部份中文普拉格雷处方资料(仅供参考) 药品名称:普拉格雷片 剂型规格:片剂:2.5mg、5mg、10mg、 20mg 有效成分 本品主要成普拉格雷(Prasugrel)。 化学名称:2-[2-(乙酰氧基)-6,7-二氢噻吩并[3,2-c]吡啶-5(4H)-基]-1-环丙基-2-(2-氟苯基)乙酮分子式:C20H20FNO3S 分子量:373.44 CAS号:150322-43-3 药理药效 普拉格雷为噻吩并吡啶类的一种止血新药,是一种前体药物,在体内经过代谢后形成活性分子,与血小板P2Y12受体结合而发挥抗血小板聚集的活性。 适应症 心力衰竭、中风、不稳定心绞痛等心脑血管疾病。有急性冠状动脉综合症需要进行经皮冠脉介入术的患者。 用法用量 先服用60mg的负荷剂量,然后维持剂量为10mg,每日一次。患者应同时服用阿司匹林75-325mg。体重<60kg的患者与体重≥60kg的患者相比,服用10mg剂量时,会增加出血的风险性,建议改成5mg的维持剂量。 原研厂家:美国礼来制药公司 国外上市信息 该品由日本Sankyo公司和美国Eli Lilly公司共同开发,并于2009年2月23日获欧盟批准上市,应用于治疗动脉粥样硬化和急性冠状动脉综合征,这是普拉格雷在全球范围内首次获得批准。 产品优势 普拉格雷是新一代强效噻蒽并吡啶类抗血小板药。通过对健康志愿者的观察及在在稳定性心绞痛和急性冠状动脉综合征介入手术中应用,发现其比氯吡格雷有更快更强更持久的抗血小板作用,能显著减少缺血事件的发生率,但出血的危险性有所增加。在临床使用中应注意识别血栓高危患者和出血风险高危人群。2009年7月,美国美国食品药品管理局(FDA)发布声明,允许抗血小板药普拉格雷用于降低经皮冠状动脉介入治疗中的血栓风险。 包装规格 片剂 2.5毫克:(PTP)100粒
3.75毫克:(瓶)100粒(PTP)100片140片(14粒×10),500片700片(14片×50)
5毫克:(PTP)16片(8粒×2)80片(8粒×10),100片
20毫克:(PTP)5片20片(5片×4)
制造厂商 第一三共有限公司 原研药品资料附件:http://www.info.pmda.go.jp/go/pack/3399009F1020_1_11/ Brand name : EFIENT TABLETS 5mg 3.75mg Active ingredient: Prasugrel hydrochloride Dosage form: faint yellowish red tablet, major axis: 8.7 mm, minor axis: 4.7 mm, thickness: approximately 2.9 mm Print on wrapping: エフィエント 5mg, 3.75mg Efient 5mg, 3.75mg,抗血小板剤 Effects of this medicine This medicine suppresses platelet aggregation caused by platelet activation and inhibits blood clotting to prevent recurrence of thrombosis. It is usually used for acute coronary syndromes ( unstable angina pectoris, non-ST elevation myocardial infarction, ST elevation myocardial infarction ), stable angina pectoris and old myocardial infarction for which percutaneous coronary intervention(PCI) is used. 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 hepatic/renal disease, hypertension or a history of cerebral infarction or transient ischemic attack. If you are bleeding, underweight ( 50 kg or less ) or scheduled for surgery/ tooth extraction. •If you are 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 4 tablets of 5 mg tablet ( 20 mg of prasugrel ) at a time once a day. Thereafter, take 1 tablet of 3.75 mg tablet ( 3.75 mg ) at a time once a day as maintenance dose. This medicine is 5 mg tablet. Strictly follow the instructions. •Avoid taking this medicine on an empty stomach. •If you miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. 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. Precautions while taking this medicine •This medicine will cause bleeding tendency. If abnormal/ prolonged bleeding occurs, consult with your doctor. Possible adverse effects of this medicine The most commonly reported adverse reactions include subcutaneous bleeding, nasal bleeding, bloody urine, hematoma at the site of vessel puncture or subcutaneous hematoma. 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. •headache, nausea/vomiting, decreased consciousness, paralysis of face/limbs on one side[bleeding] •dullness, loss of appetite, purpura, disturbance of consciousness[thrombotic thrombocytopenic purpura] •hives, swelling of eyelids/ lips/tongue, breathing difficulty[hypersensitivity] 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 direct sunlight, heat and moisture. •Discard the remainder. Do not store them.
|