ROPINIROLE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 1 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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ROPINIROLE TABLETS USP
PATIENT INFORMATION INCLUDED
DESCRIPTION
Ropinirole hydrochloride USP is an orally administered non-ergoline
dopamine agonist. It is the
hydrochloride salt of 4-[2-(dipropylamino)
ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and
has an empirical formula of C
H N O•HCl. The molecular weight is 296.84 (260.38 as the free
base).
The structural formula is:
Ropinirole hydrochloride USP is a pale cream to yellow powder with a
melting range of 243° to 250°C
and a solubility of 133 mg/mL in water.
Each circular film-coated tablet with beveled edges contains
ropinirole hydrochloride USP equivalent
to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg.
Inactive ingredients consist of: citric
acid anhydrous powder, croscarmellose sodium, lactose anhydrous,
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, and one or more of the
following: carmine, FD&C Blue No.1
aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6
aluminum lake, hypromellose,
ferric oxide black, ferric oxide red, ferric oxide yellow,
polyethylene glycol, talc and titanium dioxide.
The product meets USP Dissolution test 2.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Ropinirole hydrochloride is a non-ergoline dopamine agonist with high
relative in vitro specificity and
full intrinsic activity at the D and D dopamine receptor subtypes,
binding with higher affinity to D
than to D or D receptor subtypes.
Ropinirole has moderate in vitro affinity for opioid receptors.
Ropinirole and its metabolites have
negligible in vitro affinity for dopamine D , 5-HT , 5-HT ,
benzodiazepine, GABA, muscarinic,
alpha -, alpha -, and beta-adrenoreceptors.
Parkinson’s Disease:
The precise mechanism of action of ropinirole hydrochloride as a
treatment for Parkinson’s disease is
unknown, although it is believed to be due to stimulation of
postsynaptic dopamine D -type receptors
within the caudate-putamen in