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CARBAMAZEPINE TABLETS USP Posology

200MG/ 400MG Doses should be based on seizure control and
TAJ PHARMA the development of clinical intolerance.
Plasma levels are indicative whether a patient
is within or outside the therapeutic range in
1. NAME OF THE MEDICINAL order to explain a lack of seizure control or
PRODUCT development of intolerance. This may be
particularly useful, if combination therapy is
Carbamazepine Tablets USP 200mg Taj used. Therapeutic plasma levels of
Pharma carbamazepine are typically between 4 - 12
Carbamazepine Tablets USP 400mg Taj µg/l corresponding to a dosage of 200 -
Pharma 400mg per day.
2. QUALITATIVE AND A maximum daily dose of 1600 - 2000 mg

QUANTITATIVE COMPOSITION may be required in adults.
When patients are transferred from an
a) Each tablet contains:
immediate-release carbamazepine product,
Carbamazepine USP 200mg the same total daily dose will generally be
suitable. In a few patients, it may be
Excipients q.s.
necessary to increase the total daily dose,
particularly when it is used with other
antiepileptics.
b) Each tablet contains:
In patients with severe cardio-vascular
Carbamazepine USP 400mg
disease, liver disease or renal damage and in
Excipients q.s. older people a reduced dose may be
sufficient.
For the full list of excipients, see section 6.1.
Furthermore the dose required by some
3. PHARMACEUTICAL FORM patients may differ substantially from the
tablet. recommendation for initial and maintenance
dose below, due to increased metabolism
4. CLINICAL PARTICULARS caused by auto-induction of hepatic enzymes
4.1 Therapeutic indications or drug interactions during combination
• Epilepsy therapy.
• generalised tonic-clonic Before deciding to initiate treatment, patients

• partial seizures of Han Chinese and Thai origin should
• For the paroxysmal pain of trigeminal whenever possible be screened for HLA-
neuralgia. B*1502 as this allele strongly predicts the
risk of severe carbamazepine-associated
• For the prophylaxis of manic or hypomanic Stevens-Johnson syndrome (SJS) (see
phases of manic-depressive psychosis in information on genetic testings and
patients unresponsive or with cutaneous reactions in section 4.4).
contraindications to lithium therapy.
Dosage recommendations:
4.2 Posology and method of administration
Carbamazepine Tablets USP 200mg/ 400mg Taj Pharma Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Carbamazepine Tablets USP 200mg/ 400mg Taj Pharma Dosage & Rx Info | Carbamazepine Tablets USP 200mg/ 400mg Taj Pharma Uses, Side Effects, Carbamazepine Tablets USP 200mg/ 400mg Taj Pharma : Indications, Side Effects, Warnings, Carbamazepine Tablets USP 200mg/ 400mg Taj Pharma - Drug Information - Taj Pharma,
Epilepsy: Antiepileptic therapy is a long-term

treatment.
Treatment is started with a low dose set
individually according to the type and In general, a dose reduction or withdrawal of
severity of symptoms. The dose is then antiepileptic medication may be considered,
slowly increased to the optimal maintenance when patients are seizure-free for at least two
dose to suit the patient. or three years. Instead of age dependant dose
adjustment, children may outgrow the dose
It is recommended that a carbamazepine
per kg body weight.
monotherapy treatment is used whenever
possible. When treatment is changed from Prevention of paroxysmal pain of trigeminal
another drug to carbamazepine the dose of neuralgia:
the other antiepileptic drug should be reduced
The recommended initial daily dose is 100 -
slowly.
400 mg/day carbamazepine. The lower initial
If a change of therapy to a different dose may be sufficient for older or sensitive
antiepileptic drug is required, the change may patients. The dose is increased until the
not be done in one sudden step, but must be patient is free of pain, generally with a dose
done gradually in small increments. of 600 - 800 mg/day taken in 1 - 2 doses with
a maximum dose of 1600 mg. The dose may
Carbamazepine therapy is discontinued by
be gradually reduced if the patient is pain-
slow dose reduction.
free thereafter, and may possibly be stopped
Initial dose Maintenance after a few weeks of treatment, if there is no
dose recurrence of pain.
Adults 100 – 200mg 400 – 600mg Prophylaxis of manic-depressive psychosis
once or twice morning and
An initial dose of 100 - 400 mg daily in
daily night
divided doses, increased gradually until
Children 400mg at night 100 – 200mg symptoms are controlled, or a maximum of
5-10 (or 100mg morning and 800 mg, in exceptional cases maximum 1600
years* morning and 200 – 400mg at mg, in divided doses is reached. The
night) night recommended maintenance dose is 400 - 600
Children 200mg at night 100 – 400mg mg daily, given in divided doses.
10-15 (or 100mg morning and
Prophylaxis of manic-depressive psychosis is
years morning and 400mg – 600mg
a long-term treatment.
night) at night
In order to prevent a drug interaction, it is
necessary to keep the plasma level of
Carbamazepine tablets can be broken in half carbamazepine below 8 µg/ml and lithium at
to treat children/adults with divided doses a low therapeutic dosage (0.3 - 0.8 mval/L),
where necessary. if in exceptional cases carbamazepine is used
* Carbamazepine tablets are not generally in combination with lithium for the
suitable for children under the age of 5 years. prophylaxis of manic depressive psychosis,
A conventional tablet or syrup presentation which cannot be controlled with lithium
of carbamazepine may be given. treatment alone. Neuroleptic treatment must
not be done concurrently and must have been
discontinued at least 8 weeks beforehand.
The impairment of the ability to react quickly Suicidal ideation and behaviour have been
appears in particular with combination reported in patients treated with antiepileptic
therapy with lithium (see section 4.7). agents in several indications. A meta-analysis
of randomised placebo controlled trials of
Method of administration
antiepileptic drugs has also shown a small
The tablet can be divided into equal halves increased risk of suicidal ideation and
and the daily dose is normally taken in two behaviour. The mechanism of this risk is not
divided doses, during or after a meal with a known and the available data do not exclude
drink of water. The tablets should be the possibility of an increased risk for
swallowed whole and not chewed or crushed. carbamazepine.
Patients who have difficulties in swallowing, Therefore patients should be monitored for
may take the tablets in water following their signs of suicidal ideation and behaviours and
disintegration into their granules. The appropriate treatment should be considered.
characteristics of the tablets are maintained Patients (and caregivers of patients) should
for a short period of time after their be advised to seek medical advice should
suspension. Therefore the suspension should signs of suicidal ideation or behaviour
be taken immediately. emerge.
4.3 Contraindications Serious cutaneous reactions
Carbamazepine may not be taken with:
Serious and sometimes fatal cutaneous
- known bone marrow depression. reactions including toxic epidermal
necrolysis (TEN) and Stevens-Johnson
- atrio ventricular conduction abnormalities.
syndrome (SJS) have been reported during
- hypersensitivity to the active substance or treatment with carbamazepine. These
structurally related drugs (for example reactions are estimated to occur in 1-6 per
tricyclic antidepressants) or to any of the 10,000 new users in countries with mainly
excipients listed in section 6.1. Caucasian populations, but the risk in some
Asian countries is estimated to be about 10
- history of hepatic porphyrias (e.g. acute times higher.
intermittent porphyria, variegate porphyria,
porphyria cutanea tarda). There is growing evidence of the role of
different HLA alleles in predisposing patients
- concomitant treatment with monoamine to immune-mediated adverse reactions (see
oxidase inhibitors (MAOIs) (see section 4.5) section 4.2).
- concomitant treatment with voriconazole HLA-B*1502 allele - in Han Chinese, Thai
(see section 4.5). and other Asian populations
- herbal preparations containing St. John's HLA-B*1502 in individuals of Han Chinese
wort (Hypericum perforatum) (see section and Thai origin has been shown to be strongly
4.5). associated with the risk of developing the
4.4 Special warnings and precautions for severe cutaneous reactions known as
use Stevens-Johnson syndrome (SJS) when
Suicidal ideation and behaviour treated with carbamazepine. The prevalence
of HLA-B*1502 carrier is about 10% of Han
Chinese and Thai populations. Whenever
possible, these individuals should be subjects of European ancestry, whereas its

