Zonegran Labeling Updated with New Warning
The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Zonegran (zonisamide, Concordia) capsules to include a new warning in the prescribing information.
The sNDA update includes a subsection describing the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) to the Warnings section as well as additional DRESS information to the Medication Guide.
DRESS, also known as multi-organ hypersensitivity, has occurred with use of Zonegran. It typically presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Early manifestations of hypersensitivity may be present even though the rash is not evident. If such signs and symptoms appear, the patient should be evaluated immediately. If an alternative etiology for the signs and symptoms cannot be established, Zonegran should be discontinued.
Zonegran, a sulfonamide, is indicated as adjunct therapy in the treatment of partial ;seizures in adults with epilepsy. It is available as 25mg and 100mg strength capsules in 100-count bottles.
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