SPL Set ID: ac18e5fa-e2ee-4aa5-8d0f-94b63a076e66

Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP , an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white, odorless or practically odorless powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.24. Levodopa, USP, an aromatic amino acid, is a white to off-white, odorless , crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid and insoluble in alcohol with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C Blue #2 Aluminium Lake and FD&C Red #40 Aluminium Lake. The 25 mg/100 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L519” on one side and plain on the other. The 50 mg/200 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L520” on one side and plain on the other. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution specifications differs from the USP dissolution specifications. Structure-Carbidopa Structure-Levodopa