screened for this allele before starting absence may reduce the risk from 5.0 to
treatment with carbamazepine (see section 3.8%.
4.2). If these individuals test positive,
There are insufficient data supporting a
carbamazepine should not be started unless
recommendation for HLA-A*3101 screening
there is no other therapeutic option. Tested
before starting carbamazepine treatment.
patients who are found to be negative for
HLA-B*1502 have a low risk of SJS, If patients of European descent or Japanese
although the reactions may still rarely occur. origin are known to be positive for HLA-
A*3101 allele, the use of carbamazepine may
There are some data that suggest an increased
be considered if the benefits are thought to
risk of serious carbamazepine-associated
exceed risks.
TEN/SJS in other Asian populations.
Because of the prevalence of this allele in Patients should be advised of the signs and
other Asian populations (e.g. above 15% in symptoms and monitored closely for skin
the Philippines and Malaysia), testing reactions. The highest risk for occurrence of
genetically at risk populations for the SJS or TEN is within the first weeks of
presence of HLA-B*1502 may be treatment.
considered.
If symptoms or signs of SJS or TEN
The prevalence of the HLA-B*1502 allele is (e.g. progressive skin rash often with blisters
negligible in e.g. European descent, African, or mucosal lesions) are present,
Hispanic populations sampled, and in carbamazapine treatment should be
Japanese and Koreans (< 1%). discontinued.
HLA-A*3101 allele - European descent and The best results in managing SJS and TEN
Japanese populations come from early diagnosis and immediate
discontinuation of any suspect drug. Early
There are some data that suggest HLA-
withdrawal is associated with a better
A*3101 is associated with an increased risk
prognosis.
of carbamazepine induced cutaneous adverse
drug reactions including SJS, TEN, Drug If the patient has developed SJS or TEN with
rash with eosinophilia (DRESS), or less the use of carbamazapine, carbamazapine
severe acute generalised exanthematous must not be re-started in this patient at any
pustulosis (AGEP) and maculopapular rash time.
(see section 4.8) in people of European
Limitation of genetic screening
descent and the Japanese.
Genetic screening results must never
The frequency of the HLA-A*3101 allele
substitute for appropriate clinical vigilance
varies widely between ethnic populations.
and patient management. Many Asian
HLA-A*3101 allele has a prevalence of 2 to
patients positive for HLA-B*1502 and
5% in European populations and about 10%
treated with carbamazepine will not develop
in Japanese population.
SJS/TEN and patients negative for HLA-
The presence of HLA-A*3101 allele may B*1502 of any ethnicity can still develop
increase the risk for carbamazepine induced SJS/TEN. Similarly many patients positive
cutaneous reactions (mostly less severe) from for HLA-A*3101 and treated with
5.0% in general population to 26.0% among carbamazepine will not develop SJS, TEN,
DRESS, AGEP or maculopapular rash and - myotonic dystrophy, as cardiac conduction

patients negative for HLA-A*3101 of any abnormalities are likely in these patients
ethnicity can still develop these severe
Haematological events
cutaneous adverse reactions. The role of
other possible factors in the development of, The occurrence of agranulocytosis and
and morbidity from these severe cutaneous aplastic anaemia has been associated with
adverse reactions such as AED dose, carbamazepine; however, due to the very low
compliance, concomitant medications, co- frequency it is difficult to estimate the risk. In
morbidities, and the level of dermatologic the untreated population, the probability of
monitoring have not been studied. occurrence is 4.7 cases/million/year for
agranulocytosis and 2 cases/million/year for
Other dermatological reactions
aplastic anaemia.
Mild skin reactions e.g. isolated macular or
Blood counts, platelet count and serum
macropapular exanthemata, can also occur
biochemistry including iron and electrolytes
and are mostly transient and not hazardous,
should be checked before commencing
and they usually disappear within a few days
treatment with carbamazepine. Blood counts
or weeks, either during the continued course
should be performed on a monthly basis for
of treatment or following a decrease in
the first five months. Thereafter 2-4 times a
dosage. However, since it may be difficult to
year.
differentiate the early signs of more serious
skin reactions from mild to transient Clinical monitoring is of primary importance
reactions, the patient should be kept under during the entire treatment period.
close surveillance with consideration given to Carbamazepine must be discontinued, if
immediately withdrawing the drug should the severe leucopenia or thrombocytopenia
reaction worsen with continued use. appear.
The HLA-A*3101 allele has been found to be A temporary or lasting lowering of the
associated with less severe adverse cutaneous number of leukocytes or thrombocytes is
reactions from carbamazepine and may often seen during carbamazepine treatment,
predict the risk of these reactions from but is usually transient and does not indicate
carbamazepine, such as anticonvulsant the onset of agranulocytosis or aplastic
hypersensitivity syndrome or non- serious anaemia. However, carbamazepine must be
rash (maculopapular eruption). However, the discontinued if severe leucopenia (mainly
HLA-B*1502 allele has not been found to neutropenia) or thrombocytopenia
predict the risk of these aforementioned skin accompanied by clinical
reactions. manifestations e.g. fever or sore throat or
significant depression of the bone marrow
Carbamazepine may only be used after
appear.
careful risk/benefit evaluation and with
special care during the following conditions: If reactions such as fever, sore throat, rash,
ulcers in the mouth, easy bruising, petechial
- haematological disturbances
or purpuric haemorrhage, nausea, yellowing
- disturbed sodium metabolism of the skin, and liver enlargement appears,
the patient should be advised to consult his
- severe cardiac, liver and kidney dysfunction
physician immediately.
- pregnancy and lactation
In patients with severe cardio-vascular with DRESS, a delayed multi-organ

