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OTC Transdermal Oxybutynin Patch

Darrell Hulisz, RPh, PhamD
Associate Profes

April 1, 2014

Overactive bladder (OAB) is a condition that affects an estimated 33 million Americans, the majority of whom are older women. Although overactive bladder is a treatable medical condition, more than 80% of women with this condition do not seek out medical attention. Trandermal oxybutynin, Oxytrol® For Women is the first OTC agent for OAB approved by the FDA for women ages 18 years and older. Oxytrol® is available as a patch that is applied to the skin every 4 days. The patch delivers 3.9 milligrams of oxybutynin per day. Oxybutynin is an anticholinergic agent that works to relax the bladder muscle.

The FDA approval of the prescription to OTC switch was based on data from several well-designed studies that demonstrated a woman's ability to correctly recognize OAB symptoms, understand key safety measures on the label, judge if the product is right or wrong for her, and appropriately uses Oxytrol® For Women in an unsupervised setting. The FDA is considering this a partial switch due to the product still requiring a prescription for men with overactive bladder. When combined with daily lifestyle modifications, women saw a reduction of urinary accidents due to OAB by 75% vs. 50% with placebo. Oxytrol® For Women patches are clear and thin, making them discreet and undetectable under ordinary clothing. Side effects include itching, rash or redness where patch is applied. Sleepiness, dizziness and blurry vision may also occur. Alcohol may enhance these effects. Sine this product is now sold and marketed OTC, pharmacists are likely to receive more questions about OAB & this product. It is important to remind women to combine the use this drug with pelvic floor muscle strengthening, such as Kegel exercises.