日本第一三共公司研发的新型复方抗高血压药物Tribenzor获FDA批准用于治疗联合2种常用抗高血压药疗效不佳的难治性患者，Tribenzor由氨氯地平、奥美沙坦酯、氢氯噻嗪组成，能有效降低患者血压，但不作为一线用药。 日前，美国FDA批准，在应用血管紧张素受体阻滞剂、钙通道阻滞剂和利尿剂中任意2种药物仍无法充分控制患者血压的情况下，可考虑使用三联药物Tribenzor。 Tribenzor是日本第一三共公司研发的新型复方抗高血压药物，含氨氯地平、奥美沙坦酯、氢氯噻嗪。Tribenzor被FDA批准用于那些应用抗高血压药物的其他组合不能使高血压得到很好控制的患者。但不宜用作一线抗高血压药。 一项研究试验结果证明了Tribenzor的有效性，该试验共纳入2,492例高血压患者(平均基线血压为168.5/100.9mmHg)。在患者接受了氨氯地平/氢氯噻嗪(10/25 mg)，奥美沙坦/氢氯噻嗪(40/25mg)和奥美沙坦/氨氯地平(40/10mg)这3种双药组合疗法中的其中一种后，医生开始改用Tribenzor(40/10/25mg)对患者进行抗高血压治疗。在接受了为期8周的Tribenzor治疗后，患者的平均血压进一步降低(分别为8.1/5.4mmHg、7.6/5.4 mmHg和8.4/4.5 mmHg，对每一种双药组合治疗而言，P值均<0.0001)。 Tribenzor最常见不良反应包括头晕、外周水肿、头痛、乏力、鼻咽炎、肌肉痉挛、恶心、上呼吸道感染、腹泻、尿道感染和关节肿胀。 高血压是一种常见的多发性疾病，有效平稳控制血压是目前治疗高血压的主要目标。但在目前接受抗高血压治疗的患者中，大约有56%的患者在血压控制方面并未达到现行推荐目标。此外，有超过66%的高血压患者需要联用2种或2种以上的抗高血压药物方能达到期望的血压控制目标。 Tribenzor是一种新型的3三联混合型药物，每日只需服药1次，有望简化血压难以控制患者的给药方案，减少药丸负荷，并可以减少整张处方的费用。为难治性高血压患者提供一种更方便有效的治疗方法，一天一次用药能避免患者忘服漏服药物，避免出现血压波动现象. Tribenzor禁用于无尿或对其他磺胺类药物过敏的患者。对肾素-血管紧张素业已激活的患者[如那些血容量耗竭和(或)盐耗竭的患者]而言，其一旦开始接受Tribenzor治疗后便有可能发生症状性低血压。当患者(尤其是那些存在严重阻塞性冠状动脉疾病的患者)开始接受钙通道阻滞剂治疗或增加给药剂量时，其可能会出现心绞痛发作频率增高、持续时间延长，或病情严重程度加重，其发生急性心肌梗死的几率也会增高。应该避免对那些存在严重肾功能损害的患者使用Tribenzor。 TRIBENZOR-奥美沙坦酯/苯磺酸氨氯地平/氢氯噻嗪片剂薄膜包衣 批准日期：04/2011  生产商：Daiichi Sankyo公司 美国首次批准：2010 适应症及用法 tribenzor是血管紧张​​素2受体阻滞剂，二氢吡啶类钙通道阻滞剂，和一个用于高血压的治疗中表示的噻嗪类利尿药的组合​​。 Tribenzor没有表示对初始治疗。 【用法用量】 tribenzor可被取代其个别滴定成分奥美沙坦酯，氨氯地平，氢氯噻嗪上的患者。 可能会作为Tribenzor add-on/switch治疗提供额外的降血压没有得到充分控制上从以下两个降压类药物：血管紧张素受体阻滞剂，钙通道阻滞剂，利尿剂最大耐受的患者，标记，或常用剂量。 剂量可以增加，2周后的最大剂量为40/10/25毫克，每天一次，通常是通过增加在时间的一个组件。   剂型和优势 片剂：（奥美沙坦/氨氯地平/氢氯噻嗪） 20/5 / 12.5毫克 40/5 / 12.5毫克 40/5/25毫克 40/10 / 12.5毫克 40/10/25毫克 禁忌 无尿;过敏的磺胺类药物。   警告和注意事项 避免胎儿或新生儿暴露 低血压的体积或盐耗尽的患者开始治疗，可能会发生。正确的体积消耗在给药前。 增加与钙通道阻滞剂可能发生心绞痛或心肌梗死后开始或增加剂量。 避免在严重肾功能受损的患者（肌酐清除率≤30毫升/分钟）。 终止或中止Tribenzor，如果进行性肾功能损害明显。 应谨慎使用噻嗪类利尿剂治疗轻度至中度肝功能受损或进展性肝病。，避免患者肝功能严重受损。 观察的流体或电解质不平衡的迹象。 噻嗪类利尿剂可能会导致加重或激活系统性红斑狼疮。 急性闭角型青光眼已与噻嗪类利尿剂。   不良反应 最常见的不良反应（发生率≥2％），头晕，血管神经性水肿，头痛，疲劳，鼻咽炎，肌肉痉挛，恶心，上呼吸道感染，腹泻，尿路感染，关节肿胀。   药物相互作用 奥美沙坦酯： 非甾体抗炎药（NSAIDS）的风险增加肾损害和损失的降压作用 氢氯噻嗪： 酒精，巴比妥类药物，麻醉剂是：增强体位性低血压。 降糖药：抗糖尿病药物的剂量调整可能是必需的。 消胆胺和考来替泊噻嗪类药物的吸收减少。 糖皮质激素，促肾上腺皮质激素：电解液消耗，低血钾。 锂电池：锂毒性，使用利尿剂时，不应该给予利尿剂的肾清除率和高风险减少。 非甾体抗炎药：可减少利尿，利钠，利尿药和降压作用的。   特殊人群中使用 怀孕：避免在怀孕期间使用。 哺乳期的母亲应避免使用，而护理;中止或者护理或药物。 老年患者：没有整体的疗效或安全Tribenzor的差异，观察在这名病人的人口，但更高的灵敏度，不能排除一些老年人。 INDICATION TRIBENZOR® is a prescription medicine used to lower high blood pressure (hypertension). Medicines that lower blood pressure lower the chance of having a stroke or heart attack. TRIBENZOR is not for use as the first medicine to treat high blood pressure. Patients may require more than one type of blood pressure lowering medication. Along with lowering blood pressure, a complete treatment plan to lower the chance of a stroke or heart attack may include exercise, a diet low in sodium, stopping smoking, controlling cholesterol, treatment or prevention of blood clots, and controlling blood sugar. TRIBENZOR® Important Safety Information DAIICHI SANKYO WARNING: DO NOT TAKE TRIBENZOR DURING PREGNANCY •TRIBENZOR can cause harm or death to an unborn