英文药名：AVAPRO Tablets（Irbesartan） 中文药名：依贝沙坦片 适合病症：高血压 生产厂家：住友制药 アバプロ錠50mg／アバプロ錠100mg／アバプロ錠200mg 治疗类别名称 长效作用型ARB 商標名 AVAPRO 一般名 イルベサルタン（Irbesartan） 化学名 2-Butyl-3-{4-［2-（1H-tetrazol-5-yl）phenyl］benzyl}-1,3-diazaspiro［4.4］non-1-en-4-one 構造式 分子式 C25H28N6O 分子量 428.53 性状 它是一种白色结晶粉末。易溶于二甲基亚砜，难溶于甲醇，乙醇（99.5）微溶，并且几乎不溶于水。溶于稀氢氧化钠TS中。 融点 182.4-184.6℃ 分配係数 約10.1（pH7.4、1-オクタノール/緩衝液） 适应病症 高血压 剂量和用法 成年人，每日一次，每次50-100毫克。剂量可根据年龄，症状适当增减，每天最大剂量200毫克。 药效药理 1. 药理作用 高肾素血压正常猴子，表明通过口服给药的剂量依赖性和持续降血压作用在2肾1夹肾性高血压大鼠，中风倾向的自发性高血压大鼠（SHRSP）。厄贝沙坦并不影响心脏速率。另外，通过反复口服抑制高血压发展到高血压的发展过程（SHR）的自发性高血压大鼠。它的作用是持续的反弹现象进行观察治疗厄贝沙坦停药后。 另外，高血压肥大的发展反复口服给药对SHR，以及增厚的左心室和主动脉相关的心脏被抑制。此外，在SHRSP表现高血压器官损害和高死亡率由于盐负荷，通过反复口服给药，中风发作，观察到的高血压器官损害和死亡标记抑制。在SHRSP中风发作后，由死亡重复口服给药被抑制，中风的症状也被施用后立即显着改善。在高盐负荷5/6肾切除的SHR，肾损害已经减少了重复口服给药。 2. 作用机序 特异性地抑制血管紧张素II（AII）在体外试验离体兔主动脉引起的收缩，它表现出抗AII诱发的升压反应也在体内试验（大鼠，狗，猴）的抑制作用。从体外结合研究中，抑制效果是根据AII受体的竞争性拮抗作用建议是一个进一步AII1型受体（AT1受体）选择性。额外的受体显示没有亲和力，血管紧张素转换酶没有抑制。 包装规格 口服片 50毫克：[PTP]100片（10片×10），500片（10片×50），700片（14片×50） [瓶装]500粒 100毫克：[PTP]100片（10片×10），500片（10片×50），700片（14片×50）[瓶装]500粒 200毫克：[PTP]100片（10片×10），500片（10片×50），700片（14片×50） 原文说明书附件：http://www.info.pmda.go.jp/go/pack/2149046F1023_1_09/ AVAPRO Tablets（アバプロ錠50mg 100mg） Brand name : AVAPRO Tablets 50mg 100mg 　Active ingredient: Irbesartan 　Dosage form: white to yellowish white tablet (major axis: 8.5 mm, minor axis: 4.4 mm, thickness: 3.1 mm) 　Print on wrapping: アバプロ,100mg 50mg, DS512 Effects of this medicine This medicine is a competitive antagonist for angiotensin II type 1 receptors, and decreases 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 are a patient with diabetes mellitus. •If you are pregnant, breastfeeding or possibly pregnant. •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 1-2 tablets (50-100 mg of the active ingredient) at a time, once daily. The dosage may be adjusted according to the diseases, age or symptoms, however, the maximum daily dose is limited to 4 tablets (200 mg). Strictly follow the instructions. •If you miss a dose, take as soon as possible. However, it is almost time for the next dose, skip the missed dose and continue 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 •The medicine may cause dizziness or lightheadedness since the blood pressure is decreased. Pay close attention when you work at heights, drive a car or operate dangerous machinery. Possible adverse effects of this medicine The most commonly reported adverse reactions include dizziness, cough, headache, rash, urticaria and itch. 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. •breathing difficulty; swelling of face, tongue or throat[angioedema] •weakness of the limbs, numbness of lips, muscle weakness[hyperkalemia] •vomiting, faint, loss of consciousness[shock, syncope, unconsciousness] •swelling, malaise, decreased urine output, anuria[renal failure] •general malaise, vomiting, yellowness in the skin or conjunctiva[hepatic function disorder, jaundice] 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 the medicine out of the reach of children. Store it at room temperature ranging 1 to 30 degrees Celsius, away from direct sunlight and moisture. •Discard the remainder. Do not store them. 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.