英文药名：PRADAXA(Dabigatran Etexilate) 中文药名：达比加群酯胶囊 药品说明 达比加群酯是一种新型的合成的直接凝血酶抑制剂，是dabigatran的前体药物，属非肽类的凝血酶抑制剂。口服经胃肠吸收后，在体内转化为具有直接抗凝血活性的dabigatran。dabigatran结合于凝血酶的纤维蛋白特异结合位点，阻止纤维蛋白原裂解为纤维蛋白，从而阻断了凝血瀑布网络的最后步骤及血栓形成。dabigatran可以从纤维蛋白一凝血酶结合体上解离，发挥可逆的抗凝作用。 Pradaxa由Boehringer Ingelheim生产，有75mg和150mg的两种剂量的胶囊。 美国FDA批准Pradaxa(达比加群酯[dabigatran etexilate])胶囊 批准日期：2010年10月19日：公司：Boehringer Ingelheim Pharmaceuticals, Inc. 美国食品和药品监督管理局2010年10月19日批准Pradaxa胶囊(达比加群酯)为在有心律异常(心房颤动)患者中预防中风和凝血. 心房颤动累及超过200万美国人，涉及心脏上面两个腔室非常迅速和不协调收缩(心房)和心律异常的最常见类型之一。 美国FDA药物评价和研究中心心血管和肾产品室主任Norman Stockbridge, M.D., Ph.D.说：“心房颤动的人属于发生血凝块的高危人群，如凝块以致脑可中风致残” Pradaxa是一种抗凝剂通过抑制凝血酶起作用，一种涉及血液凝固的酶。在一项临床试验比较Pradaxa与抗凝剂华法林[warfarin]研究Pradaxa的安全性和有效性。在试验中, 服用Pradaxa患者中风比用华法林患者较少。 Stockbridge说“与华法林不一样，前者需要患者定期进行监查血液检验，Pradaxa 不需要这类监查”。 如同其它被批准的抗凝血药，出血，包括危及生命和致命出血，是用Pradaxa治疗患者中报道的最常见不良反应。胃肠道症状，包括胃内不适感(消化不良), 胃痛, 恶心, 心灼热,和还报道胃气胀。 适应证和用途 PRADAXA是一种直接凝血酶抑制剂适用于有非瓣膜性心房颤动患者中减低中风和全身栓塞的风险 剂量和给药方法 （1）对有CrCl>30 mL/min患者：150mg口服，每天2次 （2）对有CrCl 15-30 mL/min患者：75mg口服，每天2次 （3）指导患者不要咀嚼，弄碎，或打开胶囊 （4）复习对转换至或从其它口服或非肠道抗凝剂的建议 （5）当可能时在损伤性或手术操作前暂时停止PRADAXA，然后立即在开始 剂型和规格 胶囊：75mg和150mg 禁忌证 （1）活动病理性出血 （2）对PRADAXA严重超敏性反应史 警告和注意事项 出血的风险：PRADAXA可能引起严重和，有时，致命出血。及时评价失血的征象和症状暂时停止：避免治疗中过失以缩小中风的风险 P-gp诱导剂和抑制剂：避免利福平[rifampin]与PRADAXA同时给药因为对达比加群暴露的影响 不良反应 最常见不良反应(>15%)是胃炎-样症状和出血 在特殊人群中的使用 老年人使用：出血的风险随年龄增加 一般描述 达比加群酯甲磺酸盐，一种直接凝血酶抑制剂的化学名是β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate。分子量723.86(甲磺酸盐)，627.75(游离碱)。 MEDICATION GUIDE PRADAXA (pra dax' a) (dabigatran etexilate mesylate) capsulesRead this Medication Guide before you start taking PRADAXA and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. ----------------------------------------------------------------------------- What is the most important information I should know about PRADAXA? PRADAXA can cause bleeding which can be serious, and sometimes lead to death. This is because PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body. You may have a higher risk of bleeding if you take PRADAXA and: are over 75 years old have kidney problems have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer take other medicines that increase your risk of bleeding, including: aspirin or aspirin containing products long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) warfarin sodium (Coumadin Jantoven®) a medicine that contains heparin clopidogrel (Plavix®) prasugrel (Effient®) Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. PRADAXA can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take PRADAXA: you may bruise more easily it may take longer for any bleeding to stop ----------------------------------------------------------------------------- Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding:unexpected bleeding or bleeding that lasts a long time, such as: unusual bleeding from the gums nose bleeds that happen often menstrual bleed or vaginal bleeding that is heavier than normal bleeding that is severe or you cannot control pink or brown urine red or black stools (looks like tar) bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like "coffee grounds" unexpected pain, swelling, or joint pain headaches, feeling dizzy or weak Take PRADAXA exactly as prescribed. Do not stop taking PRADAXA without first talking to the doctor who prescribes it for you. Stopping PRADAXA may increase your risk of a stroke. PRADAXA may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking PRADAXA for any reason, talk to the doctor who prescribed PRADAXA for you to find out when you should stop taking it. Your doctor will tell you when to start taking PRADAXA again after your surgery or procedure. See "What are the possible side effects of PRADAXA" for more information about side effects. ----------------------------------------------------------------------------- What is PRADAXA? PRADAXA is a prescription medicine used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke. PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body. It is not known if PRADAXA is safe and works in children. ----------------------------------------------------------------------------- Who should not take PRADAXA? Do not take PRADAXA if you: currently have certain types of abnormal bleeding. Talk to your doctor, before taking PRADAXA if you currently have unusual bleeding. have had a serious allergic reaction to PRADAXA. Ask your doctor if you are not sure. ----------------------------------------------------------------------------- What should I tell my doctor before taking PRADAXA? Before you take PRADAXA, tell your doctor if you: have kidney problems have ever had bleeding problems have ever had stomach ulcers have any other medical condition are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. Tell all of your doctors and dentists that you are taking PRADAXA. They should talk to the doctor who prescribed PRADAXA for you, before you have any surgery, or medical or dental procedure. