SPL Set ID: 00699692-532a-68fd-8a51-3770a81b2208
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 molecular 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 USP is a white to almost white, crystalline powder. It is freely soluble in water, soluble in methanol, slightly soluble in alcohol (99.6%) and practically insoluble in methylene chloride. Melting occurs in the range of 293°C to 306°C, with decomposition. 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, USP. 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, USP. 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, USP. Pramipexole dihydrochloride extended-release tablets 3 mg: Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg Pramipexole Dihydrochloride, USP. 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, USP. Inactive ingredients for all strengths of pramipexole dihydrochloride extended-release tablets consist of carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and pregelatinized starch.