Albendazole Tablets 400 mg SMPC, Taj Phar maceuticals

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‘Albendazole’ is used in patients with alveolar

RX echinococcosis:
1.In inoperable disease, particularly in
ALBENDAZOLE cases of local or distant metastasis.
2. Following palliative surgery.
TABLETS 3. Following radical surgery or liver
transplantation.
400MG
4.2 Posology and method of administration
1.NAME OF THE MEDICINAL PRODUCT
Route of administration: Oral.
Albendazole 400 mg Tablets Dosage: Dosages are dependent on the parasite
2. QUALITATIVE AND QUANTITATIVE involved, the weight of the patient, and the
COMPOSITION severity of the infection:

Albendazole 400 mg Cystic Echinococcosis

Excipients with known effect: Patients weighing >60 kg
Lactose, sunset yellow lake Total daily dose: 800 mg given in two divided
For the full list of excipients, see section 6.1 doses of 400 mg for a total of 28 days.

3. PHARMACEUTICAL FORM Patients weighing <60 kg

Tablet Total daily dose: 12 mg/kg given in two equally
divided doses (maximum dose 800 mg/day) as
4. CLINICAL PARTICULARS above.
This 28-day treatment period may be repeated
4.1 Therapeutic indications after a 14-day period without treatment for a
‘Albendazole’ is a benzimidazole carbamate
total of three cycles.
anthelmintic for use in the treatment of hydatid
cysts caused by:
Alveolar Echinococcosis
Echinococcosis Patients weighing >60 kg
‘Albendazole’ shows greatest efficacy in the Total daily dose: 800 mg given in two equally
treatment of liver, lung and peritoneal cysts. divided doses for cycles of 28 days with 14 days
Experience with bone cysts and those in the between cycles.
heart and central nervous system is limited.
Patients weighing <60 kg
Cystic Echinococcosis (caused by Echinococcus Total daily dose: 12 mg/kg given in two equally
granulosus) divided doses (maximum dose 800 mg/day) as
‘Albendazole’ is used in patients with cystic above.
echinococcosis:
1. Where surgical intervention is not feasible. Treatment may need to be prolonged for months
2. Prior to surgical intervention. or years. Continuous treatment at the same dose
3. Post-operatively if pre-operative treatment has been used for periods of up to 20 months.
was too short, if spillage has occurred or if
viable material was found at surgery. Method of administration
4. Following percutaneous drainage of Albendazole should be taken with meals. Some
people, particularly young children, may
cysts for diagnostic or therapeutic experience difficulties swallowing the tablets
reasons. whole and should be encouraged to chew the
Alveolar Echinococcosis (caused by tablets with a little water, alternatively tablets
Echinococcus multilocularis) may be crushed.
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Cystic Echinococcosis Elderly

