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__________________________________________________________________________________ Indication PEGANONE is indicated for the control of tonic-clonic (grand-mal) and complex (psychomotor) seizures. Important Safety Information PEGANONE is contraindicated in patients with hepatic abnormalities or hematologic disorders. Antiepileptic drugs (AEDs), including PEGANONE, increase the risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, or suicidal thoughts or behavior. PEGANONE can cause fetal harm including neonatal coagulation defect. Use during pregnancy can result in an increased incidence of birth defects. Antiepileptic drugs should not be discontinued because of the strong possibility of precipitating status epilepticus with attendant hypoxia and risk to both mother and the unborn child. Blood dyscrasias have been reported in patients receiving PEGANONE. Isolated cases of lymphadenopathy and systemic lupus erythromatosus have occurred with PEGANONE. For more information, please see Full Prescribing Information. |
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