disease, liver disease or renal damage and in hypersensitivity disorder, which can affect
older people a special observation is the skin, liver (including intrahepatic bile
necessary. Doses should be adapted to each ducts), haematopoietic organs and lymphatic
case. system or other organs, either individually or
together in the context of a systemic reaction
Seizures
(see section 4.8).
Carbamazepine should be used with caution
The HLA-A*3101 allele has been found to be
in patients with mixed seizures, which
associated with the occurrence of
include absences, either typical or atypical. In
hypersensitivity syndrome, including
all these conditions, carbamazepine may
maculopapular rash.
exacerbate absences. In case of exacerbation
of absences, carbamazepine should be Patients who have exhibited hypersensitivity
discontinued. reactions to carbamazepine should be
informed that approximately 25-30% of the
As with other antiepileptic drugs some
patients experience hypersensitivity
patients may experience an increase in
reactions to oxcarbazepine. Cross-
seizure frequency or the onset of new types
hypersensitivity can occur between
of seizures. These phenomena may also be
carbamazepine and phenytoin.
the consequence of an overdosage, a decrease
in plasma concentrations of concomitant Treatment should be discontinued
antiepileptic treatment, or a paradoxical immediately, if severe hypersensitivity
effect. reactions occur.
Hepatic function Hyponatraemia
Liver function tests should also be performed Hyponatraemia can occur when taking
before commencing treatment and carbamazepine. In patients with pre-existing
periodically thereafter, particularly in kidney disorders associated with low serum
patients with a history of liver disease and in sodium concentrations, or in patients who are
older patients. Patients must be instructed to being concomitantly treated with medicines
contact the doctor immediately should that lower serum sodium
symptoms of hepatitis occur such as fatigue, concentration e.g. diuretics, the serum
loss of appetite, nausea, yellowing of the skin sodium concentration should be determined
or enlarged liver. Treatment with before treatment. The serum sodium
carbamazepine should be suspended, if signs concentration should be monitored after two
and symptoms of liver dysfunction develop. weeks and then monthly for three months or
according to the clinical necessity. Older
Renal function
patients are particularly susceptible to these
Baseline and periodic complete urinalysis risk factors and if hyponatraemia is
and BUN determinations are recommended. diagnosed, water restriction is an important
countermeasure.
Hypersensitivity reactions
Hypothyroidism
Carbamazepine may trigger hypersensitivity
reactions, including Drug Rash with Carbamazepine can reduce serum thyroid
Eosinophilia and Systemic Symptoms hormone concentrations through enzyme
(DRESS), reactivation of HHV6 associated induction, requiring an increased dose of
hormone replacement therapy (HRT) in Patients with glaucoma and urinary retention
patients with hypothyroidism. Monitoring the should be informed about possible hazards
thyroid function is recommended in order to associated with carbamazepine's mild
adjust the HRT dose. anticholinergic activity. The intra-ocular
pressure and kidney function of these patients
Due to the possibility of photosensitivity,
should be checked regularly.
patients should avoid excessive exposure to
sunlight during carbamazepine therapy. High doses of carbamazepine could result in
activation of latent psychosis and possibly
Monitoring plasma levels
agitation or confusion in older patients.
Although correlations between dosage and
Alcohol ingestion is not recommended,
plasma levels of carbamazepine and between
carbamazepine may increase its effects.
plasma levels and clinical efficacy or
tolerability are rather tenuous, monitoring of 4.5 Interaction with other medicinal
the plasma levels may be useful in the products and other forms of interaction
following situations: dramatic increase in Cytochrome P450 inducers and inhibitors
seizure frequency; during pregnancy; when
Cytochrome P450 3A4 (CYP3A4) is the
treating children or adolescents; in suspected
main enzyme catalysing formulation of the
absorption disorders; for verification of
active metabolite carbamazepine-10,11-
compliance; in suspected toxicity where
epoxide. Co-administration of inhibitors of
more than one drug is being used (see section
CYP3A4 may result in increased
4.5).
carbamazepine plasma concentrations, which
Dose reduction and withdrawal could induce adverse reactions. Co-
administration of CYP3A4 inducers might
Abrupt withdrawal of carbamazepine may
increase the rate of carbamazepine
precipitate seizures. Patients should be
metabolism, thus leading to a potential
gradually weaned off carbamazepine over a
decrease in carbamazepine serum level and
period of a few months. If treatment with
potential decrease in the therapeutic effect.
carbamazepine has to be withdrawn abruptly,
Similarly, discontinuation of a CYP3A4
the switch to another antiepileptic drug
inducer may decrease the rate of metabolism
should if necessary be effected under the
of carbamazepine, leading to an increase in
cover of a suitable drug e.g. i.v. or rectal
carbamazepine plasma levels.
benzodiazepines, or i.v. phenytoin.
Carbamazepine is a strong inducer of
Endocrinological effects
CYP3A4 and other phase I and II enzyme
Breakthrough bleeding has been reported in systems in the liver. Concomitant use of
women taking carbamazepine while using carbamazepine may increase the metabolism
hormonal contraceptives. The reliability of and thus decrease the plasma concentrations
hormonal contraceptives may be adversely of several drugs that are eliminated by
affected by carbamazepine and women of metabolism.
childbearing potential should be advised to
It should be noted especially that rifampicin
consider using alternative forms of birth
is known to also be a very strong inducer of
control while taking carbamazepine (see
CYP 450 and reduces carbamazepine levels.
section 4.6).
Human microsomal epoxide hydrolase has
Precautions:
been identified as the enzyme responsible for
the formation of the 10, 11-transdiol Serum levels of carbamazepine can be