Experience in patients 65 years of age or older is
1. Inoperable and multiple cysts limited. Reports indicate that no dosage
Up to three 28-day cycles of albendazole may be adjustment is required; however, albendazole
given for the treatment of liver, lung and should be used with caution in elderly patients
peritoneal cysts. More prolonged treatment may with evidence of hepatic dysfunction (see
be required for sites such as bone and brain. ‘Hepatic impairment’ below and ‘5.2 Ph
armacokinetic Properties’).
2.Pre-operative
Two 28-day cycles should be given where Renal impairment
possible prior to surgery.Where surgical Since renal elimination of albendazole and its
intervention is necessary before completion of primary metabolite, albendazole sulfoxide, is
two cycles, albendazole should be given for as negligible, it is unlikely that clearance of these
long as possible. compounds would be altered in these patients.
3.Post-operative No dosage adjustment is required; however,
Where only a short pre-operative course has patients with evidence of renal impairment
been given (less than 14 days) and in cases should be carefully monitored.
where emergency surgery is required,
albendazole should be given post-operatively for Hepatic impairment
two 28-day cycles separated by 14 drug-free Since Albendazole is rapidly metabolised by the
days. liver to the primary pharmacologically active
metabolite, albendazole sulfoxide, hepatic
Additionally, where cysts are found to be viable impairment would be expected to have
following pre-surgical treatment or where significant effects on the pharmacokinetics of
spillage has occurred, a full two-cycle course albendazole sulfoxide. Patients with abnormal
should be given. liver function test results (transaminases) prior
to commencing albendazole therapy should be
4. After percutaneous cyst drainage. Treatment carefully evaluated and therapy should be
as for post-surgery above. discontinued if liver enzymes are significantly
increased or full blood count decreased by a
Alveolar Echinococcosis clinically significant level (see ‘4.4 Sp
Treatment is normally given in 28 day cycles as ecial Warnings and Precautions for Use’
for cystic echinococcosis. It may have to be and ‘4.8 Undesirable Effects’).
continued for months or even years. Current
follow up suggests that survival times are 4.3 Contraindications
substantially improved following prolonged Albendazole should not be administered during
treatment. Continuous treatment has been pregnancy or in women thought to be pregnant.
shown in a limited number of patients to lead to Women of childbearing age should be advised to
apparent cure. take effective precautions, with non hormonal
contraceptive measures, against conception
Special Populations during and within one month of completion of
treatment with ‘Albendazole’.
Children
There has been limited experience to date with Albendazole is contra-indicated in patients with
the use of albendazole in children under six a known history of hypersensitivity to the active
years of age; therefore, usage in children less substance or to any of the excipients listed in
than six years is not recommended. The section 6.1.
recommended dose for older children is 12
mg/kg body weight/day in divided doses. 4.4 Special Warnings and precautions for use
Albendazole Tablets 400 mg SMPC, Taj Phar maceuticals
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Albendazole has been associated with mild to Oral or intravenous corticosteroids are
moderate elevations of hepatic enzymes. recommended to prevent cerebral hypertensive
Hepatic enzymes generally normalise on episodes during the first week of treatment.
discontinuation of treatment. Case reports
of hepatitis have also been received (see ‘4.8 Pre-existing neurocysticercosis may also
Undesirable Effects’). Liver function tests be uncovered in patients treated with
should be obtained before the start of each albendazole for other conditions, particularly in
treatment cycle and at least every two weeks areas with high taenosis infection. Patients may
during treatment. If hepatic enzymes are experience neurological symptoms e.g. seizures,
significantly increased (greater than twice the increased intracranial pressure and focal signs as
upper limit of normal), albendazole should be a result of an inflammatory reaction caused by
discontinued. Treatment may be restarted death of the parasite within the brain.
when hepatic enzymes have returned to normal Symptoms may occur soon after treatment,
limits, but patients should be monitored for appropriate steroid and anticonvulsant therapy
recurrence. should be started immediately.

