部分中文维拉帕米处方资料(仅供参考) 【药物别名】异搏定,戊脉安、异博定 Isoptin,Calan 【性状】本品为白色粉末;无臭。本品在甲醇、乙醇或氯仿中易溶,在水中溶解。熔点 本品的熔点为141~145℃。 【类别】钙通道阻滞药。 规格 片剂: 120mg。 缓释片:120mg 180mg; 240mg。 药理毒理 本品为钙离子拮抗剂,能选择性扩张冠状动脉,增加冠脉流量;能抑制心肌兴奋性及房室传导。用于治疗阵发性室上性心动过速。 药动学 口服吸收完全约30min起效,维持5~8h。Tmax约30~45min,肝首过效应明显,PB90%,T1/2约3~12h,。静注后1~2min开始作用,作用持续15min。T1/2β约2~5h,长期用药或肝肾功能不全时延长。血液透析不能清除本品。 适应症 1.心绞痛:变异型心绞痛;不稳定性心绞痛;慢性稳定性心绞痛。 2.心律失常:与地高辛合用控制慢性心房颤动和/或心房扑动时的心室率;预防阵发性室上性心动过速的反复发作。 3.原发性高血压。 用法用量 通过调整剂量达到个体化治疗。安全有效的剂量为不超过480mg/日。 1.心绞痛: 一般剂量为口服维拉帕米80~120mg/次,一日三次。肝功能不全者及老年人的安全剂量为40mg/次,一日三次口服。约在药后8小时根据疗效和安全评估决定是否增量。 2.心律失常: 慢性心房颤动服用洋地黄治疗的病人,每日总量为240~320mg,分三次或四次/日口服。预防阵发性室上性心动过速(未服用洋地黄的病人)成人的每日总量为240~480mg,一日三次或四次口服。年龄1~5岁:每日量4~8mg/Kg,一日分三次口服;或每隔8小时口服。任何疑问,请遵医嘱! 不良反应 以推荐的单剂量和每日总量为起始剂量并逐渐向上调整剂量用药,严重不良反应少见。发生率在1~10%的不良反应:便秘(7.3%);眩晕、轻度头痛(3.5%);恶心(2.7%);低血压(2.5%);头痛(2.2%)。外周水肿(2.1%);充血性心力衰竭(1.8%);窦性心动过缓,I度、II度或III度房室阻滞;皮疹(1.2%);乏力;心悸;转氨酶升高,伴或不伴碱性磷酸酶和胆红素的升高,这种升高有时是一过性的,甚至继续使用维拉帕米仍可消失。发生率<1%的不良反应:低血压;心动过速;潮红;溢乳;牙龈增生;非梗阻性麻痹性肠梗阻等。 注意事项 1、心力衰竭:维拉帕米的负性肌力作用可因其减轻后负荷(降低循环血管阻力)而代偿,净效应不损害心室功能。但是严重左心室功能不全(肺楔压大于20mmHg或射血分数小于30%)、中-重度心力衰竭的病人、已接受β受体阻滞剂治疗的任何程度的心室功能障碍的病人,避免使用维拉帕米。必须使用维拉帕米的轻度心功能不全的病人,治疗之前需已有洋地黄类或利尿剂控制临床症状。 2、预激综合症:维拉帕米会加速房室旁路前向传导。房室旁路通道合并心房扑动或心房颤动病人静脉用维拉帕米治疗,会通过加速房室旁路的前向传导,引起心室率加快,甚至诱发心室颤动。虽然口服维拉帕米未见上述报道,但这种病人接受口服维拉帕米可能有危险,因此禁止使用。 3、传导阻滞:维拉帕米可能导致房室结和窦房结传导阻滞,与血浆浓度增高相关,尤其是在治疗早期的增量期。引起I度房室阻滞、一过性窦性心动过缓,有时伴有结性逸搏。高度房室传导阻滞不常见(0.8%)。当出现显著的I度房室传导阻滞或逐渐发展成II或III度房室传导阻滞时,需要减量或停药。 4、肝功能损害:因维拉帕米在肝内广泛代谢,肝功能损害的病人慎用维拉帕米。严重肝功能不全时维拉帕米的清除半衰期延长至14~16小时,该类病人只需服用正常剂量的30%。 5、肾功能损害:肾功能损害的病人慎用维拉帕米。血液透析不能清除维拉帕米。 6、神经肌肉传导减弱:有报道维拉帕米减弱肌肉萎缩病人的神经肌肉传导,该类病人可能需要减量。 7、血清钙:维拉帕米不改变血清钙浓度,但也有高于正常范围的血钙水平可能影响维拉帕米疗效的报道。 8、因维拉帕米可引起转氨酶增高,为慎重起见,接受维拉帕米治疗的患者应定期监测肝功能。 禁忌 1 严重左心室功能不全。 2 低血压(收缩压小于90mmHg)或心源性休克。 3 病窦综合征(已安装并行使功能的心脏起搏器病人除外)。 4 II或III度房室阻滞(已安装并行使功能的心脏起搏器病人除外)。 5 心房扑动或心房颤动病人合并房室旁路通道。 6 已知对盐酸维拉帕米过敏的病人。 药物相互作用 1 环磷酰胺、长春新碱、甲基苄肼、强的松、长春碱酰胺、阿霉素、顺铂等细胞毒性药物减少维拉帕米的吸收。 2 苯巴比妥、乙内酰脲、维生素D、苯磺唑酮和雷米封通过增加肝脏代谢降低维拉帕米的血浆浓度。 3 西米替丁可能提高维拉帕米的生物利用度。 4 维拉帕米抑制乙醇的消除,导致血中乙醇浓度增加,可能延长酒精的毒性作用。 5 少数病例报道维拉帕米和阿斯匹林合用,出血时间较单独使用阿斯匹林时延长。 6 与β受体阻滞剂联合使用, 可增强对房室传导的抑制作用。 7 长期服用维拉帕米,使地高辛血药浓度增加50~75%。维拉帕米明显影响肝硬化病人地高辛的药代动力学,使地高辛的总清除率和肾外清除率分别减少27%和29%。因此服用维拉帕米时,须减少地高辛和洋地黄的剂量。 8 与血管扩张剂、血管紧张素转换酶抑制剂、利尿剂等抗高血压药合用时,降压作用叠加,应适当监测联合降压治疗的病人。 9 与胺碘酮合用可能增加心脏毒性。 10 肥厚性心肌病主动脉瓣下狭窄的病人, 最好避免联合用药。 11 维拉帕米与氟卡胺合用,可使负性肌力作用叠加,房室传导延长。 12 维拉帕米可增加卡马西平、环胞素、阿霉素、茶碱的血药浓度。 13 有报道维拉帕米增加病人对锂的敏感性(神经毒性)。 14 动物实验提示吸入性麻醉剂与维拉帕米同时使用时,需仔细调整两药剂量,避免过度抑制心脏。 15 避免维拉帕米与丙吡胺同时使用。 药物过量 维拉帕米过量后出现的症状与服用的剂量、开始解毒的时间以及患者的心肌收缩能力(年龄相关)有关。在严重的维拉帕米中毒的病例中可出现下列情况:意识障碍(意识模糊到昏迷)、血压下降、心动过缓、心动过速、高血糖症、钾缺失、代谢性酸中毒、低氧血症、心源性休克伴肺水肿。 Medication name Generic name: Verapamil Extended-release - Oral Brand name(s): Calan SR, Isoptin SR Uses Verapamil is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Verapamil is called a calcium channel blocker. It works by relaxing blood vessels so blood can flow more easily. It may also lower the heart rate. Other uses 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.This drug may also be used to treat other heart diseases (such as hypertrophic cardiomyopathy, fast/irregular heartbeats) and to prevent chest pain (angina). How to use Take this medication by mouth with food, usually once daily in the morning or every 12 hours or as directed by your doctor.Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.The 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, take it at the same time(s) each day.For the treatment of high blood pressure, it may take a week before you get the full benefit of this drug. