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Each film-coated tablet contains 200 mg rufinamide.
INOVELON (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3- triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2. The drug substance is a white, crystalline, odorless, and slightly bitter tasting neutral powder. Rufinamide is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile.
INOVELON is available for oral administration in film-coated tablets, scored on both sides, containing 200 of rufinamide.
Excipients/Inactive Ingredients: Colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate.
Film coating: Hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.
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