derivative from carbamazepine-10,11- reduced by concomitant use of the herbal
epoxide. Co-administration of inhibitors of preparation St. John's wort (Hypericum
human microsomal epoxide hydrolase may perforatum). This is due to induction of drug
result in increased carbamazepine-10,11- metabolising enzymes, which may persist for
epoxide plasma concentrations. at least 2 weeks after cessation of treatment
with St. John's wort. For patients taking St.
Monoamine oxidase inhibitors
John's wort, serum levels of carbamazepine
Because it is structurally related to tricyclic should be monitored and St. John's wort
antidepressants, it is not recommended to stopped. Carbamazepine levels may increase
give carbamazepine in combination with on stopping St. John's wort. The dose of
monoamine oxidase inhibitors (MAOIs). carbamazepine may need adjusting.
MAOIs should be discontinued at least 2
Drugs that increase the active metabolite
weeks before carbamazepine therapy is
carbamazepine-10,11-epoxide plasma levels
started if the clinical situation permits (see
section 4.3). The plasma level of the active
carbamazepine-10,11-epoxide metabolite
Drugs that may decrease carbamazepine
may be increased by quetiapine, progabide,
plasma levels
loxapine, valnoctamide, valpromide, valproic
The plasma level of carbamazepine may be acid, felbamate (~50%), primidone,
decreased by other enzyme inducers such as: clonazepam and digoxin.
Antiepileptics: phenobarbital, phenytoin, Drugs that may increase carbamazepine
primidone, felbamate (~25%), plasma levels
methosuximide, oxcarbazepine,
Raised plasma levels of carbamazepine may
fosphenytoin, progabide, valpromide,
lead to the symptoms listed under section
valproic acid, phensuximide, and
4.8 e.g. dizziness, tiredness, unsteady gait,
clonazepam
double vision. The carbamazepine plasma
Antimalarials: mefloquine level should be checked and the dosage
reduced, if necessary, when used
Bronchodilatators or anti-asthma
concomitantly with:
drugs: theophylline, aminophylline
Analgesic, anti-inflammatory
Antituberculosis: rifampicin,
drugs: dextropropoxyphene, propoxyphene,
Antineoplastics: cisplatin or doxorubicin ibuprofen
Cardiovascular drugs: digoxin Androgens: danazol
Dermatological drugs: isotretinoin Antibiotics: macrolide antibiotics
(e.g. erythromycin, troleandomycin,
Due to potential interactions during josamycin, clarithromycin), ciprofloxacin
combination therapy of epilepsy, plasma
levels should be regularly monitored, and Antidepressants: desipramine, fluoxetine,
dosage adjusted accordingly as required. fluvoxamine, nefazodone, paroxetine,
Blood assays of their respective plasma trazodone, viloxazine
levels may vary from one patient to another,
and moreover are usually bi-directional.
Antiepileptics: felbamate, lamotrigine, associated with hepatotoxicity), phenazone,

phenobarbital, primidone, stiripentol, tramadol
vigabatrin
Antibiotics: doxycycline, rifabutin
Antifungals: azoles (e.g. itraconazole,
Anticoagulants: oral anticoagulants
ketoconazole, fluconazole, voriconazole).
(e.g. warfarin, phenprocoumon, dicoumarol
Alternative anticonvulsants may be
and acenocoumarol)
recommended in patients treated with
itraconazole or voriconazole Antidepressants: bupropion, citalopram,
mianserin, sertraline, nefazodone, trazodone
Antihistamines: loratadine, terfenadine
Tricyclic antidepressants: imipramine,
Antipsychotics: olanzapine
amitriptyline, nortriptyline, clomipramine
Antituberculosis: isoniazid
Antiemetics: aprepitant
Antivirals: protease inhibitors for HIV
Antiepileptics: clobazam, clonazepam,
treatment (e.g. ritonavir)
ethosuximide, felbamate, lamotrigine,
Carbonic anhydrase oxcarbazepine, phenytoin, primidone,
inhibitors: acetazolamide tiagabine, topiramate, valproic acid,
zonisamide.
Cardiovascular drugs: diltiazem, verapamil
Antifungals: caspofungin, itraconazole,
Gastrointestinal drugs: possibly cimetidine,
voriconazole. Alternative anitconvulsants
omeprazole
may be recommended in patients treated with
Muscle relaxants: oxybutynin, dantrolene itraconazole or voriconazole
Neuroleptics: loxapine, olanzapine, Anihelmintics: albendrazole, praziquantel
quetiapine
Antineoplastics: imatinib,
Platelet aggregation inhibitors: ticlopidine cyclophosphamide, lapatinib, temsirolimus
Other interactions: grapefruit juice, Antipsychotics: clozapine, haloperidol,
nicotinamide (in adults, only in high dosage) bromperidol, olanzapine, quetiapine,
risperidone, aripiprazole, paliperidone,
Effect of carbamazepine on plasma levels of
ziprasidone
other drugs taken concomitantly
Antivirals: protease inhibitors for HIV
Carbamazepine may decrease, diminish or
treatment (e.g. indinavir, ritonavir,
even abolish the activity of certain drugs.
saquinavir)
Concurrent use of carbamazepine with the
following drug substances may require dose Anxiolytics: alprazolam, midazolam,
adjustment to ensure the required clinical clobazam
response, especially when starting or
Bronchodilatators or antiasthmatic
discontinuing carbamazepine –
drugs: theophylline
Analgesics, anti-inflammatory
Contraceptives: hormonal contraceptives
agents: fentanyl, methadone, buprenorphine,
(alternative contraceptive methods should be
paracetamol (long term administration of
considered)
carbamazepine and paracetamol may be
Cardiovascular drugs: calcium channel There is an indication of a higher risk of

