Pharmacologic class: Antispasmodic/ anticholinergic
Active ingredient: Oxybutynin chloride 10% (1 g/sachet); topical gel; contains alcohol.
Indication: 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 OAB. Adults with symptomatic OAB with an average of more than four incontinence episodes in a three-day period and at least eight micturitions per day were enrolled in this 12-week study. Patients were randomized to daily applications of 1 g 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 with placebo. Also, the average urine volume per micturition was increased in the study group arm, compared with placebo. The mean change in baseline in the number of daily incontinence episodes was -3.0 for Gelnique, compared with -2.5 for placebo. For daily urinary frequency, the mean change from baseline for the study drug was -2.7 compared with -2.0 for placebo. Patients using Gelnique had a change from baseline in the mean urinary void volume of 21 mL compared to 3.8 mL for placebo.
Adults: Apply 1 g 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 one hour after application.
Children: Not recommended.
Contraindications: Urinary or gastric retention. Uncontrolled narrow angle glaucoma.
Precautions: Bladder outlet obstruction. GI obstruction. Decreased GI motility. Ulcerative colitis. Intestinal atony. 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.
Interactions: Caution with drugs that can cause or exacerbate esophagitis (e.g., bisphosphonates). Central nervous system (CNS) depression with alcohol, other CNS depressants. Additive effects with other anticholinergics.
Adverse reactions: Dry mouth, application-site reactions (e.g., pruritus, dermatitis), urinary tract infection, dizziness, headache, constipation, fatigue, other anticholinergic effects.
Note: Report suspected adverse reactions to Watson at 800.272.5525 or FDA at 800.FDA.1088.
How supplied: Gel (1 g/sachet)—30
For more information, call 800.272.5525 or visit www.Gelnique.com.