近日，诺华公司出品的ExforgeHCT获美国FDA批准上市，ExforgeHCT是唯一同时含有三种抗高血压处方药物成分的复合制剂，这三种成分分别为Exforge(氨氯地平+缬沙坦)和双氢克尿塞。 诺华表示，有研究结果显示，85%的高血压患者需要多种药物—其中多数人需要3种以上抗压药联合治疗控制血压才能达到预定效果。因此，采用任何两种下列药物治疗后效果不理想的患者可转用ExforgeHCT，这些抗压药包括：钙通道阻滞剂、血管紧张素受体阻滞剂和利尿剂。实验表明，患者使用最高剂量的ExforgeHCT治疗2周之后，降压效果非常理想。 有专家表示，这种药物为患者带来了一种便利的治疗方式，它每天仅用药一次，在减轻高血压患者治疗负担上具有重要意义。同等剂量的Exforge和ExforgeHCT在美国地区的售价相同。目前，该药也正在接受欧盟委员会的审批。 2007年1月，Exforge获得欧盟批准，在包括德国和英国在内的9个欧盟国家上市，另计划在其他欧盟国家上市。Exforge也已在瑞士上市。 在两项安慰剂对照的试验中，十个接受Exforge治疗的患者中有九个血压达标，即舒张压达90mmHg以下，或舒张压比基线水平下降了10mmHg。舒张压是心脏舒张时血液对血管壁的压力，单位为毫米汞柱。 在另外两项试验中，在单独服用缬沙坦或氨氯地平而血压未得到控制的患者中，Exforge显示了卓越的降压效果。Exforge将缬沙坦和氨氯地平这两种抗压药物结合在一起。 Exforge HCT (Amlodipine and Hydrochlorothiazide and Valsartan) Exforge HCT contains a combination of amlodipine, hydrochlorothiazide and valsartan. Amlodipine is a calcium channel blocker and relaxes blood vessels and improves blood flow. Hydrochlorothiazide is a thiazide diuretic that helps prevent your body from absorbing too much salt, which can cause fluid retention. Valsartan is a angiotensin II receptor antagonist. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Exforge HCT is used to treat high blood pressure (hypertension). Exforge HCT is usually given after other blood pressure medications have been tried without successful treatment of symptoms. Exforge HCT also be used for other purposes not listed. Most important: Your chest pain may become worse when you first start taking Exforge HCT or when your dose is increased. Call your doctor if your chest pain is severe or ongoing. You should not take Exforge HCT if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic and others), valsartan (Diovan), or sulfa drugs, or if you are unable to urinate. Before taking Exforge HCT, tell your doctor if you have kidney or liver disease, congestive heart failure, asthma or allergies, low or high blood levels of potassium, gout, lupus, or diabetes. Do not use Exforge HCT without telling your doctor if you are pregnant. Exforge HCT 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 Exforge HCT and tell your doctor right away if you become pregnant during treatment. Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Exforge HCT. Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to. Exforge What is Exforge? Exforge contains a combination of amlodipine and valsartan. Amlodipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels. Valsartan is in a group of drugs called angiotensin II receptor antagonists. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Exforge is used to treat high blood pressure (hypertension). Exforge is usually given after others have been tried without successful treatment of hypertension. Exforge may also be used for purposes other than those listed in this medication guide. Important information about Exforge Do not use Exforge without telling your doctor if you are pregnant. Valsartan 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 Exforge and tell your doctor right away if you become pregnant during treatment. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Do not use potassium supplements or salt substitutes while you are taking Exforge, unless your doctor has told you to. Call your doctor at once if you have swelling in your hands or feet, rapid weight gain, fast or pounding heartbeats, jaundice (yellowing of the skin or eyes), chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, or if you feel like you might pass out. In rare cases, Exforge can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Before taking Exforge You should not use Exforge if you are allergic to amlodipine (Norvasc) or valsartan (Diovan). Before using Exforge, tell your doctor if you are allergic to any drugs, or if you have: kidney disease (or if you are on dialysis); liver disease; congestive heart failure; angina (chest pain), severe coronary artery disease; if you are vomiting or having diarrhea; or if you have recently had a heart attack. If you have any of these conditions, you may not be able to use Exforge, or you may need a dosage adjustment or special tests during treatment. If you are also taking a beta-blocker drug (such as Blocadren, Corgard, Inderal, Normodyne, Tenormin, Toprol, Trandate, Zibeta, and others) do not suddenly stop using the beta-blocker without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping a beta-blocker too quickly can cause serious heart problems that will not be prevented by Exforge. FDA pregnancy category D. Exforge can cause harm to an unborn baby. Valsartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Do not use Exforge without your doctor's consent if you are pregnant. Use an effective form of birth control. Stop using Exforge and tell your doctor right away if you become pregnant during treatment. It is not known whether Exforge passes into breast milk or if it could harm a nursing baby. Do not use Exforge without telling your doctor if you are breast-feeding a baby. How should I take Exforge? Take Exforge exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from Exforge. Take Exforge with a full glass (8 ounces) of water. To be sure this medication is helping your condition and not causing harmful effects, your blood pressure will need to be checked on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor. If you need to undergo kidney dialysis or have any type of surgery, tell the doctor ahead of time that you are using Exforge. Keep using Exforge even if you feel fine. High blood pressure often has no symptoms. Store this medication at room temperature away from moisture and heat. See also: Exforge dosage in more detail What happens if I miss a dose? Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include fast or slow heartbeat, warmth or tingling, feeling light-headed, or fainting. What should I avoid while taking Exforge? Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Do not use potassium supplements or salt substitutes while you are taking Exforge, unless your doctor has told you to. Exforge side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. In rare cases, Exforge can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Call your doctor at once if you have any other serious side effects, such as: feeling like you might pass out; swelling in your hands or feet, rapid weight gain; fast or pounding heartbeats; jaundice (yellowing of the skin or eyes); or chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling. Less serious Exforge side effects may include: dizziness, spinning sensation; runny or stuffy nose, sore throat, cough; warmth, redness, or tingly feeling under your skin; diarrhea, constipation, stomach pain; dry mouth, loss of appetite; muscle pain; or anxiety, sleep problems (insomnia). This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. See also: Exforge side effects (in more detail) What other drugs will affect Exforge? Before taking Exforge, tell your doctor if you are using any of the following drugs: heart medication; potassium supplements or salt substitutes; diuretics (water pills); or other medications that lower blood pressure. This list is not complete and there may be other drugs that can interact with Exforge. 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. Where can I get more information? Your pharmacist can provide more information about Exforge. 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. Copyright 1996-2009 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:46:15 PM.