Drug Catalog - Product Detail
ZONISAMIDE CP 50MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-6726-01 | MYLAN | 100 | 50MG | CAPSULE |
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Description
DESCRIPTION Zonisamide capsules, USP are an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C 8 H 8 N 2 O 3 S with a molecular weight of 212.23. Zonisamide, USP is a white or almost white crystalline powder, pK a = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is: Zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Red No. 28, FD&C Blue No. 1, gelatin and titanium dioxide. In addition, the 100 mg empty gelatin capsule contains FD&C Red No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Zonisamide Structural Formula
How Supplied
HOW SUPPLIED Zonisamide Capsules, USP are available containing 25 mg, 50 mg or 100 mg of zonisamide, USP. The 25 mg capsule is a violet opaque cap and lavender opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 6725 in black ink on both the cap and body. They are available as follows: NDC 0378-6725-01 bottles of 100 capsules The 50 mg capsule is a violet opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 6726 in black ink on both the cap and body. They are available as follows: NDC 0378-6726-01 bottles of 100 capsules The 100 mg capsule is a violet opaque cap and light blue opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 6727 in black ink on both the cap and body. They are available as follows: NDC 0378-6727-01 bottles of 100 capsules NDC 0378-6727-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Indications & Usage
INDICATIONS AND USAGE Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Dosage and Administration
DOSAGE AND ADMINISTRATION Zonisamide capsules are 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. Zonisamide capsules should be administered once or twice daily, using 25 mg, 50 mg or 100 mg capsules. Zonisamide capsules are 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 zonisamide capsules 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 zonisamide capsules 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 ). There is little experience with doses greater than 600 mg/day. Patients with 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 ).