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  药店国别: 美国药房
产地国家: 美国
所属类别: 泌尿生殖系统及泌乳药物->尿失禁、尿急和尿频
处方药:处方药
包装规格: 5毫克/片 30片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
安斯泰来
生产厂家英文名:
ASTELLAS
该药品相关信息网址1:
http://www.vesicare.com/
该药品相关信息网址2:
www.drugs.com/vesicare.html
该药品相关信息网址3:
www.rxlist.com/vesicare-drug.htm
原产地英文商品名:
VESICARE 5mg/tab 30tabs/bottle
原产地英文药品名:
SOLIFENACIN SUCCINATE
原产地英文化合物名称:
1-Azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate butanedioic acid
中文参考商品译名:
VESICARE 5毫克/片 30片/瓶
中文参考药品译名:
琥珀酸索非那新
中文参考化合物名称:
1-氮杂双环[2.2.2]辛烷-8-基-(1S)-1-苯基-3,4-二氢-1H-异喹啉-2-甲酸酯丁二酸盐
原产地国家批准上市年份:
2004/11/19
英文适应病症1:
Overactive Bladder
英文适应病症2:
Frequent urination
英文适应病症3:
Incontinence
临床试验期:
完成
中文适应病症参考翻译1:
膀胱过度活动症
中文适应病症参考翻译2:
尿频
中文适应病症参考翻译3:
尿失禁
药品信息:

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 详细处方信息以本药内容附件PDF文件(201251000170819.PDF)的“原文Priscribing Information”为准
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部分中文Vesicare处方资料(仅供参考)

Vesicare在荷兰首次批准
    山之内公司的新一代抗胆碱能药Vesicare (solifenacin ,暂译为 :索非那新 ) ,作为治疗膀胱过动症已首次在荷兰批准。山之内欧洲公司说 ,在欧洲其他国家上市的时间取决于欧盟各国对荷兰批准的认可。在欧洲 ,在年过 4 0岁的人群中有超过 16 %的人患有膀胱过动症。

琥珀酸索非那新投放美国市场用于膀胱过度活动症
    山之内公司已经将毒蕈碱M3受体拮抗剂琥珀酸索非那新(solifenacin succinate,Vesicare)投放于美国市场,用于治疗有尿急、尿频症状的膀胱过度活动症。它能选择性地松弛膀胱逼尿肌,减少以往的抗胆碱能药所出现的全身副作用。

英文名称:Solifenacin Succinate

中文别名:索非那新琥珀酸盐;1-氮杂双环[2.2.2]辛烷-8-基-(1S)-1-苯基-3,4-二氢-1H-异喹啉-2-甲酸酯丁二酸盐;琥珀酸索非那新;

英文名称:Solifenacin succinate

英文别名:Vesicare; 1-Azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate butanedioic acid;(3R)-1-azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate butanedioate (1:1);1-azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate butanedioate (1:1);1-azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate;

