Brand Name: Zonegran
Active Ingredient: zonisamide
Indication: Adjunctive therapy in the treatment of partial seizures in adults with epilepsy
Company Name: Elan Corporation, plc
Availability: Approved by FDA on March 28, 2000; Zonegran has been marketed under the trade name Excegran since 1989 in Japan
Another new antiseizure medication has entered to drug arena, the latest in a spate of new drugs for partial onset epilepsy (see previous articles on Keppra and Trileptal). On March 28, 2000, the FDA approved Zonegran (zonisamide) to be used in addition to other drugs in the treatment of partial seizures in adults with epilepsy. Zonegran has been marketed under the trade name Excegran since 1989 in Japan. Zonegran is manufactured by Elan Corporation, plc, a biotechnology company headquartered in Ireland.
Zonegran: Clinical Study Results
The effectiveness of Zonegran was established in three 3-month clinical trials involving 499 patients (209 women and 290 men) with a history of at last four partial onset seizures per month in spite of receiving one or two antiepilepsy drugs. Zonegran or a placebo was added to each patient’s existing therapy.
All three studies showed that patients who took Zonegran experienced a significantly greater reduction in partial seizures – between 27% and 40%, versus 1%-9% for placebo. Moreover, the percentage of patients who responded to Zonegran was greater than that for placebo – generally about twice as much. The response to Zonegran was significantly greater than that for placebo for all dose levels studied (100 mg/day, 200 mg/day, and 400-600 mg/day).
Zonegran: What You Should Know
Zonegran has been associated with side effects similar to those of other antiepileptic drugs. The most commonly observed side effects are drowsiness, weight loss, dizziness, headache, nausea and vomiting, agitation/irritability, fatigue, and difficulty concentrating. Patients should not drive a car or operate other complex machinery until they have gauged their experiences on Zonegran and determined how it affects their performance.
Patients should contact their physician immediately if they develop a skin rash or if their seizures worsen; if they develop signs or symptoms such as sudden back or abdominal pain or blood in the urine (which may indicate kidney stones); or if they develop a fever, sore throat, mouth sores, or easy bruising.
Since Zonegran may cause birth defects, patients should use contraceptives while taking the drug, and notify their physicians if they become pregnant or intend to become pregnant during therapy. Patients should also notify their physicians if they intend to breastfeed an infant while taking Zonegran. Because Zonegran is a sulfonamide, patients who are allergic to sulfa drugs should not take Zonegran.