Oxybutynin Chloride

Contraindications

Conventional Tablets and Oral Solution

• Patients with untreated angle-closure glaucoma or those with untreated narrow anterior chamber angles.100

• Obstructive uropathy.100

• Partial or complete obstruction of the GI tract, paralytic ileus, intestinal atony (in elderly or debilitated patients), megacolon, toxic megacolon complicating ulcerative colitis, or severe colitis.100

• Myasthenia gravis.100

• Unstable cardiovascular status in acute hemorrhage.100

• Known hypersensitivity to oxybutynin or any ingredient in the formulations.

Extended-release Tablets and Transdermal System

• Presence or risk of urinary retention.116 120

• Presence or risk of gastric retention and other severe decreased GI motility conditions.116 120

• Presence or risk of uncontrolled angle-closure glaucoma.116 120

• Known hypersensitivity to oxybutynin or any ingredient in the formulations.100 116

Warnings/Precautions

Warnings

Risk of heat prostration (i.e., fever and heat stroke due to decreased sweating) when administered during hot weather.100 116 120

Diarrhea may be a symptom of partial intestinal obstruction, especially in patients with ileostomies or colostomies; in this instance, treatment with oxybutynin would be inappropriate and possibly harmful.100

General Precautions

Risk of urinary retention; use with caution in patients with clinically important bladder outflow obstruction.116 120

Risk of gastric retention; use with caution in patients with GI obstructive disorders.116 120

Risk of decreased GI motility; use with caution in patients with conditions such as ulcerative colitis or intestinal atony.116 120 Use in patients with ulcerative colitis may suppress intestinal motility, resulting in paralytic ileus and precipitating or exacerbating toxic megacolon.100

Use with caution in patients who have gastroesophageal reflux (GERD) and/or in those who are concurrently receiving drugs that can cause or exacerbate esophagitis (e.g., bisphosphonates).116 120 (See Specific Drugs under Interactions.)

As with other nondeformable material, extended-release tablets should be used with caution in patients with preexisting severe GI narrowing (pathologic or iatrogenic) since obstruction may occur.116

Oxybutynin may increase risk of aggravating symptoms of myasthenia gravis.116 Use with caution in patients with myasthenia gravis.116 120

Use with caution in patients with autonomic neuropathy.100 Use of oxybutynin may exacerbate manifestations of hyperthyroidism, CHD, CHF, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, and prostatic hypertrophy.100

Specific Populations

Category B.100 116 120

Not known whether distributed into milk.100 116 120 Caution if used in nursing women.100 116 120

Safety and efficacy of conventional tablets and oral solution not established in children <5 years of age; use in these children not recommended.100

Safety and efficacy of extended-release tablets not established in children <6 years of age.116 Use of this preparation not recommended in children who cannot swallow the tablet whole without chewing, dividing, or crushing.116

Safety and efficacy of transdermal system not established in pediatric patients.120

No substantial differences in safety and efficacy relative to younger adults,116 120 but increased sensitivity cannot be ruled out.120 Use with caution in frail geriatric patients.100

Not studied in patients with renal or hepatic impairment; use with caution.116 120

Common Adverse Effects

Conventional or extended-release tablets or oral solution: dry mouth, dizziness, constipation, somnolence, impaired urination, nausea, blurred vision, dyspepsia, asthenia, pain, abdominal pain, headache, rhinitis, dry eyes, diarrhea, increased post-void residual volume, urinary tract infection.100

Transdermal system: application site reactions (e.g., pruritus, erythema, rash, vesicles, macules), dry mouth, constipation, diarrhea, abnormal vision, dysuria.120

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Consult your pharmacist.