适应症:治疗尿频与尿失禁。
 
相关资料:
    索非那新是由日本山之内(Yamanouchi)制药公司开发的新型治疗尿频、尿失禁的药物,于2005年1月19日在FDA批准在美国上市,商品名为"Vesicare",同年8月在欧洲获得批准上市,用于治疗膀胱活动过度症。本品属于蕈毒碱M3受体拮抗剂,与蕈毒碱M3受体具有高亲和力,能选择性抑制节律性膀胱收缩而不影响垂液分泌。
    国际尿控学会(ICS)对膀胱过度活动症(OAB)的定义为:一种提示下尿路功能障碍的症状综合征,主要是尿急,可伴有或不伴有急迫性尿失禁,通常伴有尿频和夜尿。无尿急主诉不能确诊为OAB,但OAB可无尿失禁的主诉。欧美地区OAB发病率为16%~17%,随年龄增长而升高。尿失禁、OAB等泌尿系统疾病虽然没有生命威胁,却严重影响生活质量,OAB对患者生活质量的影响甚至超过心绞痛、糖尿病、哮喘等常见疾病。
    我国尚无大规模膀胱过度活动症(OAB)流行病学调查,部分地区的流行病学调查结果显示,尿失禁、急迫性尿失禁在女性中患病率高。福州地区女性OAB调查的患病率结果为8%,据此推测我国至少有1亿人受该病困扰。不容乐观的是目前我国患者尤其是女性患者就诊意向或就诊率低。究其原因,一方面很多人认为OAB是正常现象或不知怎么办,另一方面大多数人尤其是女性羞于启齿,同时社会对此未给予足够的关注和宣传。因此,专家呼吁社会和广大医务人员应大力开展知识宣传,提高患者、家庭及全社会对OAB的认知,提高患者就诊意识,改变OAB诊治现状。
    膀胱过度活动症(OAB)的主要治疗方法可分为非药物治疗、药物治疗和手术/有创性治疗,但药物治疗仍然是最主要的治疗手段。在所有药物中,M受体拮抗剂是经典的OAB治疗药物。但由于M受体在膀胱以外的很多组织中发挥重要功能,因此使用M受体拮抗剂容易引发口干(最常见)、便秘、嗜睡和视物模糊等副作用。理想的OAB治疗药物必须既能缓解OAB症状,又要不良反应最低。因此,安全性更好和膀胱选择性更高是该类药物发展的趋势。
    索利那新是新一代高选择性M受体拮抗剂,与同类药物相比对膀胱选择性最高,因此疗效更强,口干等副作用更少。索利那新半衰期长达45~68小时,可一天一次给药(空腹或餐后),即使患者漏服一次也不会明显影响疗效。
    目前,已有多项国内外临床研究证实了索利那新的疗效和安全性,口服索利那新治疗12个月的完成率达到81.4%,高于口服奥昔布宁(46.2%)和托特罗定(70.6%),患者有更好的耐受性和依从性。ICS、中华医学会泌尿外科学分会、日本泌尿外科学会制订的OAB治疗指南均推荐索利那新为一线治疗药物。

Vesicare (solifenacin succinate)
Company: Yamanouchi, GlaxoSmithKline
Approval Status: Approved November, 2004
Treatment for: Overactive bladder
Areas: Urology & Kidneys

General Information
Vesicare oral tablets contain solifenacin, a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle. Antagonism at these receptors has been shown to reduce tonus (elastic tension) of the urinary bladder and slow parasympathetic contractions.

It is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Vesicare is administered via an oral tablet of 5 mg once daily, with a possible increase in dosage, to 10 mg once daily, in subjects experiencing good tollerance. Dosing should occur with liquids, and tablets should not be crushed or broken prior to administration.

Clinical Results
FDA approval of Vesicare was based upon four 12-week multi-center, double-blind, placebo-controlled, parallel-group studies. The studies enrolled a total of 3027 subjects with at least a 3 month history of increased urinary frequency, urinary urgency, and/or urge or mixed (predominantly urge) incontinence. Subjects in two of the trials received either 5 or 10 mg Vesicare or placebo once daily, and subjects in the other two received exclusively 10 mg or placebo once daily. All patients completing the 12-week studies were eligible to enter an open label long-term extension. All four trials found that Vesicare offered significantly better efficacy than placebo in both primary (mean change from baseline to 12 weeks in number of micturitions/24 hours) and secondary (including mean change from baseline to 12 weeks in number of incontinence episodes/24 hours, and mean volume voided per micturition) endpoints.

Side Effects
Adverse events associated with the use of Vesicare may include, but are not limited to, the following:
Dry mouth
Constipation
Blurred Vission
Urinary Retention
Dry Eyes

In addition, three serious intestinal complications (one fecal impaction, one colonic obstruction, and one intestinal obstruction) and one case of angioneurotic edema occurred among patients taking Vesicare in clinical trials. There was not a significant difference in the incidence of serious adverse events between subjects taking the drug for 12 weeks and 12 months.

Mechanism of Action
Solifenacin acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

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 详细处方信息以本药内容附件PDF文件(201251000170819.PDF)的“原文Priscribing Information”为准
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更新日期: 2014-06-19
附件:




201251000170819.PDF    

 
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