injection. Consulting with physicians is required to take
this medicine.

Preparation
Almitrine Bismesylate 30 mg & Raubasine 10 mg.

Truxil
TM

Active ingredient
Almitrine Bismesylate & Raubasine Tryptin
Indication
Reduces Neurological damage & accelerates
Active Ingredient
Amitriptyline.
T
recovery after stroke
Minor age related neurological disorders Indication
Visual disorders related to age Depressive illness, particularly with anxiety &
Disorders in the inner ear (hearing loss, nocturnal enuresis in children.
dizziness, buzzing etc.)
Dosage & Administration
Dosage & Administration 25-50 mg a day in divided dose.
Usually 1-2 tablets daily (with a several hours
interval) Contraindication & Precaution
Myocardial infarction; arrythmias, particularly
Contraindication & Precaution heartblock of any degree; mania; severe liver
This medicine is contraindicated to those disease. Caution in patients with a history
patients having known hypersensitivity to any of epilepsy, glaucoma, urinary retention,
component of this preparation. Without this if prostatic hypertrophy, constipation, cardiac
anybody suffers from liver disease, peripheral disease, diabetes, pregnancy, hepatic
neuropathy or history of peripheral neuropathy, impairment, thyroid disease, increased intra-
they should not take this medicine. occular pressure, psychoses (may aggravate
mania).
Side Effect
Some side effects to some people may occur
like weight loss, numbness in leg, nausea, Side Effect
heaviness or burning in stomach, vomiting, Hypotension, syncope, postural hypotension,
vertigo, constipation, diarrhea, insomnia, hypertension, tachycardia, palpitations,
sleepiness, restlessness, anxiety, palpitation etc. myocardial infarction, arrythmias, & heart
236
Product Guide
block stroke. Confusional states, disorientation, has been expelled
delusions, & hallucinations. Dry mouth, blurred If your vaginal diaphragm or your
vision, mydriasis, increased intraoccular contraceptive cap has moved or if have
pressure, hyperplasia. Skin rash, urticaria, & removed it too easily
photosensitization. Bone-marrow depression, If you are afraid that the method of coitus
Gastrointestinal: Nausea, epigastric distress, interruptus has failed or if you have had
vomiting anorexia, diarrhoea. Testicular sexual intercourse during the period
swelling, gynaecomastia; breast enlargement, when you are supposed to be fertile while
galactorrhoea. Dizziness, weakness, fatigue, using the rhythm method
headache, weight loss. In the event of rape

Drug Interaction Dosage & Administration


Monoamine oxidase inhibitors, adrenaline, One tablet should be taken orally with a
epinephrine, isoprenaline, noradrenaline, CNS glass of water within 120 hours (5 days) after
depressant, Alcohol, Cemitidine. unprotected intercourse
Side effects
Use in Pregnancy & Lactation
The drug should be used during pregnancy Undesirable effects which have been
& lactation if potential benefit justifies the observed are
potential risk to the fetus. Nausea & vomiting

T Preparation
Dizziness, fatigue, headache
Abdominal pain
10 mg & 25 mg Tablet. A feeling of breast tenderness
Bleeding can occur after taking this
medicine
Inform doctor of any unwanted effect which is
not mentioned here.

TulipTM Drug Interaction


Simultaneous administration of certain
anticonvulsant agents (phenobarbiton,
Active Ingredient phenytoin, primidone, carbamazepin),
Ulipristal Acetate also other medications such as rafimpicin
& griseofulvin can reduce or suppress the
Indication effectiveness of this emergency contraception.
This contraception is used within 120 hours (5
days) after unprotected intercourse or a known Use in Pregnancy & lactation
or suspected contraceptive failure, particularly Pregnancy Category X. Use of Ulipristal Acetate
If you have had a sexual intercourse is contraindicated during an existing or
whereas either yourself or your partner suspected pregnancy. Use of Ulipristal Acetate
did not use a contraceptive method by breastfeeding women is not recommended
If you have forgotten to take consecutive
3 regular contraceptive pills Use in Children
If your partners condom has broken, Keep out from reach of children
slipped or been improperly removed or if
he has forgotten to use it Preparation
If you fear that your intrauterine device 30 mg Tablet
237
Product Guide

Tusca Ucol 2 TM

Active Ingredient Active Ingredient


Guaiphenesin, Pseudoephedrine & Triprolidine. Tolterodine Tartrate.

Indication Indication
Symptomatic relief of upper respiratory tract Treatment of overactive bladder with
disorders accompanied by productive cough. symptoms of urinary urgency, frequency, and/
or urge incontinence.
Dosage & Administration
Adults: 2 teaspoonful 3 times a day. Children : Dosage & Administration
Over 12 years: 2 teaspoonful 3 times a day. 6-12 2 mg b.i.d. Dosage may be reduced from 2mg
years: 1 teaspoonful 3 times a day. 2-6 years : to 1mg b.i.d.
1/2 teaspoonful 3 times a day.
Contraindication & Precaution
Contraindication & Precaution contraindicated in patients with Urinary
Hypersensitive to guaiphenesin, retention, uncontrolled narrow angle
pseudoephedrine or triprolidine. Patients glaucoma, known hypersensitivity.
should not drive or operate machinery until Urinary retention decreased gastrointestinal

U
they have determined their own response. motility, impaired renal function, impaired
hepatic function.
Side Effect
CNS depression, excitation, drowsiness, Side Effect
sleep disturbance, hallucination, skin rashes, Dryness of mouth, dyspepsia and/or reduced
tachycardia, dryness of mouth, nose & lacrimation.
throat,urinary retention.
Drug Interaction
Drug Interaction Ketoconazole, warfarin, oral contraceptives.
Concomitant use with decongestants, tricyclic
antidepressants, appetite suppressants & Pregnancy & Lactation
amphetamine-like psychostimulants or with Should be used during pregnancy only if the
MAO inhibitors may occasionally cause a rise potential benefit justifies the potential risk to
in blood pressure. the foetus. Use of tolterodine during lactation
should be avoided.
Preparation
(100 mg + 30 mg + 1.25 mg)/5 ml Syrup. Preparation
2 mg film coated Tablet.
238
Product Guide

UrocureTM emesis, dizziness, drowsiness etc.

Drug Interaction
Active ingredient Co-administration of Nitrofurantoin with antacids
Nitrofurantoin USP containing Magnesium Trisilicate reduce both the
rate & extent of absorption. Uricosuric drugs, such
Indication as Probenecid & Sulnpyrazone, can inhibit renal
Treatment of uncomplicated Urinary Tract tubular secretion of Nitrofurantoin.
Infections
Use in Pregnancy & Lactation
Dosage & Administration Pregnancy: Pregnancy category B. It should be
UrocureTM 100 SR Capsule: Adults & children over used during pregnancy
12 years: One capsule every 12 hours for seven only if clearly needed.
days. Genito-urinary surgical prophylaxis - One
capsule twice daily on the day of the procedure Lactation
& for next 3 days UrocureTM Suspension: Adults: Nitrofurantoin has been detected in human
50-100 mg four times a day - the lower dosage breast milk in trace amounts. Because of the
level is recommended for uncomplicated urinary potential for serious adverse reactions from
tract infections. Pediatric Patients: 5-7 mg/kg of Nitrofurantoin in nursing infants under one
body weight per 24 hours, given in four divided month of age, a decision should be made whether

U
doses (contraindicated less than one month of to discontinue nursing or to discontinue the drug,
age). taking into account the importance of the drug to
the mother.
Contraindication & Precaution
Anuria, oliguria, or significant impairment of Use in Children
renal function (creatinine clearance under 60 ml Safety & effectiveness of Nitrofurantoin in
per minute or clinically significant elevated serum neonates below the age of one month have not
creatinine) are contraindications. Nitrofurantoin is been established.
contraindicated in patients with a previous history
of cholestatic jaundice/hepatic dysfunction Preparation
associated with Nitrofurantoin. Nitrofurantoin 100 SR Capsule &100 ml suspension.
is also contraindicated in those patients with
known hypersensitivity to it. Patients should be
instructed to complete the full course of therapy;
however, they should be advised to contact their
physician if any unusual symptoms occur during
therapy. Diarrhea is a common problem caused by
Uriten TM
antibiotics which usually ends when the antibiotic
is discontinued. Patients should be advised not to
use antacid preparations containing Magnesium Active Ingredient
Trisilicate while taking Nitrofurantoin. Alfuzosin hydrochloride.

Side Effect Indication


The most common side effects are nausea, Uriten is used for the treatment of functional
headache & flatulence. symptoms of Benign Prostatic Hyperplasia
Other side e effects are diarrhea, dyspepsia, (BPH). It is also used as a short term treatment
abdominal pain, constipation, of acute urinary retention (AUR) related to BPH
239
Product Guide
patients (over 65 years) in association with
catheterization. Valoate
Dosage & Administration Active Ingredient
BPH: 10 mg once daily immediately after the Sodium Valproate.
same meal each day.
AUR: 10 mg once daily immediately after the Indication
same meal each day. Dose should be started Epilepsy, Mania, Chronic Headache
from the first day of catheterization. The
treatment should be continued for 3-4 days Dosage & Administration
(2-3 days during catheterization & 1 day after Adults: Initial: 600mg/day in 2 divided doses,
its removal). preferably after food. Dose may be increased
The tablet should be swallowed whole. The by 200mg/day at 3 days interval to a maximum
tablets should not be chewed or crushed. of 2.5g daily in divided doses until control of
These actions may lead to an inappropriate seizure is achieved.
release & absorption of the drug & therefore Maintenance dose: Usually 1-2g daily (20-30
possible early adverse reaction. mg/kg daily).
Children (up to 20kg):
Contraindication Initial: 20mg/ kg daily in divided doses. Dose
Hypersensitivity to Alfuzosin, history of may be increased in severe cases with proper

