Source: FDA, National Drug Code (US) Revision Year: 2020
MIRAPEX tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl·H2O, and its molecular weight is 302.26.
The structural formula is:
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 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.
MIRAPEX tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.
MIRAPEX tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.
MIRAPEX 0.75 mg tablets: Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride.
MIRAPEX 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.
MIRAPEX 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.
Inactive ingredients for all strengths of MIRAPEX tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.
| Dosage Forms and Strengths |
|---|
|
0.125 mg: white, round tablet with “BI” on one side and “83” on the reverse side. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. 0.25 mg: white, oval, scored tablet with “BI” on one side and “84 84” on the reverse side. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. 0.5 mg: white, oval, scored tablet with “BI” on one side and “85 85” on the reverse side. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. 0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side. Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. 1 mg: white, round, scored tablet with “BI” on one side and “90 90” on the reverse side. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. 1.5 mg: white, round, scored tablet with “BI” on one side and “91 91” on the reverse side. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. |
| How Supplied |
|---|
|
MIRAPEX tablets are available as follows: 0.125 mg: white, round, tablet with “BI” on one side and “83” on the reverse side. Bottles of 90 NDC 0597-0183-90 0.25 mg: white, oval, scored tablet with “BI BI” on one side and “84 84” on the reverse side. Bottles of 90 NDC 0597-0184-90 0.5 mg: white, oval, scored tablet with “BI BI” on one side and “85 85” on the reverse side. Bottles of 90 NDC 0597-0185-90 0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side. Bottles of 90 NDC 0597-0101-90 1 mg: white, round, scored tablet with “BI BI” on one side and “90 90” on the reverse side. Bottles of 90 NDC 0597-0190-90 1.5 mg: white, round, scored tablet with “BI BI” on one side and “91 91” on the reverse side. Bottles of 90 NDC 0597-0191-90 Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA Licensed from: Boehringer Ingelheim International GmbH |
| Drug | Countries | |
|---|---|---|
| MIRAPEX | Canada, Ecuador, Hong Kong, Japan, United States |
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