Anturol

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Urinary Retention

Use ANTUROL with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

Use In Patients with Gastrointestinal Disorders

Use ANTUROL with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. ANTUROL, 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. ANTUROL 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.

Skin Transference

Transfer of oxybutynin to another person can occur when vigorous bare skin-to-skin contact is made with the application site. To minimize the potential transfer of oxybutynin from ANTUROL -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 ANTUROL.

Flammable Gel

ANTUROL is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried.

Myasthenia Gravis

Administer ANTUROL with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.

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.

Controlled Narrow-Angle Glaucoma

Administer ANTUROL with caution in patients being treated for narrow-angle glaucoma.

Patient Counseling Information

"See FDA-approved patient labeling (PATIENT INFORMATION)"

Instructions for Use

Inform patients of the following:

  • ANTUROL is for topical application only and should not be ingested. Keep out of reach of children.
  • ANTUROL should be applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs.
  • Do not use any ANTUROL that came out while priming.
  • Apply immediately after actuating the dose.
  • Application sites may be rotated to reduce the potential for local site reactions
  • ANTUROL should not be applied to recently shaved skin surfaces. Avoid skin with open sores, wounds, irritation, scars, and tattoos.
  • Do not apply the gel to the breasts or genital area.
  • Discard used pump dispensers in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
  • Wash hands immediately after product application.
  • Do not shower or immerse the application site in water for 1 hour after product application.
  • Cover the application sites with clothing if 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.
  • If you get ANTUROL in your eyes, thoroughly rinse your eyes right away with warm, clean water to flush out any ANTUROL. Seek medical attention if needed.

Important Anticholinergic Adverse Reactions

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, 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 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. Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no evidence of impaired fertility or harm to the fetus. The safety of ANTUROL administration to women who are or who may become pregnant has not been established. Therefore, ANTUROL should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.

Labor and Delivery

ANTUROL has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

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 ANTUROL is administered to a nursing woman.

Pediatric Use

This drug product should not be used in children because the safety and effectiveness of ANTUROL has not been established in pediatric patients.

Geriatric Use

Of the 424 patients exposed to ANTUROL in the randomized, double-blind, placebo-controlled 12-week study, 182 patients (34%) were 65 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Renal Impairment

Patients with renal impairment received ANTUROL during clinical trials. These trials were not designed to determine whether there were differences in safety or effectiveness in patients with or without impaired renal function.

Hepatic Impairment

Patients with hepatic impairment received ANTUROL during clinical trials. These trials were not designed to determine whether there were differences in safety or effectiveness in patients with or without impaired hepatic function.

Last reviewed on RxList: 1/3/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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