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FDA Approves Over-the-Counter Oxytrol for Women to Treat Overactive Bladder


The FDA approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older. Oxytrol will remain available for men with overactive bladder by prescription only. Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination. Overactive bladder affects an estimated 33 million Americans, the majority of whom are older women.

 

Oxytrol for Women contains oxybutynin, a medicine that helps relax the bladder muscle. Oxybutynin belongs to a class of drugs known as anticholinergics. It is the first drug in this class to be made available over-the-counter for treatment of overactive bladder.

 

Oxytrol for Women is a patch that is applied to the skin every four days. The patch delivers 3.9 milligrams of oxybutynin per day.

 

Side effects reported during clinical studies were mild and included skin irritation where the patch was applied, dry mouth and constipation. A leaflet with tips to help manage overactive bladder will be provided with the product.

 

See the FDA Announcement

 

 

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