blockers (dihydropyridine developing Stevens-Johnson syndrome with
group e.g. felodipine), isradipine, digoxin, concomitant use of neuroleptics.
simvastatin, atorvastatin, lovastatin,
Co-administration of carbamazepine and
cerivastatin, ivabradine
paracetamol may reduce the bioavailability
Corticosteroids: prednisolone, of paracetamol (acetaminophen) and long
dexamethasone term co-administration may be associated
with hepatotoxicity.
Drugs used in erectile dysfunction: tadalafil
The concomitant use of carbamazepine and
Immunosuppressants: ciclosporin,
lithium or metoclopramide on the one hand
everolimus, tacrolimus, sirolimus
and neuroleptics (haloperidol, thioridazine)
Thyroid agents: levothyroxine on the other can favour the occurrence of
neurological undesirable effects. In patients
Other drug interactions: quinidine,
treated with neuroleptics, it must be noted
hydroquinidine, methylphenidate,
that carbamazepine reduces the plasma levels
propranolol, flunarizine, products containing
of these medicinal products and can therefore
oestrogens or progesterones (gestrinone,
cause worsening of the disease profile.
tibolone, toremifene)
Dosage adjustment of the neuroleptic may be
Hormonal contraceptives necessary.
For products containing oestrogens and/or Risk of neurotoxic effects may be increased
progestogens, including oral contraceptives with concomitant use of carbamazepine
and hormone replacement therapy (see (ataxia) and lithium (cerebellar syndrome),
section 4.4), reliable alternative despite the lithium plasma concentrations
contraceptive methods should be used. In being in the normal range (see section 4.2).
patients taking the pill breakthrough bleeding The following additional neurotoxic
or spotting may appear suddenly due to a symptoms can be noted: unsteady gait,
decreased activity of the contraceptive. As a horizontal nystagmus, increased involuntary
result, carbamazepine may cause a failure of muscle reflexes, muscle twitching. These
the therapeutic effect of drugs containing neurological effects are reversible after
oestrogens and/or progesterone containing stopping the lithium.
drugs.
The hepatic toxicity of isoniazid may be
Carbamazepine may lower the plasma level increased by carbamazepine.
of bupropion and may increase the level of its
The combination of carbamazepine with
metabolite hydroxybupropion.
hypokalaemic diuretics (loop and thiazide
Other drug combinations to be taken into diuretics) e.g. hydrochlorothiazide and
consideration furosemide, may cause hyponatraemia (see
section 4.4).
Concurrent use of carbamazepine and other
psychotropic drugs, e.g. neuroleptics, Concomitant administration of
antidepressants, sedatives, hypnotics, carbamazepine and antiarrhythmics, cyclic
analgesics, sedative antihistaminics, may antidepressants or erythromycin, increases
increase the occurrence of neurological side the risk of cardiac conduction abnormalities.
effects.
The activity of muscle relaxants like Due to its interference with HPLC analysis,
pancuronium may be reduced by carbamazepine can lead to false positives for
carbamazepine. A rapid recovery from perphenazine concentrations.
neuromuscular blockade is therefore Carbamazepine and its 10,11-epoxide
possible. Patients must be supervised metabolite can lead to false positive
accordingly and the dosage of the relaxant concentrations of tricyclic antidepressants in
increased, if necessary. fluorescence polarised immunoassay
method.
Carbamazepine plasma levels must be
checked during concurrent treatment with 4.6 Fertility, pregnancy and lactation
isotretinoin (acne treatment), as it has been Pregnancy
reported to unpredictably alter the
Risk related to epilepsy and antiepileptic
bioavailability of carbamazepine and its
drugs in general:
active metabolite.
It has been shown that in the offspring of
Carbamazepine appears to increase the
epileptic women, the prevalence of
elimination of thyroid hormones and thus
malformations is two to three times greater
increase the hormone requirement of
than the rate of about 3% found in the general
hypothyroid patients. A thyroid test should
population. In the treated population an
therefore be performed at the start and
increase in malformed children has been
discontinuation of carbamazepine therapy in
noted with polytherapy, however the extent
patients receiving thyroid hormone
to which the treatment and/or the illness are
substitution. Dosage adjustment of thyroid
respectively responsible has not been
hormone may be required.
elucidated as yet.
A toxic serotonin-syndrome may be
The most frequently encountered
produced, if carbamazepine is taken together
malformations are labial fusion defects and
with drugs, which inhibit serotonin re-uptake
cardiovascular malformations.
(e.g. fluoxetine).
Risk linked to carbamazepine:
The severe haematological side effects of
clozapine may be increased if used in Animal experiments have provided evidence
combination with carbamazepine. of a teratogenic effect.
Concomitant use of carbamazepine and In humans, the number of women treated
levetiracetam has been reported to increase with carbamazepine in the first term trimester
carbamazepine-induced toxicity. of pregnancy in the various prospective
studies is still too limited for a firm
An increase in hypersensitivity (e.g. rash,
conclusion to be drawn about whether this
hypereosinophilia) may occur when
risk of malformation is real. However, some
procarbazine is taken concurrently.
studies suggest that carbamazepine may
Carbamazepine, like other psychoactive cause an increase in neural tube closure
drugs, may reduce alcohol tolerance. anomalies, e.g. spina bifida,
Therefore patients should abstain from myelomeningocele (the risk reaches 1%
alcohol during treatment. which is 10-fold higher than the normal rate),
malformations for which an antenatal
Interference with serological examinations
diagnostic is possible and other congenital
abnormalities e.g. craniofacial defects,
cardiovascular malformations, hypospadias Patients should be informed of the increased

and anomalies involving various body risk of malformations and access to prenatal
systems. screening be made available. A specific
antenatal diagnosis can be proposed even for
Taking these data into consideration:
women with a supplementary treatment of
Carbamazepine may be used during folic acid.
pregnancy only after careful risk/benefit
In the new-born child:
evaluation. Women of childbearing age
should be advised of the necessity to plan and Enzymatic inducers have provoked:
ensure supervision of pregnancy.
Uncommon: bleeding disorders occurring in
If a woman is pregnant or plans to become the first 24 hours of the life of a treated
pregnant, the necessity of treatment should be mother's child. Prevention by oral vitamin K1
reconsidered. In epilepsy, if possible, to the mother, in the month prior to the birth,
carbamazepine should be prescribed as a and an adapted dose to the new-born child at
monotherapy, and minimum effective doses the moment of birth, seem appropriate.
should be given, based on clinical response
Rarely: problems with the phosphocalcic
only. Monitoring of plasma concentrations of
metabolism and bone mineralisation.
unbound carbamazepine may be useful (see
section 4.2). A few cases of convulsions and/or respiratory
depression in newborn babies have been
In women of childbearing age carbamazepine
reported, as well as some cases of vomiting,
should, wherever possible, be prescribed as
diarrhoea and/or reduced nutritional intake
monotherapy, because the incidence of
have been observed in connection with
congenital abnormalities in the offspring of
administration of antiepileptics. These could
women treated with a combination of
be signs of withdrawal syndrome in newborn
antiepileptic drugs is greater than in those of
babies.
mothers receiving the individual drugs as
monotherapy. Breast-feeding
During the pregnancy, an effective Carbamazepine and its main metabolite,
antiepileptic carbamazepine treatment must carbamazepine-epoxide, are both present in
not be interrupted, since the aggravation of breast milk in concentrations of about 25 – 60
the illness is detrimental to both the mother % of the total plasma concentration. Due to
and the foetus. the possible onset of non-dose-dependent
adverse effects in the neonate, breast-feeding
Monitoring and prevention:
is not recommended during treatment for
The prevention of neural tube anomalies by safety reasons. Breast-feeding should be
folic acid in pregnant women treated with stopped if signs of sedation become apparent.
carbamazepine is not fully demonstrated at
There are some reports of cholestatic
present. However, taking into account that
hepatitis in newborn babies who were
folic acid deficiency due to the enzyme
exposed to carbamazepine antenatally or
induction caused by carbamazepine may be a
during breast-feeding. As a result, breast-fed
contributory factor for foetal abnormality, it
children whose mothers are being treated
may therefore be beneficial to take folic acid
with carbamazepine should be carefully
before (2 months) and during pregnancy.
monitored for undesirable hepatobiliary a manifestation of relative overdosage or

