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Basic Drug Info
Drug Name:Carbamazepine
Manufacturer:Morton Grove Pharmaceuticals, Inc.
Other Info:

Rx OnlyProd.

No.: 8129Thorazine® is a registered trademark of GlaxoSmithKline.Mellaril® is a registered trademark of Novartis Consumer Health, Inc.Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053A50-8129-16 REV.

11-07



Clinical Trials:


Indications and Usage

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 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).
Partial Seizure -- any seizure due to a lesion in a specific, known area of the cerebral cortex; symptoms vary with different lesion locations.

Generalized seizures -- clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells; clinical manifestations include abnormal motor, sensory and psychic phenomena; recurrent seizures are usually referred to as EPILEPSY or "seizure disorder."

Contraindications

Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc.

Likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended.

Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect.

Coadministration of carbamazepine with nefazodone is contraindicated.
Bone marrow depression --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Patients with a history of adverse hematologic reaction to any drug may be particularly at risk.

Severe dermatologic reactions, including toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, have been reported with carbamazepine.

These reactions have been extremely rare.

However, a few fatalities have been reported.Carbamazepine has shown mild anticholinergic activity; therefore, patients with increased intraocular pressure should be closely observed during therapy.Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be borne in mind.The use of carbamazepine should be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).

Acute attacks have been reported in such patients receiving carbamazepine therapy.

Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria.

As with all antiepileptic drugs, carbamazepine should be withdrawn gradually to minimize the potential of increased seizure frequency.
Branded Drugs
The following US Branded drugs contain Carbamazepine


CARBATROL -- SHIRE DEVELOPMENT INC

EQUETRO -- VALIDUS PHARMACEUTICALS INC

TEGRETOL -- NOVARTIS PHARMACEUTICALS CORP

TERIL -- TARO PHARMACEUTICALS USA INC

EPITOL -- TEVA PHARMACEUTICALS USA INC

TEGRETOL-XR -- NOVARTIS PHARMACEUTICALS CORP

TERIL -- TARO PHARMACEUTICAL INDUSTRIES LTD


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