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  药店国别: 日本药房
产地国家: 日本
所属类别: 影响血液及造血系统药物->溶栓抗凝药物
处方药:处方药
包装规格: 10毫克/20毫升/安醅 10安醅/盒
计价单位:
   
生产厂家中文参考译名:
日醫工株式會社.
生产厂家英文名:
Nichi-Iko Pharmaceutical Co., Ltd.
该药品相关信息网址1:
http://www.genome.jp/kusuri/japic_med/show/00052150
该药品相关信息网址2:
http://www.umm.edu/drug/notes/Argatroban-Injection.htm
该药品相关信息网址3:
http://www.info.pmda.go.jp/go/pack/2190408G1057_1_05/2190408G1057_1_05?view=body
原产地英文商品名:
ARGATROBAN INJECTION SYRINGE(アルガトロバン) 10mg/20ml/amp 10amps/box (Minimum Order: 10)
原产地英文药品名:
ARGATROBAN HYDRATE
原产地英文化合物名称:
(2R,4R)-4-Methyl-1-[N-[(3-methyl-1,2,3,4-tetrahydro-8-quinolinyl)sulfonyl]-L-arginyl]-2-piperidinecarboxylic acid
中文参考商品译名:
阿加曲班注射器注射剂(アルガトロバン) 10毫克/20毫升/安醅 10安醅/盒 (最低订单: 10)
中文参考药品译名:
阿加曲班水合物
中文参考化合物名称:
(2R,4R)-4-甲基-1-[N-((R,S)-3-甲基-1,2,3,4-四氢-8-喹啉磺酰基)-L-精氨酰基]-2-哌啶羧酸
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Anti-thrombotic
临床试验期:
完成
中文适应病症参考翻译1:
抗血栓
药品信息:

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 详细处方信息以本药内容附件PDF文件(2201213117565617.pdf)的“原文Priscribing Information”为准
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部分中文阿加曲班处方信息仅供参考

阿加曲班
分类名称
一级分类:血液系统药物 二级分类:抗凝血药
 
药品英文名
Argatroban

中文化学名:(2R,4R)-4-甲基-1-[N-((R,S)-3-甲基-1,2,3,4-四氢-8-喹啉磺酰基)-L-精氨酰基]-2-哌啶羧酸
  
英文化学名:(2R,4R)-4-Methyl-1-[N-[(3-methyl-1,2,3,4-tetrahydro-8-quinolinyl)sulfonyl]-L-arginyl]-2-piperidinecarboxylic acid
 
药品别名
阿戈托班
 
药物剂型
注射剂(供输注用):250mg(2.5ml)。
 
药理作用
本品为合成的左旋精氨酸的哌啶羧酸衍生物,属于抗凝药。市售品是由R-和S-同分异构体按65%和35%的比例组合而成。S-同分异构体抑制凝血酶的活力为R-同分异构体的2倍。本品为小分子物质,具有高选择性,能可逆性直接抑制凝血酶的活性。能迅速和循环中游离的和与血凝块中的凝血酶结合,产生抗凝作用。
 
药动学
在静脉滴注阿加曲班每分钟40μg/kg以内,剂量与血浆浓度呈线性关系。作用出现迅速,约30min即出现。在给药2h后血浆浓度达峰值。持续静脉滴注在1~3h内血浆浓度达稳态。阿加曲班在体内分布容积是174ml/kg,主要是在细胞外分布,它的血浆蛋白结合率为54%。阿加曲班主要是在肝脏代谢,约65%被代谢为4个代谢产物。主要代谢产物的抗凝活性较原药弱3~5倍,其他3个代谢产物在尿中含量甚低,在血浆和粪中未检测出。阿加曲班主要是通过胆汁从粪便中排出,健康志愿者的清除半衰期约为40~50min。药物监测指标为APTT,控制在原水平1.5~3倍。本品进入肝内后,经羟化作用而代谢。本品不会诱导自身的抗体形成,也不会与肝素诱导的抗体发生相互作用。
 
适应证
用于与肝素引起血小板减少有关的血栓形成。
 
禁忌证
1.对本品过敏者、哺乳者禁用。2.任何出血患者均禁用。
 
注意事项
1.严重高血压、腰穿术后、脊髓麻醉、大手术特别是脑、脊髓或眼科手术后、胃肠溃疡、先天或后天获得的出血性疾病均应慎用。2.肝功能不全者使用本品时,应减少剂量并监测APTT。中度不全者,推荐剂量为每分钟0.5μg/kg。3.老年人和肾功能不全者不必调整剂量。4.小于18岁儿童的用药安全性尚未确定。5.输注的速度根据体重而定,体重50kg,每小时输入6ml(50/6),余类推为(60/7),(70/8),(80/10),(90/11),(100/12),(110/13),(120/14),(130/16),(140/17)。6.在两项多中心临床试验中,对肝素诱发血小板减少症和肝素诱发伴有血栓血小板减少症的患者,静脉滴注阿加曲班每分钟2μg/kg,可较原水平延长APTT 1.5~3倍,且在停用肝素第3天约50%患者血小板可恢复,但出血不良反应与对照组无区别。孕妇及哺乳期妇女用药、儿童用药、老年患者用药和药物相互作用参见比伐卢定。药物过量,若应用阿加曲班过量,无特效药物纠正,须停用阿加曲班后2~4hAPTT和ACT恢复至原水平。
 
