英文药名：ComPlavin Combination Tablets （Clopidogrel Sulfate/Aspirin) 中文药名：复方硫酸氢氯吡格雷/阿司匹林片 生产厂家：赛诺菲（Sanofi K.K） コンプラビン配合錠 治疗类别名称 抗血小板剂 批准上市：2013年 商標名 ComPlavin 1. 硫酸氯吡格雷 一般名 クロピドグレル硫酸塩（Clopidogrel Sulfate） 化学名 Methyl（2S）-2-（2-chlorophenyl）-2-［6, 7-dihydrothieno［3, 2-c］pyridin-5（4H）-yl］acetate monosulfate 分子式 C16H16ClNO2S・H2SO4 分子量 419.90 構造式 融　点 約177℃（分解） 性　状 本产品是淡黄白色结晶粉末或粉白色。 它是易溶于水或甲醇，微溶于乙醇（99.5）。 该产品是由逐渐变成浅棕色。 此产品是观察晶体多态性。 2. 阿司匹林 一般名 アスピリン（Aspirin） 化学名 2-Acetoxybenzoic acid 分子式 C9H8O4 分子量 180.16 構造式 融　点 約136℃ 性　状 本产品是一种白色结晶，用谷物或粉末，无臭，稍有一个酸味。 它是易溶于乙醇（95）或丙酮，微溶于乙醚，微溶于水。 此产品是溶于氢氧化钠的TS或碳酸钠试剂。 此产品是由水杨酸和乙酸在潮湿的空气中逐渐水解。 有效成分 硫酸氯吡格雷 75mg/阿司匹林 100mg/片 药效药理 1. 薬理作用 (1) 根据血小板由ADP刺激活化硫酸氯吡格雷不表达在体外血小板凝集抑制作用，口服给药后，和由肝脏代谢成为活性代谢物，抑制血小板聚集。在大鼠还已经由胶原和低浓度的凝血酶观察血小板聚集的抑制。 (2) 硫酸氯吡格雷是，中脑动脉血栓形成模型（大鼠），动静脉分流模型（大鼠），冠状动脉周期性血流减少模型（犬），颈动脉球囊内皮损伤模型（兔），支架放置动静脉分流模型抑制（兔）的血栓形成，它是在大脑中动脉脑模型通过减少血栓形成抑制的基础上的梗塞大小。结合阿司匹林当用于颈动脉球囊内皮损伤模型中，在支架的动静脉分流模型血栓形成的抑制效果提高。 2. 作用机序 (1) 硫酸氯吡格雷活性代谢物，不可逆地抑制ADP的结合影响血小板ADP受体亚型P2Y1227），抑制基于血小板的活化血小板聚集。 (2) 阿司匹林通过抑制环氧合酶，抑制血栓烷A2的合成，抑制血小板聚集。 适应症 下面缺血性心脏疾病的经皮冠状动脉介入（PCI）被施加 急性冠脉综合征（不稳定型心绞痛，非ST段抬高心肌梗死，ST段抬高心肌梗死） 稳定型心绞痛，陈旧性心肌梗死 剂量与用法 成人，每天一次，每次1片（100毫克为75毫克和阿司匹林作为氯吡格雷）口服给药 包装规格 100錠［10錠（PTP）×10］ 生产厂家 赛诺菲日本公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/3399101F1021_1_08/ 心血管病变目前临床除介入治疗以外，阿司匹林+氯吡格雷的二联治疗是唯一的药物治疗手段 Brand name:ComPlavin Combination Tablets 　Active ingredient:Clopidogrel Salfate   Aspirin 　Dosage form: white to pale yellow tablet, diameter: 11 mm, thickness: 6 mm 　Print on wrapping: コンプラビン配合錠 ComPlavin saCA Effects of this medicine This medicine is a combination of the two active ingredients and inhibits platelet aggregation based on platelet activation, suppresses clot formation and prevents blockage of blood vessels. It is usually used for acute coronary syndrome, stable angina pectoris and old myocardial infarction for which percutaneous coronary intervention is indicated. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (asthma, itch, rash, etc.) to any medicines. •If you have bleeding, pain or tenderness in the solar plexus, heartburn, belching, nausea, vomiting, hematemesis and melena. •If you are going to undergo dental extraction or surgery. •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, take 75 mg as clopidogrel and 100 mg as aspirin once a day from the date of first administration. Strictly follow the instructions. •If you miss a dose, take the missed dose as soon as possible. You should never take two doses at one time. in general, for adults, take this medicine once a day. Strictly follow the instructions. Avoid taking this medicine on an empty stomach. Take this medicine as it is without breaking, chewing and crunching. •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 • Possible adverse effects of this medicine The most commonly reported adverse reactions include bleeding tendency including subcutaneous bleeding, nausea/vomiting and loss of appetite. 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 severe headache, nausea/vomiting, one-sided face or limbs paralysis[intracranial bleeding, subdural hematoma] •melena (black stool, bloody stool), hematemesis, vision disorder, joint pain[hematemesis, melena, gastrointestinal bleeding, ocular fundus bleeding, joint hematoma, lung bleeding] •severe fatigue/malaise, loss of appetite, yellow discoloration of the white of the eyes/the skin[liver dysfunction, jaundice] •malaise, loss of appetite, purpura, disturbed consciousness[thrombotic thrombocytopenic purpura] •sore throat, headache/feeling of dull headache, ear ringing[thrombocytopenia, leukopenia, agranulocytosis, pancytopenia] 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 this medicine out of the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them.