英文药名: Gelnique 3% gel(Oxybutynin)

中文药名: 奥昔布宁3%凝胶

生产厂家: 沃森制药公司
药品简介
美国FDA批准沃森公司（Watson）的3%氯化奥昔布宁凝胶（oxybutynin chloride，Gelnique）上市，首个和唯一用于治疗以尿急、失禁和尿频为症状的膀胱过度活动症（OAB）。
研究结果表明：84毫克，每日一次Gelnique3％是在减轻OAB症状包括尿失禁和尿频的降低，并增加了尿空隙体积优于安慰剂。
Gelnique凝胶含有奥昔布宁，解痉，抗毒蕈碱剂。它每天一次被施加到大腿，腹部，上臂或肩部。 Gelnique是在出现在1克凝胶包的10％用量的实力已经可用。
GELNIQUE 3％（奥昔布宁 Oxybutynin）凝胶3％，局部使用
最初美国批准：1975年
作用机理
奥昔布宁是R-和S-异构体的外消旋（50:50）混合物。抗毒蕈碱活性R-异构体主要位于。
奥昔布宁充当在节后毒蕈碱受体的乙酰胆碱的竞争性拮抗剂，导致膀胱平滑肌的松弛。活性代谢物，N-去乙基奥，对人体逼尿肌药理活性，它类似于在体外研究奥昔布宁。患者特征在于不自主逼尿肌收缩的条件下，膀胱测压研究已经表明，奥昔布宁增加最大膀胱容量，并增加了体积，以第一逼尿肌收缩。
适应症和用法
GELNIQUE 3％是用于与急迫性尿失禁，尿急和频率的症状膀胱过动症的治疗中所指示的毒蕈碱受体拮抗剂。
用法用量
每日一次应用GELNIQUE三泵3％（84毫克）清洁和上腹部或上臂/肩膀，大腿或干燥，完好的皮肤。
GELNIQUE 3％仅用于局部应用，不应该被摄入。
剂型和规格
凝胶; 3％
禁忌症
尿潴留
胃保留（
不受控制的窄角型青光眼
警告和注意事项
尿潴留：警告患者应行使，因尿潴留风险临床显著膀胱流出道梗阻。
胃肠病：谨慎患者胃食管反流和/或那些服用药物能引起或加剧食道炎和患者减少肠能动性或因胃内滞留的风险的胃肠阻塞性疾病使用。
皮肤转移：建议患者用衣物覆盖应用程序的网站，如果皮肤对皮肤的接触在应用部位预期。后产品应用洗手。
易燃凝胶：蕴含含酒精的凝胶。避免使用明火或者吸烟，直到凝胶已经干燥。
重症肌无力：管理GELNIQUE慎用3％的重症肌无力患者，其特点是病神经肌肉接头降低胆碱能活性。
血管性水肿：血管性水肿有报道口服奥昔布宁使用​​。如果出现血管神经性水肿症状，应停止GELNIQUE 3％，并采取适当的治疗。
受控窄角型青光眼：管理GELNIQUE慎用3％，在窄角型青光眼正在接受治疗的患者。
不良反应
最常见的不良反应（≥3％）有口干和应用部位反应。
药物相互作用
与其他抗胆碱能（抗胆碱）代理伴随使用可能会增加口干，便秘，以及视力模糊等抗胆碱能药理作用的频率和/或严重性。
特殊人群中使用
GELNIQUE 3％不应在儿童使用，因为安全性和有效性尚未确定在儿科患者。
GELNIQUE（奥昔布宁）凝胶10％
单位剂量：
热密封含GELNIQUE凝胶1克（1.14毫升）局部使用小袋。
30包纸箱（NDC52544-084-30）
储存：
商店在25°C（77°F）;游览允许15-30°C（59-86°F）。参见USP控制室温。从水分和湿度的保护。香囊打开，内容开除后立即生效。丢弃家庭垃圾袋用在防止儿童，宠物或其他意外的应用程序或摄取的方式。

Watson and Antares Announce the Introduction of Gelnique 3%™, for the Treatment of Overactive Bladder
GELNIQUE 3% GEL (Oxybutynin)
Gelnique 3%™ (oxybutynin) gel 3%, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency.  Gelnique 3%™ is a clear, odorless topical gel that has been shown to be an effective and safe treatment for OAB. The product is available in a metered pump dispenser, offering patients convenient dosing.
OAB is a condition that affects more than 33 million Americans, and the treatment market in the U.S. currently exceeds $2.0 billion annually.[i] Gelnique 3%™, developed by Antares and obtained through an exclusive licensing agreement by Watson, was approved by the U.S. Food & Drug Administration on December 8, 2011.
Because the active ingredient in Gelnique 3%™ is delivered transdermally, in a clear, odorless gel, it is not metabolized by the liver in the same way as orally administered oxybutynin products. This is thought to result in a low level of side effects such as dry mouth and constipation, common with orally administered OAB medications.
"The launch of Gelnique 3%™ further demonstrates Watson's commitment to invest in building a leadership position in urology, particularly in the overactive bladder market," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "The clinical trial demonstrated an early treatment effect versus placebo and improved efficacy over time. In addition, Gelnique 3%™ provides OAB patients with the convenience of once-daily dosing using a simple, precise metered-dose pump.
"We are very excited about the launch of Gelnique 3%™," said Paul K. Wotton Ph.D., President and Chief Executive Officer of Antares Pharma. "Watson's experience and commitment to urology coupled with their well-established and knowledgeable commercial team makes them the perfect partner to market this next generation gel product for the treatment of overactive bladder."
About Gelnique 3%™ (oxybutynin) gel 3%
Gelnique 3%™ (oxybutynin) gel 3% is a topical, translucent hydroalcoholic gel containing oxybutynin, an antispasmodic, antimuscarinic agent. Applied once daily to the thigh, abdomen, upper arm or shoulder, an 84 mg (approx. 3 mL) dose of Gelnique 3%™ delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing significant efficacy without sacrificing tolerability. 
In a Phase 3 study, 84 mg, once-daily Gelnique 3%™ was superior to placebo at relieving OAB symptoms including a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume. Gelnique 3%™ demonstrated a significant median reduction in urinary incontinence episodes (67%) versus placebo (50%) at week 12 of the clinical study supporting approval. Notably, significant reductions in incontinence episodes were seen in patients after just one week of therapy. Patients in the trial experienced more than six urinary incontinence episodes a day on average at baseline, or at the beginning of the trial.
Additional pharmacokinetic studies showed that showering one hour or later, or the application of sunscreen 30 minutes before or after gel application had no effect on the overall systemic exposure of the drug.
Important Safety Information
The most commonly reported adverse events associated with the use of Gelnique 3% included dry mouth (12.1%), application site erythema (3.7%), and application site rash (3.3%). Gelnique 3% is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions. Gelnique 3% should be used with caution in patients with clinically significant bladder outflow obstruction, myasthenia gravis, gastrointestinal obstructive disorders, ulcerative colitis, intestinal atony, gastroesophageal reflux and those concurrently taking drugs that can cause or exacerbate esophagitis. Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oxybutynin pills. If angioedema occurs, Gelnique 3% should be discontinued and appropriate therapy promptly provided. Transference of oxybutynin to another person can occur when vigorous skin-to-skin contact is made with the application site. Patients should be instructed to avoid open flame or smoking until the gel has dried.
http://www.rxresource.org/prescription-information/Gelnique-Watson-Laboratories-Inc.html