| Drug Name: | Carbamazepine |
| Manufacturer: | CARACO PHARMACEUTICAL LABORATORIES, LTD. |
| Other Info: | |
| Clinical Trials: | |
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).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.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.