Country: United States
Language: English
Source: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Lake Erie Medical DBA Quality Care Products LLC
ORAL
PRESCRIPTION DRUG
Ropinirole tablets are indicated for the treatment of Parkinson's disease. Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole hydrochloride is contraindicated in patients known to have a 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 hydrochloride 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)
Each round biconvex film-coated ropinirole tablet, USP, contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 0.25 mg: white tablets debossed “972” on one side and “HH” on the other side 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side 55700-252-60 1 mg: green tablets debossed “974” on one side and “HH” on the other side 2 mg: pink tablets debossed “975” on one side and “HH” on the other side 3 mg: purple tablets debossed “976” on one side and “HH” on the other side 4 mg: beige tablets debossed “977” on one side and “HH” on the other side 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Storage Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.
Abbreviated New Drug Application
ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- 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 hydrochloride is 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) DOSAGE AND ADMINISTRATION Ropinirole tablets can be taken with or without food (2.1) Retitration of ropinirole tablets may be warranted if therapy is interrupted (2.1) Parkinson's Disease: The recommended starting dose is 0.25 mg taken three times daily; titrate to a 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) Restless Legs Syndrome: 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) Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis (2.3) DOSAGE FORMS AND STRENGTHS Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 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 Sudden onset of sleep and somnolence may occur (5.1) Syncope may occur (5.2) Hypotension, including orthostatic hypotension may occur (5.3) May cause hallucinations and psychotic-like behaviors (5.4) May cause or exacerbate dyskinesia (5.5) May cause problems with impulse control or compulsive behaviors (5.6) ADVERSE REACTIONS Most common ad Read the complete document