Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
pramipexole dihydrochloride (UNII: 3D867NP06J) (pramipexole - UNII:83619PEU5T)
Physicians Total Care, Inc.
pramipexole dihydrochloride
pramipexole dihydrochloride 0.500 mg
ORAL
PRESCRIPTION DRUG
Mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of MIRAPEX tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES ). MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with symptoms of RLS. MIR
MIRAPEX tablets are available as follows: 0.125 mg: white, round tablet with "BI" on one side and "83" on the reverse side. 0.25 mg: white, oval, scored tablet with "BI BI" on one side and "84 84" on the reverse side. 0.5 mg: white, oval, scored tablet with "BI BI" on one side and "85 85" on the reverse side. 1 mg: white, round, scored tablet with "BI BI" on one side and "90 90" on the reverse side. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children. Address medical inquiries to: http://us.boehringer-ingelheim.com , (800) 542-6257 or (800) 459-9906 TTY.
New Drug Application
MIRAPEX - PRAMIPEXOLE DIHYDROCHLORIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) 0.125 MG, 0.25 MG, 0.5 MG, 0.75 MG, 1 MG, AND 1.5 MG TABLETS PRESCRIBING INFORMATION DESCRIPTION MIRAPEX 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 empirical formula is C H N S • 2HCl • H O, and its molecular weight is 302.27. 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, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, cornstarch, colloidal silicon dioxide, povidone, and magnesium stearate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Pramipexole is a nonergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D subfamily of dopamine receptors, binding with higher affinity to D than to D or D receptor subtypes. PARKINSON’S DISEASE: The precise mechanism of action of pramipexole as a treatment for Parkinson's disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that pramipexole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum and the substantia nigra, the site of neurons that send projections to the striatum. The relevance of D receptor binding in Parkinson’s disease is unknown. RESTLESS LEGS SYNDROME (RLS): The precise mechanism of action of Mirapex® (pramipexole dihydrochloride Soma hati kamili