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 详细处方信息以本药内容附件PDF文件（20109920455034.pdf）的“原文Priscribing Information”为准
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部分中文Tekturna HCT处方资料（仅供参考）

    诺华公司近期宣布，美国是全球首个国家批准Tekturna （aliskiren）上市。Tekturna是10多年来首个新一类高血压治疗药物。据估计，世界范围内有近10亿人患有高血压，其中70%的患者的血压尚未得到控制。
　　Tekturna作为新一类药物―直接肾素抑制剂的首个药品，获得美国食品药品监督管理局（FDA）的上市批准。Tekturna每天只需口服一次，以引发高血压产生过程的酶 ― 肾素作为靶向目标。高血压是引发心血管疾病的关键因素，也是全球第一大致死病因。
　　FDA批准Tekturna既可以用于高血压的单药治疗，也可以和其他高血压药物联合使用。预计三月份，Tekturna以150毫克和300毫克片剂规格在美国药房里有售。
　　"肾素血管紧张素系统的作用引发多种高血压并发症，”哈佛医学院医学教授，Brigham & Women's医院心脏病学家Marc A. Pfeffer博士说，“通过从肾素生成的源头抑制该重要系统，像Tekturna这一类的直接肾素抑制剂为高血压治疗提供了一个令人兴奋的全新治疗选择。”
　　在涉及6, 400多名患者的广泛的临床试验中，Tekturna显示了24小时强效降压的效果。而且，与其他广泛使用的高血压治疗药物联用时，Tekturna也显示了额外的疗效。在临床试验中，Tekturna批准的剂量显示了良好的耐受性。
　　“许多患者要求使用两种或者两种以上的药物来控制血压。作为一种全新的治疗方法，Tekturna将帮助这些患者管理疾病，” 诺华制药全球药品开发总裁James Shannon博士说，“Tekturna体现了我们致力于开发创新产品以帮助数以百万计高血压患者的承诺。”
　　诺华将开展一个大型的临床终点试验项目，以评估Tekturna和直接肾素抑制的远期疗效。
　　2006年9月，Tekturna的上市申请递交至欧盟药品审评管理局。美国之外，该药的商品名是Rasilez®。Tekturna是诺华与Speedel公司合作开发的药品。
    美国食品和药物管理局６日批准瑞士诺华公司研制的治疗高血压新药ｔｅｋｔｕｒｎａ上市，这是药管局批准的第一种肾素抑制剂类高血压治疗药物。
    据介绍，ｔｅｋｔｕｒｎａ是一种新分子实体，通过抑制与血压调节有关的肾素发挥作用。它能够在血压调节过程刚开始时就发挥作用，而目前其他高血压治疗药物都是在血压调节过程的后期才能起作用。
药管局说，ｔｅｋｔｕｒｎａ在降血压方面的安全性和有效性已经在６项临床实验中得到了验证，其降血压效果可持续长达１年。如果与利尿降压药氢氯噻嗪联合使用，降压效果更为明显。
服用ｔｅｋｔｕｒｎａ最常见的副作用是出现腹泻。药管局警告说，孕期妇女禁用此药，为可能会伤害胎儿甚至造成死胎。

    2009年7月21日，诺华公司宣布，对于采用单一降压药降压效果不理想者，美国食品药品管理局(FDA)已批准Tekturna HCT作为其初始治疗药。Tekturna HCT是由直接肾素抑制剂Tekturna(阿利吉仑)与利尿剂氢氯噻嗪(HCTZ)配伍制成的复方片剂，最初于2008年1月在美国获准作为高血压的二线治疗药。
    FDA批准Tekturna HCT作为高血压初始治疗药是基于逾2,700例患者的临床试验数据。研究结果证实，Tekturna与HCTZ联合治疗获得的血压降幅大于其中任何一种单药治疗。在临床试验中，Tekturna HCT的降压效果大多数在1w内显效，通常在治疗大约4w后，降压效果达峰值。
    Tekturna HCT有如下4种配伍规格(含阿利吉仑与氢氯噻嗪的复方片剂)上市：150 mg/12.5 mg，150 mg/25 mg，300 mg/12.5 mg以及 300 mg/25 mg。

Tekturna
Generic Name: aliskiren (a LIS ke rin)
Brand Names: Tekturna
Tekturna HCT
(aliskiren and hydrochlorothiazide) Tablets

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What is Tekturna?
Tekturna (aliskiren) is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Tekturna is used to treat high blood pressure (hypertension).

Tekturna may also be used for other purposes not listed in this medication guide.

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Important information about Tekturna
Do not use Tekturna if you are pregnant. Tekturna can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant.

Before you take Tekturna, tell your doctor if you have kidney disease, gout, heart disease, or if you are on a low-salt diet.

If you take Tekturna with meals, avoid high-fat foods. They can make it harder for your body to absorb Tekturna.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking Tekturna. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

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Before taking Tekturna
You should not take Tekturna if you are allergic to aliskiren.

If you have any of these other conditions, you may need an Tekturna dose adjustment or special tests:
kidney disease (or if you are on dialysis);
gout;
heart disease;
if you are on a low-salt diet; or
if you have ever had an allergic reaction to an ACE (angiotensin converting enzyme) inhibitor medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

FDA pregnancy category D. Do not use this medication if you are pregnant. Tekturna can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant. It is not known whether Tekturna passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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How should I take Tekturna?
Take Tekturna exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take Tekturna with a full glass of water.

You may take Tekturna with or without food, but take it the same way every time.

If you take Tekturna with meals, avoid high-fat foods. They can make it harder for your body to absorb Tekturna.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking Tekturna. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling light-headed or fainting.

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What should I avoid while taking Tekturna?
Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of Tekturna. Do not use salt substitutes or potassium supplements while taking Tekturna, unless your doctor has told you to.

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Tekturna side effects
Stop taking Tekturna and get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. If you have an allergic reaction to Tekturna you should not take it again. Call your doctor at once if you have any of these serious side effects:
feeling light-headed, fainting;
nausea with slow uneven heart rate and a weak pulse; or
swelling around your eyes.

Less serious Tekturna side effects may include:
stomach pain or upset, diarrhea, heartburn;
itching or skin rash;
headache, dizziness, tired feeling;
back pain, joint pain or swelling; or
stuffy nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Tekturna?
The following drugs can interact with Tekturna. Tell your doctor if you are using any of these:
atorvastatin (Lipitor);
cyclosporine (Gengraf, Neoral, Sandimmune);
furosemide (Lasix);
antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
a potassium supplement such as K-Dur, Klor-Con;
salt substitutes that contain potassium; or
a diuretic (water pill).

This list is not complete and other drugs may interact with Tekturna. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Tekturna.

Remember, keep this and all other medicines out of the reach of children. Never share your medicines with others and only use this medication for the condition prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件（20109920455034.pdf）的“原文Priscribing Information”为准
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2011-4-6更新