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NDC 51672-4005-03

Carbamazepine 200 mg/1 TABLET

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NDC
51672-4005-03
Generic Name
Carbamazepine
Brand Name
Carbamazepine
Strength
200 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
Labeler
Sun Pharmaceutical Industries, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patter…

Important Warnings

WARNINGS Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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