US Pharm. 2013;38(8):8-11.
Occasionally, the nonprescription product market undergoes
a significant change. There is no greater change than the debut of a
new product labeled to treat a medical condition that has never before
been judged amenable to self-care. The September 2013 introduction of
Oxytrol For Women (oxybutynin transdermal system) to the nonprescription
product market is a perfect example of an Rx-to-OTC switch that could
alter the health care habits of countless women.1,2
Overactive bladder (OAB) is also known as urinary incontinence.3
In classical OAB, bladder muscles are overactive. Patients with little
or no urine in the bladder may feel a strong urge to urinate (urge
incontinence), often along with nocturia.3-5
OAB exists on a range of severity. When some OAB patients
lose bladder control, they only notice a mild leakage that cannot be
stopped. However, patients with a more severe form of OAB may experience
uncontrolled voiding. More severe OAB can decrease the patient’s
quality of life, increase the risk of depression, and reduce
productivity at work.4
Some women experience a different type of bladder problem
that also results in incontinence. They have weak bladder muscles that
cannot hold urine back when they cough, sneeze, laugh, or lift a heavy
object. This is not OAB, but is known as stress incontinence.3,6
Prevalence and Epidemiology of OAB
As many as 17% to 40% of adult women in the United States have OAB.4,7
This is approximately 20 million OAB patients. However, the true number
is likely to be far higher, as many patients do not enter the health
care system. There are three major reasons for this reluctance to do so.4
First, many patients view OAB as an inevitable part of aging and choose
to take various self-care measures rather than visit a physician for
advice. Second, as many as 61% of OAB sufferers do not realize that the
condition can be successfully treated with medication and therefore do
not seek help. Finally, OAB can induce shame and embarrassment in
patients, and the resultant negative social stigma may cause them to
avoid any mention to health care providers.
Although OAB occurs in women of all ages, it exhibits a strong age association.3,8 The median age is 52 years, and the most common age range is 45 to 60 years.4
Coping Methods and Quality of Life Issues
Most women visit their physicians without hesita-tion for
such conditions as urinary tract infections (UTIs), vaginal fungal
infections, and birth control. However, for some inexplicable reason, a
large number of those suffering from OAB postpone a medical appointment,
many for as long as 6 or 7 years.4 During this time, they
employ a variety of coping mechanisms of dubious efficacy and
questionable safety. For instance, the use of absorbent pads is
partially effective, but increases the risk of a UTI.4 Some
women also take great pains to ascertain the location of all bathrooms
in advance of an attack of OAB, a behavior known as toilet mapping.4
Women with symptoms of OAB may reduce the extent of
activities they once found pleasurable, such as movies, walks, tennis,
golf, or visiting with friends. They may voluntarily reduce fluid
intake, which can lead to dehydration. They may feel forced to wear
clothing that would conceal a urine leak, and only sit on furniture that
would not be permanently stained if a leak were to occur. It becomes
apparent that OAB can cause constant concern due to fear of an accident
and also the perception that odor from underclothing or absorbent pads
might be detected by others. If a patient feels forced to lead a more
sedentary lifestyle, she may experience greater medical and
Oxytrol For Women
Oxybutynin is an anticholinergic and antispasmodic agent
that has been available in oral form since 1976 (originally as Ditropan)
and in a topical patch form on a prescription basis since 2003.4,9
It relaxes bladder smooth muscle cells, which increases the maximum
capacity of the bladder and also increases the volume to which the
bladder fills before the patient begins to experience contractions of
the detrusor muscle. The FDA approval of nonprescription Oxytrol For
Women (oxybutynin transdermal system, 3.9 mg/day) marks the first time
that women can purchase a nonprescription product for OAB. The product
is identical to the prescription Oxytrol Patch.4
As with any newly released non-prescription product,
pharmacists must take extra care in examining the label closely to
understand all of the FDA-required safe conditions for use.4
Each patch contains a total of 36 mg of oxybutynin, delivering 3.9 mg of
oxybutynin daily. The label instructs potential purchasers that they
may have OAB if they experience two or more of the following symptoms
for at least 3 months: 1) urinary frequency (a need to urinate more
often than normal, especially more than 8 times in 24 hours); 2) urinary
urgency (strong and immediate need to urinate); and/or 3) urge
incontinence (leaking or wetting if the urge to urinate cannot be
controlled). The label warns that frequent urination may also be caused
by a UTI, diabetes, early pregnancy, or other more serious conditions,
and urges the woman to see a physician if she thinks that any of those
conditions are present.
