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  药店国别: 欧洲共同体药房
产地国家: 欧洲共同体国家
所属类别: 心血管系统药物->凝血酶抑制剂
处方药:处方药
包装规格: 75毫克/胶囊 30胶囊/瓶
计价单位:
  点击放大  
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 Pharma GmbH & Co. KG
该药品相关信息网址1:
http://www.pradaxa.com/
原产地英文商品名:
PRADAXA 75mg/cap 30caps/bottle
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 30胶囊/瓶
中文参考药品译名:
达比加群酯
原产地国家批准上市年份:
2010/10/19
英文适应病症1:
Stroke
英文适应病症2:
Systemic embolism
临床试验期:
完成
中文适应病症参考翻译1:
中风
中文适应病症参考翻译2:
全身栓塞
药品信息:

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 详细处方信息以本药内容附件PDF文件(201011118451315.pdf)的“原文Priscribing Information”为准
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部分中文Pradaxa处方资料(仅供参考)

    2010年10月19日,美国食品药品监督管理局(FDA)批准了Pradaxa(Dabigatran Etexilate)胶囊的NDA,该药用于心房颤动患者中风及血栓的预防。
  在美国约有二百万心房颤动患者,此病容易形成血栓,而血栓流入大脑后会有很高的中风风险,Pradaxa是通过抑制凝血酶而起作用的抗凝剂。通过与抗凝剂warfarin(华法林)的临床对比研究试验显示,使用Pradaxa的患者具有更低的中风风险。FDA药品评价及研究中心,心血管及肾病药品办公室的负责人Norman Stockbridge博士表示:Pradaxa不需要像华法林那样进行周期性的血液化验。
  与其他抗凝血药物一样,Pradaxa最常见的不良反应是出血,严重可能危及生命,此外还有消化不良,胃痛恶心、胃灼烧、胃胀等胃肠道不良反应。由于其有严重出血的风险,每个Pradaxa处方都要给患者发放用药指导。
  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:勃林格殷格翰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:150 mg口服,每天2次
(2)对有CrCl 15-30 mL/min患者:75 mg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:75 mg和150 mg

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) capsules
Read 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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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What are the ingredients in PRADAXA?
Active ingredient: dabigatran etexilate mesylate
Inactive 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.

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 详细处方信息以本药内容附件PDF文件(201011118451315.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-08-25
附件:






201011118451315.pdf    

 
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