baby •Talk with your doctor about other ways to lower your blood pressure if you become pregnant •If you get pregnant while taking TRIBENZOR, tell your doctor immediately Please see the WARNINGS AND PRECAUTIONS section of the Full Product Information about Fetal Toxicity. Before taking TRIBENZOR, tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breast-feeding or plan to breast-feed. A medicine in TRIBENZOR can pass into your breast milk. This may harm your baby. You and your doctor should decide if you will take TRIBENZOR or breast-feed. You should not do both. Do not take TRIBENZOR if you: •Have less urine than normal or if you cannot urinate •Are allergic to other sulfonamide type medicines •Take medicine that contains aliskiren and you have diabetes or kidney problems •Have severe kidney disease Let your doctor know about any health conditions you may have Tell your doctor if you are allergic to any of the ingredients in TRIBENZOR (see Full Product Information for a list of the ingredients in TRIBENZOR). Also let your doctor know if you have any of the health conditions listed below:  Let your doctor know if you have these, or any other, medical conditions:  •Kidney or liver problems •Lupus •Heart problems (including narrowing of the aortic valve) •Coronary heart disease •A lot of diarrhea or are vomiting Tell your doctor about all the medicines you take Some of your other medicines and TRIBENZOR could affect each other. This may cause serious side effects. These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements:  If you take TRIBENZOR, tell your doctor if you also take:  •Water pills (diuretics) •Other medicines for high blood pressure or a heart problem •Potassium supplements or a salt substitute that contains potassium •Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) •Diabetes medicine, including insulin •Narcotic pain medicine •Sleeping pills and antiseizure medicines called barbiturates •Lithium for certain types of depression •Steroids •Simvastatin and other cholesterol-lowering medicines About alcohol and other drug interactions If you are taking TRIBENZOR, do not drink alcohol. Your blood pressure may become too low if you drink alcohol. Some of your other medicines and TRIBENZOR could affect each other. This may cause serious side effects. Take TRIBENZOR as prescribed by your doctor. Talk with your doctor before you stop taking TRIBENZOR. Know about possible side effects of TRIBENZOR TRIBENZOR may cause serious side effects. These may include injury or death to an unborn baby; low blood pressure (hypotension), which may cause you to feel faint or dizzy; and kidney problems, which may get worse in people with kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose. Tell your doctor if you get swelling in your feet, ankles, or hands, or have unexplained weight gain. These may be signs of kidney problems. If you have heart failure, your doctor should also check your kidney function before prescribing TRIBENZOR. Because of