Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
SOLCO HEALTHCARE US, LLC
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 0.25 mg
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 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 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 administered in combination [see Data]
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 Bottles of 100 – NDC 43547-268-10 Bottles of 500 – NDC 43547-268-50 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side Bottles of 100 – NDC 43547-269-10 Bottles of 500 – NDC 43547-269-50 1 mg: green tablets debossed “974” on one side and “HH” on the other side Bottles of 100 – NDC 43547-270-10 Bottles of 500 – NDC 43547-270-50 2 mg: pink tablets debossed “975” on one side and “HH” on the other side Bottles of 100 – NDC 43547-271-10 Bottles of 500 – NDC 43547-271-50 3 mg: purple tablets debossed “976” on one side and “HH” on the other side Bottles of 100 – NDC 43547-272-10 Bottles of 500 – NDC 43547-272-50 4 mg: beige tablets debossed “977” on one side and “HH” on the other side Bottles of 100 – NDC 43547-273-10 Bottles of 500 – NDC 43547-273-50 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Bottles of 100 – NDC 43547-274-10 Bottles of 500 – NDC 43547-274-50 Storage Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 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 SOLCO HEALTHCARE US, 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 Warnings and Precautions, 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) DOSAGE AND ADMINISTRATION • • Parkinson's Disease: • • Restless Legs Syndrome: • • 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 • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were: • • • Withdrawal Symptoms (5.8) 7/2021 Melanoma-removal (5.9) 7/2021 Ropinirole tablets can be taken with or without food. (2.1) Retitration of ropinirole tablets may be warranted if therapy is interrupted. (2.1) 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) 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) 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 hal Lees het volledige document