Dosing and uses of Oxytrol, Oxytrol For Women (oxybutynin transdermal)
Adult dosage forms and strengths
transdermal patch
- 3.9mg/day
Overactive Bladder
Indicated for symptom relief in uninhibited neurogenic or reflex neurogenic bladder (urge incontinence, frequency and urgency)
Apply 1 patch (releases 3.9 mg/day) twice/week (ie, q3-4 days)
Rotate application sites; need not be removed during bathing, swimming, exercising, or sleeping
Pediatric dosage forms and strengths
Safety and efficacy not established
Oxytrol, Oxytrol For Women (oxybutynin transdermal) adverse (side) effects
NOTE: anticholinergic adverse effects are less with transdermal application compared with oral administration
>10%
Pruritus at application site (14-16.8%)
1-10%
Xerostomia (4.1-9.6%)
Erythema at application site (5.6-8.3%)
Constipation (3.3%)
Vesicles, macules, rash at application site (2.5-3.3%)
Diarrhea (3.2%)
Blurred vision (2.5%)
Dysuria (2.4%)
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)
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
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether distributed in breast milk
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
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 of Oxytrol, Oxytrol For Women (oxybutynin transdermal)
Mechanism of action
Exerts antispasmodic and antimuscarinic effects on smooth muscle; decreases uninhibited contractions, and delays desire to void; increases bladder capacity
Pharmacokinetics
Peak Plasma Concentration: 3-6.6 ng/mL
Metabolism: bypasses first-pass in liver by CYP3A4, AUC ratio of N-desethyloxybutynin (active metabolite) to parent compound is 1:1