amlodipine, an ingredient in TRIBENZOR, other serious side effects may include chest pain that gets worse or heart attack. Get medical help right away if you have chest pain that gets worse or does not go away. TRIBENZOR also contains a thiazide diuretic (water pill), which may cause allergic reactions and changes in body salts (such as sodium and potassium) and fluids. Tell your doctor if you have signs of a change in body salts and body fluids. Signs of a change include: dry mouth, thirst, weakness, tiredness or sleepiness, or restlessness. These signs may also include confusion, seizures, muscle pains or cramps, muscle tiredness, dizziness or fainting, having little or no urine, fast heartbeat, and nausea and vomiting. The thiazide diuretic in TRIBENZOR can also cause eye problems which may lead to vision loss. Symptoms can happen within hours to weeks of starting TRIBENZOR. Tell your doctor right away if you have decrease in vision or eye pain. The most common side effects of TRIBENZOR include dizziness; swelling of the ankles, feet, and hands; headache; tiredness; stuffy or runny nose and sore throat; muscle twitching (spasms); nausea; upper respiratory tract infection; diarrhea; urinary tract infection; and swelling of the joints. Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of TRIBENZOR. For more information, talk with your doctor or pharmacist. Call your doctor for medical advice about side effects. 附件: 200951223093431.pdf     ------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时请以咨询为准！ ------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: TRIBENZOR (40/5/25)mg/tab 30tabs/bottle 原产地英文药品名: OLMESARTAN MEDOXOMIL/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: TRIBENZOR (40/5/25)毫克/片 30片/瓶 中文参考药品译名: 奥美沙坦酯/苯磺酸氨氯地平/氢氯噻嗪 生产厂家中文参考译名: 第一三共 生产厂家英文名: DAIICHI SANKYO ------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: TRIBENZOR (40/5/12.5)mg/tab 30tabs/bottle 原产地英文药品名: OLMESARTAN MEDOXOMIL/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: TRIBENZOR (40/5/12.5)毫克/片 30片/瓶 中文参考药品译名: 奥美沙坦酯/苯磺酸氨氯地平/氢氯噻嗪 生产厂家中文参考译名: 第一三共 生产厂家英文名: DAIICHI SANKYO ----------------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: TRIBENZOR (40/10/25)mg/tab 30tabs/bottle 原产地英文药品名: OLMESARTAN MEDOXOMIL/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: TRIBENZOR (40/10/25)毫克/片 30片/瓶 中文参考药品译名: 奥美沙坦酯/苯磺酸氨氯地平/氢氯噻嗪 生产厂家中文参考译名: 第一三共 生产厂家英文名: DAIICHI SANKYO ----------------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: TRIBENZOR (40/10/12.5)mg/tab 30tabs/bottle 原产地英文药品名: OLMESARTAN MEDOXOMIL/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: TRIBENZOR (40/10/12.5)毫克/片 30片/瓶 中文参考药品译名: 奥美沙坦酯/苯磺酸氨氯地平/氢氯噻嗪 生产厂家中文参考译名: 第一三共 生产厂家英文名: DAIICHI SANKYO ----------------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: TRIBENZOR (40/5/12.5)mg/tab 30tabs/bottle 原产地英文药品名: OLMESARTAN MEDOXOMIL/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: TRIBENZOR (40/5/12.5)毫克/片 30片/瓶 中文参考药品译名: 奥美沙坦酯/苯磺酸氨氯地平/氢氯噻嗪 生产厂家中文参考译名: 第一三共 生产厂家英文名: DAIICHI SANKYO