SPL Set ID: b6935240-ee81-49ef-adad-fb900d7f5127
1 drug(s) with this SPL Set ID
Pramipexole dihydrochloride extended-release tablets contain pramipexole, a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride 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, 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, microcrystalline cellulose, ethylcellulose, hydroxypropyl methyl cellulose, colloidal silicon dioxide, and magnesium stearate. Structure