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 详细处方信息以本药内容附件PDF文件（2011113017445020.pdf）的“原文Priscribing Information”为准
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部分中文Cardizem LA处方资料（仅供参考）

FDA批准Cardizem LA用于慢性稳定型心绞痛的治疗

    Biovail医药公司近日宣布，美国FDA已经批准该公司的盐酸地尔硫卓(diltiazem HCl,Cardizem LA)用于治疗慢性稳定型心绞痛。Cardizem LA是每日一次口服的长效缓释剂，早晨或晚上服用都可以。

    此前，该药已经获准用于治疗高血压。每日一次的Cardizem LA能够在24小时之内控制血压稳定，在早晨，该药能够有效地抑制血压的上升，而此时缺血性心血管疾病的发生率是最高的。

    Cardizem LA既能控制高血压又能治疗慢性稳定型心绞痛的双重功效以及它独特的药物代谢动力学特征使该药成为医生治疗这两种重要心血管疾病的极好选择。

    Cardizem LA是Biovail公司利用其在美国完善的销售渠道直接向医生销售的第一种药物。临床反馈表明该药具有极好的疗效，最近，该药在每日一次的diltiazem HCl市场的总处方量和新处方量所占的比例分别高达10.4％和7.3％。Biovail已于近期对美国的销售完成了一次战略调整，其目的是保持销售力量的地域均衡以及更高的市场占有率。

    心绞痛是一种反复发作的疾病，当心脏得不到足够的血量时，病人的胸部就出现疼痛和不舒服的症状。心绞痛是一种常见的冠心病，而冠心病最常见的诱因是血管受动脉硬化（atherosclerosis）的影响而变窄或堵塞。心绞痛是一种流行性疾病，美国约有640万冠心病患者，而且每年新诊断的患者高达40万。目前，慢性心绞痛一般需要两种药物治疗，但是仅有17％的患者认为他们的疾病得到了满意的控制。

    心绞痛一般需要药物治疗，药物的选择取决于患者发病的严重程度以及患者是否患有其它疾病。Cardizem LA是一种钙离子通道抑制剂，该药单独使用或与其它药物合用能够有效地降低心绞痛发生的频率和严重程度。对大多数患者而言，将该药与其它药物联合使用的效果要好于单用该药。

    一项对311名慢性稳定心绞痛患者进行的随机、双盲的平行对照试验评估了不同剂量的Cardizem LA的疗效，试验比较了晚上服用180mg、360mg和420mg剂量的药物以及早上服用安慰剂或360mg剂量药物的各组之间的效果。结果发现，与安慰剂相比，晚上服药的各组在21小时后运动耐量都有上升，治疗组的平均运动耐量较对照组增加了20到28秒，各个治疗组之间没有显著差别。早上服用360mg剂量的Cardizem LA也能在25小时后提高患者的运动耐量。

    试验发现Cardizem LA的副作用与以前描述的有关该药的副作用一致，这与地尔硫卓的其它处方也是一致的。治疗组病人出现副作用的概率与对照组基本相当，而且副作用一般都比较轻微。试验中治疗组最常见的副作用是下肢水肿、眩晕、疲劳、心跳过缓、Ⅰ度房室传导阻滞和咳嗽等。

    长期服用地尔硫卓的剂量高于每天540mg的患者可能会导致PR间期的较小延长，有时还会引起PR间期的异常增加。服用细胞色素P450（CYP450）底物等药物的患者在开始服用地尔硫卓之前或停止使用该药的时候都要调整药物的用量以保持血压的稳定，对于肝肾功能不全的患者尤其要注意这一点。

    Biovail公司是一家国际化的全科医药公司，该公司主要依靠他们特有的高级药物释放技术致力于处方改良、临床试验、新药注册以及药物的生产和销售等业务。

GENERIC NAME: DILTIAZEM EXTENDED-RELEASE TABLET - ORAL (dill-TIE-uh-zem)

BRAND NAME(S): Cardizem LA

USES: Diltiazem is used to treat high blood pressure (hypertension) and prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. When used regularly, diltiazem can decrease the number and severity of episodes of chest pain from angina. It may help increase your ability to exercise.Diltiazem is called a calcium channel blocker. It works by relaxing blood vessels in the body and heart so blood can flow more easily. Diltiazem also lowers your heart rate. These effects help the heart work less hard and lower blood pressure.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.Diltiazem may also be used to control your heart rate if you have a fast/irregular heartbeat (such as atrial fibrillation).

HOW TO USE: Take this medication by mouth with or without food, usually once daily at the same time or as directed by your doctor. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once and may increase your risk of side effects. Depending on your specific brand, take this medication either in the morning or at bedtime as directed. Consult your pharmacist if you have any questions about when to take the medication.Your doctor may gradually increase your dose. Follow your doctor's instructions carefully. Dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. For the treatment of high blood pressure, it may take 2 weeks before you get the full benefit of this drug.This medication must be taken regularly to prevent angina. It should not be used to treat angina when it occurs. Use other medications (such as nitroglycerin placed under the tongue) to relieve an angina attack as directed by your doctor. Consult your doctor or pharmacist for details.Tell your doctor if your condition worsens (for example, your chest pain worsens or your routine blood pressure readings increase).

SIDE EFFECTS: Dizziness, lightheadedness, weakness, nausea, flushing, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To lower the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, slow/irregular/pounding/fast heartbeat, swelling ankles/feet, shortness of breath, unusual tiredness, unexplained/sudden weight gain, mental/mood changes (such as depression, agitation), unusual dreams.Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, severe constipation, dark urine, persistent nausea/vomiting, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diltiazem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as sick sinus syndrome/atrioventricular block unless you have a pacemaker).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure, narrowing of any part of the stomach/intestines.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist that you are taking this medication.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: amiodarone, digoxin.Other medications can affect the removal of diltiazem from your body, which may affect how this medication works. Examples include atazanavir, cimetidine, quinidine, St. John's wort, azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, rifamycins including rifabutin and rifampin.Diltiazem may also affect how your body gets rid of many drugs (such as buspirone, cyclosporine, sirolimus, certain statins including lovastatin, certain anti-seizure drugs including carbamazepine, certain benzodiazepines including triazolam and midazolam).Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or heart rate (such as pseudoephedrine, phenylephrine, ibuprofen, naproxen). Ask your pharmacist about using these products safely.If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because cimetidine may interact with diltiazem, ask your pharmacist about other products to treat extra stomach acid.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.Laboratory and/or medical tests (such as kidney/liver function tests, pulse, blood pressure, EKG) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.There are different brands and types of this medication available. Many do not have the same effects. Do not change brands or types without consulting your doctor or pharmacist.Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Different brands of this medication may have different storage needs. Ask your pharmacist how to store the brand you are using.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

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 详细处方信息以本药内容附件PDF文件（2011113017445020.pdf）的“原文Priscribing Information”为准
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