英文药名：AIMIX（Irbesartan/Amlodipine Besilate Tablet） 文药名：复方厄贝沙坦/氨氯地平斯汀片 生产厂家：大日本住友 アイミクス配合錠LD／アイミクス配合錠HD 治疗类别名称 长效ARB/持续钙拮抗剂配方 批准日期：2012年12月 适应症 高血圧症 用法与用量 成人，每天口服一片，（100mg/5mg或100mg/10mg厄贝沙坦/氨氯地平）。 该药不被用作治疗高血压的一线药物。 本品特点： 本品包括厄贝沙坦/氨氯地平斯汀两种降压活性成份，这两种成份在控制血压方面作用机制互补：氨氯地平属于钙通道阻滞剂类药物，厄贝沙坦 属于血管紧张素Ⅱ拮抗剂类药物。两种成份合用的降压效果优于其中任一成份单药治疗。 目前临床使用的抗高血压药物单独治疗可能获得的降压达标率不足50%，对于多数患者需要联合用药。研究结果证实，单一使用降压药的临床需求在降低，而联合用药治疗高血压已成为一种趋势。 联合抗高血压药物治疗能够以分别较小的剂量获得与单一药物加倍剂量相似或更大的降压幅度，因而大大提高抗高血压药物治疗的降压达标率。在多个抗高血压药物的临床试验中，对轻中度高血压患者，联合抗高血压药物的降压达标率均达到70%以上；即使对重度高血压患者，亦能获得更好的疗效，降压幅度更大，血压控制达标率更高。同时，由于使用分别较小的剂量以及药物作用机制不同，临床不良反应发生率降低，长期接受治疗的安全性和耐受性显著提高。联合降压药物治疗应成为普遍适用的初始抗高血压药物治疗临床策略。 厄贝沙坦/氨氯地平斯汀为两种抗高血压药物的复方制剂，适用于单用一种药物治疗而不能控制血压的患者，此复方制剂疗效好，用药方便，大大提高患者用药顺应性，另具有以下优势特点： 1.两种药物从不同角度和不同机制发挥了抗高血压的协同作用，显著降压，更好地保护靶器官。 2.有利于兼顾病人存在的多种危险因素与并存疾病。 3.联合用药可减少单药剂量，使与剂量相关的副作用或不良反应明显降低。 4.固定复方制剂使治疗简化，每日一次给药，能改善病人的依从性与生活质量。 一项入选5000多例患者的大型临床试验为此次批准提供了支持数据。在两项安慰剂对照试验中，接受复方氨氯地平缬沙坦片治疗的患者中有90%血压达标。在另外两项试验中，单独服用厄贝沙坦/氨氯地平斯汀而血压未得到控制的患者，用复方厄贝沙坦/氨氯地平斯汀显示了很强的降压效果，且常见不良反应症状均较轻微。 包装规格 混合片LD： [PTP] 100片（10片×10），500片（10片×50），700片（14片×50） [瓶装] 500粒 混合片HD： [PTP] 100片（10片×10），500片（10片×50），700片（14片×50） [瓶装] 500粒 制造商 大日本住友制药公司 注：以上中文资料仅参考，使用者以原处方资料为准。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/2149118F1020_2_13/ Acquisition of manufacturing and marketing approval for antihypertensive medicine "Eimics blended tablet LD / HD" Dainippon Sumitomo Pharmaceutical Co., Ltd. (Head Office: Chuo-ku, Osaka-shi, Chuo-ku, President: Masayo Tada) announced on September 28, approval of manufacturing and marketing by the Ministry of Health, Labor and Welfare on September 28 concerning hypertension treatment drug " We have informed you that we have acquired. Eimics combination tablets have long-acting ARB (angiotensin II receptor antagonist) irbesartan (product name: "avapro") that lasts for 24 hours antihypertensive effect and calcium antagonism with potent and sustained antihypertensive effect It is a formulation with amlodipine besylate (product name: "Amlodin") which is a drug, developed by the Company, and applied for manufacturing and marketing approval in November 2011. In clinical trials carried out in Japan, Eimics combination tablets showed a good antihypertensive effect on patients who could not obtain sufficient antihypertensive effect by single administration of irbesartan or amlodipine besylate at the usual dose. "Eimics combination tablet LD" is a combination tablet of irbesartan 100 mg / amlodipine 5 mg, "Eimics combination tablet HD" is a combination tablet of irbesartan 100 mg / amlodipine 10 mg. Eimics blended tablet HD will be the first compounding ingredient in Japan including amlodipine 10mg. In June 2012, we entered into a parallel distribution agreement with Shionogi Pharmaceutical Co., Ltd. (Head Office: Chuo Ward, Osaka City, President and Representative: Isao Teshirogi) regarding the Eikoku tablet LD / HD, Combined tablets LD / HD are scheduled to be released after receipt of drug price criteria. We promote information provision activities in parallel with Shionogi & Co., Ltd., so we can use Eikoku mixed tablet LD / HD in Japan for many high blood pressure patients, and contribute more to the treatment of hypertension I aim for what I can do. ○ For inquiries concerning this matter (Reference) Outline of "Eikoku mixed lock LD / HD" Name of sale: Eimics blended tablet LD Iimics blended