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FDA Approves Over-the-Counter Oxytrol Patch for Overactive Bladder Treatment in Women

The Food and Drug Administration approved Oxytrol for Women earlier this year. The patch is the first FDA-approved over-the-counter treatment of overactive bladder for women 18 years of age and older. Meanwhile, oxytrol will remain available by prescription only for men with overactive bladder.


Overactive bladder is a condition where the bladder squeezes too often or without warning. People with overactive bladder may experience symptoms such as leaking urine, feeling the sudden and urgent need to urinate, and increased urination frequency.


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


Oxytrol for Women delivers 3.9mg of oxybutynin per day and the patch is applied to the skin every four days.


Studies involving more than 5,000 subjects showed that overall,” consumers can understand the information on the label, properly select whether the product is right for them, and use the drug properly,” according the FDA’s News Release. Side effects reported during clinical studies were mild and included localized skin irritation, dry mouth, and constipation.


Oxytrol for Women Is marketed by Merck, and as of August 2013, is available for purchase over-the-counter.


 


Source: FDA News Release, January 25, 2013

 

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