The label cautions against use in the following
situations: male gender; under the age of 18 years; allergy to
oxybutynin; narrow-angle glaucoma; symptoms of a UTI or other serious
condition for which patients should see a physician immediately (e.g.,
pain or burning when urinating, accompanied by fever or chills); blood
in the urine; unexplained lower back or side pain; urine that is cloudy
or foul smelling; urine loss only when the patient coughs, sneezes, or
laughs (since the product is not effective for stress incontinence); and
present diagnosis of urinary retention or gastric retention.4
Patients are urged to ask a physician before using Oxytrol
For Women if they have risk factors or symptoms of diabetes (e.g., a
history of diabetes in the immediate family, excessive thirst, extreme
hunger, increasing tiredness), unexplained weight loss, a history of
kidney stones, or liver or kidney disease.4 They should also
speak to a health professional before use if they are pregnant or
breast-feeding. Labels warn patients to speak to a physician or
pharmacist before use if they are already taking a prescription
medication for OAB or a diuretic.
Patients are warned that, when using the product, they may
notice mild redness when the patch is removed, which usually abates
after a few hours. They may also notice sleepiness, dizziness, or
blurred vision. Ingestion of alcohol may worsen the drowsiness. Users
are cautioned to be careful when driving a vehicle or operating
Patients are cautioned to stop use and ask a physician if
they are not able to empty the bladder; if the condition worsens or new
symptoms appear; if the condition does not improve after 2 weeks of use;
if they experience an allergic reaction to the product; or if they have
severe redness, itchiness, or blistering at the site of application.4
To use Oxytrol For Women, patients should open a patch and
apply it immediately to a clean, dry, and smooth area of skin on the
abdomen, hips, or buttocks. They should avoid oily, damaged (cut or
scraped), or irritated skin (e.g., with an active rash). They should not
place patches on skin that is treated with lotions, powders, or oils,
as the patch may not adhere to those areas. They should wear the patch
under clothing, avoiding areas exposed to sunlight. Patches should be
applied whole and not cut into pieces. Patients should wear only one
patch at a time, for 4 consecutive days, after which they remove and
discard the used patch and apply a new one. They should continue to
change the patch every 4 days, rotating application sites each time to
reduce the risk of skin irritation. To dispose of a used patch, they
should fold the sticky sides together and discard the patch where it
cannot be retrieved and ingested by a child or pet.4
Other Useful Counseling Information
The pharmacist should be familiar with other useful
information regarding Oxytrol For Women that is not required on the
nonprescrip-tion product label.4 For instance, patients using
anticholinergics such as oxybutynin should be warned not to enter hot
environments, since that group of medications reduces the ability to
sweat, and the wearer may suffer heat prostration, with fever and heat
stroke. Oral dosage forms of oxybutynin have caused angioedema,4
and patients should be informed that the appearance of any symptoms
that might be angioedema is sufficient cause for a 911 call, with
immediate transport to an emergency room.
The label warning against use in gastric retention is required because anticholinergics decrease gastric motility.4
However, the label omits other examples of patients who are at high
risk of complications due to decreased gastric motility, such as those
with ulcerative colitis, intestinal atony, and myasthenia gravis. It is
also vital to know that patients with gastroesophageal reflux should use
Oxytrol For Women with caution, a warning that also includes patients
who are taking bisphosphonates (e.g., alendronate, ibandronate,
risedronate), since these drugs can induce or worsen reflux.4
Patients purchasing Oxytrol For Women should be warned that it might induce other adverse reactions not listed on the label.4
These include application site abnormalities (rash, macules, pruritus,
or burning), back pain, dry mouth, constipation, nausea, abdominal pain,
flatulence, fatigue, headache, flushing, or diffuse rash. Most of these
events are mild or moderate in severity.
To facilitate compliance, patients can be instructed to
change patches on the same 2 days each week. Product packages have a
calendar on the back to help patients remember when changing is due.4
Water may come into contact with the patch during routine
activities such as swimming, bathing, showering, or exercising. This
does not affect the patch. However, the manufacturer cautions patients
not to rub the patch area when carrying out those activities.4
It is predictable that men will ask about using Oxytrol
For Women for their OAB. The problem is that their symptoms may be due
to prostate problems, so a prostate examination is required to rule out
more serious conditions. For this reason, men should be strongly
discouraged from using the product and urged to visit their physician
for a differential diagnosis regarding the etiology of their OAB
What Is Overactive Bladder?
