Oxytrol For Overactive Bladder In Women Approved By FDA

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Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jan 2013 - 0:00 PST


Oxytrol (Oxybutynin Transdermal System) the first over-the-counter medication for overactive bladder was given approval by the U.S. Food and Drug Administration for use by women, but still remains available just by prescription for men.

Oxytrol consists of a medicine called oxybutynin (a anticholinergic) that functions by easing the bladder muscle. It comes in the form of a patch that a person replaces on the skin every four days. The patch emits 3.9 milligrams of oxybutynin per day.

Shaw Chen, M.D., Ph.D., deputy director of the Office of Drug Evaluation IV in the FDA's Center for Drug Evaluation and Research said:

"Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder. Women should make sure to follow the Drug Facts label and consult their doctor if their condition does not improve."

The safety and efficacy of Oxytrol for women was tested in nine studies including over 5,000 females. Results revealed that consumers can clearly understand the information on the label and easily select whether the product is right for them, and use the drug correctly.

Side effects seen during the clinical trials included:

• dry mouth
• constipation
• skin irritation where the patch is applied

During the urge to urinate in a healthy person, nerve signals inform the brain that the bladder is full. This causes relaxation of the muscles of the pelvic floor and the urethra making the bladder muscles contract, resulting in urination.

When someone has an overactive bladder, the bladder muscles contract unintentionally, making a person feel like they must urinate, according to the Mayo Clinic.

This can result in frequent urination, sudden urges to urinate, and uncontrolled urination. Risk of overactive bladder rises as you age, however, it is not considered a normal part of aging. It is also linked to some ailments, such as diabetes, enlarged prostate, and Alzheimer's.

Treatments for overactive bladder include:

• surgery
• behavioral interventions (kegal exercises)
• taking medications

A recent study done by Loyola University in Chicago noted that Botox can be used to treat an overactive bladder in women. Injected into the bladder, Botox acts addresses urinary urgency problems, and is two times as effective in eliminating symptoms completely compared to medicaitons, researchers say.

Written by Kelly Fitzgerald


Copyright: Medical News Today
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