Gelnique (oxybutynin topical) dosing, indications, interactions, adverse effects, and more

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Sections oxybutynin topical
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

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

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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%)

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.

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

Images

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Patient Handout

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Formulary

FormularyPatient Discounts

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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.

View explanations for tiers and restrictions

Tier	Description
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.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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