V
orthostatic hypotension, moderate & severe monitoring of plasma concentration.
liver problem, in combination with other Children (over 20kg):
alpha-blockers. This is contraindicated for use Initial: 400mg/ day (irrespective of weight).
in women & children (under the age 18). Dose may be increased by 20-30 mg/kg if
required to achieve control.
Side Effect
Dizziness, Headache, Fatigue, Vertigo, Malaise, Contraindication & Precaution
Tachycardia, Palpitation, Nausea, Abdominal Sodium valproate is contra-indicated in
pain, Rash, Diarrhea, Postural hypotension, patients with known hypersensitivity of
Syncope, Dry mouth. sodium valproate, personal or family history of
severe active liver disease hepatic dysfunction,
Drug Interaction porphyria & known urea cycle disorder.
Alfuzosin may interact with other alpha-
blockers, Atenolol, Cimetidine, Diltiazem, Side Effect
Ketoconazole & Ritonavir. Gastric irritation, nausea, ataxia & tremor;
hyperammonaemia, increased appetite &
Use in Pregnancy & Lactation weight gain; transient hair loss, oedema,
Alfuzosin should not be used by women. thrombocytopenia, & inhibition of platelet
aggregation, impaired hepatic function leading
Preparation rarely to fetal hepatic failure; rashes; sedation;
10 mg Extended Release Tablet. rarely lethargy & confusion & also increased
alertness; rarely pancreatitis, leucopenia,
pancytopenia, red cell hypoplasia, fibrinogen
reduction; irregular periods, amenorrhoea,
gynaecomastia, toxic epidermal necrolysis,
hearing loss, Fancolis syndrome, dementia,
Stevens-Johnson syndrome, & vasculitis have
240
Product Guide
also been reported. Pharyngitis and/or tonsillitis: 200 mg 12 hourly
5-10 days.
Drug Interaction Uncomplicated urinary tract infection: 200 mg
Sodium valproate is a non specific inhibitor of 12 hourly 7 days
drug metabolism. Phenobarbital, Phenytoin, Acute maxillary sinusitis: 400 mg/200 mg 12
Warfarin, Aspirin etc most significantly hourly 10 days
interacts with sodium valproate Child: 15 days-6 months : 4 mg/kg every 12
hours, 6 months-2 years : 40 mg every 12 hours,
Use in Pregnancy & Lactation 3-8 years: 80 mg every 12 hours, Over 9 years :
Pregnancy category D 100 mg every 12 hours.

Use in Children Contraindication & Precaution


Can be used for children Known allergy to the cephalosporin class
of antibiotics. In patients with transient or
Preparation persistent reduction in urinary output due
200 mg, 300 mg & 500 mg CR Tablet & 200 mg/ to renal insufficiency, the total daily dose of
5 ml Syrup. Cefpodoxime should be reduced because high
& prolonged serum antibiotic concentration
can occur in such individuals following usual
doses. As with other antibiotics, prolonged

V use of Cefpodoxime may result in overgrowth


of nonsusceptible organisms. If superinfection

Vanprox occurs during therapy, appropriate measures


TM

should be taken.

Active Ingredient Side Effect


Cefpodoxime. Gastrointestinal disorders (such as diarrhoea,
nausea, vomiting & abdominal pain), rash,
Indication urticaria & itching.
Lower respiratory tract infections, Upper
respiratory tract infections, Urinary tract Use in Pregnancy & Lactation
infections including gonorrhoea, cystitis, Pregnancy Category B.
Skin & soft tissue infections, Gynecological Cefpodoxime is excreted in breast milk &
infections, Acute otitis media, Childhood caution should be exercised when administered
infections. to a nursing women..

Dosage & Administration Drug Interaction


Adults (Including age 13 years & older): Antacids, H2-blockers, Probenecid,
Acute community-acquired pneumonia: 400 Nephrotoxic drugs.
mg / 200 mg 12 hourly 14 days.
Acute bacterial exacerbation of chronic Preparation
bronchitis 400 mg / 200 mg 12 hourly 10 days. 200 mg Capsule, 40 mg/5 ml Suspension, 80
Uncomplicated gonorrhea (men/women): 200 mg/5 ml Suspension, 20 mg/ml Paediatric
mg Single dose. Drops.
Rectal gonococcal infection in women: 200 mg
Single dose.
Skin & soft tissue infections: 200 mg twice days.
241
Product Guide

Vasopril Versia TM

Active Ingredient Active Ingredient


Enalapril. Neostigmine Methyl Sulphate.

Indication Indication
Hypertension & renovascular hypertension, Versia Injection is used for -
heart failure, congestive heart failure (adjunct), Reversal of non-depolarizing neuromuscular
coronary ischaemic events, angina, diabetic blockade for surgical anesthetic procedures
nephropathy & Raynauds disease. prevention & treatment of post-
The
operative distention & urinary retention
Dosage & Administration after mechanical obstruction has been
2.5-5 mg once daily up to 20 mg daily if used excluded
in addition to diuretics. Heart failure (adjunct) Treatment of the systemic control of
& asymptomatic left venticular disfunction: Myasthenia gravis when oral therapy is
Initially 2.5 mg, then 20mg daily in 1-2 divided impractical
doses.
Dosage & Administration
Contraindication & Precaution Adults: By intramuscular or subcutaneous

V
Hypersensitivity, patient should be observed injection:
under medical supervision for at least two hours Symptomatic control of myasthenia gravis: 1 ml
& until blood pressure has been stabilized, of the 1:2000 solution (0.5 mg) intramuscularly
dose should be adjusted if the patient is found or subcutaneously. Subsequent dose should
to have renal insufficiency. Hypotension may be based on the individual patients response.
result shortly after initiation of the treatment Treatment of post-operative distention: 1 ml of
in patients with severe heart failure or those the 1:2000 solution (0.5 mg) intramuscularly or
who have been volume depleted by diuretic subcutaneously or as required.
therapy, dietary salt restriction, dialysis, Prevention of post-operative distention &
diarrhoea or vomiting. The risk of hypotension urinary retention: 1 ml of the 1:4000 solution
is also present in patients undergoing major (0.25 mg) intramuscularly or subcutaneously as
surgery or during anesthesia with agents that soon as possible after operation; repeat every
produce hypotension. Safety & Effectiveness of 4-6 hours for 2-3 days.
the drug have not been established in children. Treatment of urinary retention: 1 ml of the
1:2000 solution (0.5 mg) intra-muscularly
Side Effect or subcutaneously. If urination does not
Dizziness & headache, Fatigue & asthenia, occur within an hour, the patient should be
hypotension, orthostatic hypotension, catheterized. After the patient has voided,
syncope, nausea, diarrhoea, muscle cramps, or the bladder has been emptied, continue
rash & cough, renal dysfunction, renal failure the 0.5 mg injection every 3 hrs, for at least 5
& oliguria, Angioedema, hyperkalemia & injections.
hyponatremia. Reversal of Effects of Non-depolarizing
Neuromuscular Blocking Agents; when
Preparation Neostigmine is administered intravenously, it is
5 mg & 10 mg Tablet. recommended that Atropine Sulphate (0.6-1.2
mg) also be given intravenously using separate
syringe. The usual dose is 0.5 to 2 mg is given
242
Product Guide
by slow intravenous injection, repeated as
required. On exceptional cases total dose Vertina Plus TM

should be exceed 5 mg.


Neonates: 50-250 micrograms every 4 hrs. Active Ingredient
Children: 200-500 micrograms as Meclizine & Pyridoxine.
recommended.
Indication
Contraindication & Precaution For prophylaxis & symptomatic relief of nausea,
Neostigmine is contraindicated in patients vomiting, dizziness, motion sickness, radiation
with known hypersensitivity to the drug. It is sickness & vertigo associated with diseases of
also contraindicated in patients with peritonitis vestibular system (e.g. Menieres syndrome,
or mechanical obstruction of the intestinal or labyrinthitis & other vestibular disturbances) &
urinary tract. morning sickness during pregnancy.
Asthma, bradycardia, recent myocardial
infarction, epilepsy, hypotension, Dosage & Administration
parkinsonism, vagotonia, peptic ulceration. Nausea & vomiting (including morning
Atropine or other antidote to muscarinic sickness in pregnancy): One tablet 1-2 times
effccts may be necessary (particularly when daily or as directed by physician.
Neostigmine is given by injection), but it Motion sickness: The initial dose is one or
should not be given routinely as it may mask two tablets daily; it should be taken one hour

V signs of overdose. prior to journey for protection against motion


sickness. Therefore, the dose may be repeated
Side Effect every 24 hours as indicated for the duration of
Nausea, vomiting, increased salivation, journey.
diarrhea & abdominal cramps (more marked Vertigo: One tablet two times daily or as
with high doses). Signs of overdose are directed by physician.
increased gastrointestinal discomfort, Labyrinthine & vestibular disturbances: The
bronchial secretions & sweating, involuntary optimal dose of Meclizine HCl is usually 25 to
defecation & micturition, miosis, nystagmus, 100 mg daily in divided doses, depending on
bradycardia, hypotension, agitation, excessive the clinical response.
dreaming & weakness eventually leading to Radiation sickness: 50 mg (Meclizine HCl)
fasciculation & paralysis. administered 2 to 12 hours prior to radiation
treatment. Pyridoxine (vitamin B6) has been
Use in Pregnancy & Lactation shown to be safe & Effective in dosages of 50
Pregnancy category C. But use during lactation to 200 mg per day.
hasnt been determined.
Contraindication & Precaution
Preparation The fixed-dose combination is contra-
IM/IV Injection; Each 1 ml containing indicated in individuals who have shown a
Neostigmine Methyl Sulphate USP 0.5 mg previous hypersensitivity to these ingredients.
(each box contains 10 ampoules in blister Due to its potential anticholinergic action,
packaging). patient with asthma, bronchitis, emphysema,
enlarged prostate, glaucoma or urinary tract
blockade should take Meclizine HCl (like other
antiemetics) with caution.
243
Product Guide
Side-Effect agents. Taking Combination of Vildagliptin &
Drowsiness, dry mouth, urinary retention Metformin with or just after food may reduce
or rare occasions, blurred vision have been gastrointestinal symptoms associated with
reported. Sensory neuropathy reported with Metformin.
high dosage of Pyridoxine hydrochloride given
for extended periods. Contraindication & Precaution
Combination (Vildagliptin & Metformin HCl) is
Use in Pregnancy & Lactation contraindicated in patients with:
Indicated. Hypersensitivity to the active substance or to
any of the excipients
Preparation Patients with Renal Impairment: Creatinine
Meclizine HCl 25 mg & Pyridoxine HCl 50 mg clearance <60 mL/min.
film coated Tablet. Patients with Hepatic Impairment: patients
with pre-treatment alanine aminotransferase
(ALT) or aspartate aminotrasferase (AST) >2.5
times the upper limit of normal (ULN).
patients with type 1 diabetes

