Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Carilion Materials Management
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 1 mg
ORAL
PRESCRIPTION DRUG
Ropinirole Tablets USP are indicated for the treatment of Parkinson’s disease. Ropinirole Tablets USP are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole Tablets USP are contraindicated in patients known to have hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to 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 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
Product: 68151-4073 NDC: 68151-4073-2 1 TABLET in a PACKAGE
Abbreviated New Drug Application
ROPINIROLE- ROPINIROLE TABLET CARILION MATERIALS MANAGEMENT ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ROPINIROLE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE TABLETS USP. ROPINIROLE TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Dosage and Administration (2.2, 2.3) 8/2014 Warnings and Precautions (5.4, 5.6, 5.9) 8/2014 INDICATIONS AND USAGE Ropinirole Tablets USP are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS) (1.1, 1.2) (1) DOSAGE AND ADMINISTRATION • • Parkinson’s Disease: (2) • • Restless Legs Syndrome: (2) • • DOSAGE FORMS AND STRENGTHS Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 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 • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence with ropinirole at least 5% greater than placebo) in the respective indications we re : • • • To report SUSPECTED ADVERSE REACTIONS, contact Roxane Laboratories, Inc. at 1-800-962-8364 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Ropinirole Tablets USP can be taken with or without food (2.1) Retitration of ropinirole may be warranted if therapy is interrupted (2.1) The recommended starting dose is 0.25 mg taken three times daily; titrate to maximum daily dose of 24 mg (2.2) Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis (2.2) The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to maximum recommended dose of 4 mg daily (2.3) Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis (2.3) Sudden ons Lugege kogu dokumenti