Normally, your urinary tract functions quite well. Your
kidneys produce urine that is stored in the bladder, and your bladder is
relaxed when there is no urine present. As your bladder fills with
urine, your nerves send a signal that it needs to be emptied. When you
have overactive bladder, the signals to empty the bladder are sent even
though the bladder is not full. As a result, you may notice the
following: 1) you feel the need to urinate 8 or more times during the
day, and 2 or more times during a typical night; 2) you feel a sudden,
strong, and immediate urge to urinate; and 3) you leak urine
uncontrollably after you have the sudden and strong urge to urinate.
Further, when you attempt to urinate, there is often very little urine
or no urine at all.
Overactive bladder is not the same as stress incontinence.
With stress incontinence, you leak urine when sneezing, laughing, or
carrying out other physical activities.
Who Is Likely to Have Overactive Bladder?
Overactive bladder is more common with aging, in both men
and women. Women past the age of menopause and men with prostate
problems are at greater risk, as are patients with a history of stroke
or multiple sclerosis.
How Can Diet Affect Overactive Bladder?
Some foods and drinks irritate the bladder, possibly
contributing to the problem. You should strive to eliminate caffeine
from your diet by halting use of coffee, tea, and all caffeinated soft
drinks. Alcohol should be eliminated entirely, as it is another bladder
irritant. Spices such as pepper add flavor to foods, but they also can
cause severe irritation to the bowels and bladder. It may be helpful to
keep a diary of your intake of these foods and drinks to see if they
actually do produce a worsening of symptoms.
A New Nonprescription Product
Women may try the behavioral changes mentioned above, as
well as one of several prescription medications (e.g., Ditropan, Detrol,
Toviaz, Vesicare) that relax the muscles of the bladder to prevent
contractions. Physicians may also attempt such therapies as application
of electrical impulses or Botox.
A new nonprescription product may be helpful for overactive bladder. It is known as Oxytrol For Women, which is available as a patch that is worn continuously on the skin for 4 days and contains the medication oxybutynin.
This product may be appropriate for you if you have had
two or more of the following symptoms (as described above) for at least 3
months: 1) urinary frequency, more than 8 times in 24 hours; 2) urinary
urgency; and 3) urge incontinence. However, urinary frequency can also
be caused by urinary tract infections, diabetes, pregnancy (in the early
stages), and other more serious conditions. If you think you have any
of these, you should see a physician instead.
The product’s label will have many additional use
precautions, warnings, and instructions. You should read and heed each
of these. Further, it is wise to Consult Your Pharmacist for additional assistance regarding use of this innovative new approach to overactive bladder.
Remember, if you have questions, Consult Your Pharmacist.
1. Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC. Drug Store News.
January 25, 2013.
Accessed June 24, 2013.
2. Schiff D. Merck’s Oxytrol could be OTC trailblazer for chronic conditions. The Tan Sheet. March 11, 2013. http://usciencesblogs.typepad.com/files/t130311_oxytrol_otc_trailblazer.pdf. Accessed June 24, 2013.
3. Urinary incontinence. MedlinePlus. www.nlm.nih.gov/medlineplus/urinaryincontinence.html. Accessed June 24, 2013.
4. Oxytrol For Women (oxybutynin transdermal system, 3.9
mg/day). FDA advisory committee briefing document. Merck Consumer Care.
November 9, 2012.
Accessed June 24, 2013.
5. What I need to know about bladder control for women.
National Institute of Diabetes and Digestive and Kidney Diseases.
http://kidney.niddk.nih.gov/kudiseases/pubs/bcw_ez/. Accessed June 24,
6. Overactive bladder. MedlinePlus. www.nlm.nih.gov/medlineplus/overactivebladder.html. Accessed June 24, 2013.
7. Overactive bladder (OAB). Urology Care Foundation.
www.urologyhealth.org/urology/index.cfm?article=112. Accessed June 24,
8. Urgency urinary incontinence/overactive
bladder. National Association for Continence.
June 24, 2013.
9. Evaluating prescription drugs used to treat overactive bladder. Consumer Reports. 2010. www.consumerreports.org/health/resources/pdf/best-buy-drugs/Overactive_Bladder-FINAL.pdf. Accessed June 24, 2103.
10. Oxytrol For Women. Merck Consumer Care. www.oxytrolforwomen.com. Accessed July 8, 2013.
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