ROPINIROLE HYDROCHLORIDE tablet, film coated, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Wockhardt Limited

INN (International namn):

ROPINIROLE HYDROCHLORIDE

Sammansättning:

ROPINIROLE 2 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Ropinirole Extended-release Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. None. Pregnancy Category C. There are no adequate and well-controlled studies using ropinirole in pregnant women. Ropinirole Extended-release Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.   In animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. Treatment of pregnant rats with ropinirole during organogenesis resulted in decreased fetal body weight, increased fetal death, and digital malformations at 24, 36, and 60 times the MRHD, respectively. The combined administration of ropinirole at 8 times the MRHD and a clinically relevant dose of L-dopa to pregnant rabbits during organogenesis produced a greater incidence and severity of fetal malformations (primarily digit defects) than were seen in the offspring of rabbits treated with L-d

Produktsammanfattning:

Each biconvex, circular-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: ●   2 mg Pink, coated, circular shaped tablets with beveled edge, debossed with ‘W’ on                                                                                                                                 771      one side and plain on other side, in bottle of 30 (NDC 64679-771-01), 90 (NDC             64679-771-02), 100 (NDC 64679-771-05), 500 (NDC 64679-771-03) and Unit dose       packages of 100 (NDC 64679-771-04). ●   4 mg Light brown, coated, circular shaped tablets with beveled edge, debossed with       ‘W’  on one side and plain on other side, in bottle of 30 (NDC 64679-773-01),           773       90 (NDC 64679-773-02), 100 (NDC 64679-773-05), 500 (NDC 64679-773-03) and       Unit dose packages of 100 (NDC 64679-773-04). ●     6 mg White, coated, circular shaped tablets with beveled edge, debossed with ‘W’ on                                                                                                                                     776      one side and plain on other side, in bottle of 30 (NDC 64679-776-01), 90 (NDC       64679-776-02), 100 (NDC 64679-776-05), 500 (NDC 64679-776-03) and Unit dose       packages of 100 (NDC 64679-776-04). ●    8 mg Brown, coated, circular shaped tablets with beveled edge, debossed with ‘W’ on                                                                                                                                      774      one side and plain on other side, in bottle of 30 (NDC 64679-774-01), 90 (NDC       64679-774-02), 100 (NDC 64679-774-05), 500 (NDC 64679-774-03) and Unit dose       packages of 100 (NDC 64679-774-04). ●   12 mg Green, coated, circular shaped tablets with beveled edge, debossed with ‘W’ on                                                                                                                                      775      one side and plain on other side, in bottle of 30 (NDC 64679-775-01), 90 (NDC       64679-775-02), 100 (NDC 64679-775-05), 500 (NDC 64679-775-03) and Unit dose       packages of 100 (NDC 64679-775-04). Storage: Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
WOCKHARDT LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE EXTENDED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROPINIROLE EXTENDED-RELEASE TABLETS.
ROPINIROLE EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Ropinirole Extended-release Tablet is an orally administered,
non-ergoline dopamine agonist indicated for the treatment of
signs and symptoms of idiopathic Parkinson’s disease. (1.1)
DOSAGE AND ADMINISTRATION
Ropinirole Extended-release Tablets are taken once daily, with or
without food. Tablets must be swallowed whole and
must not be chewed, crushed, or divided. (2.1)
The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed
by increases of 2 mg/day at 1 week or longer
intervals as appropriate, depending on therapeutic response and
tolerability, up to a maximally recommended dose of
24 mg/day. Patients should be assessed for therapeutic response and
tolerability at a minimal interval of 1 week or
longer after each dose increment. Caution should be exercised during
dose titration because too rapid a rate of titration
can lead to dose selection that does not provide additional benefit,
but that increases the risk of adverse reactions. (2.2,
14.2)
Patients may be switched directly from immediate-release ropinirole
tablets to Ropinirole Extended-release Tablets.
The initial switching dose of Ropinirole Extended-release Tablets
should most closely match the total daily dose of
immediate-release ropinirole, see Table 1. (2.3)
If Ropinirole Extended-release Tablets must be discontinued, it should
be tapered gradually over a 7-day period. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Falling asleep during activities of daily living may occur, including
the operation of motor