Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
ROPINIROLE (UNII: 030PYR8953) (ROPINIROLE - UNII:030PYR8953)
Solco Healthcare US, LLC
ORAL
PRESCRIPTION DRUG
Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole extended-release 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] . In the U.S. general population, the estimated background ris
Each biconvex, round, film-coated tablet contains ropinirole hydrochloride, USP, equivalent to the labeled amount of ropinirole as follows: Storage Store at 20°C to 25°C (68°F-77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
ROPINIROLE- ROPINIROLE TABLET, EXTENDED RELEASE Solco Healthcare US, LLC ---------- PATIENT INFORMATION Ropinirole Tablets, USP (roe pin’ i role”) Ropinirole Extended-Release Tablets (roe pin’ i role”) Dispense with Patient Information available at: www.solcohealthcare.com/medguide/ropinirole-er-tablets.pdf If you have Parkinson’s disease, read this side. If you have Restless Legs Syndrome (RLS), read the other side. Important Note: Ropinirole extended-release tablets have not been studied in RLS and are not approved for the treatment of RLS. However, an immediate-release form of ropinirole is approved for the treatment of moderate to severe primary RLS (see other side of this leaflet). What is the most important information I should know about ropinirole tablets and ropinirole extended- release tablets? Ropinirole tablets and ropinirole extended-release tablets can cause serious side effects including: • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole tablets or ropinirole extended-release tablets. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking ropinirole tablets or ropinirole extended-release tablets are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting ropinirole tablets or ropinirole extended-release tablets, be sure to tell your healthcare provider if you take any medicines that make you drowsy. • Fainting. Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking ropinirole tablets or ropinirole extended-release tablets or your dose is increased. Tell your healthcare provider if you faint, feel dizzy, or feel light-headed. • Decrease in blood pressure. Ropinirole tablets and ropini Διαβάστε το πλήρες έγγραφο
ROPINIROLE- ROPINIROLE TABLET, EXTENDED RELEASE SOLCO HEALTHCARE US, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ROPINIROL EEXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Warnings and Precautions, Hallucinations/Psychotic-Like Behavior (5.5) 7/2021 Warnings and Precautions, Impulse Control/Compulsive Behaviors (5.7) 7/2021 Warnings and Precautions, Withdrawal Symptoms (5.9) 7/2021 Warnings and Precautions, Melanoma-removal (5.10) 7/2021 INDICATIONS AND USAGE Ropinirole extended-release tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. (1) DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 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 • • Ropinirole extended-release tablets are taken once daily, with or without food; tablets must be swallowed whole and not be chewed, crushed, or divided. (2.1) The recommended starting dose is 2 mg taken once daily for 1 to 2 weeks; the dose should be increased by 2 mg/day at 1 week or longer intervals. The maximum recommended dose of ropinirole extended-release tablets is 24 mg/day. (2.2, 14.2) Renal Impairment: In patients with end-stage renal disease on hemodialysis, the maximum recommended dose is 18 mg/day. (2.2) If ropinirole extended-release tablets must be discontinued, it should be tapered gradually over a 7- day period; retitration of ropinirole extended-release tablets may be warranted if therapy is interrupted. (2.1, 2.2) Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tabl Διαβάστε το πλήρες έγγραφο