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英文药名：Mirapex-LA（Pramipexole Hydrochloride Hydrate Tablets）
中文药名：盐酸普拉克索缓释片
生产厂家：勃林格殷格翰
药品介绍
药理作用
本品是人工合成的氨苯噻唑(aminobenzothiazole)的衍生物。具有D2-受体激动剂活性。采用UPDRS评分评估本品对早期帕金森病的作用，与安慰剂对照组相比，用药组患者生活能力显著改善，呈“关”状态的时间明显缩短，但两组患者的运动功能检查评分没有差别。
药动学
空腹口服后可迅速吸收，2h可达血药峰值；进食时口服本品后，3h达血药峰值。消除t1/2约9h，生物利用度＞90%，只有小部分被代谢，几乎全部经肾排出。
适应证
本品主要用于治疗帕金森病及其综合征。可单用或与左旋多巴合用。
禁忌证
哺乳者禁用。
注意事项
1.肾功能不全者慎用。
2.可引起睡眠发作，因此开车和机械操作者应特别注意。
不良反应
有幻觉、嗜睡、运动障碍、口干、恶心、便秘等。
用法用量
在开始第1周中，口服125μg，每天3次，第2周，口服250μg，每天3次；以后每周增加750μg，达最高每天4.5mg。
药物相应作用
西咪替丁可减少本品的清除。
专家点评
本品为一种选择性作用于多巴胺D3受体的多巴胺激动剂。可明显减少帕金森病静息时的震颤。晚期帕金森病用该药与左旋多巴共同治疗时，可使患者对左旋多巴需要量减少，并可延长症状最佳控制时间平均每天2h。有报道表明，虽然本品可用于治疗帕金森氏病及其综合征，但临床效果不肯定。
ミラペックスLA錠0.375mg／ミラペックスLA錠1.5mg
包装
ミラペックスLA錠0.375mg：100錠（10錠×10）PTP
ミラペックスLA錠1.5mg：100錠（10錠×10）PTP
製造販売
日本ベーリンガーインゲルハイム株式会社
完整资料附件：http://www.info.pmda.go.jp/go/pack/1169012G1028_1_04/
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name : Mirapex-LA Tablets 0.375mg
Active ingredient: Pramipexole hydrochloride hydrate
Dosage form: White Tablet (9.0mm in diameter, 4.1mm in thickness, 0.25g in weight)
Print on wrapping: (Face） Mirapex-LA 0.375mg, P1, (back) ミラペックスLA 0.375mg,社マーク, Boehringer Ingelheim
Effects of this medicine
By stimulating dopamine D2 receptors in the brain, this medicine improves symptoms of Parkinson's disease (shaking of hands, muscle stiffness, slow movement and inability to maintain posture).
Usually, this medicine is used to treat Parkinson's disease.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have problems in kidney requiring dialysis.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
•In general, for adults, start with 1 tablet (0.375mg of pramipexole hydrochloride hydrate) after the meal once daily for the first week, and increase to 2 tablets (0.75mg) daily for the second week. Thereafter increase the daily dose by an increment of 2 tablets (0.75mg) at weekly intervals by checking your condition and your maintenance dose is determined [standard daily dose: 4-12 tablets (1.5-4.5mg)]. The dosage may be adjusted according to your age and the severity of symptoms, but the maximum daily dose should not exceed 12 tablets (4.5mg). Strictly follow the instructions.
•This medicine is to be swallowed whole, not chewed since the side effects are possibly developed to be taken by breaking or crunching of the tablets.
•If you miss a dose, take a dose as soon as you remember. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so. It may cause side effects when you rapidly decrease the dosage amount or when you stop taking the medicine.
Precautions while taking this medicine
•Do not engage in driving a car, operating machinery, working at high places or engaging in other hazardous activities. This medicine may cause drowsiness or sudden onset of sleep without warning signs, etc.
•Avoid drinking alcohol since it may increase the effects of this medicine.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include somnolence (clouding of consciousness and almost sleeping state), nausea, dizziness, constipation and dry mouth. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•sudden onset of sleep without warning signs [sudden onset of sleep]
•seeing or hearing something that is not really there, baseless and subjective thought, having trouble thinking clearly[hallucination, delusion, delirium, confusion, agitation]
•convulsion, disturbance of consciousness[syndrome of inappropriate secretion of antidiuretic hormone (SIADH)]
•fever, strong muscle stiffness, clouding of consciousness[syndrome malin]
•lassitude, muscle pain, brown urine[rhabdomyolysis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from heat and moisture.
•Discard unused medicine. Ask the pharmacy or medical institutions how to discard.
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