Viglimet TM Side Effect


The majority of adverse reactions were

Active Ingredient
Vildagliptin & Metformin HCl
mild & transient, not requiring treatment
discontinuations. V
Lactic acidosis can occur due to Metformin.
Rare cases of hepatic dysfunction. Some
Indication common side effects like tremor, headache,
Viglimet is indicated in patients with type 2 dizziness, nausea, hypoglycaemia, fatigue
diabetes who are unable to achieve sufficient are seen. Clinical trials of up to & more than
glycemic control at their maximally tolerated 2 years duration did not show any additional
dose of oral Metformin alone or who are already safety signals or unforeseen risks when use this
treated with the combination of Vildagliptin & combinatin.
Metformin as separate tablets.
Drug Interaction
Dosage & Administration In pharmacokinetic studies, no interactions
Adults: Based on the patients current dose were seen with pioglitazone, Metformin,
of Metformin, Combination of Vildagliptin glibenclamide, digoxin, warfarin, amlodipine,
& Metformin may be initiated at either 50 ramipril, valsartan or simvastatin. As with
mg/500 mg or 50 mg/850 mg twice daily, 1 tab other oral antidiabetic medicinal products the
in the morning & the other in the evening. The glucose-lowering effect of Vildagliptin may be
recommended daily dose is 100 mg Vildagliptin reduced by certain active substances, including
plus 2000 mg Metformin HCl. Patients receiving thiazides, corticosteroids, thyroid products
Vildagliptin & Metformin from separate tablets & sympathomimetics. Close monitoring of
may be switched to combination of Vildagliptin glycemic control is required, when cationic
& Metformin containing the same doses of drugs are co-administered. Glucocorticoids,
each component. Doses higher than 100 mg of beta 2-agonists, diuretics & ACE inhibitors
Vildagliptin are not recommended. There is no may alter blood glucose. The patient should
clinical experience of Vildagliptin & Metformin be informed & more frequent blood glucose
in triple combination with other antidiabetic monitoring performed, especially at the
244
Product Guide
beginning of treatment. If necessary, the Dosage & Administration
dosage of Vildagliptin & Metformin tablets The recommended dose of Viglita is
may need to be adjusted during concomitant 50 mg or 100 mg daily for monotherapy. 50
therapy & on its discontinuation. mg twice daily (morning & evening) when
used in dual combination with Metformin or
Use in pregnancy & Lactation a thiazolidinedione; 50mg once daily in the
Pregnancy: There are no adequate data on the morning when used in dual combination with
use of Vildagliptin & Metformin in pregnant a sulphonylurea.
women; hence the potential risk for humans is Viglita may be taken with or without a meal. No
unknown. dosage adjustment is required in the elderly, or
Nursing Mothers: It is not known whether in patients with mild renal impairment.
Vildagliptin is excreted in human milk. Due to
lack of human data, Vildagliptin & Metformin Contraindication & Precaution
should not be used during lactation. Vildagliptin is contraindicated in patients with:
Hypersensitivity to the active substance or to
Use in Children any of the excipients, Patients with moderate to
Combination of Vildagliptin & Metformin is not severe renal Impairment, Patients with Hepatic
recommended in patients 18 years of age. Impairment: patients with pre-treatment
alanine aminotransferase (ALT) or aspartate
Preparation aminotrasferase (AST) >3 times the upper limit

V Viglimet 50/500: Each film coated tablet


contains Vildagliptin INN 50 mg & Metformin
of normal (ULN), patients with type 1 diabetes

HCl BP 500 mg. Viglimet 50/850: Each film Side Effect


coated tablet contains Vildagliptin INN 50 mg The majority of adverse reactions were
& Metformin HCl BP 850 mg. mild & transient, not requiring treatment
discontinuations. Rare case of hepatic
dysfunction is seen. Clinical trials of up to &
more than 2 years duration did not show any
additional safety signals or unfore seen risks
when use this combination.

Drug Interaction

Viglita TM In pharmacokinetic studies, no interactions


were seen with pioglitazone, Metformin,
glibenclamide, digoxin, warfarin, amlodipine,
Active ingredient ramipril, valsartan or simvastatin. As with
Vildagliptin other oral antidiabetic medicinal products
the glucose-lowering effect of Vildagliptin
Indication may be reduced by certain active substances,
Viglita is indicated as an adjunct to diet & including thiazides, corticosteroids, thyroid
exercise to improve glycemic control in patients products & sympathomimetics.
with type 2 diabetes mellitus. Or monotherapy
in dual combination with Metformin, a Use in Pregnancy & Lactation
sulphonylurea, a thiazolidinedione, or insulin Pregnancy: Vildagliptin should not be used in
when diet, exercise & a single antidiabetic pregnancy
agent do not result in adequate glycemic Nursing Mothers: Vildagliptin should not be
control. used during lactation.
245
Product Guide
Use in Children bleeding at the back of the eye, red eyes, eye
Vildagliptin is not recommended in patients 18 pain, double vision, abnormal sensation in the
years of age. eye, irregular or rapid heartbeat, muscle pain,
feeling sleepy, reduced sense of touch, vertigo,
Preparation ringing in the ears, nausea, dry mouth, chest
Each tablet contains Vildagliptin INN 50 mg. pain & feeling tired.

Warnings
In patients with preexisting cardiovascular
disease, there is a potential risk in sexual
activity. Sildenafil should not be generally used

Vigorex TM in men for whom sexual activity is inadvisable


because of their underlying cardiovascular
status. There is no controlled clinical data on
Active Ingredient the safety or efficacy of Sildenafil in Patients
Sildenafil who have suffered from a myocardial infarction,
stroke, or life-threatening arrhythmia within
Indication the last 6 months. Caution should be taken in
Erectile Dysfunction. patients with resting hypotension (BP <90/50)
or hypertension (BP >170/110), cardiac failure

V
Dosage & Administration or coronary artery disease causing unstable
The usual starting dose of Vigorex is 50 mg once angina, retinitis pigmentosa. Prolonged
daily. It should be taken before 30-40 minutes erection greater than 4 hours & priapism
of intercourse. Depending on effectiveness (painful erections greater than 6 hours in
& tolerance; the dose may be increased to a duration) have been reported infrequently
maximum recommended dose of 100 mg or since market approval of Sildenafil. In this
decreased to 25 mg. The maximum dosing situation, patient should seek immediate
frequency is once per day. Vigorex may takes medical assistance.
longer time to work if you take it with a heavy
meal. Precaution
Sildenafil tablets may interfere with some
Contraindication medicines, especially those used to treat chest
Sildenafil was shown to potentiate the pain. In the event of a medical emergency, you
hypotensive effects of nitrates & its should tell the healthcare professional treating
administration to patients who are using organic your condition that you have taken Sildenafil
nitrates, either regularly & or intermittently, in & if you did, do not take Sildenafil with other
any form is therefore contraindicated. medicines unless your doctor tells you can.
You should not take Sildenafil if you are taking
medicines called nitrates as the combination
Side Effect of these products may cause a potentially
Sildenafil: sudden wheeziness, difficulty in dangerous decrease in your blood pressure.
breathing or dizziness, swelling of the eyelids, Always tell your doctor or pharmacist if you are
face, lips or throat. Common side effect taking any of these medicines that are often used
includes headache, facial flushing, indigestion, for the relief of angina pectoris (or chest pain).
effects on vision, light sensitivity, blurred vision You should not take Sildenafil if you are using any
or reduced, stuffy nose & dizziness. Uncommon of the drugs known as nitric oxide donors such
side effect includes vomiting, skin rash, as amyl nitrite as the combination may also lead
246
Product Guide
to potentially dangerous decrease in your blood lesions, burns, incisions & other topical lesions.
pressure. If you are taking medicines known as Viodin ointment can cure abrasions, minor cuts
protease inhibitors, such as for the treatment & wounds. Mouth-wash is indicated for acute
of HIV, your doctor may start you on the lowest mucosal infection for mouth & pharynx.
dose (25 mg) of Sildenafil. Some patients who
take alpha-blocker therapy for the treatment of Dosage & Administration
high blood pressure or prostate enlargement Once or twice daily or at dressing change.
may experience dizziness or light-headedness,
which may be caused by low blood pressure Contraindication & Precaution
upon sitting or standing up quickly. Certain It is contraindicated in known or suspected
patients have experienced these symptoms iodine hypersensitivity. Regular use is
when taking Sildenafil with alpha-blocker. This is contraindicated in patients or users with
most likely to occur within 4 hours after taking thyrod disorders. Povidone iodine is not
Sildenafil. In order to reduce the likelihood of recommended for regular use in neonates.
these symptoms occur, you should be on a Special caution is needed when regular
regular daily dose of your alpha-blocker before applications to broken skin are made to
you start Sildenafil. Your doctor may start you patients with pre-existing renal insufficiency.
on a lower dose (25 mg) of Sildenafil if you have Regular use should be avoided in patients on
hypotension (avoid if systolic blood pressure concurrent lithium therapy.
below 90 mmHg), recent stroke, unstable angina

V & myocardial infarction. Drinking alcohol can


temporally impair your ability to get an erection,
Povidone iodine 1% Mouthwash/Gargle is not
for use in children under 6 years of age. Do not
to get the maximum benefit from your medicine; use for more than 14 days.
you are advised not to drink excessive amounts
of alcohol before taking Sildenafil. Side Effect
Local skin reactions, severe burns may produce
Pregnancy, Lactation & Paediatric use systemic adverse effects such as metabolic
Sildenafil is not indicated for use in newborns, acidosis, hypernatraemia & impairment of
children & women. renal function.

Preparation Preparation
25 mg, 50 mg & 100 mg Tablet. 1% (50 mg/5 ml) Mouth-wash/Gargle, 15 ml
& 100 ml 10% (500 mg/5 ml) Solution, 5 % (50
mg/gm) Ointment.

Viodin
Active Ingredient
Povidone-Iodine

Indication
Viodin solution is used in the treatment of
Primary or secondary topical infections,
infected surgical incisions, infected decubitus
or stasis ulcers, pyodermas, secondarily
infected dermatoses, & infected traumatic
247
Product Guide

Virux Treatment of herpes zoster (Shingles): 800 mg


5 times daily for 7 days.
Treatment of initial rectal (Proctitis) herpes
Active Ingredient infections: An oral Aciclovir dosage of 400
Aciclovir. mg 5 times daily for 10 days or until clinical
resolution occurs has been recommended.
Indication Cream : Virux cream should be applied to
For the treatment of viral infections due to lesions or impending lesions 5 times daily (at 4
Herpes simplex virus (type I & II) & Varicella hourly intervals omitting the night-time dose).
zoster virus (herpes zoster & chickenpox). Treatment should continue for 5 days. If healing
For the treatment of Herpes simplex virus does not occur, treatment may be extended for
infections of the skin & mucous membranes up to 10 days.
including initial & recurrent genital herpes. Children :
For the prophylaxis of herpes simplex infections HSV infections in children over 2 years should
in immunocompromised patients. be given adult doses & children below 2 years
should be given half of the adult dose.
Dosage & Administration
Treatment of initial Herpes simplex: 200 Contraindication & Precaution
mg 5 times daily usually for 5 days. For Known to be hypersensitive to Aciclovir. Virux
immunocompromised patients 400 mg 5 times cream is not recommended for application to

V
daily for 5 days (longer if new lesions appear mucous membrane such as eye, mouth, vagina
during treatment or if healing incomplete; etc.
increase dose to 800 mg 5 times daily for
genital herpes in immuno-compromised) or as Side Effect
directed by the registered physician. Skin rashes, nausea, vomiting, diarrhea,
Children under 2 years: half of the adults dose. headache & abdominal pain.
Children over 2 years: Adult dose.
Prevention of recurrence of Herpes simplex: Drug Interaction
200 mg 4 times daily or 400 mg twice daily Probenecid, Amphotericin B, Ketoconazole.
possibly reduced to 200 mg 2 or 3 times daily &
interrupted every 6-12 months. Use in Pregnancy & Lactation
Children under 2 years: Half of the adult dose. The drug should be used during pregnancy
Children over 2 years: Adult dose. only when the potential benefits justify the
Prophylactic treatment of Herpes simplex in the possible risks to the fetus; the drugs potential
immunocompromised: 200 to 400 mg 4 times for causing chromosomal damage at high
daily. concentrations should be considered. Because
Children under 2 years: Half of the adult dose. of the potential for serious adverse reactions to
Children over 2 years: Adult dose. aciclovir in nursing infants, a decision should
Treatment of varicella (chicken pox): Adult & be made whether to discontinue nursing or
children over 40 kg - 800 mg 4 times daily for the drug.
5 days.
Children below 40 kg: 20 mg / kg (maximum Preparation
800 mg) per dose orally 4 times daily (80 mg / 200 mg & 400 mg Tablet, 200 mg/5ml
kg/day) for 5 days. Suspension & 50 mg/gm Cream, 500 mg IV inj.
Or, Children under 2 years : 200 mg 4 times daily
Children 2-5 years : 400 mg 4 times daily
Children Over 6 years : 800 mg 4 times daily
248
Product Guide

Xcid daily, at least 30 minutes before meal.


TM

Contraindication & Precaution


Active Ingredient Known hypersensitivity, History of asthma,
Calcium Carbonate BP 1000 mg chewable urticaria, or other allergic-type reactions after
antacid tablet. taking aspirin or other NSAIDs, during the peri-
operative period in the setting of coronary
Indication artery bypass graft (CABG) surgery, Late
Fast relief from hyperacidity & related pregnancy.
symptoms like acid indigestion, heartburn,
sour stomach & upset stomach. Side Effect
Most common side Effects are erosive gastritis,
Dosage & Administration dyspepsia, gastritis, diarrhea, gastric ulcer,
2-3 tablets when symptoms occurs; may be upper abdominal pain, nausea etc.
repeated hourly if needed or as directed by the
physicians. Drug Interaction
Concomitant use of NSAIDs may reduce the
Contraindication & Precaution antihypertensive Effect of ACE inhibitors,
Hypersensitivity to any of the ingredients, diuretics, & beta-blockers.
hypercalcemia, renal calculi & hypophosatemia.

X Side Effect
Generally well tolerated.
Use in Pregnancy & Lactation
Pregnancy category C.

Use in Children
Use in Pregnancy & Lactation Use in children less than 18 years has not been
Thought to be the safest antacid during established yet
pregnancy & lactation.
Preparation
Preparation Naproxen 375 mg + Esomeprazole 20 mg
Calcium Carbonate 1000 mg Chewable antacid Tablet & Naproxen 500 mg + Esomeprazole 20
tablet. mg Tablet

Xenole TM

Active Ingredient
Naproxen & Esomeprazole Xfin
Indication Active Ingredient
For the relief of signs & symptoms of Terbinafine HCL.
Osteoarthritis, Rheumatoid Arthritis &
Ankylosing Spondylitis & to decrease the risk Indication
of developing gastric ulcers in patients at risk Fungal infections of the skin caused by candida,
of developing NSAID associated gastric ulcers. dermatophytes & Pityriasis versicolor.

Dosage & Administration Dosage & Administration


One Xenole 375 or Xenole 500 tablet twice Once or twice daily.
249
Product Guide
Contraindication & Precaution be raised to adult dosage if well tolerated.
Hypersensitivity, Contact with the eyes should
be avoided. Contraindication & Precaution
Dexibuprofen is contraindicated in patients
Side Effect with previous history of hypersensitivity to
Redness, itching or stinging, allergic reaction. Dexibuprofen or other NSAIDs. Dexibuprofen
is contraindicated in patients, who experience
Drug Interaction attack of asthma, bronchospasm, acute
There is no known drug interaction with rhinitis, urticaria or edema after use of similar
Terbinafine cream. drugs (e.g., aspirin or other NSAIDs). It is also
contraindicated in patients with active or
Use in Pregnancy & Lactation suspected hemorrhage, Crohns disease or
Unless the potential benefits outweigh the Ulcerative Colitis, patients with serious heart
potential risks, Terbinafine cream should not diseases, kidney function impairment (GFR <
be administered during pregnancy. Mothers 30ml/min), & severe liver function impairment.
should not receive Terbinafine whilst breast
feeding. Side Effect
Dyspepsia, diarrhea, fatigue, & headache,
Preparation nausea, vomiting, & abdominal pain. Less
5 gm Cream. common Side Effect: Flatulence, urticaria,
pruritus, purpura, rhinitis, bronchospasm,
insomnia, & tinnitus. X
Use in Pregnancy & Lactation
Use of Dexibuprofen should be avoided during

Xflam the pregnancy. Dexibuprofen should be used


TM

with cautions in nursing mothers.

Active Ingredient Use in Children


Dexibuprofen Patients below 18 years of age have not been
established.
Indication
Management of pain & inflammation associated Preparation
with Osteoarthritis & other musculoskeletal 300 mg & 400 mg Tablet.
disorders.
Symptomatic treatment of mild to moderate
pain & inflammation including dysmenorrhoea
& dental pain.

Dosage & Administration


Xten TM

The recommended dosage is 600-900 mg


Active Ingredient
Dexibuprofen per day, at 2-3 divided doses.
Tenoxicam.
Maximum single dose is 400 mg. The dosage
can be raised temporarily up to 1200 mg
Indication
Dexibuprofen per day in patients with acute
disorders or exacerbations. Elderly patient: Lowest Rheumatoid Arthritis
Effective dose is recommended. The dosage can Osteoarthritis
Ankylosing Spondylitis
250
Product Guide
attenuates the blood pressure lowering Effect
Post-operative pain of Hydrochlorothiazide. As known from other
Acute gout NSAIDs, Tenoxicam might attenuate the
Primary dysmenorrhoea antihypertensive Effects of alpha-adrenergic
Dosage & Administration blockers & ACE-inhibitors.
For all indications except primary
dysmenorrhoea, post-operative pain & acute No interactions have been reported between
gout, a daily dosage of 20 mg should be given Tenoxicam & centrally acting alpha agonists or
at the same time of day. calcium channel blockers.
The recommended dose for primary There was no clinically relevant interaction
dysmenorrhoea is 20 to 40 mg once daily. For when Tenoxicam was administered together
post-operative pain the recommended dose is with Atenolol.
40 mg once daily up to five days & for acute
attacks of gout the recommended dose is 40 Use in Pregnancy & Lactation
mg once daily for two days followed by 20 mg Treatment during the third trimester of
once daily for a further five days. pregnancy should be avoided.
There is no evidence of adverse reactions in
Contraindication & Precaution breast-fed infants of mothers taking Tenoxicam.
Hypersensitivity to Tenoxicam or any
Use in Children

X
component of the product or other non-
steroidal anti-inflammatory drugs (NSAIDs); Not yet established
in whom salicylates or other NSAIDs induce
symptoms of asthma, rhinitis or urticaria; Preparation
suffering from gastritis, gastric & duodenal 20 mg Tablet.
ulcer.

