SPL Set ID: fe15e56e-8b86-4a65-825c-31d37dd81612

Zonisamide, USP is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, USP, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C 8 H 8 N 2 O 3 S with a molecular weight of 212.23 g/mol. Zonisamide, USP is a white 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, USP is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide, USP plus the following inactive ingredients: hydrogenated vegetable oil, microcrystalline cellulose, and sodium lauryl sulfate. The printed capsule shell of the different strengths is made from the following ingredients: 25 mg – D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide 50 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide 100 mg – D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and titanium dioxide The dyes used in the printing ink are FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 aluminum lake and iron oxide black. Additionally, the printing ink also contains propylene glycol and shellac. structure.jpg