Important Safety Information for Health Care Professionals

• Carbatrol^® contains carbamazepine. Please ensure patient is not taking any other form of carbamazepine.
• The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. Initiating therapy at the lowest possible effective dose can minimize adverse reactions.
• Toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported with use of carbamazepine. These skin disorders are rare, but appear to be more common in patients of Asian ancestry. A strong association between Asian ancestry and the presence of HLA-B*1502 allele in the development of toxic epidermal necrolysis and Stevens-Johnson syndrome has been reported. Patients of 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 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.
• Carbamazepine is Pregnancy Category D.
• Absence seizures (petit mal) do not appear to be controlled by carbamazepine.

View Important Safety Information for Patients & Caregivers