SPL Set ID: 1b0458ea-e718-4d48-ae55-ad9b4d863810

Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23 H 15 N 3 O ∙ ¾H 2 O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is: Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&C Blue No. 2 and the 8 mg contains FD&C Red No. 40. Chemical Structure