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zonisamide
Zonegran
  Pharmaceutical company:
Eisai Inc.
www.eisai.com

NEW WARNING
After reviewing clinical data, the Food and Drug Administration (FDA) has determined that zonisamide (Zonegran), a drug used as adjunct therapy for partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Metabolic acidosis is an acid-base imbalance that results from excess acid in the blood. This imbalance is diagnosed by measuring the level of bicarbonate in the blood. Metabolic acidosis can cause hyperventilation, fatigue, anorexia, cardiac arrhythmias, and stupor. Chronic metabolic acidosis can have adverse effects on the kidneys and bones and can retard growth in children. Patients with renal disease, diarrhea, or severe respiratory conditions or individuals following a ketogenic diet or taking certain other drugs may be at higher risk for developing metabolic acidosis while taking zonisamide. Zonisamide-associated metabolic acidosis tends to occur more frequently and be more severe in younger patients.
    The FDA recommends that health care providers monitor bicarbonate levels before and periodically during treatment with zonisamide. If metabolic acidosis develops and persists, reduce the dose or discontinue the drug by tapering it and modifying antiepileptic therapy, as needed. If continuing the drug with metabolic acidosis, consider treating acidosis with an alkali.

     
   

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