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ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
DOSAGE AND ADMINISTRATION
ZONEGRAN (zonisamide) is recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below the age of 16 have not been established. ZONEGRAN should be administered once or twice daily, using 25 mg or 100 mg capsules. ZONEGRAN is given orally and can be taken with or without food. Capsules should be swallowed whole.
Adults Over Age 16
The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment. Although the regimen described below is one that has been shown to be tolerated, the prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of zonisamide at steady state, noting that many of the side effects of zonisamide are more frequent at doses of 300 mg per day and above. Although there is some evidence of greater response at doses above 100–200 mg/day, the increase appears small and formal dose-response studies have not been conducted.
The initial dose of ZONEGRAN should be 100 mg daily. After two weeks, the dose may be increased to 200 mg/day for at least two weeks. It can be increased to 300 mg/day and 400 mg/day, with the dose stable for at least two weeks to achieve steady state at each level. Evidence from controlled trials suggests that ZONEGRAN doses of 100–600 mg/day are effective, but there is no suggestion of increasing response above 400 mg/day (see CLINICAL PHARMACOLOGY, Clinical Studies subsection). There is little experience with doses greater than 600 mg/day.
Patients Qith Renal Or Hepatic Disease
Because zonisamide is metabolized in the liver and excreted by the kidneys, patients with renal or hepatic disease should be treated with caution, and might require slower titration and more frequent monitoring (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “Eisai” and “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:
|Dosage Strength||Capsule Colors||NDC #|
|25 mg||White opaque body with white opaque cap.||62856-681-10|
|100 mg||White opaque body with red opaque cap.||62856-680-10|
Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.
Manufactured by: Eisai Manufacturing Ltd. Distributed by:Eisai Inc.,Woodcliff Lake, NJ 07677.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/28/2015
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