不良反应
常见的有各种不同的出血、呼吸困难、低血压、发热、腹泻、脓毒症、房室传导阻滞、恶心、室性心动过速、疼痛、尿路感染和呕吐。过敏反应的发生率为14%。以阿加曲班治疗不稳定型心绞痛患者停药后可出现心绞痛,及时给予阿司匹林可避免。
 
用法用量
1.本品供持续输注。给药前,先将注射剂配制成1mg/ml的溶液,稀释液采用0.9%氯化钠注射剂、5%右旋糖酐注射剂或乳酸林格液均可。配制时,要反复倒转瓶子数min,使溶液充分溶化。配制好的溶液室温上可保持稳定24h,置冰箱中可保持48h。2.防治HIT患者的血栓形成,开始给予每分钟2μg/kg,静脉输注,同时监测ATPP。在治疗后1~3h,常可达较稳定的抗凝效果。在开始输入本品和(或)调查剂量后2h,应当测定APTT,并证实其达到靶值(1.5~3倍的基础值,但不要超过100秒钟)。根据临床调整速度时,不要>每分钟100μg/kg。3.在使用本品治疗后,可继续接用华法林。4.对出现肝素诱发血小板减少的患者,应先停用肝素治疗,并测基础的APTT值,推荐剂量为首先以阿加曲班每分钟2μg/kg静脉滴注,此后根据APTT值调整剂量,最大不超过每分钟10μg/kg。对于中度肝功能不全患者,首先以阿加曲班每分钟0.5μg/kg静脉滴注,此后根据APTT值调整剂量。
 
药物相应作用
1.与华法林合用可能发生药动学相互作用,使凝血酶原时间延长。2.合用其他抗凝药均可增加出血的危险性。
 
专家点评
本品为合成的左旋精氨酸的哌啶羧酸衍生物,属于抗凝药。为小分子物质,具有高选择性,能可逆性直接抑制凝血酶的活性。能迅速和循环中游离的与血凝块中的凝血酶结合,产生抗凝作用。用于与肝素引起血小板减少有关的血栓形成。

Argatroban (Injection)
Introduction:
Argatroban
Treats or prevents blood clots in patients with bleeding problems caused by another medicine called heparin. Also given to patients before having balloon angioplasty, a procedure to open a clogged artery.

Brand Name(s):
There may be other brand names for this medicine.

When This Medicine Should Not Be Used:
You should not receive this medicine if you have ever had an allergic reaction to argatroban. This medicine should not be given if you have severe bleeding from any cause.

How to Use This Medicine:
Injectable
•Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
•This medicine is given in a hospital. A nurse or other trained health professional will give you this medicine.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
•Make sure your doctor knows if you are using a blood thinner (such as warfarin or Coumadin®), streptokinase (Streptase®), aspirin, or other medicines that affect blood platelets (such as dextran, dipyridamole, hydroxychloroquine, ibuprofen, indomethacin, phenylbutazone, Advil®, Aggrenox®, InfeD®, Indocin®, Motrin®, Persantine®, or Plaquenil®).

Warnings While Using This Medicine:
•Make sure your doctor knows if you are pregnant or breastfeeding, or if you have hemophilia or any other bleeding problem. Also tell your doctor if you have a stomach or intestinal ulcer, liver disease, very high blood pressure, or if you have had a stroke or recent surgery or procedure on your eyes, brain, or spine.
•You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries until the effects of the medicine have worn off. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.
•Watch for any bleeding from open areas such as around the injection site. Also check for blood in your urine or stool. If you have any bleeding or injuries, tell your doctor right away.
•Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
•Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
•Black, tarry stools.
•Chest pain, shortness of breath, or coughing up blood.
•Fast, slow, or uneven heartbeat.
•Fever, chills, cough, sore throat, and body aches.
•Lightheadedness or fainting.
•Numbness or weakness in your arm or leg, or on one side of your body.
•Red or dark brown urine.
•Sudden or severe headache, problems with vision, speech, or walking.
•Unusual bleeding, bruising, or weakness.
•Vomiting of blood or material that looks like coffee grounds.

If you notice these less serious side effects, talk with your doctor:
•Diarrhea, nausea, or vomiting.
•Mild bleeding, itching, or rash where the needle is placed.

If you notice other side effects that you think are caused by this medicine, tell your doctor:
•Reviewed last on: 1/4/2010 


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 详细处方信息以本药内容附件PDF文件(201213117565617.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2018-08-27
附件:




201213117565617.PDF    

 
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