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way PRADAXA works. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about PRADAXA?" Especially tell your doctor if you take:rifampin (Rifater, Rifamate, Rimactane, Rifadin) Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. ----------------------------------------------------------------------------- How should I take PRADAXA? Take PRADAXA exactly as prescribed by your doctor. Do not take PRADAXA more often than your doctor tells you to. You can take PRADAXA with or without food. Swallow PRADAXA capsules whole. Do not break, chew, or empty the pellets from the capsule. If you miss a dose of PRADAXA, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of PRADAXA at the same time. Your doctor will decide how long you should take PRADAXA. Do not stop taking PRADAXA without first talking with your doctor. Stopping PRADAXA may increase your risk of stroke. Do not run out of PRADAXA. Refill your prescription before you run out. If you plan to have surgery, or a medical or a dental procedure, tell your doctor and dentist that you are taking PRADAXA You may have to stop taking PRADAXA for a short time. See "What is the most important information I should know about PRADAXA?" If you take too much PRADAXA, go to the nearest hospital emergency room or call your doctor or the Poison Control Center right away. ----------------------------------------------------------------------------- What are the possible side effects of PRADAXA? PRADAXA can cause serious side effects.See "What is the most important information I should know about PRADAXA? Allergic Reactions. In some people, PRADAXA can cause symptoms of an allergic reaction, including hives, rash, and itching. Tell your doctor or get medical help right away if you get any of the following symptoms of a serious allergic reaction with PRADAXA: chest pain or chest tightness swelling of your face or tongue trouble breathing or wheezing feeling dizzy or faint Common side effects of PRADAXA include:indigestion, upset stomach, or burning stomach pain Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. ----------------------------------------------------------------------------- How should I store PRADAXA? Store PRADAXA at room temperature between 59°F to 86°F (15°C to 30°C). After opening the bottle, use PRADAXA within 30 days. Safely throw away any unused PRADAXA after 30 days. Store PRADAXA in the original package to keep it dry. Keep the bottle tightly closed. Keep PRADAXA and all medicines out of the reach of children. ----------------------------------------------------------------------------- General information about PRADAXA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PRADAXA for a condition for which it was not prescribed. Do not give your PRADAXA to other people, even if they have the same symptoms. It may harm them. This Medication Guide summarizes the most important information about PRADAXA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about PRADAXA that is written for health professionals. ----------------------------------------------------------------------------- What are the ingredients in PRADAXA? Active ingredient: dabigatran etexilate mesylateInactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carageenan, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink. 附件： --------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时请以电话咨询为准！ --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 750mg KAPS 56.33mg/cap 10caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 75毫克胶囊剂 56.33毫克/胶囊 10胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 750mg KAPS 56.33mg/cap 30caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 75毫克胶囊剂 56.33毫克/胶囊 30胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 110mg KAPS 82.63mg/cap 10caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 110毫克胶囊剂  82.63毫克/胶囊 10胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 110mg KAPS  82.63mg/cap 30caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 110毫克胶囊剂 82.63毫克/胶囊 30胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 75mg KAPS 82.63mg/cap 10caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 75毫克胶囊剂 82.63毫克/胶囊 10胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 150mg KAPS 112.666mg/cap 60caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 150毫克胶囊剂 112.666毫克/胶囊 60胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 150mg KAPS 112.666mg/cap 30caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 150毫克胶囊剂 112.666毫克/胶囊 30胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: PRADAXA 150mg KAPS 112.666mg/cap 10caps/box 原产地英文药品名: DABIGATRAN ETEXILATE 原产地英文化合物名称: β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl] amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate 中文参考商品译名: PRADAXA 150毫克胶囊剂 112.666毫克/胶囊 10胶囊/盒 中文参考药品译名: 达比加群酯 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM ESPAÑA