Albendazole has been shown to cause bone Patients with rare hereditary problems of
marrow suppression and therefore blood counts galactose intolerance, the Lapp lactase
should be performed at the start and every two deficiency or glucose-galactose malabsorption
weeks during each 28-day cycle. Patients with should not take this medicine.
liver disease, including hepatic echinococcosis,
appear to be more susceptible to bone marrow 4.5 Interaction with other medicinal
suppression leading to pancytopenia, aplastic products and other forms of interaction
anaemia, agranulocytosis and leucopenia and
therefore warrant closer monitoring of blood Albendazole has been shown to induce liver
enzymes of the cytochrome P450 system
counts. Albendazole should be discontinued if
clinically significant decreases in blood cell responsible for its own metabolism.
counts occur (see ‘4.2 Posology and Method of
Administration’ and ‘4.8 Undesirable Effects’). Drugs that can reduce the effectiveness of
albendazole – monitor effect - other dose
regimens or therapies may be required.
Precautions:
In order to avoid administering albendazole •Anticonvulsants (eg phenytoin: fosphenytoin:
during early pregnancy, women of childbearing carbamazepine: phenobarbital: primidone)
age should: • Levamisole
-initiate treatment only after a negative • Ritonavir
pregnancy test. These tests should be repeated at
least once before initiating the next cycle. Drugs that may increase levels of the active
- be advised to take effective precautions against metabolite of albendazole – monitor to possible
conception during and within one month of increased albendazole adverse effects.
completion of treatment with albendazole for a • Cimetidine
systemic infection. • Dexamethasone (continuous use raises
albendazole levels by 50%)
Symptoms associated with an inflammatory • Praziquantel
reaction following death of the parasite may
occur in patients receiving albendazole treatment Grapefruit juice also increases the plasma levels
for neurocysticercosis (e.g. seizures, raised of albendazole sulfoxide.
intracranial pressure, focal signs).
These should be treated with appropriate steroid Other possible interactions
and anticonvulsant therapy. Because of possible alterations in cytochrome
P450 activity, there is a theoretical risk of an
interaction with the following
Albendazole Tablets 400 mg SMPC, Taj Phar maceuticals
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• Oral contraceptives
• Anticoagulants Patients with liver disease, including hepatic
• Oral hypoglycaemics echinococcosis, appear to be more susceptible to
• Theophylline bone marrow suppression (see ‘4.2 Posology and
Care should be exercised when albendazole is Method of Administration’ and ‘4.4 Special
given to patients taking these medicines. Warnings and Precautions for Use’).

4.6 Fertility, Pregnancy and lactation Immune system disorders

Uncommon: Hypersensitivity reactions
Pregnancy: including rash, pruritus and urticaria
‘Albendazole’ should not be administered during
pregnancy or in women thought to be pregnant Nervous system disorders
(see contra-indications). Very common: Headache
Common: Dizziness
Breast-feeding:
It is not known whether albendazole or its Gastrointestinal disorders
metabolites are secreted in human breast milk.
Common: Gastrointestinal distur
Thus ‘Albendazole’ should not be used during bances (abdominal pain, nausea,
lactation unless the potential benefits are vomiting)
considered to outweigh the potential risks
Gastrointestinal disturbances have been
associated with treatment.
associated with albendazole when treating
patients with echinococcosis.
4.7 Effects on ability to drive and use
machines Hepato-biliary disorders
Dizziness is reported as a common reaction. Very common: Mild to moderate elevations of
Patients should be advised that if affected they
hepatic enzymes
should not drive, operate machinery or take part Uncommon: Hepatitis
in activities where this could put them or others
at risk. Skin and subcutaneous tissue disorders
4.8 Undesirable Effects Common: Reversible alopecia (thinning of hair,
Data from large clinical studies were used to and mode rate hair loss)
determine the frequency of very common to rare Very rare: Erythema multiforme, Stevens-
undesirable reactions. The frequencies assigned Johnson syndrome
to all other undesirable reactions (i.e. those
occurring at < 1/1000) were mainly determined General disorders and administrative site
using post-marketing data and refer to a conditions
reporting rate rather than a true frequency. Common: Fever

The following convention has been used Reporting of suspected adverse reactions
for the classification of frequency: Reporting suspected adverse reactions after
Very common ≥1/10 authorisation of the medicinal product is
Common ≥1/100 to <1/10 important. It allows continued monitoring of the
Uncommon ≥1/1000 to < 1/100 benefit/risk balance of the medicinal product.
Rare ≥1/10,000 to < 1/1000
Very rare < 1/10,000 4.9 Overdose
In case of overdosage, symptomatic therapy
Blood and the lymphatic system disorders (gastric lavage) and general supportive measures
Uncommon: Leucopenia should be undertaken.
Very rare: Pancytopenia, aplastic anaemia,
agranulocytosis
5. PHARMACOLOGICAL PROPERTIES
Albendazole Tablets 400 mg SMPC, Taj Phar maceuticals
Albendazole Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Albendazole Dosage & Rx Info | Albendazole Uses, Side Effects -: Indications, Side Effects, Warnings, Albendazole - Drug Information - Taj Phar ma, Albendazole dose Taj pharmac euticals Albendazole interactions, Taj Phar maceutical Albendazole contraindications, Albendazole price, Albendazole Taj Pharma Alb endazole Tablets 400 mg SM PC- T aj Phar ma . Stay connected to all updated on Albendazole Taj Pharmac euticals Taj pharmaceuticals Hyderabad.

