产地国家：日本 处 方 药：是 所属类别：50毫克/片 100片/盒 包装规格：50毫克/片 100片/盒 计价单位：盒 生产厂家中文参考译名：辉瑞公司 生产厂家英文名：Pfizer Japan Inc 原产地英文商品名：Selara(セララ錠)50mg/Tablets 100Tablets/box 原产地英文药品名：Eplerenone 中文参考商品译名：Selara(セララ錠)50毫克/片 100片/盒 中文参考药品译名：依普利酮

简介

部份中文依普利酮处方资料(仅供参考) 英文名：Eplerenone 商品名：Selara Tablets 中文名：依普利酮片 生产商：辉瑞公司 药品简介 依普利酮(eplerenone)是第一个获准上市的选择性醛固酮受体阻断剂(SARA)，由法玛西亚普强公司开发，2002年首次在美国上市，商品名为Inspra。2007在日本批准上市，商品名为：Selara。本品主治高血压，可与其它抗高血压药合用，且于2003年又新增适应证为心力衰竭。 セララ錠25mg/セララ錠50mg/セララ錠100mg 药用分类名称 选择性阿尔多斯特龙阻滞剂 批准日期：2007年11月 Selara Tablets 25mg Selara Tablets 50mg Selara Tablets 100mg 一般的名称：エプレレノン(Eplerenone) 化学名：9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone 分子式：C24H30O6 分子量：414.49 性状：它是白色结晶粉末。容易溶于醋酸盐，不易溶于甲醇，很难溶于水或乙醇(99.5)。 批准条件 依普利酮片剂 25mg /50mg/100mg 制定并适当实施药品风险管理计划。 作用机制 埃普雷列酮与矿物皮质激素受体结合，抑制肾素-血管紧张素-醛固酮(RAAS)的激素阿多斯特龙的结合。 醛固酮与上皮组织和心脏，如肾脏，血管和大脑等非上皮组织中的矿物皮质激素受体结合，通过钠再吸收和其他机制提高血压。 埃普雷列酮被认为通过抑制这些醛固酮的作用来表现出降压作用。 为了抑制醛固酮对肾素分泌的阴性反馈，血浆中肾素活性和血清中醛固酮浓度持续升高，这些升高不会削弱埃普雷列酮的作用。 受体结合的选择性 埃普雷列酮选择性地与大鼠和人类矿物皮质激素受体结合。 糖皮质激素受体、雄激素受体、黄体酮受体等，与其他类固醇激素受体的亲和力，与矿物皮质激素受体的亲和力相比，小于1/20。 在大鼠的试验中，临床剂量的Epreleon，由于对类固醇激素受体的影响，除矿物皮质激素受体外，未观察到副作用。 对高血压的影响 Epreenon，在单侧肾切除高血压大鼠中，对阿尔多斯特龙持续给药/盐负荷，对收缩血压表现出持续的降压作用。 Epreenon，在中风易发展自然发展高血压大鼠(SHRSP)中，在两周的给药期间，对收缩血压表现出持续的降压作用。 此外，通过与ACE抑制剂利西诺普利的组合，降压作用显著增强。 在达勒盐敏感大鼠中，是盐敏感度低肾素型高血压的动物模型，Epreleon在持续4周的给药中表现出剂量依赖性降压作用，对收缩血压有4周的持续剂量。 慢性心力衰竭的作用 在心力衰竭动物模型(小鼠、大鼠、狗)中，Epreenon 改进了与心脏功能相关的参数(如左室提取分数)，并表现出心脏保护作用(心脏肥大、抑制左室重塑)。 适应症 高血压 接受血管紧张素转化酶抑制剂或血管紧张素II受体拮抗剂、β阻滞剂、利尿剂等基本治疗的患者。 慢性心力衰竭 用法与用量 高血压 通常，成人每天从50mg开始施用一次，作为Epreleon，如果效果不足，可以增加到100mg。 慢性心力衰竭 通常，成人每天从25mg开始施用一次，作为Epreleon，血清钾值，根据患者的状态，从给药开始4周后，每天增加一次50mg作为指南。 然而，在中度肾功能障碍患者中，每天从25mg开始给药，最大剂量为每天25mg。另外，血清钾值，根据患者的状态适当减肥或中断。 包装 片剂 25毫克：100片 [10 片 (PTP) x 10] 50毫克：100片 [10 片 (PTP) ×10]， 700片[14片(PTP)× 50]，500片(瓶) 100毫克：100片 [10 片 (PTP) x 10] 制造商 辉瑞制药有限公司 注：以上中文处方资料不够完整，使用者以原处方资料为准。