Side Effect
The following undesirable Effects have been
reported in few cases:
Gastrointestinal tract: gastric, epigastric &
Xylocon
abdominal discomfort, dyspepsia, heartburn, Active Ingredient
nausea. Central nervous system: dizziness, Oxymetazoline.
headache.
Indication
Drug Interaction Relief of nasal congestion associated with acute
Tenoxicam may have the following drug & chronic rhinitis, Common cold & Sinusitis.
interactions:
Acetylsalicylate & Salicylates: Salicylates Dosage & Administration
increase the clearance & volume of distribution Adults & children 6 years of age : 2 to 3 drops
of NSAIDs including Tenoxicam of Xylocon 0.05% in each nostril twice daily, in
Anti-platelet agents & SSRIs: There is an increased the morning & evening. Children 2-5 years of
risk of gastrointestinal bleeding when anti- age : 2 to 3 drops of Xylocon 0.025% in each
platelet agents & selective serotonin-reuptake nostril twice daily in the morning & evening.
inhibitors (SSRIs) are combined with NSAIDs. Oxymetazoline HCl should generally be used
Diuretics & antihypertensives: No clinically for no longer than 3-5 days.
significant interaction between Tenoxicam
& Frusemide was noted, but Tenoxicam
251
Product Guide
Contraindication & Precaution Dosage Use 2-4 mg Antioxidant, Cardiovascular
MAO inhibitor, Tricyclic antidepressant. Patients Health, Immune System Enhancer 4-8 mg
sensitive to other nasal decongestants may be Internal Beauty & Skin Improvement, Strength
sensitive to this medication also. & endurance, Brain & Central Nervous System
Health, Eye Health 4-12 mg Arthritis, Silent
Side Effect in ammation(C-reactive protein), Internal
Stinging, burning, sneezing, increased nasal Sunscreen
discharge, drying of the nostrils, & altered taste.
Dosage Use
Drug Interaction
Causes hypertensive crisis if used 2-4 mg Antioxidant,
Cardiovascular
simultaneously with MAO inhibitor or Tricyclic Health, Immune
antidepressant. System Enhancer
4-8 mg Internal Beauty &
Use in Pregnancy & Lactation Skin Improvement,
Safe in the third trimester of a normal Strength &
pregnancy. Caution should be exercised when endurance, Brain
& Central Nervous
administering to a nursing mother. System Health, Eye
Health
Preparation

Z
4-12 mg Arthritis, Silent
0.05% Nasal Drops for adults, 0.025% Paediatric in ammation(C-
Nasal Drops for children. reactive protein),
Internal Sunscreen

Contraindication & precaution


Astaxanthin is contraindicated in those
hypersensitive to any component of an
Zanthin TM Astaxanthin containing supplement. Pregnant
women & nursing mothers should avoid
Astaxanthin containing supplements.
Active ingredient
Astaxanthin Side Effect
No reports have been found regarding
Indication Astaxanthin.
Astaxanthin is indicated as strong antioxidant.
Also indicated in Drug interaction
Internal beautification & skin improvement There are no known adverse reactions when
Improvement of cardiovascular health taken in conjunction with medications.
Improvement of brain & central nervous
system health Use in pregnancy & Lactation
For healthy immune system Both pregnant women & lactating mother
should avoid Astaxanthin containing
supplements.
Dosage & Administration
The recommended daily dosage is fairly Preparation
standardized at a 4 mg per day. Following is a ZanthinTM 2: Each pack contains 30 capsules in
table of recommended dosages: blister pack.
252
Product Guide
ZanthinTM 4: Each pack contains 20 capsules in 1-3 times daily.
blister pack.
This drug is most Effective if they are taken
at least 1 hour before or 2 hour after meals.
However, if it causes stomach upset, this may
be taken with a meal. This medicine should be
used regularly to get the most benefit from it.
Zesup Contraindication & Precaution
Active Ingredient It is contraindicated in those who are
Zinc Sulphate. hypersensitive to any component of the
ingredient of this zinc containing supplement.
Indication In acute renal failure zinc accumulation may
occur; so doses adjustment is needed.
Zesup & Zesup Forte are indicated in zinc
deficiency and/or zinc losing conditions. Zinc
Side Effect
deficiency can occur as a result of inadequate
Zinc may cause nausea, vomiting, diarrhoea,
diet or malabsorption, excessive loss of zinc
stomach upset, heartburn & gastritis.
can occur in trauma, burns, diarrhoea & protein
losing conditions. A zinc supplement is given

Z
Use in Pregnancy & Lactation
until clinical improvement occurs but it may
Zinc is used during pregnancy & lactation
need to be continued in severe malabsorption,
at a dose of 20 mg per day. Zinc crosses the
metabolic disease or in zinc losing states. It is
placenta & is present in breast milk.
indicated in the following conditions -
Recurrent Respiratory Tract Infections,
Drug Interaction
Diarrhoea, Loss of appetite, Severe growth
Concomitant intake of a Tetracycline & Zinc
retardation, Deformed bone formation,
may decrease the absorption of both the
Impaired immunological response,
Tetracycline & Zinc. Similarly concomitant
Acrodermatitis enteropathica, Parakeratotic
administration of Zinc & Quinolone may also
skin lesions, Defective & delayed wound
decrease the absorption of both. Concomitant
healing, Anaemia, Night blindness & Mental
intake of Penicillamine & Zinc may depress
disturbances.
absorption of Zinc.
Dosage & Administration
Preparation
Zesup Syrup:
Zesup 100 ml Syrup and
Child under 10 kg : 5 ml (1 teaspoonful) 2 times
daily. Zesup Forte 100 ml Syrup.
Child between 10 - 30 kg : 10 ml (2 teaspoonful)
1-3 times daily.
Adults & child over 30 kg : 20 ml (4 teaspoonful)
1-3 times daily. Zif
Zesup Forte Syrup:
Child under 10 kg : 5 ml (1 teaspoonful) 1 time Active Ingredient
daily. Ferrous Sulphate, Zinc Sulphate & Folic Acid.
Child between 10 - 30 kg : 5 ml (1 teaspoonful)
1-3 times daily. Indication
Adults & child over 30 kg : 10 ml (2 teaspoonful) Treatment & prophylaxis of Iron, Folic Acid &
253
Product Guide
Zinc deficiency specially during pregnancy & directed by the physician.
lactation.
Contraindication & Precaution
Dosage & Administration Known hypersensitivity to any of its component
1 capsule daily. 2 capsule may be required in or those with Iron overload. Special care
more severe cases. should be taken in patient with Iron overload
states, such as haemochromatosis, haemolytic
Contraindication & Precaution anaemia or red cell aplasia. In patients with
Hypersensitivity, care should be taken in renal failure there may be the risk of Zinc
haemochromatosis, haemolytic anaemia or accumulation.
red cell aplasia.
Side Effect
Drug Interaction Nausea, anorexia, vomiting, discomfort,
Tetracycline, penicillamine, antacids & zinc constipation, diarrhoea may occur. Patients
accumulation could exist. may complain of dark stool. Rarely allergic
reactions.
Use in Pregnancy
Should be avoided during first trimester of Drug Interaction
pregnancy. Carbonyl Iron: Tetracycline antibiotics,

Z
quinolone antibiotics, levodopa, levothyroxine,
Side Effect methyldopa & penecillamine. Folic Acid:
Dark stools, nausea, gastrointestinal irritation, Phenobarbital, phenytoin & primidone.
anorexia, vomiting, discomfort, constipation &
diarrhoea, allergic reactions.
Use in Pregnancy & Lactation
Preparation Use of any drug during the first trimester of
Each timed release capsule contains dried pregnancy should be avoided if possible. Thus
Ferrous Sulphate 150 mg, Foil Acid 500 mcg & administration of Iron during the first trimester
Zinc Sulphate Monohydrate 61.80 mg. requires definite evidence of Iron deficiency.
Prophylaxis of Iron deficiency where
inadequate diet calls for supplementary Zinc
& Folic Acid is justified during the remainder
of pregnancy.

Zif-CI
TM
Preparation
Each TR capsule contains Elemental Iron 50
mg as Carbonyl Iron, Folic Acid 0.50 mg & Zinc
Active Ingredient
Sulphate Monohydrate 61.80 mg.
Carbonyl Iron + Folic Acid + Zinc.

