Zep Alcohol Sanitizer Recall
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Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease.
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Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its molecular formula is C10 H17 N3 S 2HCl H2O, and its molecular weight is 302.26. The structural formula is:
Pramipexole dihydrochloride (monohydrate), USP is a white to almost white crystalline powder and it is freely soluble in water, soluble in methanol, slightly soluble in alcohol and practically insoluble in methylene chloride. Melting occurs in the range of 296o to 301oC, with decomposition.
Each pramipexole dihydrochloride tablet intended for oral administration contains 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, mannitol, magnesium stearate, pregelatinized starch and povidone. Additionally each 0.125 mg tablet contains D&C red no. 27 aluminum lake, each 0.25 mg tablet contains FD&C blue no. 1 aluminum lake, each 0.5 mg tablet contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake, each 1 mg tablet contains ferric oxide red and each 1.5 mg tablet contains ferric oxide yellow.