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:

Rebel Distributors Corp

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of ropinirole hydrochloride tablets were 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 hydrochloride 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

Product summary:

Tablets Each circular, biconvex, film-coated tablet contains ropinirole hydrochloride as follows: 0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side in bottles of 60 (NDC 21695-793-60). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use. Dispense in a tight, light-resistant container. * SINEMET® is the registered trademark of Merck & Co., Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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ROPINIROLE HYDROCHLORIDE TABLETS
DESCRIPTION
Ropinirole hydrochloride 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 molecular 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 is a white to cream-colored crystalline
powder with a melting range of 241°
to 245°C and a solubility of 133 mg/mL in water.
Each circular, biconvex, film-coated tablet contains ropinirole
hydrochloride equivalent to ropinirole,
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients
consist of: croscarmellose
sodium, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, and one or more of the
following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6
aluminum lake,
hypromellose, iron oxides (iron oxide yellow, iron oxide red and iron
oxide black), polyethylene
glycol, polysorbate 80 and 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 -
, 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 an