Indication
Treatment & prophylaxis of Iron, Folic Acid &
Zinc deficiency especially during pregnancy & Zif Forte
lactation.
Active Ingredient
Carbonyl Iron, Folic Acid , Vitamin B-Complex,
Dosage & Administration Vitamin C (as Ascorbic Acid) & Zinc Sulphate
Adult : One capsule daily before food or as Monohydrate.
254
Product Guide
Indication penicillamine. Folic Acid interacts with
It is indicated for the treatment & prophylaxis of antiepileptics, so plasma concentrations of
Iron, Folic Acid, Vitamin B-Complex, Vitamin C phenobarbital, phenytoin & primidone are
& Zinc deficiency especially during pregnancy possibly reduced.
& lactation. It is also indicated for the geriatric
patients with generalized weakness due to Preparation
vitamins & minerals deficiency. Each capsule contains Elemental Iron 50 mg
(as Carbonyl Iron INN), Folic Acid BP 0.50 mg,
Dosage & Administration Thiamine Mononitrate USP 2 mg, Riboflavin
Adult: One Capsule daily before food or as USP 2 mg, Pyridoxine Hydrochloride BP 1 mg,
directed by the physician. Nicotinamide USP 10 mg, Vitamin C (as Ascorbic
Acid) USP 50 mg & Zinc Sulphate Monohydrate
Contraindication & Precaution USP 61.80 mg.
It is contraindicated in patients with known
hypersensitivity to any of its component or
those with Iron overload. Special care should be
taken in patients with Iron overload states, such
as haemochromatosis, haemolytic anaemia or
Zifolet TM
red blood cell aplasia. Failure to response to

Z
the treatment requires further investigations
to exclude other causes of anaemia. In patients
Active Ingredient
with renal failure there may be the risk of Zinc
Folic Acid & Zinc.
accumulation.
Indication
Side Effect
Prophylaxis & in the prevention of Zinc & Folic
Gastrointestinal irritations such as nausea,
Acid deficiencies.
anorexia, vomiting, discomfort, constipation &
diarrhoea may occur. Patients may complain of
Dosage & Administration
dark stool. Carbonyl Iron pellets incorporated
One tablet daily or as recommended by the
into the capsules to reduce the possibility of
physician.
gastrointestinal irritations. Rarely there may be
allergic reactions.
Contraindication
Zinc is contraindicated in patients having
Use in Pregnancy & Lactation
hypersensitivity to Zinc. Folic Acid is contraindicated
Use of any drug during first trimester of
in untreated cobalamine deficiency.
pregnancy should be avoided if possible.
Thus administration of Iron during the first
Side Effect
trimester requires definite evidence of Iron
Abdominal pain, dyspepsia, nausea, vomiting,
deficiency. Prophylaxis of Iron deficiency where
fever & respiratory distress.
inadequate diet calls for supplementary Zinc &
Folic Acid is justified during the remainder of
Drug Interaction
pregnancy.
Large amount of Calcium decreases the
absorption of Zinc.
Drug Interaction
Carbonyl Iron decreases the absorption of
Use in Pregnancy & Lactation
tetracycline antibiotics, quinolone antibiotics,
Recommended.
levodopa, levothyroxine, methyldopa &
255
Product Guide
Preparation Drug Interaction
Each film coated tablet contains Folic Acid 5 mg No interactions have been observed. Since, the
& Zinc 20 mg. Iron is complex bound, ionic interaction with
foodstuff components (phytates, oxalates,
tannin, etc.) & concomitant administrations
of medicaments (tetracyclines, antacids) are
unlikely to occur.

Preparation
Each capsule contains Iron (III) Hydroxide

Ziliron-B Polymaltose Complex INN 188 mg equivalent


to elemental Iron 47 mg, Folic Acid BP 0.5 mg,
Thiamine Hydrochloride BP 5 mg, Riboflavin
Active Ingredient BP 2 mg, Pyridoxine Hydrochloride BP 2 mg,
Iron (III) Hydroxide Polymaltose Complex, Nicotinamide BP 20 mg & Zinc Sulphate
Folic Acid, Vitamin B-complex & Zinc Sulphate Monohydrate USP 61.80 mg.
Monohydrate.

Indication
For the prevention & treatment of Iron, Folic

Z
Acid, Zinc & Vitamin B-Complex deficiencies.

Dosage & Administration Zimax


One capsule daily. Two capsules may be
required a day in severe cases or as directed by Active Ingredient
the physician. Azithromycin.

Contraindication & Precaution Indication


Contraindicated in patients with a known Bronchitis & pneumonia, sinusitis &
hypersensitivity to any of the ingredients of pharyngitis/ tonsillitis, otitis media, skin & soft
this product. As with all Iron preparations, a tissue infections, sexually transmitted diseases.
dark coloration of the stool may occur which
is without clinical significance. Dosage & Administration
Adults: 500 mg once daily for 3 days. Children:
Side Effect 10 mg/kg body weight once daily for 3 days.
Generally well tolerated. Very few allergic
reaction may be seen. Contraindication & Precaution
Known hypersensitivity, should not be
Use in Pregnancy used in patients with hepatic disease. Avoid
Use of any drug during the first trimester of concomitant administration with terfenadine
pregnancy should be avoided if possible. or astemizole. Precaution should be taken in
Thus administration of Iron during the first patients with more severe renal impairment.
trimester requires definite evidence of Iron
deficiency. Prophylaxis of Iron deficiency where Side Effect
inadequate diet calls for supplementary Zinc & Nausea, vomiting, abdominal discomfort
Folic Acid is justified during the remainder of (pain/cramps), flatulence, diarrhoea, headache,
pregnancy. dizziness & skin rashes, reversible elevations in
liver transaminases.
256
Product Guide
Drug Interaction Nursing mother: Caution should be exercised
Antacids, Ergot Derivatives, Digoxin & when Nitazoxanide is administrated to a
Cyclosporin, Anti-histamines. nursing woman.

Use in Pregnancy & Lactation Drug Interaction


The initial treatment of chlamydial cervicitis in Caution should be taken when administering
Nitazoxanide concurrently with other highly
pregnancy. In other infections, Azithromycin
plasma-protein bound drugs.
should be used only when clearly needed.
Exercise caution when administering to a Preparation
nursing woman. 500 mg Tablet, 30 ml & 60 ml Suspension (100
mg/5 ml).
Preparation
500 mg Tablet, 250 mg Tablet, 250 mg Capsule,
200 mg/5 ml Suspension, 500 mg IV Infusion.

Zox
Z Active Ingredient
Nitazoxanide.

Indication
Diarrhoea caused by Cryptosporidium parvum
& Giardia lamblia, Amoebiasis & helminth
infections.

Dosage & Administration


Age 1 - 3 years : 5 ml (100 mg) twice daily for
3 days, Age 4 - 11 years : 10 ml (200 mg) twice
daily for 3 days, Age >12 years : 25 ml or 1 tablet
(500 mg) twice daily for 3 days.

Contraindication & Precaution


Known hypersensitivity to Nitazoxanide or any
other ingredient in the formulations. Should
be administrated with caution to patients with
hepatic, renal & biliary disease.

Side Effect
Abdominal pain, diarrhoea vomiting &
headache have been reported rarely.

Use in Pregnancy & Lactation


Pregnancy category B. This drug should be
used during pregnancy only if clearly needed.
257
Product Guide

NATURAL MEDICINE
258
Product Guide

Adovas Scurvy
Anemia in children
Active Ingredient
Dosage & Administration
Basak (Adhatoda Vasica) with some other herbs.
Children under 12 years: 1 teaspoonful (5 ml)
2 times daily.
Indication
Adult: 1 - 2 teaspoonfuls (5 - 10 ml) 2 - 3 times
All kinds of cough, dry irritable cough, allergic
daily or as directed by the physician.
& smokers cough. It is also effective in throat
irritation & hoarseness.
Contraindication & Precaution
There is no evidence available on
Dosage & Administration
contraindication. Precaution should be taken
Adults: 3 teaspoonfuls (15 ml) 2 - 3 times a day.
in patients who are hypersensitive to any of its
In acute cough, warm water can be added for
ingredients.
better result.
Children under 12 years of age: 1-2 teaspoonfuls
Side Effect
(5 - 10 ml) 3 times a day.
There is no known significant side Effect.
Contraindication & Precaution
Use in Pregnancy & Lactation
There is no evidence available on
No adverse Effect of Amcivit syrup has been
contraindication but it may happen in patients
reported.
who are hypersensitive to any of its ingredients.
Preparation
Side Effect
100 ml syrup.
No known side Effects.

Use in Pregnancy & Lactation


The safety of Adovas syrup in pregnancy has not

Amocid
been established. Therefore, it should be used TM
during pregnancy only under the supervision
of a physician.
Active Ingredient
Preparation Holarrhena antidysenterica (HA) with some
100 ml & 200 ml syrup. other herbs.

Indication
Dysentery (Both amoebic & bacillary), Giardiasis
& Inflammatory bowel disease (Colitis &
Crohns disease). It is also effective in hepatic
amoebiasis, hepatosplenomegaly & intestinal
AmCivit parasites.

Dosage & Administration


Active Ingredient
Below 6 years: - 1 teaspoonful (2.5 - 5 ml) 2 - 3
Amlaki (Emblica officinalis).
times daily.
6 12 years: 1 teaspoonful (5 ml) 3 times daily.
Indication
Above 12 years & Adults: 2 teaspoonfuls (10
Vitamin C deficiency
259
Product Guide
ml) 3 times daily after meal for 7 14 days. In Children: Not recommended under 12 years of
case of colitis, duration should be increased of age.
3 months.
Contraindication & Precaution
Contraindication There is no evidence available on
Holarrhena antidysenterica is well tolerated contraindication but it may happen in-patients
but caution should be taken in hypotension, who are hypersensitive to any of its ingredients.
kidney disease & DM. Patients with any severe Caution should be taken with concomitant
medical conditions should talk to their doctors use of antacid, calcium supplements & tannin
before taking Holarrhena antidysenterica. containing herbal preparations. So iron
supplements should not be taken within 1 hour
Side Effect before or 2 hours after ingestion of any of the
Holarrhena antidysenterica (Amocid) is above.
completely safe & non-toxic to use. It works
naturally without toxic side effects like nausea, Side Effect
diarrhea, & headaches. Arubin capsules are not known to have any side
effects if taken as per prescribed dosage.
Use in Pregnancy & Lactation
It should not be taken during pregnancy Use in Pregnancy & Lactation
although medical literature has not reported In the first trimester of pregnancy, adequate
any adverse effects related to fetal development iron intake is usually obtained from a proper
during pregnancy or to infants who are breast- diet; however, in the second & third trimesters,
fed. when iron deficiency is more prevalent
because of greatly increased requirements,
Preparation iron supplements may be recommended.
100 ml syrup. Some clinicians prefer to evaluate the patient
before giving routine iron supplementation.
Problems in humans have not been
documented with intake of normal daily
recommended amounts.
Arubin Preparation
500 mg Capsule.
Active Ingredient
Ferrous fumarate, Emblica officinalis, Termanalia
chebula with some other herbs.

