SPL Set ID: 0eb24333-3c11-41dd-888d-3a30d3c9d188
1 drug(s) with this SPL Set ID
Carbidopa and levodopa extended-release tablets, USP are 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 g/mol. It is designated chemically as (-)-L-α- hydrazino-3,4-dihydroxy-α-methyldrocinnamic acid monohydrate. Its molecular 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 226.23 g/mol. Levodopa, USP an aromatic amino acid, is a white to off-white crystalline powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and insoluble in alcohol, with a molecular weight of 197.19 g/mol. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. Its molecular 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: hydroxypropyl cellulose, lake blend purple (contains FD&C Red No. 40, FD &C Blue No. 2) and magnesium stearate. The 50 mg/200 mg tablets are supplied as purple, oval, convex tablets, debossed with “G” left of bisect on one side and “391” on the other side with mottled appearance. The 25 mg/100 mg tablets are supplied as purple, oval, convex tablets, debossed with “G” on one side and “392” on other side with mottled appearance. The 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 tablet, 25 mg/100 mg is available to facilitate titration and as an alternative to the half-tablet of carbidopa and levodopa extended-release tablet, 50 mg/200 mg. Meets USP Dissolution Test 2. 1 1