The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women 18 and older.
貼片結構:
The condition affects more than 20 million American women, according to Merck, the drug's manufacturer.
It will still only be available in prescription form for men.
Oxytrol helps relax the overactive bladder muscle that leads to symptoms such as the sudden need to urinate and leaking of urine.
Oxytrol for Women is in the form of a patch, applied to the skin every four days, Merck says.
It is expected to hit store shelves by the fall. No cost estimates are yet available, according to Merck.
Oxytrol in pill form by prescription will still be available. Oxytrol for Women containsoxybutynin, a drug that helps to relax the bladder muscle. It belongs to a class of drug called anticholinergics. It is the first of this class to go over-the-counter for overactive bladder treatment.
Each patch delivers 3.9 milligrams of the drug every day.
The FDA approved the drug after reviewing its safety and effectiveness in nine studies involving more than 5,000 women. According to the FDA, the study participants could understand the label information and use the drug appropriately.
Among side effects reported in the studies were skin irritation at the site of the patch, constipation, and dry mouth. Merck will supply an educational leaflet with the product.
Most women who develop overactive bladder are 45 to 60 years old. Many do not seek professional medical help due to embarrassment.
According to the National Association for Continence, those who suffer with bladder problems wait on average seven years before seeking treatment.
Among other prescription medications for the condition are fesoterodine (Toviaz), solifenacin (Vesicare) and tolterodine (Detrol).
Bladder training and pelvic floor exercises are other common treatment options.
貼片教學:
Where to apply Oxytrol:
- Put the patch on a clean, dry, and smooth (fold-free) area of skin on your abdomen (stomach area), hips or buttocks. See Figure A.
- Avoid your waistline area, since tight clothing may rub against the patch.
- The areas you choose should not be oily, damaged (cut or scraped), irritated (rashes) or have any other skin problems.
- Do not put Oxytrol on areas that have been treated with oils, lotions, or powders that could keep the patch from sticking well to your skin.
- When you put on a new patch, use a different area of skin from the most recent patch site. You may find it useful to change the site from one side of your body to the other.
- Do not use the same area for the patch for at least 1 week. You may choose to try different sites when using Oxytrol to find the sites that are most comfortable for you and where clothing will not rub against it.
How to apply Oxytrol:
Step 1.
- Each patch is sealed in its own protective pouch. See Figure B.
- When you are ready to put on your Oxytrol patch, tear open the pouch and remove the patch. See Figure C.
Step 2.
- The sticky adhesive side of the patch is covered by 2 strips of overlapping protective liner.See Figure D.
- Remove the first piece of the protective liner and place the patch, adhesive face down, firmly onto the skin. See Figure E.
Step 3.
- Bend the patch in half and gently roll the remaining part onto your skin using the tips of your fingers. As you roll the patch in place, the second piece of the protective liner should come off the patch. See Figure F.
- Apply firm pressure over the surface of the patch with your fingers to make sure the patch stays on. See Figure G.
- When putting on the patch, avoid touching the sticky adhesive side.
- Touching the adhesive may cause the patch to fall off early.
- Throw away the protective liners.
- If the patch partly or completely falls off, press it back in place and continue to follow your application schedule.
- If the patch does not stay on, throw it away. Put on a new patch on a different area of skin, and continue to follow your original application schedule.
- If you forget to change your patch after 3 or 4 days, remove the old patch, put on a new patch in a different area of skin and continue to follow your original application schedule.
How to remove Oxytrol:
- When changing your Oxytrol patch, remove the old patch slowly and carefully to avoid damaging your skin.
- After the old patch is removed, fold it in half with the sticky sides together.
- The patch will still contain some oxybutynin, throw the patch away so that it cannot be worn or swallowed by another person, child, or pet.
- Gently wash the application site with warm water and a mild soap to remove any adhesive that stays on your skin after removing the patch.
- A small amount of baby oil may also be used to remove any adhesive remaining on your skin. Rings of adhesive that become dirty may require a medical adhesive removal pad that you can get from your pharmacist.
- Alcohol or other dissolving liquids (nail polish remover or other solvents) may cause skin irritation and should not be used.
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