制造商：
华生制药公司
药理分类：
解痉/抗胆碱
活性成分（补）：
奥昔布宁氯10％（1g/sachet）;外用凝胶，含有酒精。
指示（补）：
膀胱过动症（OAB）时与急迫性尿失禁，紧迫性和频率。
药理作用：
奥昔布宁是一种抗胆碱剂，毒蕈碱受体在节后工程，引起膀胱平滑肌松弛。它已被证明能增加膀胱容量最大，增加与病人的非自愿逼尿肌收缩量第一逼尿肌收缩。当适用于完整的皮肤，奥昔布宁，达到全身吸收后，本周连续给药稳态水平。
临床试验：
采用随机，双盲平行组研究是为了评估在治疗膀胱过度活动症Gelnique。有症状的膀胱过动超过4尿失禁在3天时间平均每天至少8 micturitions是成人参加了这一为期12周的研究。患者被随机分配到一克Gelnique或安慰剂凝胶日常应用。与药物治疗的研究曾在每一天的平均每日服用安慰剂相比，尿频尿失禁发作次数显着改善。此外，平均每排尿尿量增加在研究组的手臂，而安慰剂。在基线，在日常尿失禁发作次数平均改变为对Gelnique -3.0，-2.5，安慰剂组相比。为便于日常尿频，从基线的平均变化是研究药物相对于安慰剂-2.7 -2.0。患者使用Gelnique有一个从基线的平均相对于安慰剂3.8mL 0.5ML的尿空隙体积的变化。
法律分类：
接收
成人：
应用1克凝胶（一小袋）每天一次干燥，腹部，上臂/肩膀，或大腿完整的皮肤。旋转应用网站，避免对同一地点连续两天使用。申请后要洗手。避免洗涤区/申请后1小时洗澡。
儿童：
不推荐。
禁忌（补）：
泌尿系统或胃潴留。不受控制的窄角型青光眼。
警告/注意事项：
膀胱出口梗阻。肠胃道阻塞。胃肠运动减少。溃疡性结肠炎。肠道安东尼。胃食管反流。食管炎。肝，肾功能不全。重症肌无力。控制窄角型青光眼。如果皮肤出现过敏停止。皮肤转移：封面与服装已经干凝胶后，如果直接接触，预计申请地点。暴露于高环境温度。凝胶是易燃。妊娠（Cat.B）。哺乳的母亲。
互动（补）：
药物可导致或加剧食管炎警告（例如，二膦酸盐）。中枢神经系统抑郁症与酒精，镇静剂等中枢神经系统。与其他抗胆碱能药物添加剂的效果。
不良反应（补）：
口干，应用部位反应（如皮肤瘙痒，皮炎），尿路感染，头晕，头痛，便秘，疲劳，其他抗胆碱作用。
注释：
报告可疑的（800）272-5525或FDA的不良反应沃森（800）美国FDA - 1088。
如何提供：
凝胶（1克/小袋）-30
最后更新：
2009年5月28日
 |
GELNIQUE
Manufacturer:
Watson Pharmaceuticals, Inc.
Pharmacological Class:
Antispasmodic/anticholinergic
Active Ingredient(s):
Oxybutynin chloride 10% (1g/sachet); topical gel; contains alcohol.
Indication(s):
Overactive bladder (OAB) with urge urinary incontinence, urgency, and frequency.
Pharmacology:
Oxybutynin is an anticholinergic agent that works at postganglionic muscarinic receptors to cause the relaxation of bladder smooth muscle. It has been shown to increase the maximum urinary bladder capacity and to increase the volume to the first detrusor contraction in patients with involuntary detrusor contractions. When applied to intact skin, oxybutynin is absorbed systemically and achieves steady-state levels after a week of continuous dosing.
Clinical Trials:
A randomized, double-blind parallel-group study was conducted to evaluate Gelnique in the treatment of overactive bladder. Adults with symptomatic overactive bladder with an average of more than 4 incontinence episodes in a 3-day period and at least 8 micturitions per day were enrolled in this 12-week study. Patients were randomized to daily applications of one gram of Gelnique or placebo gel. Those treated with the study drug had significant improvements in the number of urinary incontinence episodes per day and in the average daily urinary frequency compared to placebo. Also, the average urine volume per micturition was increased in the study group arm, compared to placebo. The mean change in baseline in the number of daily incontinence episodes was -3.0 for Gelnique, compared to -2.5 for placebo. For daily urinary frequency, the mean change from baseline for the study drug was -2.7 compared to -2.0 for placebo. Patients using Gelnique had a change from baseline in the mean urinary void volume of 21mL compared to 3.8mL for placebo.
Legal Classification:
Rx
Adults:
Apply 1 gram gel (one sachet) once daily to dry, intact skin on abdomen, upper arm/shoulders, or thighs. Rotate application sites; avoid use of same site on consecutive days. Wash hands after application. Avoid washing area/showering for 1 hour after application.
Children:
Not recommended.
Contraindication(s):
Urinary or gastric retention. Uncontrolled narrow angle glaucoma.
Warnings/Precautions:
Bladder outlet obstruction. Gastrointestinal obstruction. Decreased GI motility. Ulcerative colitis. Intestinal antony. Gastroesophageal reflux. Esophagitis. Hepatic or renal dysfunction. Myasthenia gravis. Controlled narrow angle glaucoma. Discontinue if skin hypersensitivity occurs. Skin transference: cover application site with clothing after gel has dried if direct contact is anticipated. Exposure to high environmental temperatures. Gel is flammable. Pregnancy (Cat.B). Nursing mothers.
Interaction(s):
Caution with drugs that can cause or exacerbate esophagitis (eg, bisphosphonates). CNS depression with alcohol, other CNS depressants. Additive effects with other anticholinergics.
Adverse Reaction(s):
Dry mouth, application site reactions (eg, pruritus, dermatitis), urinary tract infection, dizziness, headache, constipation, fatigue, other anticholinergic effects.
Notes:
Report suspected adverse reactions to Watson at (800) 272-5525 or FDA at (800) FDA-1088.
How Supplied:
Gel (1 gram/sachet)—30