País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Avera McKennan Hospital
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 8 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE AVERA MCKENNAN HOSPITAL ---------- 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 a, non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. (1.1) DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 2 mg, 4 mg, 6 mg, 8 mg and 12 mg (3) CONTRAINDICATIONS History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients (4) WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS • • To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO- RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS • 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 one 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 ropinirol Leia o documento completo