Indication
Iron deficiency anemia
Colmint
TM
Anemia due to malnutrition
Loss of appetite
It is the only herbal haematinic, which does Active Ingredient
not cause constipation like some other iron Peppermint oil
preparations due to the herbs used in it. (Mentha x piperita).

Dosage & Administration Indication


Adults: 1 or 2 capsule to be taken 2 times daily Irritable bowel syndrome
with water.
260
Product Guide
Anovulatory infertility
Abdominal pain & spasm Polycystic ovarian syndrome (PCOS)
Abdominal distersion /bloating
Dosage & Administration Dose & Administration
Adults: 1 capsule 3 times daily 30 to 60 minutes Children under 12 years: Not applicable.
before meal with a glass of water. The dose Above 12 years & Adults: 2 - 3 teaspoonfuls (10
may be increased to a maximum of 2 capsules - 15 ml) 2 - 3 times daily after meal for 3 6
3 times daily or as directed by a physician. months or as directed by the physician.
Children (8 years & above): 1 capsule 3 times Contraindication/Pre-caution:
daily or as directed by a physician. No known.

Contraindication & Precaution Side Effect


Contraindicated in patients with achlorhydria & No health hazards or side effects are known in
also contraindicated for infants & small children conjunction with the proper administration of
due to the potential risk of spasm of the tongue designated therapeutic dosages.
or respiratory tract. It should not be taken with
food or immediately after meals. It should be Preparation
taken 30 to 60 minutes before meals. Must be 100 ml syrup.
swallowed whole, with a little liquid. Capsules
must not be chewed or crushed.

Enerton
Side Effect
No known side effects according to Commission
E.
Active Ingredient
Use in Pregnancy & Lactation Extracts of Sida cordifolia.
No known restrictions.
Indication
Preparation General weakness
187 mg (0.2 ml) enteric coated licap. Strength & energy booster
Superb sports tonic
Tonic for asthmatic patients
Dosage & Administration
Children: Under the age of 12 years: Not
recommended.
Adult: 2 - 3 teaspoonfuls (10 - 15ml) 2 - 3 times
daily or as directed by the physician.

Dubarel
TM
Contraindication & Precaution
There is no evidence available on
Active Ingredient contraindication. But caution should be taken
Saraca indica with some other herbs. in hypertension, DM & others CNS stimulants.

Indication Side Effect


Metrorrhagia When used within the recommended dosage
Secondary amenorrhea range, Enerton is well tolerated.
261
Product Guide
Use in Pregnancy & Lactation
Eredex TM

It is not recommended during pregnancy.

Preparation Active Ingredient


200 ml syrup. Yohimbe (Pausinystalia yohimbe).

Indication
Erectile dysfunction (Male impotence)
Eprim Loss of libido
Exhaustion
Active Ingredient Dosage & Administration
Evening primrose oil (Oenothera biennis). Adult: 1 tablet 3 times daily or as advised by the
physician.
Indication
PMS symptoms Contraindication & Precaution
Dysmenorrhea The drug should not be used by patients with
Cyclical mastalgia liver & kidney diseases, chronic inflammation of
Atopic dermatitis the sexual organs or prostate gland or with a
Skin disorder history of gastric or duodenal ulcers.

Dosage & Administration Side Effect


1 or 2 capsules 2 to 3 times daily or as directed Anxiety states, elevated blood pressure,
by the physician. exanthema, nausea, insomnia, tachycardia,
tremor, mania & vomiting.
Contraindication & Precaution
Caution should be taken in schizophrenia or Drug Interaction
those already receiving epileptogenic drugs Theoretically, Yohimbe may counteract
such as phenothiazines. the hypotensive effect of antihypertensive
medications, resulting inadequate blood
Side Effect pressure control. It may potentiate
Adverse Effects are rare at recommended pharmaceutical MAO-inhibitors.
dosages. Overdose may cause loose stool &
abdominal pain. Preparation
5.4 mg Tablet.
Pregnancy & Lactation
No known restriction. LA, GLA, & DGLA are
important components of human breast milk, so
it is reasonable to assume that evening primrose TM
oil should be taken while nursing. According to
World Health Organization (WHO), pregnant & Eyebil
lactating women should get 5% of their total
daily caloric intake from EFAs. Active Ingredient
Bilberry (Vaccinium myrtillus L).
Preparation
500 mg Capsule. Indication
Retinopathy (hypertensive & diabetic)
Night blindness
262
Product Guide
Side Effect
Cataracts Gastro-intestinal symptoms, changes to the
Macular degeneration flora of the intestine and allergic reactions are
Retinitis pigmentosa
Hemorrhagic retinopathy rare.

Dosage & Administration Use in Pregnancy & Lactation


1 capsule should be taken 2-3 times daily or as None known. Major sulfur containing volatiles
per the instruction of physician. from garlic are transmitted to breast milk
leading to improved drinking habits of infants.
Contraindication & Precaution
None known. Preparation
10 mg Licap
Side Effect
None known.

Drug Interaction
None known.

Use in Pregnancy & Lactation


Giloba
No known restriction. Active Ingredient
Ginkgo biloba.
Preparation
160 mg Capsule. Indication
Cerebral insufficiency
Demential syndromes: memory deficit,
poor concentration, depression, dizziness &
headache
Vertigo & tinnitus
Garlin TM
Licap Peripheral vascular diseases
Sexual dysfunction secondary to SSRI use
Active Ingredient Acute cochlear deafness
Garlic oil (standardized).
Dosage & Administration
Indication Giloba 60 mg 1 or 2 capsules 2 to 3 times daily
Hyperlipidemia, Atherosclerosis, Mild or as advised by the physician.
Hypertension.
Contraindication & Precaution
Dose & Administration Ginkgo should always be used with caution in
1 - 2 capsules daily for 8 18 weeks or as advised patients taking anticoagulants or antiplatelet
by the physician. agents i.e. warfarin, heparin & aspirin. It is also
contraindicated in bleeding disorders due to
Contraindication increase bleeding potential associated with
None known. The World Health Organization chronic use (6 - 12 months) or before elective
cautions against the use of garlic by patients surgery. Contraindicated in patients with
with a known allergy to garlic and those taking known risk factors for intracranial hemorrhage.
Warfarin.
263
Product Guide
Side Effect Use in Pregnancy & Lactation
No side Effects following proper administration No known restriction according to the
of designated therapeutic dosages. American Herbal Product Association &
German Commission E.
Use in Pregnancy & Lactation
There is no known restriction on the use of Preparation
ginkgo in pregnancy & lactation. 500 mg Capsule.

Preparation
60 mg Capsule.

Inacea
Gintex
Active Ingredient
Echinacea (Echinacea purpurea).

Active Ingredient Indication


Panax ginseng. Treatment & prevention of upper respiratory
tract infections (URTls), Urinary tract infection,
Indication Infection tendency, Immune deficiency.
General weakness & tiredness
Infertility in men Dosage & Administration
Type 2 diabetes mellitus 1 or 2 capsules 2 to 3 times daily or as advised
Cognitive function & mental performance by the physician.
enhancement
Contraindication & Precaution
Dosage & Administration Individuals with an increased tendency to have
One Gintex capsule 1 or 2 times a day or as allergies, especially allergies to members of the
advised by the physician. family Asteraceae including arnica (Arnica spp.)
flower, chamomile (Matricaria spp.) flower,
Contraindication & Precaution marigold (Calendula officinalis L.) flower, yarrow
Ginseng can be taken with any other vitamin, (Achillea spp.) flower, ragweed (Ambrosia
minerals or herbal supplement. No known spp.), asters (Ast tataricus) & chrysanthemum
contraindications according to the German (Chrysanthemum spp.).
E Commission & World Health Organization
(WHO). Side Effect
Over stimulation & insomnia have also been There are few reported adverse effects for
reported with Ginseng. Anecdotal evidence internal & external applications. Anaphylaxis
suggests that excessive doses may mildly elevate has been reported with ingestion of an
blood pressure and/or cause hyper sexuality. echinacea preparation made of E. purpurea
root. Pyrrolizidine alkaloids (PAs) do not
Side Effect constitute a significant part of echinacea.
Over Ginsengs many years of use, no serious side
Effects or drug interactions have been reported. Drug Interaction
The Commission E stated that there are no
264
Product Guide
known interactions. antidiabetic agents may result in increased
risk of hypokalemia & hypoglycemia.
Use in Pregnancy & Lactation Carbamazepine bio-availability may reduce
The Commission E found no known restrictions. during concomitant administration of psyllium
seed.
Preparation
400 mg Capsule. Use in Pregnancy & Lactation
No adverse Effects of Ispergul have been
reported.

Preparation
3.5 gm Sachet & 100 gm Container.

Ispergul
Active Ingredient
Plantago ovata husk.

Indication Jort
Constipation, Hemorrhoids, Ulcerative colitis &
Hyperlipidemia. Active Ingredient
St. Johns wort (Hypericum perforatum).
Dosage & Administration
For adult: 3.5 gm (1 sachet) 2 to 3 times daily Indication
with a glass of water. Depression, Insomnia, Seasonal Affective
Children (6 to 12 year): 2 gm to 3.5 gm ( to 1 Disorder (SAD), Obsessive Compulsive Disorder
Sachet) 2 to 3 times daily with a glass of water. (OCD).

