ROPINIROLE HYDROCHLORIDE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Alembic Pharmaceuticals Limited

DCI (Dénomination commune internationale):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 0.25 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Parkinson’s Disease Ropinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole 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 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 asle

Descriptif du produit:

Tablets Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side NDC 46708-030-30     bottle of 30 tablets NDC 46708-030-31     bottle of 100 tablets   0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side NDC 46708-031-30    bottle of 30 tablets NDC 46708-031-31    bottle of 100 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side NDC 46708-032-30     bottle of 30 tablets NDC 46708-032-31     bottle of 100 tablets 2 mg: Peach tablets debossed with “H” on one side and “124” on other side NDC 46708-033-30     bottle of 30 tablets NDC 46708-033-31     bottle of 100 tablets 3 mg: Purple tablets debossed with “H” on one side and “125” on other side NDC 46708-034-30     bottle of 30 tablets NDC 46708-034-31     bottle of 100 tablets 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side NDC 46708-035-30     bottle of 30 tablets NDC 46708-035-31     bottle of 100 tablets 5 mg: Blue tablets debossed with “H” on one side and “127” on other side NDC 46708-036-30     bottle of 30 tablets NDC 46708-036-31     bottle of 100 tablets 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 by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revision Date: 09/2019

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ROPINIROLE HYDROCHLORIDE - ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC PHARMACEUTICALS LIMITED
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ROPINIROLE HYDROCHLORIDE - ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC PHARMACEUTICALS LIMITED
DESCRIPTION
Ropinirole 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 C16H24N2O•HCl. The
molecular
weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole Hydrochloride, USP 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 USP
equivalent to ropinirole free base, 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 D2 and D3 dopamine
receptor subtypes,
binding with higher affinity to D3 than to D2 or D4 receptor subtypes.
Ropinirole has moderate in vitro affinity for opioid receptors.
Ropinirole and its
metabolites have negligible in vitro affinity for dopamine D1, 5-HT1,
5-HT2,
benzodiazepine, GABA, muscarinic, alpha1-, alpha2-, 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 D2-type receptors within the caudate-putamen in
the brain. This
conclusion is supported by studies