Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
NCS HealthCare of KY, Inc dba Vangard Labs
ORAL
PRESCRIPTION DRUG
Ropinirole tablets areindicated for the treatment of Parkinson’s disease. Ropinirole tablets areindicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole tablets in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (MRHD) for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. In pregnant rabbits, ropinirole potentiated the teratogenic effects of L-dopa when these drugs were admini
Ropinirole Tablets: Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side NDC 0615-8188-39 blistercards of 30 tablets 0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side NDC 0615-8189-39 blistercards of 30 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side NDC 0615-8190-39 blistercards of 30 tablets 2 mg: Peach tablets debossed with “H” on one side and “124” on other side NDC 0615-8191-39 blistercards of 30 tablets 3 mg: Purple tablets debossed with “H” on one side and “125” on other side 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side 5 mg: Blue tablets debossed with “H” on one side and “127” on other side STORAGE: Protect from light and moisture. Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
Abbreviated New Drug Application
ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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 (2.3) 9/2016 Warnings and Precautions (5.7, 5.9) 9/2016 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 Citiți documentul complet