英文药名：BI・Sifrol（Pramipexole Hydrochloride Hydrate Tablets） 中文药名：盐酸普拉克索 日文药名：ビ・シフロール錠 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 1，帕金森氏病 通常，开始每日剂量为0.25mg如普拉克索盐酸盐水合物，它假定0.5mg的每日剂量在2周后，同时观察随后的过程中，为0.5mg每周各增加的每日剂量为成人的，以确定维持剂量（1.5〜4.5mg标准日剂量）。早餐和晚餐后，口服给药后每一餐分成三个在为1.5mg的情况下，或分成两个if每日剂量小于1.5毫克普拉克索作为盐酸盐水合物。应当指出的是，适当的增加或减少可以是年龄和症状，每日剂量不应超过4.5mg。 2，中度原发性不宁腿综合征 成人每天一次在为0.25mg盐酸普拉克索水合物前2-3小时。从0.125第一天给药开始适当范围是不超过0.75毫克1天根据症状之内增加或减少，体重增加可在1周以上的时间间隔进行。 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。 包装 ビ・シフロール錠0.125mg：100錠（10錠×10）PTP、500錠（10錠×50）PTP ビ・シフロール錠0.5mg ：100錠（10錠×10）PTP、500錠（10錠×50）PTP  原文资料附件：http://www.info.pmda.go.jp/go/pack/1169012F1022_1_18/1169012F1022_1_18?view=body 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 : BI・Sifrol Tablets 0.125mg [Medication for Restless Legs Syndrome] 　Active ingredient: Pramipexole hydrochloride hydrate 　Dosage form: white tablet (length: 6.0mm, thickness: 2.3-2.5mm) 　Print on wrapping: (Face) BI・Sifrol 0.125mg, P6 (Back) ビ・シフロール0.125mg, company logo, Boehringer Ingelheim Effects of this medicine By stimulating dopamine D2 receptors in the brain, this medicine improves symptoms of idiopathic restless legs syndrome (a condition in which your legs, or sometimes your arms, feel extremely uncomfortable while you're sitting or lying down, and feel an irresistible urge to move or jerk the legs). Usually, this medicine is used to treat idiopathic restless legs syndrome. 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 heart disease, kidney disease or a history of such problems. If you have hypotension. •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 (0.125mg of pramipexole hydrochloride hydrate) two to three hours before bedtime. Increase the daily dose by an increment of 1 tablet (0.125mg) at weekly intervals by checking your condition and your maintenance dose is determined. The maximum daily dose should not exceed 6 tablets (0.75mg). •If you miss a dose, take a dose as soon as you remember. Take the remaining dose for that day at an equal interval. 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. Especially, if you suddenly reduce the dose or stop the medication, side effects may occur. Precautions while taking this medicine •Do not engage in driving a car, operating machinery, working at high places or 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 feeling of sickness (upset stomach or nausea), somnolence (clouding of consciousness and almost sleeping state), headache and stomach discomfort. Also onset of the symptom of restless legs syndrome at night more than two hours earlier than usual, a progressive worsening of symptoms, or expanding the symptoms to other limbs, etc. 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, agitation, confusion] •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, moisture and light. •Discard unused medicine. Ask the pharmacy or medical institutions how to discard