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FDA已经批准诺华出品的复方高血压治疗药Tekturna HCT作为一线药物，该药为片剂，同时含有两种抗高血压成分，可用于需要多种药物联合治疗的患者。
药物含有的两种成分为Tekturna（Aliskiren，在美国以外地区以Rasilez为商品名销售）和利尿剂双氢克尿噻，其中前者是唯一获准的直接肾素抑制剂。2008年初，Tekturna已分别在欧美地区获准作为高血压二线治疗药，而这次再次通过FDA批准作为治疗该症的一线药物将会进一步推动其销量，它在今年的第二季度的销售额达到6700万美元。
诺华就该药作评论时，引用了美国天普大学教授艾伦·格莱德曼的观点——85%的高血压患者需要多种药物联合治疗才能将血压控制到正常水平。这次获准以后，医生可以采取更为大胆的治疗方案，发挥这种复方药的疗效，与单用其中任一药物相比更能造福于患者。
诺华还表示，目前美国高血压治疗指南赞同适用患者选择复方药作为一线治疗方案，认为多种药物成分有助于患者及时地将血压调至理想水平。
Tekturna HCT is a combination of hydrochlorothiazide and aliskiren.
Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.
Aliskiren (Tekturna) is an anti-hypertensive (blood pressure lowering) medication. It is a direct renin inhibitor and works by decreasing substances in the body that narrow blood vessels and raise blood pressure.
Tekturna HCT is used to treat high blood pressure (hypertension).
Tekturna HCT may also be used for other purposes not listed here.
Most important: Do not use Tekturna HCT without telling your doctor if you are pregnant. It may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using Tekturna HCT and tell your doctor right away if you become pregnant during treatment.
Do not use potassium supplements or salt substitutes while you are taking this medication, unless your doctor has told you to. There are many other medicines that can interact with Tekturna HCT. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
It may take up to 4 weeks for Tekturna HCT to control your blood pressure. Keep using this medication even if you feel fine. High blood pressure often has no symptoms.
Tekturna
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.
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, 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
You should not take Tekturna if you are allergic to aliskiren.
To make sure you can safely take Tekturna, tell your doctor if you have any of these other conditions:
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kidney disease (or if you are on dialysis);
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heart disease;
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if you are on a low-salt diet; or
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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.
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
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.
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.
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.
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:
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feeling light-headed, fainting;
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nausea with slow uneven heart rate and a weak pulse; or
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swelling around your eyes.
Less serious Tekturna side effects may include:
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stomach pain or upset, diarrhea, heartburn;
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itching or skin rash;
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headache, dizziness, tired feeling;
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back pain, joint pain or swelling; or
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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.
What other drugs will affect Tekturna?
The following drugs can interact with Tekturna. Tell your doctor if you are using any of these:
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atorvastatin (Lipitor);
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cyclosporine (Gengraf, Neoral, Sandimmune);
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furosemide (Lasix);
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antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
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a potassium supplement such as K-Dur, Klor-Con;
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salt substitutes that contain potassium; or
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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.
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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