Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Alembic Pharmaceuticals Limited
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 2 mg
ORAL
PRESCRIPTION DRUG
Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. Ropinirole extended-release tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Oral 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, respectively, the maximum recommended human dose (MRHD) for Parkinson’s disease (24 mg/day) on a mg/m2 basis. The combined oral administration of ropinirole at 8 t
Each capsule shaped, film coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 2 mg: pink tablets debossed with 'L191' NDC 46708-262-30 bottle of 30 tablets NDC 46708-262-90 bottle of 90 tablets NDC 46708-262-31 bottle of 100 tablets NDC 46708-262-71 bottle of 500 tablets NDC 46708-262-91 bottle of 1000 tablets NDC 46708-262-10 carton of 100 (10X10) unit dose tablets 4 mg: light brown tablets debossed with 'L193' NDC 46708-263-30 bottle of 30 tablets NDC 46708-263-90 bottle of 90 tablets NDC 46708-263-31 bottle of 100 tablets NDC 46708-263-71 bottle of 500 tablets NDC 46708-263-91 bottle of 1000 tablets NDC 46708-263-10 carton of 100 (10X10) unit dose tablets 6 mg: white to off white tablets debossed with 'L321' NDC 46708-264-30 bottle of 30 tablets NDC 46708-264-90 bottle of 90 tablets NDC 46708-264-31 bottle of 100 tablets NDC 46708-264-71 bottle of 500 tablets NDC 46708-264-91 bottle of 1000 tablets NDC 46708-264-10 carton of 100 (10X10) unit dose tablets 8 mg: dark brown to red tablets debossed with 'L194' NDC 46708-265-30 bottle of 30 tablets NDC 46708-265-90 bottle of 90 tablets NDC 46708-265-31 bottle of 100 tablets NDC 46708-265-71 bottle of 500 tablets NDC 46708-265-91 bottle of 1000 tablets NDC 46708-265-10 carton of 100 (10X10) unit dose tablets 12 mg: light green tablets debossed with 'L195' NDC 46708-266-30 bottle of 30 tablets NDC 46708-266-90 bottle of 90 tablets NDC 46708-266-31 bottle of 100 tablets NDC 46708-266-71 bottle of 500 tablets NDC 46708-266-91 bottle of 1000 tablets NDC 46708-266-10 carton of 100 (10X10) unit dose tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
ROPINIROLE - ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE ALEMBIC PHARMACEUTICALS 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 RECENT MAJOR CHANGES Dosage and Administration (2.2, 2.3) 8/2014 Contraindications (4) 8/2014 Warnings and Precautions (5.5, 5.7) 8/2014 INDICATIONS AND USAGE Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1) (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 recommended starting dose is 2 mg taken once daily for 1 to 2 weeks; the dose should be increased by 2 mg/day at 1 week or longer intervals; the maximum dose is 24 mg/day (2.2, 14.2) •Renal Impairment: In patients with end-stage renal disease on hemodialysis, the maximum recommended dose is 18 mg/day (2.2) •If ropinirole extended-release tablets must be discontinued, it should be tapered gradually over a 7-day period; retitration of ropinirole extended-release tablets may be warranted if therapy is interrupted (2.1, 2.2) •Patients may be switched directly from immediate-release ropinirole 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. (2.3) (2) DOSAGE FORMS AND STRENGTHS Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg (3) (3) CONTRAINDICATIONS History of hypersensitivity/ allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients (4) (4) WARNINGS AND PRECAUTIONS •Sudden onset of sleep and somnolence may occur (5.1) •Syncope may Preberite celoten dokument