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:

Dispensing Solutions, Inc.

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropinirole tablets USP are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of ropinirole hydrochloride was demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole tablets USP 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 moderate-to-

Product summary:

Tablets: Each tablet contains ropinirole hydrochloride USP 2 mg: pale pink to pink, circular, beveled edged, biconvex film coated tablets with ‘256’ debossed on one side and ‘G’ on the other side NDC 68258-7163-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
DISPENSING SOLUTIONS, INC.
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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 2 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, aluminum lake, hypromellose,
ferric oxide red, 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 the brain. This conclusion is supported
by studies that show that
ropinirole improves motor function in various animal models of
Parkinson’s disease. In particular,
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