Manufacturer:

Watson Pharmaceuticals, Inc.

Pharmacological Class:

Antispasmodic/anticholinergic

Active Ingredient(s):

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

Indication(s):

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

Pharmacology:

Oxybutynin is an anticholinergic agent that works at postganglionic muscarinic receptors to cause the relaxation of bladder smooth muscle. It has been shown to increase the maximum urinary bladder capacity and to increase the volume to the first detrusor contraction in patients with involuntary detrusor contractions. When applied to intact skin, oxybutynin is absorbed systemically and achieves steady-state levels after a week of continuous dosing.

Clinical Trials:

A randomized, double-blind parallel-group study was conducted to evaluate Gelnique in the treatment of overactive bladder. Adults with symptomatic overactive bladder with an average of more than 4 incontinence episodes in a 3-day period and at least 8 micturitions per day were enrolled in this 12-week study. Patients were randomized to daily applications of one gram of Gelnique or placebo gel. Those treated with the study drug had significant improvements in the number of urinary incontinence episodes per day and in the average daily urinary frequency compared to placebo. Also, the average urine volume per micturition was increased in the study group arm, compared to placebo. The mean change in baseline in the number of daily incontinence episodes was -3.0 for Gelnique, compared to -2.5 for placebo. For daily urinary frequency, the mean change from baseline for the study drug was -2.7 compared to -2.0 for placebo. Patients using Gelnique had a change from baseline in the mean urinary void volume of 21mL compared to 3.8mL for placebo.

Legal Classification:

Rx

Adults:

Apply 1 gram 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 1 hour after application.

Children:

Not recommended.

Contraindication(s):

Urinary or gastric retention. Uncontrolled narrow angle glaucoma.

Warnings/Precautions:

Bladder outlet obstruction. Gastrointestinal obstruction. Decreased GI motility. Ulcerative colitis. Intestinal antony. Gastroesophageal reflux. Esophagitis. Hepatic or renal dysfunction. Myasthenia gravis. Controlled narrow angle glaucoma. Discontinue if skin hypersensitivity occurs. Skin transference: cover application site with clothing after gel has dried if direct contact is anticipated. Exposure to high environmental temperatures. Gel is flammable. Pregnancy (Cat.B). Nursing mothers.

Interaction(s):

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

Adverse Reaction(s):

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

Notes:

Report suspected adverse reactions to Watson at (800) 272-5525 or FDA at (800) FDA-1088.

How Supplied:

Gel (1 gram/sachet)—30

Last Updated:

5/28/2009