国家: 台湾
语言: 中文
来源: 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)
五洲製藥股份有限公司 桃園市新屋區赤欄里17之1號 (18560031)
N04BC05
錠劑
PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE) (7600001520) (eq. to Pramipexole 0.18mg)MG
ALU-ALU鋁箔盒裝
製 劑
須由醫師處方使用
五洲製藥股份有限公司 桃園市新屋區赤欄村二鄰17號之1 TW
pramipexole
治療自發性巴金森氏症的徵候及症狀。治療原發性腿部躁動症(Primary Restless Legs Syndrome)的症狀。
有效日期: 2028/07/31; 英文品名: PEXO Tablets 0.25mg
2013-07-31
0.25 (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole dihydrochloride monohydrate pramipexole base 0.18 Pramipexole (dopamine agonist) D 2 D 3 Pramipexole (striatum) pramipexole dopamine Pramipexole metamphetamine Pramipexole (Restless Legs Syndrome,RLS) (positron emission tomographic,PET) pramipexole levodopa pramipexole ( ) pramipexole 4.5 pramipexole pramipexole 4 1000 pramipexole 12 9 Pramipexole 26 (IRLS) pramipexole 13.7 11.1 -2.6 (p=0.008) - (Clinical Global Impression-Improvement , CGI-I) (much improved) (very much improved) pramipexole 50.3%(80/159) 68.5%(111/162)(p=0.001) (number needed to treat) 6 (95%CI:3.5, 13.4) Pramipexole 90% 1 3 pramipexole Pramipexole pramipexole ( 20%) (400 ) pramipexole ( 8 ) Pramipexole pramipexole 80% C14 90% 2% Pramipexole 500 / 400 / (t ) 1/2 pramipexole pramipexole pramipexole 30% Pramipexole ( 65 ) ( 40 ) 40% 30% pramipexole ( ) pramipexole 30% Pramipexole pramipexole pramipexole 90% pram pexole pramipexole ( 20mL/min) pramipexole 75% ( 40mL/min) pramipexole 60% (starting dose) (maintenance dose)( ) pramipexole pramipexole pramipexole pramipexole pramipexole pramipexole levodopa levodopa Citric Acid Povidone Starch Mannitol Microcrystalline Cellulose Magnesium Stearate 0.25 PEXO Tablets 0.25mg pramipexole levodopa levodopa levodopa (Unified Parkinson's Disease Rating Scale; UPDRS) UPDRS (part I) (part II) (part III) (part IV) UPDRS partII 13 0( ) 4 ( ) ( ) 52 UPDRS partIII 27 ( ) partII Part III ( ) ( ) 108 (N=599) levodopa ( levodopa) (on-off phenomenon) (N=335) selegilina (anticholinergics) levodopa amantadine pramipexole Pramipexole 0.375 4.5 / ( ) pramipexole (baseline) UPDRS part II 1.9 -0.4 Pramipexole UPDRS part III 5.0 -0.8 UPDRS part II pramipexole ( pramipexole 0.75 / ) UPDRS part III pramipexole ( pramipexole 1.5 / ) (N=264) selegiline amantadine levodopa 1.5 3.0 4.5 6.0 pramipexole ( ) UPDRS part II 1.8 0.3 Pramipexole UPDRS part III 4.2 0.6 (dose-response) Pramipexole ( ) UPDRS part lI partIII pramipexole selegiline UPDRS " " " " (N=360) 9 ( 8 ) le 阅读完整的文件