Information for pharmacists

Important information about Gelnique®—the first and only gel for overactive bladder

Dear Pharmacist:

Healthcare providers have the option of prescribing a unique gel formulation—Gelnique (oxybutynin chloride) Gel 10%—to treat patients with overactive bladder (OAB). Gelnique is being marketed by Watson Pharma, Inc.

Gelnique delivers oxybutynin in an easy-to-use, once-daily topical gel that patients rub onto their skin for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.1

Efficacy highlights

Gelnique has been shown to significantly reduce the number of incontinence episodes per day1,*,‡
Patients experienced a 71% reduction in incontinence episodes2,*,§

How Gelnique is applied

Patients can apply Gelnique after showering in the morning or at night, as long as the time is consistent from day to day
Patients should be advised to rotate application sites, which include the upper arms/shoulders, thighs, or abdomen, daily1

How Gelnique is supplied

Gelnique is available as a 1-month supply of thirty (30) 1-gram unit dose (1.14 mL) sachets contained in a box1
Each sachet contains 100 mg/g oxybutynin chloride gel1

Favorable safety profile1,*

Gelnique has a low incidence of bothersome side effects that can make patients stop treatment—such as dry mouth and constipation.1 Gelnique is absorbed directly into the bloodstream through the skin and bypasses the gastric system and first-pass metabolism of the liver.1 Avoiding first-pass metabolism reduces the amount of N-desethyloxybutynin (N-DEO) metabolite in the bloodstream.1 Researchers believe that N-DEO may play a role in the development of drying side effects with oral oxybutynin, such as dry mouth.4,5

Anticholinergic adverse events—such as dry mouth, constipation, and dizziness—were only 6.9%, 1.3%, and 1.5%, respectively, in a clinical trial1,†
No serious adverse events related to treatment were reported1

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%). Most treatment-related adverse events were described as mild or moderate in intensity. Only 0.8% of Gelnique-treated patients discontinued treatment in a clinical trial due to application site reactions, compared with 0.3% for placebo.1

If you have any questions, please call 1-888-GELNIQUE (1-888-435-6478). On behalf of Watson Pharma, Inc., thank you for your continued support.

Prescribing Information
Healthcare Provider FAQ
Ordering Information

*In a phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel group study comparing Gelnique (n=389) to placebo (n=400).

†Incidence with placebo: dry mouth, 2.8%; constipation, 1.0%; dizziness, 0.5%.3

‡Mean change from baseline: Gelnique, -3.0; placebo, -2.5 (P<0.0001).1

§Represents median change from baseline. Reduction with placebo was 55.6%.2

+ View References

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.
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.
Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336.
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.
Sussman DO. Overactive bladder: treatment options in primary care medicine. J Am Osteopath Assoc. 2007;107(9):379-385.
Rovner ES, Wein AJ. Incidence and prevalence of overactive bladder. Curr Urol Rep. 2002;3(6):434-438.
van der Vaart CH, de Leeuw JR, Roovers JP, Heintz AP. The effect of urinary incontinence and overactive bladder symptoms on quality of life in young women. BJU Int. 2002;90(6):544-549.
Kolcaba K, Dowd T, Winslow EH, Jacobson AF. Kegel exercises. Strengthening the weak pelvic floor muscles that cause urinary incontinence. Am J Nurs. 2000;100(11):59.
Wyman JF. Management of urinary incontinence in adult ambulatory care populations. Annu Rev Nurs Res. 2000;18:171-194.
Johnson ST. From incontinence to confidence. Am J Nurs. 2000;100(2):69-74, 76.
Kirby M. Managing stress urinary incontinence—a primary care issue. Int J Clin Pract. 2006;60(2):184-189.
Robert M, Ross S, Farrell SA, et al; Society of Obstetricians and Gynaecologists of Canada. Conservative management of urinary incontinence. J Obstet Gynaecol Can. 2006;28(12):1113-1125.
Dmochowski RR, Davila GW, Zinner NR, et al; Transdermal Oxybutynin Study Group. Efficacy and safety of transdermal oxybutynin in patients with urge and mixed urinary incontinence. J Urol. 2002;168(2):580-586.
Kegel AH. Physiologic therapy for urinary stress incontinence. JAMA. 1951;146(10):915-917.
Newman DK. Managing and Treating Urinary Incontinence. Baltimore, MD: Health Professions Press; 2002.
Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-178.
Chapple CR, Gormley EA. Developments in pharmacological therapy for overactive bladder. BJU Int. 2006;98(suppl 1):78-87;discussion 88-89.
Nitti VW. Clinical impact of overactive bladder. Rev Urol. 2002;4(suppl 4):S2-S6.
Chapple CR, Yamanishi T, Chess-Williams R. Muscarinic receptor subtypes and management of the overactive bladder. Urology. 2002;60(5 suppl 1):82-88;discussion 88-89.
Hampel C, Wienhold D, Benken N, Eggersmann C, Thüroff JW. Definition of overactive bladder and epidemiology of urinary incontinence. Urology. 1997;50(6A suppl):4-14; discussion 15-17.
MacDiarmid SA. How to choose the initial drug treatment for overactive bladder. Curr Blad Dysf Rep. 2008;3:41-46.

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. 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.