心寧美持續性藥效錠

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)

资料单张 资料单张 (PIL)
04-06-2021
公众评估报告 公众评估报告 (PAR)
11-04-2020

有效成分:

CARBIDOPA;;LEVODOPA

可用日期:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC代码:

N04BA02

药物剂型:

錠劑

组成:

LEVODOPA (1208002900) MG; CARBIDOPA (2408000400) as equivqlent to Carbidopa Anhydrous 50 mgMG

每包单位数:

瓶裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

MYLAN PHARM, INC. 781 CHESTNUT RIDGE ROAD, MORGANTOWN, WEST VIRGINIA 26505 US

治疗领域:

levodopa and decarboxylase inhibitor

疗效迹象:

.特發性帕金森氏症。.腦炎後之帕金森氏徵候群。.症狀性帕金森氏徵候群(一氧化碳或錳中毒)。.正服用含有PYRIDOXINE維他命製劑之帕金森氏症或帕金森氏徵候群的病人。可降低先前曾以levodopa/decarboxylase抑制劑之複方製劑或使用levodopa單方製劑治療的病人之無反應期,這些病人的運動功能波動特徵在藥效末期時有惡化(Wearing off)現象,尖峰劑量之運動困難,運動不能或短期運動失調之類似現象。

產品總結:

註銷日期: 2020/10/08; 註銷理由: 自請註銷; 有效日期: 2022/04/17; 英文品名: SINEMET CR 50/200 TABLETS

授权状态:

已註銷

授权日期:

1997-04-17

资料单张

                                S-IPC-MK0295B-CR-082013
0295B-TWN-2014-008480
SINEMET CR 50/200 Tablets
(carbidopa and levodopa)
SINEMET CR is a combination of carbidopa, an aromatic amino acid
decarboxylase inhibitor, and levodopa, the
metabolic precursor of dopamine, in a polymer-based controlled-release
tablet formulation, for use in the treatment of
Parkinson's disease and syndrome. SINEMET CR is particularly useful to
reduce "off" time in patients treated
previously with a conventional levodopa/decarboxylase inhibitor
combination who have had predictable peak-dose
dyskinesias and unpredictable motor fluctuations.
Patients with Parkinson's disease treated with preparations containing
levodopa may develop motor fluctuations
characterized by end-of-dose failure, peak dose dyskinesia, and
akinesia. The advanced form of motor fluctuations ("on-
off" phenomenon) is characterized by unpredictable swings from
mobility to immobility. Although the causes of the
motor fluctuations are not completely understood, it has been
demonstrated that they can be attenuated by treatment
regimens that produce steady plasma levels of levodopa.
Levodopa relieves the symptoms of Parkinson's disease by being
decarboxylated to dopamine in the brain. Carbidopa,
which does not cross the blood-brain barrier, inhibits only the
extracerebral decarboxylation of levodopa, making more
levodopa available for transport to the brain and subsequent
conversion to dopamine. This normally obviates the
necessity for large doses of levodopa at frequent intervals. The lower
dosage reduces or may help eliminate
gastrointestinal and cardiovascular side effects, especially those
which are attributable to dopamine being formed in
extracerebral tissues.
SINEMET CR is designed to release the active ingredients over a 4- to
6-hour period. With this formulation there is less
variation in plasma levodopa levels and the peak plasma level is 60%
lower than with conventional SINEMET.
In clinical trials, patients with motor fluctuations experienced
reduced "off" time with SINEMET CR when compared 
                                
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