MIRAPEX- pramipexole dihydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pramipexole dihydrochloride (UNII: 3D867NP06J) (pramipexole - UNII:83619PEU5T)

Available from:

Physicians Total Care, Inc.

INN (International Name):

pramipexole dihydrochloride

Composition:

pramipexole dihydrochloride 0.500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 , [phone] or [phone] TTY.

Authorization status:

New Drug Application

Summary of Product characteristics

MIRAPEX - PRAMIPEXOLE DIHYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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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