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当前位置:药品说明书与价格首页 >> 心血管系统 >> 新药动态 >> 美国FDA批准阿利克仑片(商品名:Tekturna)上市

美国FDA批准阿利克仑片(商品名:Tekturna)上市

2010-10-16 14:58:43  作者:新特药房  来源:中国新特药网天津分站  浏览次数:480  文字大小:【】【】【
简介: 美国FDA批准诺华公司的阿利克仑(aliskiren)片(商品名:Tekturna)上市,用于治疗高血压。剂量规格:150mg/片,300mg/片。阿利克仑系一新分子实体,是美国FDA批准的首个直接抑制引起血压升高肾脏酶肾素 ...

美国FDA批准诺华公司的阿利克仑(aliskiren)片(商品名:Tekturna)上市,用于治疗高血压。剂量规格:150mg/片,300mg/片。阿利克仑系一新分子实体,是美国FDA批准的首个直接抑制引起血压升高肾脏酶肾素的高血压治疗药。据预测,至2015年阿利克仑销售额将达2l亿美元。
在6项8周对2000多例轻至中度高血压患者的安慰剂对照临床研究中,证明了阿利克仑降血压的疗效。此作用可维持长达1年。Tekturna对所有人口统计学亚群均有效,但对非洲裔美国人患者的降压作用较高加索人和亚洲人小。本品与利尿药氢氯塞嗪联合用药可进一步降低血压。
对6460多例患者评价了阿利克仑的安全性。其中l740例长达6个月的治疗、l250多例用药超过1年。本品的不良反应通常是轻微的。服用批准的2个较高剂量患者约2%出现腹泻.安慰剂对照组约为l%。服用阿利克仑片的患者偶尔出现与直接作用于肾素一血管紧张素系统的其它高血压治疗药相似的过敏反应:脸、唇或舌肿胀。呼吸困难。

Tekturna HCT

Brand name:

Tekturna HCT

Generic name:

 Aliskiren
 Hydrochlorothiazide

What is Tekturna HCT?

Tekturna HCT is used to treat high blood pressure. It contains two medicines: aliskiren and the diuretic hydrochlorothiazide. Tekturna HCT may be used alone or in combination with other blood pressure medications.

What is the most important information I should know about Tekturna HCT?

Do not use Tekturna HCT during pregnancy. If you become pregnant while on this medication, stop taking it and call your doctor right away. Tekturna HCT may harm an unborn baby, causing injury and even death.

Tekturna HCT may cause an allergic reaction. This can occur any time during treatment and is more likely to happen if you have had an allergic reaction to other blood pressure medications known as ACE inhibitors or angiotensin receptor antagonists. Stop using Tekturna HCT and seek medical attention right away if you experience breathing problems or swelling of the face, lips, tongue, throat, arms, or legs.

Tekturna HCT could cause your blood pressure to drop too low, leading to dizziness or lightheadedness. This is more likely to happen if you also take certain medications (e.g., diuretics, barbiturates, or narcotics), drink alcohol, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy, and contact your doctor right away, as you may need your dose of Tekturna HCT adjusted.

Who should not take Tekturna HCT?

You should not take this medication if you are pregnant, plan to become pregnant, or are breastfeeding. Do not take Tekturna HCT if you make very little or no urine due to kidney problems; or if you are allergic to any of its ingredients or to sulfa drugs (sulfonamides).

Tekturna HCT has not been studied in children <18 years old.

What should I tell my doctor before I take the first dose of Tekturna HCT?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Tekturna HCT. Also, talk to your doctor about your complete medical history, especially if you have any of the following: kidney or liver problems, systemic lupus erythematosus, allergies or asthma, or if you have had an allergic reaction to any blood pressure medication. Alert your doctor immediately if you are pregnant, plan on becoming pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The usual starting dose is 150 milligrams (mg) of aliskiren/12.5 mg of hydrochlorothiazide taken once daily. Your doctor may increase the daily dose up to 300 mg/25 mg if your blood pressure is not adequately controlled on a lower dose.

How should I take Tekturna HCT?

Take Tekturna HCT once a day, with or without food. Take the medication at the same time each day, since it is best to establish a routine.

What should I avoid while taking Tekturna HCT?

Avoid taking Tekturna HCT with high-fat meals, since this may decrease absorption.

It is best to avoid treatment with Tekturna HCT if you are taking lithium or cyclosporine.

What are possible food and drug interactions associated with Tekturna HCT?

If Tekturna HCT is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tekturna HCT with the following: alcohol, antifungal medicines (e.g., ketoconazole), atorvastatin, barbiturates or narcotic medicines, blood thinners, cholestyramine, colestipol, corticosteroids, cyclosporine, diuretics (e.g., furosemide), lithium, other medicines for high blood pressure or heart problems (e.g., verapamil), potassium-containing medicines, potassium supplements, drugs that increase blood pressure such as epinephrine, salt substitutes containing potassium, skeletal muscle relaxants (e.g., tubocurarine), diabetes medications including insulin, and nonsteroidal anti-inflammatory drugs.

What are the possible side effects of Tekturna HCT?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: dizziness, flulike symptoms, diarrhea, cough, tiredness, low blood pressure (e.g., feeling faint or dizzy), active or worsened systemic lupus erythematosus

Serious side effects that require immediate medical attention include: difficulty breathing; swelling of the face, lips, tongue, throat, arms and legs

Can I receive Tekturna HCT if I am pregnant or breastfeeding?

You should not take Tekturna HCT if you are pregnant. If you become pregnant while on this medication, inform your doctor right away. It is not known whether Tekturna HCT passes into breast milk, but it could potentially harm a nursing infant. You should discuss with your doctor whether it is best to stop nursing or to stop taking this medication.

What should I do if I miss a dose of Tekturna HCT?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and return to your regular schedule. Never take two doses at once.

How should I store Tekturna HCT?

Store at room temperature in a dry place. Keep the medication in the original prescription bottle; do not remove the drying agent from the bottle.

责任编辑:admin


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