effects. significant fluctuation in plasma levels. In
such cases it is advisable to monitor the
Fertility
plasma levels and divide the daily dosage into
There have been rare reports of impaired smaller fractional doses.
male fertility and/or abnormal
Side effects listed according to organ system
spermatogenesis.
with the frequency estimate very common
Women of child bearing age and (≥1/10), common (≥1/100 to <1/10),
contraception uncommon (≥1/1,000 to <1/100), rare
(≥1/10,000 to <1/1,000), very rare
Due to the adverse interactions of
(≤1/10,000) and not known (cannot be
carbamazepine with oestrogen and/or
estimated from the available data):
progesterone containing drugs, an alternative
method of contraception should be used (see Infections and infestations
section 4.5).
Not known: Reactivation of an infection with
4.7 Effects on ability to drive and use human herpes virus 6
machines
Blood and lymphatic system disorders
Carbamazapine has major influence on the
ability to drive and use machines. It affects Very common: Leucopenia
patients' reactions, causing dizziness,
Common: eosinophilia, thrombocytopenia
drowsiness, fatigue, ataxia, double vision,
blurred vision, especially in the early stages Rare: Lymphadenopathy, leucocytosis
of treatment. This may be further influenced
Very rare: Agranulocytosis, aplastic
by higher dose levels or the use of
anaemia, pure red cell aplasia, anaemia,
carbamazepine in combination with other
megaloblastic anaemia, reticulocytosis,
centrally acting drugs or in conjunction with
haemolytic anaemia, enlarged spleen,
alcohol consumption. Patients should be
pancytopenia
warned of the possible hazards when driving
or operating machinery. Not known: Bone marrow depression
4.8 Undesirable effects According to literature sources the most
The following undesirable effects appear frequent disorder is benign leucopenia, 10%
dependent on the dose in particular at the start of the cases being of a transient nature, 2%
of therapy, too high initial dose or in older persistent.
patients. These symptoms may abate
spontaneously within a few days or if the Immune system disorders
dose is transiently reduced: Uncommon: Delayed multi-organ
dizziness, headache, ataxia, drowsiness, hypersensitivity disorder with fever, skin
fatigue, diplopia, nausea, vomiting and rashes, vasculitis, swollen lymph nodes,
allergic skin reactions. pseudolymphoma, painful joints (arthralgia),
leucopenia, eosinophilia,
The dose-related adverse reactions usually hypogammaglobulinaemia, enlargement of
abate within a few days, either spontaneously liver and spleen or altered liver function tests
or after a transient dosage reduction. The and vanishing bile duct syndrome occurring
occurrence of CNS adverse reactions may be in various combinations. Other organs such
as lung, kidney, pancreas, colon and cardiac Not known: Memory impairment
muscle may also be affected
Eye disorders
Very rare: Generalised acute allergic
Common: Accommodation disorders,
reactions, anaphylactic reactions,
diplopia
angioedema, hypogammaglobulinaemia
Rare: Lenticular opacities
Not known: Drug rash with eosinophilia and
systemic symptoms (DRESS) Very rare: Conjunctivitis, retinotoxicity,
cataracts
Endocrine disorders
Ear and labyrinth disorders
Common: Weight gain, hyponatraemia
Uncommon: Tinnitus
Metabolism and nutrition disorders
Very rare: Change in pitch perception,
Common: Fluid retention
hypoacusis and hyperacusis
Rare: Folic acid deficiency, reduced appetite
Cardiac disorders
Psychiatric disorders
Uncommon: Conduction disorders, AV-
Uncommon: Confusion and agitation in older block, in isolated cases with syncope,
patients, depressive disorders, aggressive bradycardia, cardiac arrhythmias,
behaviour, thinking difficulties, aggravation of coronary artery disease,
hallucinations (visual or auditory), activation congestive heart failure
of latent psychosis
Vascular disorders
Rare: Restlessness, mania
Uncommon: Vasculitis
Very rare: Phobias
Rare: Hypertension, hypotension
Nervous system disorders
Very rare: Thrombophlebitis, thrombo-
Very common: Dizziness, somnolence, embolism, circulatory collapse
sedation, ataxia (atactic and cerebral
Respiratory, thoracic and mediastinal
disturbances)
disorders
Common: Headache
Very rare: Pulmonary hypersensitivity
Uncommon: Lack of drive, involuntary reactions with fever, dyspnoea, pneumonitis
movements like asterixis, tremor, dystonia or or pneumonia (alveolitis), lung fibrosis
tics or nystagmus.
Gastrointestinal disorders
Rare: Dyskinetic disorders like orofacial
Very common: Nausea, vomiting
dyskinesia, choreoathetosis, eye movement
disturbances, speech disorders, paraesthesia, Common: Loss of appetite, dry mouth
neuropathy peripheral, polyneuropathy,
Uncommon: Diarrhoea, constipation
peripheral neuropathy, paresis
Rare: Abdominal pain
Very rare: Taste disturbances, neuroleptic
malignant syndrome, aseptic meningitis with Very rare: Stomatitis, gingivitis, glossitis,
myoclonus and peripheral eosinophilia pancreatitis
Not known: Colitis Very rare: Arthralgia, muscle pain, muscle

