ROPINIROLE HYDROCHLORIDE tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Aidarex Pharmaceuticals LLC

INN (Isem Internazzjonali):

ROPINIROLE HYDROCHLORIDE

Kompożizzjoni:

ROPINIROLE 0.25 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Parkinson’s Disease 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). Restless Legs Syndrome 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

Sommarju tal-prodott:

Tablets Each circular, biconvex, film-coated tablet contains ropinirole hydrochloride as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side in bottles of 100 (NDC 53217-166-30). 0.25 mg: white tablets debossed with “H” on one side and “121” on other side in bottles of 100 (NDC 53217-166-60). STORAGE: Protect from light and moisture. Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP]. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ08837 1.866.901.DRUG (3784) Manufactured by: Alembic Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Repackaged By: Aidarex Pharmaceuticals, LLC Corona CA 92880 SINEMET is a registered trademark of Merck & Co., Inc. Revised: 04/201

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
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ROPINIROLE HYDROCHLORIDE TABLETS
RX ONLY
PRESCRIBING INFORMATION
PATIENT INFORMATION INCLUDED
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 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 is a white to yellow solid with a melting
range of 243° to 250°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
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