英文药名：Irbetan（Irbesartan tablets） 中文药名：厄贝沙坦片 生产厂家：盐野义制药 イルベタン錠50mg／イルベタン錠100mg／イルベタン錠200mg 治疗类别名称 长效ARB 欧文商標名 Irbetan 一般的名称：イルベサルタン（JAN） 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 分子式：C25H28N6O 分子量：428.53 化学構造式： 性状 它是一种白色结晶粉末。 它易溶于二甲基亚砜，稍少溶于甲醇，微溶于乙醇（99.5），并且几乎不溶于水。 它溶于稀氢氧化钠TS中。 熔点：182.4〜184.6℃ 分配系数：约10.1[pH7.4,1-辛醇/缓冲] 药效药理 药理作用 高肾素血压正常猴，表明通过口服给药剂量依赖性和持续降血压作用在2肾一夹高血压大鼠，中风倾向的自发性高血压大鼠（SHRSP）。厄贝沙坦不影响心脏率。另外，它抑制了高血压的发展通过反复口服给药对高血压的发展过程（SHR）的自发性高血压大鼠。它的作用是持续反弹的现象，观察厄贝沙坦停药后还是一样。 此外，随着高血压反复口服给药对SHR，以及左心室和主动脉增厚的发展相关的心脏肥大被抑制。此外，在SHRSP表现出由重复口服给药，中风高血压器官功能衰竭和高死亡率由盐负荷，观察到的高血压器官损害和死亡一个显著抑制。在SHRSP中风发作后，死亡是由重复口服给药抑制，中风症状，也分别从施用后立即显着的改善。在高盐负荷5/6肾切除SHR和16），以20肾功能衰竭得到缓解的反复口服给药）。 作用机制 具体地抑制血管紧张素II的离体兔主动脉（AⅡ）引起的收缩在体外试验表明对AII诱发的增压应答也可以在体内试验（大鼠，狗，猴）的抑制作用。在体外结合研究，其抑制效果是根据AII受体的竞争性拮抗作用，这表明更AII-1型受体（AT1受体）选择性。不表现出亲合性对其它受体，血管紧张素转换酶不抑制。 适应症 高血圧症 用法用量 通常情况下，成人口服每天一次50〜100毫克。此外，年龄，和将根据症状进行调整，每日最大剂量为高达200毫克。 包装规格 片 50毫克：一瓶500粒 PTP 100片（10片×10） PTP 500片（10片×50） PTP 700片（14粒×50） 100毫克：瓶500粒 PTP 100片（10片×10） PTP 500片（10片×50） PTP 700片（14粒×50） 200毫克：PTP 100片（10片×10） 生产厂商 盐野义制药有限公司 IRBETAN Tablets（Irbesartan） IRBETAN Tablets 50mg（イルベタン錠50mg） Brand name :IRBETAN Tablets 50mg 　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:(Face) イルベタン 50mg, (Back) イルベタン 50mg 132 50 IRBETAN Tablets 100mg（イルベタン錠100mg） Brand name :IRBETAN Tablets 100mg 　Active ingredient:Irbesartan 　Dosage form:white to yellowish white tablet, major axis: 11.0 mm, minor axis: 5.7 mm, thickness: 3.8 mm 　Print on wrapping:(Face) イルベタン 100mg, (Back) イルベタン 100mg 133 100 IRBETAN Tablets 200mg（イルベタン錠200mg） Brand name :IRBETAN Tablets 200mg 　Active ingredient:Irbesartan 　Dosage form:white to yellowish white tablet, major axis: 14.0 mm, minor axis: 7.3 mm, thickness: 4.8 mm 　Print on wrapping:(Face)イルベタン 200mg, (Back)イルベタン 200mg 134 200 Effects of this medicine This medicine decreases blood pressure by antagonizing the type 1 angiotensin II receptor competitively. It is usually used for the treatment of 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 pregnant or breastfeeding, or may possibly be 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 50 to 100 mg of the active ingredient at a time, once daily. The dosage may be adjusted according to your diseases, age or symptoms. The daily dosage can be increased up to one tablet (200 mg). Strictly follow the instructions. If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose. 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 the medicine unless your doctor instructs you to do so. Precautions while taking this medicine The medicine may cause dizziness or lightheadedness due to decreased blood pressure. Pay close attention when you work at height, drive a car or operate dangerous machinery. If you are breastfeeding, discontinue it while taking this medicine. Possible adverse reactions to this medicine The most commonly reported adverse reactions include dizziness, cough, headache, rash, hives 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 reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. breathlessness, swelling of face, tongue, throat, etc. [angioedema] losing strength in a limb, numbness of lips, muscle weakness [hyperkalemia] vomiting, faint, loss of consciousness [shock, syncope, unconsciousness] swelling, malaise, decreased urine output or anuria [renal failure] malaise, anorexia, yellowness in skin or in the white of eyes [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 infants and children. Store it at room temperature (1 to 30 degrees Celsius) away from direct sunlight and moisture. Discard the remainder. Do not store them. Shionogi & Co., Ltd. Internal Published: 6/2013The 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. http://www.info.pmda.go.jp/go/pack/2149046F1031_1_11/