Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Heritage Pharmaceuticals Inc.
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 0.25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ROPINIROLE - ROPINIROLE TABLET, FILM COATED HERITAGE PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ROPINIROLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE TABLETS. ROPINIROLE TABLETS, 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 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 · Ropinirole tablets can be taken with or without food (2.1) (2) · Retitration of ropinirole tablets may be warranted if therapy is interrupted (2.1) (2) Parkinson’s Disease: (2) · The recommended starting dose is 0.25 mg taken three times daily; titrate to a maximum daily dose of 24 mg (2.2) (2) · Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis (2.2) (2) Restless Legs Syndrome: (2) · The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to a maximum recommended dose of 4 mg daily (2.3) (2) · Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis (2.3) (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 · Sudden onset of sleep and somnolence may occur (5.1) (5) · Syncope may occur (5.2) (5) · Hypotension, including orthostatic hypotension may occur (5.3) (5) · May cause hallucinations and psychotic-like behaviors (5.4) (5) · May cause or exacerbate dyskinesia (5.5) (5) · May cause problems with impulse control or compuls Belgenin tamamını okuyun