英文版说明书

Brand name:Selara Tablets 50mg Active ingredient:Eplerenone Dosage form:pale red tablet, diameter: 7.1mm, thickness: 4.0mmPrint on wrapping:セララ 50mg, Selara50mg, NSR50, 高血圧症慢性心不全の薬 Effects of this medicine This medicine inhibits the binding of aldosterone to receptors which is involved in hypertensive effects, heart andvascular fibrosis, heart hypertrophy or ventricular arrhythmia. It consequently shows antihypertensive effects andanti-heart failure effects. It is usually used to treat hypertension and chronic heart failure (for the case of receiving base treatment such as ACE inhibitors, angiotensin II receptorantagonist, beta-blocker or diuretic). 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: hyperkalemia, diabetes mellitus with microalbuminuria or proteinuria, renal dysfunction or liverdysfunction. • If you are pregnant or breastfeeding. • If you are taking any other medicinal products(Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescriptionmedicines) Dosing schedule(How to take this medicine) • Your dosing schedule prescribed by your doctor is(( to be written by a healthcare professional)) • For treatment of hypertension: In general, for adults, start with 1 tablet (50 mg of the active ingredient) at atime, once a day.If it is not effective enough, the dosage may be increased up to 2 tablets (100 mg) per day. However, if you take the medicine in combination with other medicinal products that suppress its metabolism,the daily dosage may not exceed 25 mg at a time, once a day. For treatment of chronic heart failure: In general, for adults, start with 25 mg of the active ingredient at atime, once a day. After 4 weeks from the start as a guide, the dosage may be increased up to 50 mg at a time,once a day according to the serum potassium level or conditions. However, if you have moderate renal dysfunction, start with 25 mg at a time, once every other day. The maximum daily dose is up to 25 mg at atime, once a day, but the dosage may be decreased or discontinued according to the serum potassium level or conditions. If you take the medicine in combination with other medicinal products that suppress its metabolism, the daily dosage may not exceed 25 mg at a time, once a day. This preparation contains 50 mg of the active ingredient in a tablet. In any case, strictly follow theinstructions. • If you miss a dose and remember it within one day, take the missed dose when you remember. You shouldnever 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 • Since this medicine may cause dizziness by declining blood pressure, pay close attention to performingdangerous operations/machinery such as driving a car or working at heights. • Avoid taking health supplements containing St. John's wort (a kind of herb) with the medicine, since it maydiminish medicinal effects with its enhanced metabolism. Possible adverse reactions to this medicineThe most commonly reported adverse reactions include headache, dizziness, nausea, fatigue, hypotension, renaldysfunction, indigestion and muscle cramp.If any of these symptoms occur, consult with your doctor orpharmacist. The symptoms described below are rarely seen as initial symptoms of the adversereactions indicated in brackets.If any of these symptoms occur, stop taking thismedicine and see your doctor immediately. • numbness of limbs or lips, muscle weakness, paralysis of limbs [hyperkalemia] 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 otherthan those listed above. Storage conditions and other information • Keep out of reach of children. Store away from direct sunlight, heat and moisture. • Discard the remainder. Do not store them. Internal Revised: 05/2017 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatmen