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Basic Drug Info
Drug Name:Carbamazepine
Manufacturer:CARACO PHARMACEUTICAL LABORATORIES, LTD.
Other Info:



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 appearĀ 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 (petitmal) 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."

Absence Epilepsy -- A childhood seizure disorder characterized by rhythmic electrical brain discharges of generalized onset. Clinical features include a sudden cessation of ongoing activity usually without loss of postural tone. Rhythmic blinking of the eyelids or lip smacking frequently accompanies the SEIZURES. The usual duration is 5-10 seconds, and multiple episodes may occur daily. Juvenile absence epilepsy is characterized by the juvenile onset of absence seizures and an increased incidence of myoclonus and tonic-clonic seizures. (Menkes, Textbook of Child Neurology, 5th ed, p736)

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.Co-administration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect.

Co-administration 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

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 to be about 10 times higher.

Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related.

If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
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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