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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->膀胱活动过度症
处方药:处方药
包装规格: 3.9毫克/贴片 8贴片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
华生实验室
生产厂家英文名:
WATSON LABS (UTAH)
该药品相关信息网址1:
http://www.oxytrol.com/
该药品相关信息网址2:
http://www.drugs.com/oxytrol.html
该药品相关信息网址3:
http://www.rxlist.com/oxytrol-drug.htm
原产地英文商品名:
OXYTROL 3.9MG/PATCH 8PATCHS/BOX
原产地英文药品名:
OXYBUTYNIN
中文参考商品译名:
OXYTROL 3.9毫克/贴片 8贴片/盒
中文参考药品译名:
奥昔布宁
原产地国家批准上市年份:
2003/02/26
英文适应病症1:
Overactive bladder syndrome excitement
英文适应病症2:
Frequent urination
英文适应病症3:
Urinary incontinence
临床试验期:
完成
中文适应病症参考翻译1:
膀胱过度兴奋症
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(201112517442915.pdf)的“原文Priscribing Information”为准
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部分中文奥昔布宁处方资料(仅供参考)

FDA批准透皮吸收贴片Oxytrol治疗膀胱过度兴奋症
    2月26日,FDA宣布批准Watson制药公司开发研制的透皮吸收贴片Oxytrol用于治疗膀胱过度兴奋。
    目前美国市场上治疗此类病症的常用药物有法玛西亚的Detrol LA及强生公司的Ditropan XL。与这些药物不同,由于Oxytrol是透过皮肤将药物传输入血的一种贴片,不需经过肝肠系统,因此可避免常用药物引起的不良反应如口干,便秘等。Oxytrol贴片含有的活性药物为奥昔布宁。可将它贴于腹部、髋部、臀部,用于缓解膀胱过度活动症相关的症状,效果可持续四天。
    公司发言人称,计划在第二季度全面上市这种半透明的Oxytrol贴片。临床试验中Oxytrol常见的不良反应是对皮肤的刺激。Oxytrol不被推荐用于尿潴留,胃潴留,青光眼或对奥昔布宁过度敏感的患者使用。
 
透皮奥昔布宁配方Oxytrol的Ⅲ期试验结果阳性
    Watson pharmaceutical公司的透皮奥普布宁配方,Oxytrol(Ⅰ)的第一个Ⅲ期试验资料显示,该药能显著地减少膀胱过度活跃的症状,且其抗胆碱能副作用并不多于安慰剂。
  如获得批准,(Ⅰ)较少的抗胆碱能副作用如口干,可能使它优于奥昔布宁的口服制剂。这些创作用的严重程度常是病人耐受口服剂型的制约因素。Watson提出(Ⅰ)的抗胆碱能副作用减少是因为它不通过肝脏与胃肠道代谢,导致能引起这些副作用的代谢产物的产生减少。(Ⅰ)的主要竞争药是AIza/Sanofi-Syhthelabo公司的每天口服一次的奥音布宁缓释剂Ditropan XL及Pharmacia公司的每天一次的De trol LA(tolterocline,托特罗定酒石酸盐缓释片)。
  在这项Ⅲ期研究中,520例病人用(Ⅰ)1.3mg、2.6mg或3.9mg/日或安慰剂贴片每周贴二次共治疗12周,随后有12 周的公开标记、调整剂量期。(Ⅰ)3.9mg/日组的症状比安慰剂组有显著改善(P< 0.05)。例如,在每周尿失禁发作的中数次数,每天尿频的中数改变,每次排尿的尿量增加及尿失禁询问表上的评分都有改善。
  最常见的副作用是贴片部位瘙痒,(Ⅰ)3.9mg/日组有16.8%的病人发生。较高剂量组9.6%的病人有口干,而安慰剂组是8.3%。双育期未有73例退出试验,其中53例是因有不良事件而退出的。

Oxytrol (oxybutynin transdermal system)
Company: Watson Pharmaceuticals
Approval Status: Approved March 2003
Treatment for: Overactive Bladder
Areas: Gastrointestinal; Urology & Kidneys

General Information
Oxytrol (oxybutynin transdermal system), is a transdermal patch designed to deliver oxybutynin continuously and consistently over a 3- to 4-day interval after application to intact skin. Oxytrol is available as a 39 cm2 patch system containing 36 mg of oxybutynin. Oxytrol is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

The dose of Oxytrol is one 3.9 mg/day system applied twice weekly (every 3 to 4 days).

Clinical Results
FDA approval of Oxytrol was based on the efficacy and safety evaluated in patients with urge/urinary incontinence in two phase III controlled studies and one open-label extension study.

Study 1 was a randomized, double blind, placebo-controlled study, comparing the safety and efficacy of Oxytrol at dose levels of 1.3, 2.6, and 3.9 mg/day to placebo in 520 subjects. Results showed that subjects experienced a significant reduction in weekly incontinence episodes, urinary frequency, and urinary void volume in active treatment groups versus placebo. An open-label, dose titration treatment extension allowed continued treatment for up to an additional 40 weeks for patients completing the double-blind period. All subjects had urge or mixed incontinence with incontinence episodes of at least 10 per week, and at least 8 micturitions per day.

Study 2 was a randomized, double blind, double-dummy trial comparing the safety and efficacy of Oxytrol 3.9 mg/day versus active and placebo controls in 361 subjects. All subjects had urge or mixed incontinence and had achieved a beneficial response from the anticholinergic treatment they were using at the time of study entry. Results showed a significant reduction in daily incontinence episodes, urinary frequency, and urinary void volume between placebo and active treatment groups.

Side Effects
Adverse events associated with the use of Oxytrol may include (but are not limited to) the following:
Diarrhea
Dysuria
Headache
Dry mouth
Flatulence
Nausea
Abdominal pain
Application site pruritus
Application site erythema
Application site vesicles

Mechanism of Action
Oxybutynin is an antispasmodic, anticholinergic agent. The active ingredient is dissolved in the thin layer of adhesive that sticks the patch to the skin. Oxytrol delivers the medicine slowly and constantly through the skin and into the bloodstream for the 3 or 4 days that the patch is worn. Oxytrol's transdermal delivery system delivers 3.9 mg per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to four days.

Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to oxybutynin or other components of Oxytrol should not use Oxytrol.

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 详细处方信息以本药内容附件PDF文件(201112517442915.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-12-23
附件:






201112517442915.PDF    

 
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