Contraindication & Precaution Dosage & Administration


Psyllium is contraindicated in patients who 1 Capsule 3 times daily. For depression, the
have pathological narrowing in the GIT, onset of response to St. Johns wort is similar
intestinal obstruction, fecal impaction, difficulty to that for conventional antidepressants,
in swallowing or esophageal narrowing, requiring 2-4 weeks, or as long as 6 weeks.
difficulties in regulating diabetes mellitus. To prevent relapse, antidepressant should be
continued at full therapeutic doses for at least
6 months after remission.
Side Effect
Incorrect administration procedure (with too Contraindication & Precaution
little fluid) can cause the product to swell & lead The Commission E Stated None Known. Recent
to obstruction of the esophagus or intestine, drug interaction reports suggest professional
particularly with older people. Patients with guidance when certain conventional
exocrine pancreatic insufficiency should avoid pharmaceuticals may be simultaneously
use of psyllium due to its inhibitory actions on administered.
pancreatic lipase.
Side Effect
Drug Interaction St. Johns wort is generally very well tolerated.
Concurrent use of licorice, laxatives & In general, it produces few adverse side effects.
265
Product Guide
Use in Pregnancy & Lactation
No known restrictions. LecorTM
Preparation Active Ingredient
300 mg Capsule. Extracts of Caesalpinia sappan & Woodfordia
fruticosa (Patrangasav)

Indication

Kamomil Leucorrhea
Cervicitis
Non-specific vaginitis
Active Ingredient Pelvic inflammatory disease
Chamomile (Matricaria recutita), Peppermint
oil, Sage oil, Anise oil, Pine needle oil, Bergamot Dosage & Administration
oil, Eucalyptol & Methyl Salicylate. Above 12 years & Adult: 3 teaspoonfuls (15 ml)
3 times daily after meal for 15 days.
Indication
Inflammation of buccal & pharyngeal cavity Contraindication & Precaution
Periodontitis Not known.
Acute gingivitis
Pain after tooth extraction Side Effect
Mucosal irritation caused by dental plates No health hazards or side effects are known
Tonsillary angina in conjunction with the proper administration
Canker sores of designated therapeutic dosages. But in rare
Bad breath case high dose may cause burning sensation,
diarrhea or may increase urine output.
Dosage & Administration
Adult: Inflamed areas in the mouth & pharynx Drug Interaction
to be sprayed 3 times daily. Two puffs are Not known.
equivalent to 1 fully effective single dose. It is
recommended to carry out the spray treatment Use in Pregnancy & Lactation
after meals. Children: Not recommended for It should not be taken during pregnancy
the children under 12 years. although medical literature has not reported
any adverse effects related to fetal development
Contraindication & Precaution during pregnancy or to infants who are breast-
Do not spray directly into the nose. Should not fed.
be administered in infants & children.
Use in Children
Side Effect Not known.
In patients with known allergy to anethole
intolerance reactions may appear. Preparation
Each PET bottle contains 200 ml syrup.
Drug Interaction
None known.

Preparation
15 ml Oral Spray.
266
Product Guide

Livolite Attention Deficit Disorder (ADD)


Attention Deficit Hyperactivity Disorder
(ADHD)
Active Ingredient Dementia
andrographis (andrographis paniculata). Alzheimers disease
Autistic Spectrum Disorder (ASD)
Indication
Viral fever, flu Dosage & Administration:
Common cold Children 2 - 5 years: 1/2 teaspoonful (2.5 ml)
Sinusitis 2 - 3 times daily after meal for 3 months.
Viral hepatitis 6 12 years: 1 teaspoonful (5 ml) 2 3 times
daily after meal for 3 months.
Dosage & Administration Above 12 years & Adult: 2 3 teaspoonfuls (10
1 capsule 3 times daily between meals for 5 to - 15 ml) 3 times daily after meal for 3 months.
10 days or as directed by the physician.
Contraindication & Precaution
Contraindication & Precaution Generally is well tolerated but caution should be
andrographis is contraindicated in cases of taken in hyperthyroidism, fever & acute infection.
known allergy to plants of the Acanthaceae Patients with medical conditions should talk to
family. their doctors before taking Monera.

Side Effect Side Effect


Large oral doses may cause gastric discomfort, No side effects in mentioned therapeutic doses.
vomiting & loss of appetite.
Drug Interaction
Drug Interaction Bacopa may potentiate the activity of thyroid
May have a synergistic effect with Isoniazid. stimulating drugs or decrease the effects of anti-
thyroid medications. May work to decrease the
Use in Pregnancy & Lactation toxicity of several drugs like morphine & other
andrographis should not be used during opiate drugs. It has also been shown to reduce
pregnancy or lactation. the decline in cognitive function associated
with phenytoin, an anti-seizure medication.
Preparation
200 mg Capsule. Use in Pregnancy & Lactation
Women who are pregnant or nursing are
advised to consult with a physician prior
to use. Although medical literature has not
reported any adverse effects related to fetal
development during pregnancy or to infants
Monera who are breast-fed.

Preparation
Active Ingredient
100 ml Syrup.
Bacopa monnieri (Brammi) with some other
ingredients as per BNAF.

Indication
Memory loss.
267
Product Guide

Navit Abdominal gas or flatulence


Nausea, vomiting & anorexia
Active Ingredient Abdominal colic
Spirulina (Arthrospira platensis).
Dosage & Administration
Children under 12 years: 1- 2 teaspoonfuls (5 -
Indication
10 ml) 2 to 3 times daily.
Malnutrition Adult: 2 - 3 teaspoonfuls (10 - 15 ml) 3 times
Immune deficiency daily or as directed by the physician.
High Cholesterol
Allergic reaction Contraindication & Precaution
Skin disorders & hair loss There is no evidence available on
Decreased milk supply in lactating mothers contraindication but it may happen in patients
who are hypersensitive to any of its ingredients.
Dosage & Administration
Ginger is contraindicated in people suffering
4 to 6 Capsules (500 mg each) per day or as per
from gallstones as it promotes the production
the instruction of an appropriate health care
of bile. So Pepnor should be taken carefully in
provider.
obstructive jaundice.
Contraindication & Precaution
Side Effect
Spirulina is contraindicated in those who
There is no known significant side effect.
are hypersensitive to any component of a
Spirulina-containing supplement.
Use in Pregnancy & Lactation
Pepnor is a very good supplement for lactating
Side Effect
mother & pregnant women.
Occasional gastrointestinal symptoms, such as
nausea, have been reported. Also, there are a
Preparation
few reports of allergic reactions to spirulina-
100 ml Syrup.
containing supplements.

Use in Pregnancy & Lactation


Safe as per clinical study.

Preparation
500 mg Capsule.

Probio
TM

Active Ingredient
A Probiotic combination (Lactobacillus
Pepnor acidophilus, Lactobacillus bulgaricus,
Bifidobacterium bifidum & fructo-
Active Ingredient oligosaccharides).
Cuminum cyminum.
Indication
Indication Diarrhea
Dyspepsia or indigestion Lactose intolerance
268
Product Guide
Contraindication/Precaution
Vaginal infection Vitis vinifera is well tolerated but caution
Antibiotic related illness should be taken in hypertension, liver disease,
Dosage & Administration alcohol dependence & diabetes. Patients with
1 or 2 capsules 1-2 times daily or as directed by any medical conditions should talk to their
the physician. doctors before taking Revatol. Lactobacillus
products (e.g., Probiotics) should be taken 2 or
Contraindication & Precaution more hours apart.
Not known.
Side Effect
Side Effect There are no side effects associated with the
No side Effects following proper administration use of Vitis vinifera in the above mentioned
of designated therapeutic dosages. therapeutic doses. Vitis vinifera has been used
safely as an Ayurvedic medicine for hundreds
Use in Pregnancy & Lactation of years. But in very rare case stomach pain,
There is no known restriction on the use of headache, & an allergic reaction have been
Probiotics in pregnancy & lactation. reported.

Preparation Use in Pregnancy & Lactation


4 billion probiotics in a Capsule. Women who are pregnant or nursing are
advised to consult with a physician prior to use
Revatol. Although medical literature has not
reported any adverse effects related to fetal
development during pregnancy or to infants
who are breast-fed. So, this product should be
used only when clearly needed.

Preparation
Revatol TM
100 ml syrup.

Active Ingredient
Vitis vinifera with some other herbs.

Indication
Chronic Obstructive Pulmonary Disease
(COPD)
Silybin
Asthma
Active Ingredient
Pulmonary fibrosis
Silymarin (Silybum marianum).
Dose & Administration
Indication
Children under 12 years: 1 - 2 teaspoonfuls (5
Acute viral hepatitis, Toxic liver damage for
10 ml) 2 times daily after meal.
supportive treatment in patients with jaundice,
Above 12 years & Adults: 3 - 4 teaspoonfuls (15
Toxic hepatitis produced by psychotropic
- 20 ml) 2 times daily after meal for 4 8 weeks
agents, Alcohol related liver disease including
or as directed by the physician.
cirrhosis, Poisoning by A. phalloides.
269
Product Guide
Dosage & Administration Apply a small amount of Torel TM muscle rub
1 capsule should be taken 3 times daily; as a (an amount equal to the surface area of the tip
maintenance dose, 1 capsule 2 times daily of a nger) 3 to 4 times daily or as directed by the
is sufficient or advised by the physician physician. Children under 6 years of age: Not
depending up on the severity. The capsules to be used.
should be taken whole with some liquid.
Contraindication
Contraindication & Precaution Capsicum preparations are contraindicated for
There is no available information about application on injured skin, allergies to aspirin,
contraindication. allergic inammation of skin, eczema, itchy rash
& near the eyes.
Side Effect
A mild laxative Effect has occasionally been Side Effect
observed. In rare cases hypersensitivity reaction may
occur. Inhalation of medicine may cause
Use in Pregnancy & Lactation bronchoconstriction.
No information is available about the use of
Silymarin in pregnancy & lactation. Therefore, Use In Pregnancy & Lactation
it should only be used under the supervision There is no information available about
of a physician. restriction of this medicine during pregnancy
& lactation. May be safely used in pregnancy
Preparation or breastfeeding providing the benets to the
70 & 140 mg Capsule. mother outweigh the risks of foetus.

Preparation
20 mg cream.

Torel
TM

Active Ingredient
l-Menthol, d- Camphor, methyl salicylate &
Oleoresin capsicum.

Indication
Muscle pain Sprains
Headache
Joint pain & stiffness
Sprain,strains & sports injuries
Bruising
Fibrositis
Osteoarthritis
Dose & Administration
Children over 6 years & Adult:
Clean the aected area.

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