tablet HD Common name: irbesartan / amlodipine besylate Dosage form / content Ionic mix tablet LD: A white to yellowish white film-coated tablet containing 100 mg irbesartan in one tablet and 5 mg (amlodipine besylate 6.93 mg) as amlodipine Eye mix tablet HD: Light-darker film-coated tablets containing 100 mg irbesartan in 1 tablet and 10 mg (amloadodine besylate 13.87 mg) as amlodipine Indications / effects: hypertension DOSAGE AND ADMINISTRATION: For adults, 1 tablet (100 mg / 5 mg or 100 mg / 10 mg as irbesartan / amlodipine) is administered orally once a day. This drug is not used as a first-line drug for treatment of hypertension. Manufacturing distributor: Dainippon Sumitomo Pharmaceutical Co., Ltd. Overview of irbesartan It is a long-acting ARB (Angiotensin II receptor antagonist) that was created by sanofi (Headquarters: France), has a long half-life in blood and lasts 24 hours antihypertensive effect, is excellent from mild to severe hypertension Hypotensive effect is recognized. Overseas, renal protection has been demonstrated by results of large-scale clinical trials such as IDNT and IRMA 2, which were released in 1997 and also described in major overseas guidelines, and early nephropathy resulted in overt nephropathy It is known as an ARB with evidence in a wide range of stages from the beginning to the end and is highly regarded as one of ARB's top brands. In Japan, in July 2008, we released the product name "Avapro" and Shionogi Pharmaceutical Co., Ltd. as the product name "Irbetan". The indications, dosages and dosages approved in Japan are as follows. Indications / effects: hypertension DOSAGE AND ADMINISTRATION: Ordinarily, 50 to 100 mg as irbesartan once daily for adults. The dose may be increased or decreased according to age and symptoms, but the maximum daily dose is up to 200 mg. Outline of amlodipine besylate It is highly appreciated both in Japan and abroad as a potent and stable antihypertensive effect that lasts for a long time. We launched it in Japan as "Amrozin" in December 1993. In Japan, in February 2009 a standard dose of 10 mg prescribed overseas (as amlodipine) became possible, making it possible to treat this drug for a wider range of hypertension patients. In addition, evidence of brain / cardioprotective action has been reported from large-scale clinical trial results such as ASCOT-BPLA and CAMELOT conducted overseas, and it is widely prescribed as a drug that can expect improvement in the prognosis of patients with hypertension. The indications, dosages and dosages approved in Japan are as follows. Indications/effects: hypertension, angina pectoris Dosage / administration: ·high blood pressure Usually, 2.5 to 5 mg of amlodipine is orally administered to adults once a day. Incidentally, although it will be increased or decreased according to the symptoms as appropriate, if the effect is insufficient, it can be increased to 10 mg once a day. * Usually, 2.5 mg as amlodipine is orally administered to children aged 6 years or older once a day. Incidentally, it should be increased or decreased according to age, body weight and symptoms. (The part is applied only to "Amlodin tablets 2.5 mg / 5 mg" and "Amrozine OD tablets 2.5 mg / 5 mg".) Angina pectoris Usually, 5 mg of amlodipine is orally administered to adults once a day. Incidentally, increase or decrease appropriately according to symptoms.