home > drugs a-z list > gelnique (oxybutynin chloride 10 % gel) drug center > gelnique (oxybutynin chloride 10 % gel) drug - warnings and precautions

Included as part of the PRECAUTIONS section.

Urinary Retention

Administer GELNIQUE (oxybutynin chloride 10 % gel) with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

Use in Patients with Gastrointestinal Disorders

Administer GELNIQUE (oxybutynin chloride 10 % gel) with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.

GELNIQUE (oxybutynin chloride 10 % gel) , like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis or intestinal atony. GELNIQUE (oxybutynin chloride 10 % gel) should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

Angioedema

Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, oxybutynin containing product should be discontinued and appropriate therapy promptly provided.

Skin Hypersensitivity

In a controlled clinical trial of skin sensitization, 1 of 200 patients (0.5%) demonstrated skin hypersensitivity to GELNIQUE (oxybutynin chloride 10 % gel) . Patients who develop skin hypersensitivity to GELNIQUE (oxybutynin chloride 10 % gel) should discontinue drug treatment.

Skin Transference

Transfer of oxybutynin to another person can occur when vigorous skin-to-skin contact is made with the application site. To minimize the potential transfer of oxybutynin from GELNIQUE (oxybutynin chloride 10 % gel) -treated skin to another person, patients should cover the application site with clothing after the gel has dried if direct skin-to-skin contact at the application site is anticipated [see CLINICAL PHARMACOLOGY]. Patients should wash their hands immediately after application of GELNIQUE (oxybutynin chloride 10 % gel) .

Flammable Gel

GELNIQUE (oxybutynin chloride 10 % gel) is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried.

Myasthenia Gravis

Administer GELNIQUE (oxybutynin chloride 10 % gel) with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.

Patient Counseling Information

[See FDA-approved Patient Labeling]

Instructions for Use

GELNIQUE (oxybutynin chloride 10 % gel) is for topical application only and should not be ingested.

GELNIQUE (oxybutynin chloride 10 % gel) should not be applied to recently shaved skin surfaces. Patients should wash hands immediately after product application. Application sites should not be subject to showering or water immersion for 1 hour after product application. Application sites should be covered with clothing if close skin-to-skin contact at the application site is anticipated.

Alcohol based gels are flammable. Avoid open fire or smoking until the gel has dried.

Important Anticholinergic Adverse Reactions

Patients should be informed that anticholinergic (antimuscarinic) agents, such as GELNIQUE (oxybutynin chloride 10 % gel) , may produce clinically significant adverse reactions related to anticholinergic pharmacological activity including constipation, urinary retention and blurred vision. Heat prostration (due to decreased sweating) can occur when anticholinergics such as GELNIQUE (oxybutynin chloride 10 % gel) are used in a hot environment. Because anticholinergic (antimuscarinic) agents, such as GELNIQUE (oxybutynin chloride 10 % gel) , may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until GELNIQUE (oxybutynin chloride 10 % gel) 's effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic (antimuscarinic) agents such as GELNIQUE (oxybutynin chloride 10 % gel) .

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

A 24-month study in rats at dosages of oxybutynin chloride of 20, 80 and 160 mg/kg showed no evidence of carcinogenicity. These doses are approximately 6, 25 and 50 times the maximum exposure in humans taking an oral dose, based on body surface area. Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems. Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of topical or oral oxybutynin use in pregnant women. Subcutaneous administration to rats at doses up to 25 mg/kg (approximately 50 times the human exposure based on surface area) and to rabbits at doses up to 0.4 mg/kg (approximately 1 times the human exposure) revealed no evidence of harm to the fetus due to oxybutynin chloride. The safety of GELNIQUE (oxybutynin chloride 10 % gel) administration to women who are or who may become pregnant has not been established. Therefore, GELNIQUE (oxybutynin chloride 10 % gel) should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.

Nursing Mothers

It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GELNIQUE (oxybutynin chloride 10 % gel) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of GELNIQUE (oxybutynin chloride 10 % gel) in pediatric patients have not been established.

Geriatric Use

Of the 496 patients exposed to GELNIQUE (oxybutynin chloride 10 % gel) in the randomized, double-blind, placebo-controlled 12-week study and the 14-week safety extension study, 188 patients (38%) were 65 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Renal Impairment

There is no experience with the use of GELNIQUE (oxybutynin chloride 10 % gel) in patients with renal impairment.

Hepatic Impairment

There is no experience with the use of GELNIQUE (oxybutynin chloride 10 % gel) in patients with hepatic impairment.

Last reviewed on RxList: 3/28/2011
This monograph has been modified to include the generic and brand name in many instances.