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.