SPL Set ID: e18b67b6-a085-43e5-bb2b-fe74fa00cb65
1 drug(s) with this SPL Set ID
Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is, a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S ·2HCl·H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride monohydrate USP is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride monohydrate USP is freely soluble in water, soluble in methanol, slightly soluble in alcohol, practically insoluble in methylene chloride. Pramipexole Dihydrochloride Extended-Release Tablets 0.375 mg: Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 0.75 mg: Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 1.5 mg: Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 2.25 mg: Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 3 mg: Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 3.75 mg: Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 4.5 mg: Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets, for oral administration, contain 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg or 4.5 mg of pramipexole dihydrochloride monohydrate USP. Inactive ingredients are betadex, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methyl cellulose, magnesium stearate and microcrystalline cellulose. Structure