ROPINIROLE HYDROCHLORIDE 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:

Major Pharmaceuticals

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE HYDROCHLORIDE 0.25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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ROPINIROLE HYDROCHLORIDE TABLETS
5282
5283
5284
5285
5286
5287
5288
RX ONLY
DESCRIPTION
Ropinirole hydrochloride is an orally administered non-ergoline
dopamine agonist. It is the
hydrochloride salt of
4-[2-(dipropylamino)ethyl]-1,3-dihydro-2_H_-indol-2-one
monohydrochloride. The
structural formula is:
CHEMICAL STRUCTURE
C
H N O•HCl M.W. 296.84 (260.38 as the free base)
Ropinirole hydrochloride is a pale yellow to greenish powder with a
melting range of 243° to 250°C
and a solubility of 133 mg/mL in water.
Each irregular hexagonal film-coated tablet contains ropinirole
hydrochloride equivalent to ropinirole,
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg and the following
inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate,
hypromellose, microcrystalline
cellulose, and one or more of the following: carmine, FD&C Blue No. 2
aluminum lake, iron oxide
black, iron oxide yellow, iron oxide red, polyethylene glycol 400,
titanium dioxide.
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 -
16
24
2
2
3
3
2
4
1
1
2
1
, 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 the brain. This conclusion is supported
by studies that show that
ropinirole improves motor function in various animal models of
Parkinson’s diseas