5.1 Pharmacodynamic properties Excretion

Albendazole sulfoxide and its metabolites
Pharmacotherapeutic group: Benzimidazole appear to be principally eliminated in bile, with
derivatives only a small proportion appearing in the urine.
Elimination from cysts has been shown to occur
Albendazole is a benzimidazole carbamate with over several weeks following high and
anthelmintic effects against tissue parasites. prolonged dosing.

Albendazole exhibits larvicidal, ovicidal and Special Patient Populations

vermicidal activity, and it is thought to exert its Elderly
anthelmintic effect by inhibiting tubulin Although no studies have investigated the effect
polymerisation. of age on albendazole sulfoxide
This causes the disruption of the helminth pharmacokinetics, data in 26 hydatid cyst
metabolism, including energy depletion, which patients (up to 79 years) suggest
immobilises and then kills the susceptible pharmacokinetics similar to those in young
helminth. healthy subjects. The number of elderly patients
treated for either hydatid disease or
Albendazole is effective in the treatment of neurocysticercosis is limited, but no problems
tissue parasites including cystic echinococcosis associated with an older population have been
and alveolar echinococcosis caused by observed.
infestation of Echinococcus granulosus
and Echinococcus multilocularis, respectively. Renal Impairment
The pharmacokinetics of albendazole in patients
In the treatment of cysts due to E. multilocularis, with impaired renal function have not been
a minority of patients were considered to be studied.
cured and a majority had an improvement or
stabilisation of disease due to albendazole. Hepatic Impairment
The pharmacokinetics of albendazole in patients
5.2 Pharmacokinetic properties with impaired hepatic function have not been
studied.
Absorption and metabolism
In man, albendazole is poorly absorbed (<5%)
following oral administration. 5.3 Preclinical safety data
Albendazole rapidly undergoes extensive first- There are no pre-clinical data of relevance to the
pass metabolism in the liver, and is generally not prescriber which are additional to that already
detected in plasma. Albendazole sulfoxide is the included in other sections of the SPC.
primary metabolite, which is thought to be the
active moiety in effectiveness against systemic
tissue infections. The plasma half-life of 6. PHARMACEUTICAL PARTICULARS
albendazole sulfoxide is 8½ hours.
6.1 List of excipients
Following oral administration of a single dose of Lactose
400 mg albendazole, the pharmacologically Maize starch
active metabolite, albendazole sulfoxide, has Sunset yellow lake
been reported to achieve plasma concentrations Sodium lauryl sulphate
from 1.6 to 6.0 micromol/litre when taken Polyvinylpyrrolidone
with breakfast. The systemic pharmacological Microcrystalline cellulose
effect of albendazole is augmented if the dose is Sodium saccharin
administered with a fatty meal, which enhances Sodium starch glycollate
the absorption by approximately 5-fold. Vanilla flavour
Orange flavour
Albendazole Tablets 400 mg SMPC, Taj Phar maceuticals
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Passion fruit flavour

Magnesium stearate
Hydroxypropylmethylcellulose
Propylene glycol
Purified water

6.2 Incompatibilities
None
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store at or below 30°C
6.5 Nature and contents of container
Polypropylene 'securitainer' with polyethylene
lid, each pack containing 60 tablets

6.6 Special precautions for disposal and

other handling
No special instructions.
7. MANUFACTURER:

Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA

This leaflet was last revised in October 2019