GELNIQUE

Gelnique Generic Name & Formulations

Legal Class

General Description

Oxybutynin chloride 10% (1g/sachet); topical gel; contains alcohol.

Pharmacological Class

Antispasmodic/anticholinergic.

How Supplied

Gel (1g/sachet)—30

Manufacturer

AbbVie

Generic Availability

Gelnique Indications

Indications

Overactive bladder (OAB) with urge urinary incontinence, urgency, and frequency.

Gelnique Dosage and Administration

Adult

Apply 1g gel (one sachet) once daily to dry, intact skin on abdomen, upper arm/shoulders, or thighs. Rotate application sites; avoid use of same site on consecutive days. Wash hands after application. Avoid washing area/showering for 1hr after application.

Children

Not established.

Gelnique Contraindications

Contraindications

Urinary or gastric retention. Uncontrolled narrow angle glaucoma.

Gelnique Boxed Warnings

Not Applicable

Gelnique Warnings/Precautions

Warnings/Precautions

Bladder outflow obstruction. GI obstruction. Decreased GI motility. Ulcerative colitis. Intestinal antony. Gastroesophageal reflux. Esophagitis. Controlled narrow angle glaucoma. Discontinue if skin hypersensitivity or angioedema develops. Monitor for anticholinergic CNS effects; consider discontinuing if occur. Avoid in myasthenia gravis; discontinue if symptoms occur. Hepatic or renal dysfunction. Minimize skin transference: cover application site with clothing if direct contact is anticipated. Exposure to high environmental temperatures. Gel is flammable. Pregnancy. Nursing mothers.

Gelnique Pharmacokinetics

Metabolism

Hepatic (CYP3A4). >97% serum protein bound.

Elimination

Fecal. Half-life: ~2 hours.

Gelnique Interactions

Interactions

Caution with drugs that can cause or exacerbate esophagitis (eg, bisphosphonates). Additive effects with other anticholinergics.

Gelnique Adverse Reactions

Adverse Reactions

Dry mouth, application site reactions (eg, pruritus, dermatitis, papules, erythema), urinary tract infection, dizziness, nasopharyngitis, fatigue, headache, constipation, other anticholinergic effects (eg, CNS).

Gelnique Clinical Trials

See Literature

Gelnique Note