MIRAPEX pramipexole dihydrochloride tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Cardinal Health

ІПН (Міжнародна Ім'я):

pramipexole dihydrochloride

Склад:

pramipexole dihydrochloride 0.250 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

New Drug Application

Характеристики продукта

MIRAPEX- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
CARDINAL HEALTH
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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, corn starch,
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) tablets as