Please click here to view the Full Prescribing Information
Please click here to view the Medication Guide
Indications
Carbatrol 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 improvements 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.
Important Safety Information
WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with the use of carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian populations, but the risk is estimated to be about 10 times higher in some patients of Asian ancestry. Studies have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502 allele. This allele is found almost exclusively in patients with Asian ancestry. Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating Carbatrol. Patients testing positive for the allele should not be treated with Carbatrol unless the benefit clearly outweighs the risk.
APLASTIC ANEMIA AND AGRANULOCYTOSIS
Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine. Reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of carbamazepine. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis. Nonetheless, complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.
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. Use of carbamazepine with monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days after their discontinuation, is not recommended. Coadministration of carbamazepine with nefazodone is contraindicated.
Carbatrol 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. Carbatrol should not be used with any other medications containing carbamazepine.
Antiepileptic drugs, including Carbatrol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.
Carbamazepine is in Pregnancy Category D. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients carbamazepine has been associated with increased frequency of generalized convulsions. Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac, hepatic, or renal damage; adverse hematologic reaction to other drugs; or interrupted courses of therapy with carbamazepine.
Some cardiovascular complications (congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy) have resulted in fatalities. Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, and hepatitis have been observed.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive patient with epilepsy may lead to seizures or even status epilepticus with its life-threatening hazards.
Please see Full Prescribing Information, including Boxed WARNING regarding Serious Dermatologic Reactions/HLA-B*1502 Allele, and Aplastic Anemia and Agranulocytosis.
