Gelnique (oxybutynin chloride)
Company: Watson Labs
Approval Status: Approved January 2009
Treatment for: overactive bladder
Areas: Nephrology/Urology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Gelnique (oxybutynin chloride) is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
Gelnique is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Gelnique is supplied as a gel designed for topical administration. The recommended initial dose of the drug is one sachet (a 1 gram unit dose (1.14 mL) of 100 mg/g) applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated.
Clinical Results
FDA Approval
FDA approval of Gelnique was based on the results a single randomized, double-blind, placebo-controlled, parallel group 12-week study. The study entolled 789 subjects with symptomatic overactive bladder with an average of at least four incontinence episodes in a 3-day period and at least 8 micturitions per day. The subjects were randomized to daily applications of Gelnique 1 gram or matching placebo gel. Gelnique treatment resulted in a statistically significant decrease in the number of urinary incontinence episodes per day from baseline to endpoint (the primary efficacy endpoint) compared with placebo (p<0.0001) as well as a decrease in the average daily urinary frequency (p=0.0017) and an increase in the average urine volume per void (p=0.0018).
Side Effects
Adverse events associated with the use of Gelnique may include, but are not limited to, the following:
- dry mouth
- urinary tract infection
- application site reactions
- upper respiratory tract infections
- dizziness
- nasopharyngitis
Mechanism of Action
Gelnique (oxybutynin chloride) is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
Literature References
Lackner TE, Wyman JF, McCarthy TC, Monigold M, Davey C Randomized, placebo-controlled trial of the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired nursing home residents with urge urinary incontinence. Journal of the American Geriatrics Society 2008 May;56(5):862-70
Sahai A, Mallina R, Dowson C, Larner T, Khan MS Evolution of transdermal oxybutynin in the treatment of overactive bladder. International Journal of Clinical Practice 2008 Jan;62(1):167-70
Staskin DR, Rosenberg MT, Dahl NV, Polishuk PV, Zinner NR Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions. International Journal of Clinical Practice 2008 Jan;62(1):27-38
Reiz JL, Salem P, Darke AC Pharmacokinetics and pharmacodynamics of once-daily controlled-release oxybutynin and immediate-release oxybutynin. Journal of Clinical Pharmacology 2007 Mar;47(3):351-7
Sand P, Zinner N, Newman D, Lucente V, Dmochowski R, Kelleher C, Dahl NV Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study. BJU International 2007 Apr;99(4):836-44
Dmochowski RR, Nitti V, Staskin D, Luber K, Appell R, Davila GW Transdermal oxybutynin in the treatment of adults with overactive bladder: combined results of two randomized clinical trials. World Journal of Urology 2005 Sep;23(4):263-70
Additional Information
For additional information regarding Gelnique or overactive bladder, please visit the Gelnique web page.The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
