দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Wockhardt Limited
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 2 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 সম্পূর্ণ নথি পড়ুন