País: Taiwan
Língua: chinês
Origem: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE)
台灣百靈佳殷格翰股份有限公司 台北市中山區民生東路三段2號12樓 (12469866)
N04BC05
持續性藥效錠
PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE) (7600001520) (1.5)MG
鋁箔盒裝
製 劑
須由醫師處方使用
Rottendorf Pharma GmbH Am Fleigendahl 3, 59320 Ennigerloh, Germany DE
pramipexole
治療巴金森氏症的徵候及症狀
有效日期: 2025/08/24; 英文品名: Mirapex 1.5mg prolonged-release tablets
2010-08-24
MIRAPEX ® abcd PROLONGED-RELEASE TABLETS 0.375 MG & 0.75 MG & 1.5 MG FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Treatment of the signs and symptoms of Parkinson’s disease. 2 DOSAGE AND ADMINISTRATION 2.1 GENERAL DOSING CONSIDERATIONS MIRAPEX PR tablets are taken orally once daily, with or without food. MIRAPEX PR tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with MIRAPEX PR tablets has occurred, re-titration of therapy may be warranted. 2.2 DOSING FOR PARKINSON’S DISEASE The starting dose is 0.375 mg given once per day. Based on efficacy and tolerability, dosages may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. In clinical trials, dosage was initiated at 0.375 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 4.5 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment. Due to the flexible dose design used in clinical trials, specific dose-response information could not be determined. When discontinuing therapy with MIRAPEX PR, taper the dose gradually over a period of one week (see Warnings and Precautions). In some studies with immediate-release pramipexole tablets, however, abrupt discontinuation was uneventful. _Dosing in Patients with Renal Impairment _ The elimination of pramipexole is dependent on renal function [_see Clinical Pharmacology (12.3)_]. Patients with mild renal impairment (a creatinine clearance above 50 mL/min) require no reduction in daily dose. In patients with moderate renal impairment (creatinine clearance between 30 and 50 mL/min), MIRAPEX PR tablets should initially be taken every other day. Caution should be exercised and careful assessment of therapeutic response and tolerability should Leia o documento completo