spasms, bone metabolism disorder
Hepatobiliary disorders
Not known: Fracture
Rare: Jaundice, hepatitis (cholestatic,
hepatocellular, granulomatous, mixed type), There have been reports of decreased bone
vanishing bile duct syndrome, liver failure mineral density, osteopenia, osteoporosis and
fractures in patients on long-term therapy
Skin and subcutaneous tissue disorders
with carbamazepine. The mechanism by
Very common: Allergic skin reactions with which carbamazepine affects bone
or without fever like urticaria (which may be metabolism has not been identified.
severe)
Carbamazepine may increase the metabolism
Uncommon: Pruritus, exfoliative dermatitis, of 25-OH-Cholecalciferol leading to a
erythroderma, alopecia, hyperhidrosis decreased calcium level, which rarely causes
osteomalacia, arthralgia, myalgia and muscle
Rare: Systemic lupus erythematosus
cramps.
Very rare: Severe cutaneous adverse
Renal and urinary disorders
reactions (SCARS): Stevens-Johnson
syndrome (SJS) and toxic epidermal Uncommon: Renal impairment such as
necrolysis (TEN) (see section 4.4), proteinuria, haematuria, oliguria, elevated
alterations in skin pigmentation, acne, BUN/azotaemia
hirsutism, photosensitivity, erythema
Rare: Other micturition disorders like
exudativum, multiforme and nodosum,
dysuria, pollakiuria, urinary frequency and
purpura, acute generalised exanthematous
urinary retention
pustulosis (AGEP)
Very rare: Renal failure, interstitial nephritis
Not known: Lichenoid keratosis,
onychomadesis Reproductive system and breast disorders
There is increasing evidence regarding the Rare: Gynaecomastia, galactorrhoea
association of genetic markers and the
Very rare: Sexual dysfunction like
occurrence of cutaneous ADRs such as SJS,
impotence, decreased libido and impaired
TEN, DRESS, AGEP and maculopapular
male fertility and/or abnormal
rash. In Japanese and European patients,
spermatogenesis (reduces sperm count and/or
these reactions have been reported to be
motility)
associated with the use of carbamazepine and
the presence of the HLA-A*3101 allele. Congenital, familial and genetic disorders
Another marker, HLA-B*1502 has been
Very rare: Porphyria acute (acute intermittent
shown to be strongly associated with SJS and
porphyria and variegate porphyria),
TEN among individuals of Han Chinese,
porphyria non-acute (porphyria cutanea
Thai and some other Asian ancestry (see
tarda)
sections 4.2 and 4.4).
General disorders and administration site
Musculoskeletal and connective tissue
conditions
disorders
Very common: Fatigue
Rare: Muscle weakness
Common: Oedema cardiovascular, gastrointestinal,

musculoskeletal, renal or respiratory
Investigations
systems.
Very common: Elevated gamma-GT (due to
Central nervous system: CNS depression,
hepatic enzyme induction), usually not
disorientation, somnolence, agitation,
clinically relevant
hallucination, coma, stupor, vertigo,
Common: Elevated alkaline phosphatase in restlessness, confusion, blurred vision,
the blood, reduced plasma osmolality due to slurred speech, dysarthria, nystagmus, ataxia,
an antidiuretic hormone (ADH)–like effect, dyskinesia, initially hyperreflexia, later
leading in rare cases to water intoxication hyporeflexia; convulsions, psychomotor
accompanied by lethargy, vomiting, disturbances, myoclonus, opisthotonus,
headache, mental confusion, neurological involuntary movements, tremor, flushing,
abnormalities seizures, EEG dysrhythmia, hypothermia,
mydriasis.
Uncommon: Increased transaminases
Respiratory system: Respiratory depression,
Very rare: Elevated levels of cholesterol,
pulmonary oedema, cyanosis, respiratory
including HDL cholesterol, and triglycerides,
arrest.
increased intraocular pressure, abnormal
thyroid function tests: decreased L-Thyroxin Cardiovascular system: Tachycardia,
(free thyroxine, thyroxine, tri-iodothyronine) changes in blood pressure (hypotension and
and increased blood thyroid stimulating at times hypertension), cardiac arrhythmias,
hormone, usually without clinical AV block, cardiac arrest, flushing,
manifestations, blood prolactin increased, conduction disturbance with widening of
increase in serum cortisol QRS complex; syncope in association with
cardiac arrest.
Carbamazepine may lower the plasma levels
of folic acid and vitamin B12, and may Gastrointestinal system: Nausea, vomiting,
increase the plasma level of homocysteine. delayed gastric emptying, reduced bowel
motility.
Reporting of suspected adverse reactions
Musculoskeletal system: Rhabdomyolysis
Reporting suspected adverse reactions after
authorisation of the medicinal product is Renal function: Retention of urine, oliguria
important. or anuria; fluid retention, water intoxication
due to ADH-like effect of carbamazepine.
4.9 Overdose
Carbamazepine overdose has been reported Laboratory findings: Hyponatraemia,
only with very high doses (4 - 20 g). Plasma possibly metabolic acidosis, possibly
levels were always above 20 µg/ml. A plasma hyperglycaemia, increased muscle creatinine
level of 38 µg/ml was not lethal for the phosphokinase, leucocytosis, leucopenia,
patient. Lethal cases of carbamazepine neutropenia, glycosuria, acetonuria.
overdose have been reported in literature.
Management of symptoms
Symptoms
There is no specific antidote for
The presenting signs and symptoms of carbamazepine overdose.
overdosage involve the central nervous,
Management of symptoms due to overdosage 5.1 Pharmacodynamic properties

will vary according to the patient's condition. Pharmacotherapeutic group: Antiepileptic
This includes admission to hospital.
Mechanism of action
Measurement of the plasma levels to confirm
carbamazepine poisoning and to ascertain the It is thought to block cyclic-AMP mediated
size of the overdose. Evacuation of the calcium influx associated with transmitter
stomach, gastric lavage, and administration release, and it is known to be an adenosine
of activated charcoal or laxative. Delayed receptor antagonist: either of these actions
evacuation of the stomach may lead to might account for its antiepileptic action.
delayed absorption, leading to relapse during Work in animals has shown that it has
recovery from intoxication. Supportive inhibitory effects on hippocampal discharges
medical care in an intensive care unit with and it also inhibits the reticulo-thalamic and
cardiac monitoring and careful correction of thalamocortical projections which are
electrolyte imbalance, if required. involved in tonic-clonic seizures.
Special recommendations: Antiepileptics have membrane-stabilising
properties which have been found useful in
Hypotension: administer dopamine or
the relief of neurogenic pain especially where
dobutamine i.v.
there is a lancinating element, as in
Disturbances of cardiac rhythm: to be trigeminal neuralgia.
managed on an individual basis.
5.2 Pharmacokinetic properties
Convulsions: administer a benzodiazepine Absorption
(e.g. diazepam) or another
Carbamazepine is almost completely
anticonvulsant, e.g. phenobarbitone (with
absorbed but the rate of absorption is slow
caution because of increased respiratory
and may vary between patients.
depression) or paraldehyde.
Peak plasma concentrations of the unchanged
Hyponatraemia (water intoxication): fluid
active substance are attained within 24 hours.
restriction and slow careful NaCl 0.9 %
The bioavailability of carbamazepine has
infusion i.v.
been shown to lie between 85 - 100 % and is
These measures may be useful in preventing unaffected by food.
brain damage.
Evaluation of literature allows the conclusion
Charcoal haemoperfusion has been concerning therapeutic and toxic plasma
recommended. Haemodialysis is an effective levels that seizures are controlled at plasma
option in the treatment of carbamazepine levels between 4 and 12 µg/ml, levels above
overdose. Forced diuresis, and peritoneal 20 µg/ml resulted in a deterioration of
dialysis have been reported not to be symptoms. Control of pain of trigeminal
effective. neuralgia was effective at plasma levels
between 5 and 18 µg/ml. Side effects start
Relapse and aggravation of symptomatology
appearing at plasma levels above 8–9 µg/ml.
on the 2nd and 3rd day after overdose, due to
delayed absorption, should be anticipated. Distribution
5. PHARMACOLOGICAL Carbamazepine is 70 - 80 % bound to plasma.
PROPERTIES The proportion of unbound carbamazepine is
constant at a concentration of up to 50 μg/ml.
The pharmacologically active metabolite medication. In patients receiving co-

