Approved January 27, 2009

OXYBUTYNIN CHLORIDE
(FDA Category 3S)

GELNIQUE(TM) (Watson Pharmaceuticals) is an antimuscarinic which acts to relax the smooth muscle of the bladder.

DOSING INFORMATION: Apply the contents of one sachet (100 mg/gram) topically once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated.

PHARMACOKINETICS: Oxybutynin chloride is transported across intact skin and into the systemic circulation by passive diffusion. Steady-state concentrations are reached within 7 days of continuous dosing. Transdermal application of oxybutynin chloride bypasses first-pass gastrointestinal and hepatic metabolism. Oxybutynin chloride displays biphasic elimination with plasma concentrations beginning to decrease 24 hours after dosing. The apparent elimination half-life is 64 hours.

CAUTIONS: Contraindicated in patients with urinary or gastric retention, uncontrolled narrow-angle glaucoma, or with a known hypersensitivity, including skin hypersensitivity, to oxybutynin chloride. Use with caution in patients with clinically significant bladder outflow obstruction, gastrointestinal obstructive disorders or decreased intestinal motility, gastroesophageal reflux, and/or those taking medications that can cause or exacerbate esophagitis. The most common adverse reactions include dry mouth and application site reactions.

FDA APPROVED INDICATIONS: Oxybutynin chloride is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.