carbamazepine

FDA Drug Profile — Tegretol XR, carbamazepine, Carbamazepine, Tegretol, Carbatrol

Drug Details

Generic Name
carbamazepine
Brand Names
Tegretol XR, carbamazepine, Carbamazepine, Tegretol, Carbatrol, CARBAMAZEPINE ER
Application Number
NDA020234
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
29
Dosage Forms
TABLET, EXTENDED RELEASE, SUSPENSION, CAPSULE, EXTENDED RELEASE, TABLET
Routes
ORAL
Active Ingredients
CARBAMAZEPINE

Indications and 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: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS , General). Trigeminal Neuralgia Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.