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»Important Safety Information
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About Taking Equetro
Important Safety Information
Please see Full Prescribing Information including contraindications, warnings and boxed warnings concerning serious and sometimes fatal dermatologic reactions, aplastic anemia, and agranulocytosis.

Equetro 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.

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.

Because the possibility of suicide attempts is inherent in bipolar disorder, close supervision of high-risk patients should accompany drug therapy. Before prescribing Equetro, the physician should be thoroughly familiar with the details of the product prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.

© 2008, Validus Pharmaceuticals, Inc. All rights reserved.


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