Gelnique® (oxybutynin chloride) Gel 10% for the treatment of OAB symptoms

Highly effective, tolerable, and easy to use, once-daily Gelnique^® is the first and only topical gel for overactive bladder (OAB), delivering oxybutynin through the skin for 24-hour efficacy against the symptoms of urge urinary incontinence, urgency, and frequency.¹
89%

median
reduction

in daily urinary incontinence episodes due to OAB (vs 62.5% with placebo; P=0.0148)²
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At week 12, patients reported a median reduction of 2.0 incontinence episodes per day with Gelnique® compared with 1.3 for placebo (P=0.0053).² Results from a post-hoc analysis of patients with 2-3 daily incontinence episodes at baseline in the phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group study comparing Gelnique® (n=85) with placebo (n=86).

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Gelnique® (oxybutynin chloride) Gel 10% [prescribing information]. Corona, CA: Watson Pharmaceuticals, Inc.; 2009.
Data on file. Watson Laboratories, Inc.
Staskin DR, Dmochowski RR, Sand PK, et al. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009;181(4):1764-1772.
Basra RK, Wagg A, Chapple C, et al. A review of adherence to drug therapy in patients with overactive bladder. BJU Int. 2008;102(7):774-779.
Staskin DR, Robinson D. Oxybutynin chloride topical gel: a new formulation of an established antimuscarinic therapy for overactive bladder. Expert Opin Pharmacother. 2009;10(18):3103-3111.
Lee SY, Phanumus D, Fields SD. A primary care guide to managing acute and chronic symptoms in older adults. Geriatrics. 2000;55(11):65-71.
Ouslander JG, Shih YT, Malone-Lee J, Luber K. Overactive bladder: special considerations in the geriatric population. Am J Manag Care. 2000;6(11)(suppl):S599-S606.
Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760-766.
Newman DK. Managing and Treating Urinary Incontinence. Baltimore, MD: Health Professions Press; 2002.
Srougi M, Nesrallah LJ, Kauffmann JR, Nesrallah A, Leite KRM. Urinary continence and pathological outcome after bladder neck preservation during radical retropubic prostatectomy: a randomized prospective trial. J Urol. 2001;165(3):815-818.
Kegel AH. Physiologic therapy for urinary stress incontinence. JAMA. 1951;146(10):915-917.
Waldeck K, Larsson B, Andersson KE. Comparison of oxybutynin and its active metabolite, N-desethyl-oxybutynin, in the human detrusor and parotid gland. J Urol. 1997;157(3):1093-1097.
MacDiarmid S, Sandage BW Jr, Malhotra BK. The effects of reformulation: improved therapeutic index. Curr Urol Rep. 2008;9(6):465-471.
SDI Formulary Impact Analyzer, December 2010.

Prescribing Information Request a Representative Contact Us Product Update Notification References Site Map

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

Important Safety Information

The most commonly reported adverse events associated with the use of Gelnique® included dry mouth (6.9%), urinary tract infection (6.9%), and application site reactions (5.4%). Gelnique® is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to Gelnique®, including skin hypersensitivity and in patients who are at risk for these conditions. Gelnique® should be used with caution in patients with hepatic or renal impairment, clinically significant bladder outflow obstruction, myasthenia gravis, and gastrointestinal obstructive disorders. Gelnique® should also be used with caution in patients with conditions such as ulcerative colitis, intestinal atony, gastroesophageal reflux and those concurrently taking drugs that can cause or exacerbate esophagitis. Patients who develop skin hypersensitivity to Gelnique® should discontinue drug treatment. Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oxybutynin pills. If angioedema occurs, Gelnique® 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 fire or smoking until the gel has dried.