GELNIQUE - oxybutynin chloride gel 
Watson Pharma, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
Gelnique®
(oxybutynin chloride) gel 10%
Revised: June 2011
193908-00
Rx only

These highlights do not include all the information needed to use GELNIQUE safely and effectively.
See full prescribing information for GELNIQUE.

GELNIQUE (oxybutynin chloride) 10% gel
Initial U.S. Approval: 1975
 
RECENT MAJOR CHANGES
Contraindications: Hypersensitivity reactions (4) 01/2011
Warnings and Precautions: Angioedema (5.3) 01/2011
 
INDICATIONS AND USAGE
GELNIQUE is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
 
DOSAGE AND ADMINISTRATION
Apply contents of one sachet or one actuation of the metered-dose pump of GELNIQUE once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. (2)
Rotate application sites, avoiding use of the same site on consecutive days. (2)
GELNIQUE is for topical application only and should not be ingested. (2)
 
DOSAGE FORMS AND STRENGTHS
Gel: 10%

CONTRAINDICATIONS
Urinary retention (4)
Gastric retention (4)
Uncontrolled narrow-angle glaucoma (4)
Known serious hypersensitivity reaction to GELNIQUE, oxybutynin, or to any of the components of GELNIQUE (4)
 
WARNINGS AND PRECAUTIONS
Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. (5.1)
Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis. (5.2)
Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue GELNIQUE and initiate appropriate therapy. (5.3)
Skin Hypersensitivity: Discontinue GELNIQUE in patients with skin hypersensitivity. (5.4)
Skin Transference: Advise patients to cover the application site with clothing if skin-to-skin contact at the application site is anticipated. Wash hands immediately after product application. (5.5)
Flammable Gel: Contains alcohol-based gel. Avoid open fire or smoking until the gel has dried. (5.6)
 
ADVERSE REACTIONS
The most common adverse reactions (incidence > 5% and > placebo) were dry mouth, urinary tract infection, and application site reactions. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Watson Pharmaceuticals, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
 
DRUG INTERACTIONS
Other Anticholinergics (muscarinic antagonists): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. (7.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 

Revised: 06/2011
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FULL PRESCRIBING INFORMATION

1  INDICATIONS AND USAGE
GELNIQUE is a muscarinic antagonist indicated for the treatment