Dosing & Uses
Dosage Forms & Strengths
topical gel
- 10%; supplied as 100mg/1g unit (1.14mL) sachet
Overactive Bladder
Indicated for treatment of overactive bladder with symptoms of urge incontinence, frequency, and urgency
Gel sachet (10%): Apply 100 mg (content of 1 sachet 10%) qDay
Administration
For topical application only; should not be ingested
Apply to dry, intact skin on abdomen, upper arms/shoulders, or thigh
Wash hands immediately after application; cover application site with clothing after gel has dried if direct skin-to-skin contact is anticipated
Avoid showering for 1 hr following application
Rotate application sites, avoid same site on consecutive days
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
NOTE: anticholinergic adverse effects are less with topical application compared with oral administration
1-10%
Xerostomia (7.5%)
Urinary tract infection (6.9%)
Application site reaction (5.4%)
Dizziness (2.8%)
Fatigue (2.1%)
Constipation (1.3%)
Warnings
Contraindications
Hypersensitivity
Gastric retention
Uncontrolled narrow-angle glaucoma
Urinary retention
Conditions that severely decrease GI motility
Cautions
Caution with clinically significant bladder outflow obstruction because of the risk of urinary retention
Caution with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention
Caution with GERD and/or those taking drugs that can cause or exacerbate esophagitis (eg, bisphosphonates)
Caution with myasthenia gravis because of decreased cholinergic activity
Discontinue if skin hypersensitivity occurs
Caution with other anticholinergics (antimuscarinics); may increase risk for xerostomia, constipation, headache, dizziness, somnolence, and blurred vision
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 products should be discontinued and appropriate therapy promptly provided
Somnolence reported with oxybutynin-containing products; use caution with activities requiring mental alertness
Gelnique is flammable
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Unknown whether distributed in breast milk, caution advised
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Exerts antispasmodic and antimuscarinic effects on smooth muscle; decreases uninhibited urinary contractions, and delays desire to void; increases bladder capacity
Pharmacokinetics
Vd: 193 L (IV)
Peak Plasma Concentration: 6.8-8.3 ng/mL (gel)
Metabolism: bypasses first-pass in liver by CYP3A4, AUC ratio of N-desethyloxybutynin (active metabolite) to parent compound is 1:1
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Formulary
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