carbamazepine-10,11-epoxide is bound to medication with other enzyme-inducing
plasma protein at 48-53% (about 0.74 L/kg). drugs such as phenytoin, phenobarbitone,
half-life values averaging 9-10 hours have
The concentration of carbamazepine in the
been observed.
cerebrospinal fluid is 33% of the current
plasma concentration. The concentration of Special population
unchanged substance in the saliva represents
Carbamazepine should be used with caution
the unbound portion in plasma, i.e. 20 - 30 %
in patients with renal impairment.
of total plasma concentration. In breast milk
the concentration is 25 - 60% of total plasma In advanced hepatic disease, carbamazepine
concentration. Carbamazepine crosses the metabolism may be impaired.
placental barrier. Apparent volume of
The pharmacokinetics of carbamazepine are
distribution: 0.8 - 1.9 L/kg.
unaltered in older people but its metabolism
Biotransformation may be affected by hepatic dysfunction. The
formulation of carbamazepine produces a
Carbamazepine is extensively metabolised in
substantial reduction in intra-dose
the liver, mainly by oxidative pathways of
fluctuations in carbamazepine concentrations
which only the metabolite carbamazepine-
and tolerability and seizure control in patients
epoxide is pharmacologically active. This
with epilepsy may be improved.
may constitute up to 30 % of the circulating
active material originality as carbamazepine. The formulation should be considered in
The inactive 10,11-diol represents the final patients receiving high doses who suffer
stage of carbamazepine biotransformation. In intermittent adverse effects such as diplopia,
children, the relatively high rate of nausea, dizziness and tiredness and may offer
metabolism of the drug may require higher the opportunity to reduce the dosage regimen.
dose (in mg/kg b.w.) of carbamazepine to
maintain therapeutic concentrations. 5.3 Preclinical safety data
Non-clinical data reveal no special hazard for
Elimination humans based on conventional studies of
safety pharmacology, repeated dose toxicity,
Only about 1 % of the administered dose is
genotoxicity and carcinogenic potential.
excreted in the urine in the unchanged form.
Reproductive toxicity studies in animals were
A greater part is excreted in the urine almost
insufficient to rule out a teratogenic effect of
entirely in the form of its metabolites; some
carbamazepine in humans.
is excreted in faeces.
Carcinogenicity
Plasma clearance in healthy subjects is about
19.8 ± 2.7 ml/h/kg, in patients under In rats treated with carbamazepine for 2
monotherapy about 54.6 ± 6.7 ml/h/kg, in years, there was an increased incidence of
patients under combination therapy about hepatocellular tumours in females and benign
113.3 ± 33.4 ml/h/kg. testicular tumours in males. However, there
is no evidence that this observation is of
The elimination half-life of unchanged drug
importance for the therapeutic use of
in the plasma averages approximately 36
carbamazepine in humans.
hours following a single dose, whereas after
repeated administration, it averages only 16 - Reproductive toxicity
24 hours, depending on the duration of the
In animal studies in mice, rats and rabbits oral 6.5 Nature and contents of container
administration of carbamazepine during Child-proof containers:
organogenesis led to an increased embryo-
PVC/PVDC/Al blisters.
foetal mortality and foetal growth retardation
at daily doses which were associated with Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100
maternal toxicity (above and 500mg modified-release tablets.
200mg/400mg/kg/day). Carbamazepine was
Not all pack sizes may be marketed.
teratogenic in a number of studies,
particularly in mice, however showed no or 6.6 Special precautions for disposal and
only minor teratogenic potential at doses other handling
relevant to humans. In a reproductive study No special requirements
in rats, nursing offspring exhibited reduced
weight gain at a maternal dosage level of 192
mg/kg/day. 7. MANUFACTURED IN INDIA BY:
6. PHARMACEUTICAL
PARTICULARS TAJ PHARMACEUTICALS LTD.
Mumbai, India
a) Each tablet contains:
Unit No. 214.Old Bake House,
Carbamazepine USP 200mg Maharashtra chambers of Commerce Lane,
Fort, Mumbai - 400001
Excipients q.s.
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-
b) Each tablet contains:
800-222-825)
Carbamazepine USP 400mg Monday through Saturday 9:00 a.m. to 7:00
p.m. EST
Excipients q.s.
E-mail: tajgroup@tajpharma.com
6.1 List of excipients
Ammonio methacrylate copolymer (type B)
(contains: sorbic acid and sodium
hydroxide), Methacrylic acid - ethyl acrylate
copolymer (1:1) (contains: sodium
laurilsulfate and polysorbate 80), Triacetin,
Talc, Cellulose, microcrystalline,
Crospovidone, Silica, colloidal anhydrous,
Magnesium stearate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
No special precautions for storage

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Carbamazepine Tablets USP 200mg/ 400mg Taj Pharma Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings,

CARBAMAZEPINE TABLETS USP Posology

2. QUALITATIVE AND A maximum daily dose of 1600 - 2000 mg

• generalised tonic-clonic Before deciding to initiate treatment, patients

Epilepsy: Antiepileptic therapy is a long-term

possible, these individuals should be subjects of European ancestry, whereas its

DRESS, AGEP or maculopapular rash and - myotonic dystrophy, as cardiac conduction

In patients with severe cardio-vascular with DRESS, a delayed multi-organ

the formation of the 10, 11-transdiol Serum levels of carbamazepine can be

Antiepileptics: felbamate, lamotrigine, associated with hepatotoxicity), phenazone,

Cardiovascular drugs: calcium channel There is an indication of a higher risk of

cardiovascular malformations, hypospadias Patients should be informed of the increased

monitored for undesirable hepatobiliary a manifestation of relative overdosage or

Not known: Colitis Very rare: Arthralgia, muscle pain, muscle

Common: Oedema cardiovascular, gastrointestinal,

Management of symptoms due to overdosage 5.1 Pharmacodynamic properties

The pharmacologically active metabolite medication. In patients receiving co-

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