英文药名：ZACRAS Combination Tablets LD/HD（Azilsartan/Amlodipine Besilate） 中文药名：阿齐沙坦/苯磺酸氨氯地平复合片 生产厂家：武田药品 ザクラス配合錠LD／ザクラス配合錠HD 治疗类别名称 持续发展AT1受体阻滞剂/持续性钙拮抗剂 批准上市日期：2014年6月 商標名 ZACRAS Combination Tablets LD ZACRAS Combination Tablets HD 阿齐沙坦 化学構造式 一般名 アジルサルタン（Azilsartan）〔JAN〕 化学名 2-Ethoxy-1-｛［2´-（5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl）biphenyl-4-yl］methyl｝-1H-benzo[d]imidazole-7-carboxylic acid 分子式 C25H20N4O5 分子量 456.45 融点 190℃ 性状 阿齐沙坦是白色结晶或结晶性粉末，以黄色。 N，易溶于N-二甲基乙酰胺，略溶于甲醇，乙醇（99.5）微溶，并且几乎不溶于水。 苯磺酸氨氯地平 化学構造式 一般名 アムロジピンベシル酸塩（Amlodipine Besilate）〔JAN〕 化学名 3-Ethyl 5-methyl （4RS）-2-［（2-aminoethoxy）methyl］-4-（2-chlorophenyl）-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate monobenzenesulfonate 分子式 C20H25ClN2O5・C6H6O3S 分子量 567.05 融点 198℃（分解） 性状 苯磺酸氨氯地平是一种白色至黄白色结晶性粉末。它是易溶于甲醇，并且难溶于乙醇（99.5），微溶于水。显示无旋光（1→100）的甲醇溶液。 适应病症： 降低血压过度风险，治疗高血压的药物 用法用量： 给药口服：成人每日1片一次 药效药理 1. 作用机理 阿齐沙坦显示降血压作用，由于减少外周血管阻力引起的通过结合（AT1）受体血管紧张素Ⅱ1型，主要是抑制其强大的血管收缩作用拮抗血管紧张素II。 苯磺酸氨氯地平显示效果为二氢吡啶类钙拮抗剂，但有一个特点是发病是持续缓慢的动作。 通过二氢吡啶类钙拮抗剂特异性结合的膜电位依赖性L-型钙通道，减少钙离子内流进入细胞内，我放松周围血管和冠状血管的平滑肌。 2. 影响血管紧张素系统 - 肾素 当它被执行一次，连用7天，敏捷20毫克阿齐沙坦健康成年人（12例），增加血浆肾素活性和血管紧张素Ⅱ浓度与血浆中血管紧张素I浓度进行了观察。 包装规格 配合錠LD ： 100錠（10錠×10）、140錠（14錠×10）、500錠（バラ、10錠×50）、700錠（14錠×50） 配合錠HD ： 100錠（10錠×10）、140錠（14錠×10）、500錠（バラ、10錠×50）、700錠（14錠×50） 制造厂商 武田药品有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/2149121F1021_1_06/ ZACRAS Combination Tablets LD/HD（Azilsartan/Amlodipine Besilate）奥美沙坦/苯磺酸氨氯地平复合片 ZACRAS Combination Tablets LD（ザクラス配合錠LD）  Brand name : ZACRAS Combination Tablets LD Active ingredient: Azilsartan  Amlodipine besilate 　Dosage form: slightly red tablets, diameter 8.2 mm, thickness 4.7 mm 　Print on wrapping: (face) ザクラス LD 274, (back) ザクラス LD ZACRAS Combination Tablets HD（ザクラス配合錠HD） Brand name : ZACRAS Combination Tablets HD 　Active ingredient: Azilsartan  Amlodipine besilate 　Dosage form: light yellow tablets, diameter 8.2 mm, thickness 4.7 mm 　Print on wrapping: (face) ザクラス HD 275, (back) ザクラス HD Effects of this medicine This medicine acts antagonistically upon the receptor for angiotensin II which is a pressor substance and also acts on the calcilum channel of smooth muscle of blood vessels to reduce resistance of peripheral blood vessels and eventually lower blood pressure. It is usually used to treat hypertension. 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 renal disorder, liver disorder, cerebrovascular disorder, or hyperkalemia. If you are receiving hemodialysis, under low-salt diet treatment, or a preoperative patient. •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>> •For adults: In general, take 1 tablet at a time, once a day. Strictly follow the instructions. •If you miss a dose, take the missed dose as soon as possible. If there is less than 8 hours to the next dose, skip the missed dose and take the next dose at your regular time. 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 •As dizziness and light-headedness may appear due to excessive lowering of blood pressure. Therefore, be aware of working at heights or operating dangerous machinery such as driving a car. Do not take this medicine together with grapefruits juice as it may enhance antihypertensive effect of the medicine. Possible adverse reactions to this medicine The most commonly reported adverse reactions include eczema, dizziness, light-headedness, swelling, bradycardia, palpitation, decreased blood presure, hot flash, headache, diarrhea, pain in the pit of stomach, constipation, stomatitis, and gingival hyperplasia. 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 reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •facial/tongue/throat swelling, breathlessness [angioedema] •feeling cold, vomiting, falling unconscious [shock, syncope, loss of consciousness] •decreased urination output, swelling of face and hands/feet, fever [acute renal failure] •numbness of hands/feet and lips, muscle weakness [hyperkalemia] •yellowing of the skin or whites of the eyes, dullness, loss of appetite [liver dysfunction, jaundice] •nose bleeding, gingival bleeding, subcutaneous hemorrhage, fever, throat pain [decreased platelet count, decreased white blood cell] •bradycardia, dizziness [atrioventricular block] 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. Takeda Chemical Industries, Ltd.Internal Published: 6/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.