英文药名:ILUAMIX Combination Tab LD/HD(Irbesartan/Amlodipine Besilate)
中文药名:厄贝沙坦/苯磺酸氨氯地平复合片
生产厂家:武田特瓦制药
イルアミクス配合錠LD「武田テバ」/イルアミクス配合錠HD「武田テバ」
药物分类名称 长效ARB/持续性Ca拮抗剂组合 批准日期:2018年6月 欧文商標名 ILUAMIX Combination Tab. LD "TAKEDA TEVA" ILUAMIX Combination Tab. HD "TAKEDA TEVA" ●厄贝沙坦 一般名 イルベサルタン(Irbesartan) 化学名 2-Butyl-3-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one 分子式 C25H28N6O 分子量 428.53 性 状 它是一种白色结晶粉末。 易溶于乙酸(100),微溶于甲醇,难溶于乙醇(99.5),几乎不溶于水。 观察到晶体多态性。 構造式
●苯磺酸氨氯地平 一般名 アムロジピンベシル酸塩(Amlodipine Besilate) 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 約198℃(分解) 性 状 它是白色至黄白色结晶粉末。 易溶于甲醇,微溶于乙醇(99.5),难溶于水。 甲醇溶液(1→100)显示没有旋光。 结构式
处理注意事项 1.即使在有效期内,也请在开封后尽快使用。 2.稳定性试验结果概要 作为加速试验(40℃,相对湿度75%,6个月)的结果,Ilamics组合片剂LD“Takeda Teva”和Ilamics组合片剂HD“Takeda Teva”被认为在正常市场流通下稳定3年。 药用药理学 ●厄贝沙坦 血管紧张素II受体亚型AT1受体的拮抗剂。它在受体水平上竞争性地拮抗内源性加压物质血管紧张素II,从而表现出抗高血压作用。 ●苯磺酸氨氯地平 它表现出作为二氢吡啶类钙拮抗剂的作用,但它具有起效缓慢和持续的特征。 二氢吡啶类钙拮抗剂特异性结合膜电压依赖性L型钙通道,并通过减少钙流入细胞而使冠状血管和外周血管的平滑肌松弛。 适应症 高血圧症 用法与用量 通常,每天一次向成人口服一片(100mg/5mg或100mg/10mg,如厄贝沙坦/氨氯地平)。该药不用作治疗高血压的一线药物。 包装 ●组合片LD PTP包装:100片(10片×10),500片(10片×50) 瓶包装:500粒 ●组合片HD PTP包装:100片(10片×10),500片(10片×50) 瓶包装:500粒
制造供应商 武田特瓦制药有限公司 注:以上中文说明资料不够完整,使用者以原资料为准。 完整说明资料附件: 1):http://database.japic.or.jp/pdf/newPINS/00067343.pdf 2):http://www.info.pmda.go.jp/go/pack/2149118F1143_1_01/
ILUAMIX COMBINATION TABLETS LD/HD(Irbesartan/Amlodipine Besilate) Brand name:ILUAMIX COMBINATION TABLETS LD/HD Active ingredient:Irbesartan Amlodipine besilate Dosage form:white to yellowish white tablet, diameter: 8.2 mm, thickness: 3.8 mm Print on wrapping:イルアミクス LD/HD 配合錠, イルベサルタン, アムロジピン, 血圧降下薬, 1日1回服用, ILUAMIX Combination Tab LD/HD Effects of this medicine This medicine decreases blood pressure by competitively antagonizing against angiotensin II type 1 receptors, and by reducing calcium ion flow into cell and relaxing smooth muscle of peripheral vessels. 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 diabetes mellitus. ・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)) ・In general, for adults, 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. However, if 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 due to decreased blood pressure. Pay attention when working at heights, driving a car or operating dangerous machinery. ・Do not take grapefruit juice with this medicine since it may intensify the medicinal effect of the medicine. Possible adverse reactions to this medicine The most commonly reported adverse reactions include dizziness, lightheadedness, edema, liver dysfunction, rash, itch, hives, photosensitivity (exaggerated sunburn caused by sunlight, itch, pigmentation), erythema multiforme, vasculitis, angioedema, and gum 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. ・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, loss of consciousness] ・edema, malaise, decreased urine output or anuria [renal failure] ・general malaise, loss of appetite, yellowing of the skin and white of eyes [fulminant hepatitis, liver dysfunction, 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 out of reach of children. Store it at room temperature (1 to 30℃)direct sunlight and moisture. ・Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them. Internal Published: 06/2018 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.
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