Dosing & Uses
Dosage Forms & Strengths
- 10%; supplied as 100mg/1g unit (1.14mL) sachet
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
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
Serious - Use Alternative
Significant - Monitor Closely
NOTE: anticholinergic adverse effects are less with topical application compared with oral administration
Urinary tract infection (6.9%)
Application site reaction (5.4%)
Uncontrolled narrow-angle glaucoma
Conditions that severely decrease GI motility
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
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.
Mechanism of Action
Exerts antispasmodic and antimuscarinic effects on smooth muscle; decreases uninhibited urinary contractions, and delays desire to void; increases bladder capacity
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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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.