Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Aphena Pharma Solutions - Tennessee, 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. 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/m2 basis. The combined oral adm
Ropinirole Tablets, USP are available containing ropinirole hydrochloride, USP equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole. The 0.25 mg tablets are white, round unscored tablets debossed with M on one side of the tablet and N over 25 on the other side. They are available as follows: NDC 60429-817-01 bottles of 100 tablets The 0.5 mg tablets are yellow, round unscored tablets debossed with M on one side of the tablet and N over 5 on the other side. They are available as follows: NDC 60429-818-01 bottles of 100 tablets The 1 mg tablets are green, round unscored tablets debossed with M on one side of the tablet and N over 10 on the other side. They are available as follows: NDC 60429-819-01 bottles of 100 tablets The 2 mg tablets are orange, round unscored tablets debossed with M on one side of the tablet and N over 20 on the other side. They are available as follows: NDC 60429-820-01 bottles of 100 tablets The 3 mg tablets are lavender, round unscored tablets debossed with M on one side of the tablet and N over 30 on the other side. They are available as follows: NDC 60429-821-01 bottles of 100 tablets The 4 mg tablets are grayish beige, round unscored tablets debossed with M on one side of the tablet and N over 40 on the other side. They are available as follows: NDC 60429-822-01 bottles of 100 tablets The 5 mg tablets are blue, round unscored tablets debossed with M on one side of the tablet and N over 50 on the other side. They are available as follows: NDC 60429-823-01 bottles of 100 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
Abbreviated New Drug Application
ROPINIROLE HYDROCHLORIDE- ROPINIROLE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, 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 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 at least 5% greater than placebo) in the respective indications we re : • • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS INC. AT 1-877-446-3679 (1-877- 4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. 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 read_full_document