DESCRIPTION

MIRAPEX Tablets contain pramipexole, a dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinsons disease. The chemical name of pramipexole dihydrochloride is (S)-2-amino- 4,5,6,7-tetra-hydro-6-(propylamino) benzothiazole dihydrochloride mono-hydrate. Its empirical formula is C₁₀H₁₇N₃S · 2 HCl · H₂O, and its molecular weight is 302.27.

Pramipexole dihydrochloride is a white to off- white powder substance. Melting occurs in the range of 296° C to 301° C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane.

MIRAPEX Tablets, for oral administration, contain 0.125 mg, 0.25 mg, 1.0 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.