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition does not improve or if it worsens (for example, your routine blood pressure readings remain high or increase). Precautions Before taking verapamil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.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 second- or third-degree atrioventricular block, sick sinus syndrome unless you have a pacemaker, Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure, certain muscle/nerve disorders (muscular dystrophy, myasthenia gravis).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, but it is unlikely to harm a nursing infant. Discuss the risks and benefits with 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.This drug should not be used with the following medication because very serious interactions may occur: dofetilide.If you are currently using the medication listed above, tell your doctor or pharmacist before starting verapamil.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, clonidine, disopyramide, fingolimod, lithium.Other medications can affect the removal of verapamil from your body, which may affect how this product works. Examples include atorvastatin, erythromycin, phenobarbital, rifamycins (such as rifampin), ritonavir, St. John's wort, among others.Verapamil can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include buspirone, carbamazepine, colchicine, eplerenone, midazolam, certain drugs for organ transplant (cyclosporine, sirolimus, tacrolimus), certain "statin" drugs (lovastatin, simvastatin), temsirolimus, theophylline, tizanidine, triazolam, among others.Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or heart rate. Ask your pharmacist about using those products safely.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. Side effects Dizziness, slow heartbeat, constipation, nausea, headache, and tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To lower your 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: swelling ankles/feet, shortness of breath, unusual tiredness, unexplained/sudden weight gain, severe dizziness, fainting, very slow heartbeat.Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, dark urine, yellowing eyes/skin, persistent nausea/vomiting.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. 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. Overdose If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very slow heartbeat, severe dizziness, fainting. Notes Do not share this medication with others.Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes).Laboratory and/or medical tests (such as liver function test) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.There are different brands and types of this medication available. Some do not have the same effects. Do not change brands or types without consulting your doctor or pharmacist. Medical alert Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.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. ------------------------------------------------ 产地国家: 美国 原产地英文商品名: CALAN SR Extended Release 120mg SA 100Tablets 原产地英文药品名: VERAPAMIL HCL) 中文参考商品译名: CALAN 缓释片 120毫克/片 100片/瓶 中文参考药品译名: 维拉帕米缓释片 生产厂家中文参考译名: 辉瑞制药 生产厂家英文名: Pfizer
------------------------------------------------ 产地国家: 美国 原产地英文商品名: CALAN SR Extended Release 180mg SA 100 Tablets 原产地英文药品名: VERAPAMIL HCL) 中文参考商品译名: CALAN 缓释片 180毫克/片 100片/瓶 中文参考药品译名: 维拉帕米缓释片 生产厂家中文参考译名: 辉瑞制药 生产厂家英文名: Pfizer
------------------------------------------------ 产地国家: 美国 原产地英文商品名: CALAN SR Extended Release 240mg SA 100 Tablets 原产地英文药品名: VERAPAMIL HCL) 中文参考商品译名: CALAN 缓释片 240毫克/片 100片/瓶 中文参考药品译名: 维拉帕米缓释片 生产厂家中文参考译名: 辉瑞制药 生产厂家英文名: Pfizer
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