SPL Set ID: 5b6519ff-d1af-402b-83eb-b4fce6743a18

Carbidopa and Levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino- 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 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. 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 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake. The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. Carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP. image description image description