Anticonvulsants should be taken in the manner and at the times prescribed by the
physician.
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.
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