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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。 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。 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 What is Tekturna? Tekturna is used to treat high blood pressure (hypertension). Tekturna may also be used for other purposes not listed in this medication guide. Important information about Tekturna 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. Before taking Tekturna If you have any of these other conditions, you may need an Tekturna dose adjustment or special tests: 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. How should I take Tekturna? 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. What happens if I miss a dose? What happens if I overdose? Overdose symptoms may include feeling light-headed or fainting. What should I avoid while taking Tekturna? Tekturna side effects Less serious Tekturna side effects may include: 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. What other drugs will affect Tekturna? 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. Where can I get more information? 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.
Indications for TEKTURNA HCT 300/12.5Hypertension. Adult dose for TEKTURNA HCT 300/12.5Take consistently with regard to meals (absorption reduced by high-fat meals). ≥18yrs: 1 tablet once daily. Add-on or initial therapy and not volume-depleted: initially 150mg/12.5mg; may increase after 2–4 weeks up to max 300mg/25mg. Replacement therapy: may be substituted for the titrated components. Maximum effect usually seen at 4 weeks. Children's dosing for TEKTURNA HCT 300/12.5<18yrs: not recommended. Also:TEKTURNA HCT 150/12.5
TEKTURNA HCT 150/25
TEKTURNA HCT 300/25
Contraindications for TEKTURNA HCT 300/12.5Anuria. Sulfonamide allergy. Warnings/Precautions for TEKTURNA HCT 300/12.5Severe renal impairment (CrCl<30mL/min): not recommended. Severe renal disease. Correct salt/volume depletion before starting, or monitor closely. Hepatic dysfunction. Asthma. SLE. Monitor electrolytes. Pregnancy (Cat.D). Nursing mothers: not recommended. Interactions for TEKTURNA HCT 300/12.5Concomitant cyclosporine, lithium (risk of toxicity): not recommended. Potentiates antihypertensives, possibly non-depolarizing muscle relaxants. Potentiated by ketoconazole, atorvastatin. Antagonized by irbesartan, NSAIDs, cholestyramine, colestipol resins. May antagonize furosemide. ACTH, corticosteroids increase hypokalemia risk. Adjust antidiabetic drugs. Orthostatic hypotension potentiated by alcohol, CNS depressants. Adverse Reactions for TEKTURNA HCT 300/12.5Dizziness, diarrhea, cough, asthenia, arthralgia, elevated BUN/creatinine, ALT, uric acid; rare: angioedema (discontinue if occurs). How is TEKTURNA HCT 300/12.5 supplied?Tabs—30, 90 原产地英文商品名: NOVARTIS |
高血压新药物-TEKTURNA（aliskiren富马酸阿利吉仑）获准上市简介：
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。 ... 责任编辑：admin
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