Frequently
Asked Questions (FAQ's)
Questions About Efficacy
How much oxybutynin is delivered daily with OXYTROL?
Tell me more about OXYTROL. How is it made? How large is it?
How long does it take from the first application of OXYTROL
to reach the maximum concentration and steady-state concentration
of oxybutynin?
Questions About Safety and Tolerability
Why use the transdermal form
of delivery?
How well does OXYTROL adhere to the skin for the 3-4 days
of use?
Were there any reports of skin irritation with OXYTROL?
What about anticholinergic adverse reactions with OXYTROL?
Is OXYTROL safe to use in severely underweight/overweight patients?
Will the dosing schedule (every 3 to 4 days) make it difficult
for patients to remember when to change their patch?
Which patients should not receive OXYTROL?
Questions About Application and Disposal
Where should OXYTROL be
applied?
Can my patients bathe, shower, swim, and exercise with OXYTROL?
What should my patients do if OXYTROL comes off?
What if my patients forget to change OXYTROL after 3-4 days?
How do my patients remove adhesive that is left on their skin after
they remove a patch?
How do my patients store OXYTROL?
Where can my patients find additional information about OXYTROL?
How are OXYTROL patches disposed of?
How much oxybutynin is delivered daily with OXYTROL?
OXYTROL contains 36 mg of oxybutynin
per patch and delivers 3.9 mg of oxybutynin daily when dosed twice
weekly.
Tell me more about OXYTROL. How is it made? How large is it?
OXYTROL, a matrix transdermal
system, is composed of three layers. The first layer is the
backing film, a thin flexible film that provides the matrix system
with occlusivity and physical integrity. At the same time, the backing
film protects the second layer. The adhesive/drug layer, the second
layer, is a cast film of acrylic adhesive that contains the oxybutynin
and triacetin (a skin permeation enhancer). The third layer, formed
of two overlapping strips, is the release liner. Prior to application,
the patient peels off these strips to expose the adhesive/drug layer.
Regarding size, OXYTROL is a credit card-size patch, small
enough to be applied and worn comfortably. The OXYTROL 3.9 patch is
7.6 cm X 5.7 cm and delivers 3.9 mg of oxybutynin per day.
How long does it take from the first
application of OXYTROL to reach the maximum concentration
and steady-state concentration
of oxybutynin?
In pharmacokinetic studies involving OXYTROL,
the maximum oxybutynin
concentration was achieved within about 24-48 hours after the first
application. Steady-state concentrations are reached during the
second application of OXYTROL. The benefit of these pharmacokinetic
qualities is that the OXYTROL system is applied only twice weekly,
yet it effectively controls the symptoms of OAB.
Why use the transdermal form of delivery?
- Convenient twice weekly dosing
- Long lasting
- Achieves therapeutic levels at less than half the daily dose of oral immediate release oxybutynin
- Easy to use
- Easy to wear
- Discrete and does not limit activities
How well does OXYTROL adhere to the skin for the 3-4 days
of use?
- Consistent adhesion observed in more than 4700 evaluations
- System falloff was observed in 0.4% of evaluations
- Partial detachment was observed in 0.7% of evaluations
- Bathing, swimming, and exercise should not affect adhesion
Were there any reports of skin irritation with OXYTROL?
In safety
and efficacy studies, the most common
adverse events were related to the application sites
(eg, pruritus, erythema). However, most treatment-related adverse
events were described as mild or moderate in intensity. Severe
application site reactions were reported by 6.4% of OXYTROL-treated
patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2. Most
patients experienced only mild or no skin irritations.
What about anticholinergic adverse reactions with OXYTROL?
The most common anticholinergic symptoms
were dry mouth, dry eyes, constipation,
and difficulty urinating. With OXYTROL, dry mouth occurred in 9.6%
of patients in one pivotal study (versus 8.3% with placebo) and
4.1% of patients in the other (versus 1.7% with placebo). No patients
discontinued OXYTROL treatment due to dry mouth. Constipation,
abnormal vision, and dysuria (painful
urination) occurred in 2% to <5% of patients.
Is OXYTROL safe to use in severely underweight/overweight patients?
No specific
studies investigating severely underweight or overweight patients have been conducted.
Will
the dosing schedule (every 3 to 4 days) make it difficult
for patients to remember when to change their patch?
Patients are provided with a convenient
dosing calendar with each carton of OXYTROL. Your patients can also
use the application calendar/reminder to help them with their schedule.
Which patients should not receive OXYTROL?
OXYTROL should not be
used in patients experiencing urinary retention, gastric retention,
or uncontrolled narrow-angle glaucoma or in patients
at risk for these conditions. If there
is any known hypersensitivity to any component, OXYTROL should be
avoided.
Where should OXYTROL be applied?
OXYTROL should be applied to a clean,
dry, smooth area of skin on the abdomen, hip, or buttock. The waistline
should be avoided to
prevent tight clothing from rubbing against OXYTROL. Sites should
be rotated with each new application, with at least 7 days between
applications in a single spot.
Can my patients bathe, shower, swim, and exercise with OXYTROL?
Yes,
they can wear OXYTROL all of the time until it is time to apply a
new one. Baths, showers, swimming, and exercise should not affect
OXYTROL as long as patients don’t rub the patch as they
wash. They should avoid soaking in a hot tub for a long period of
time, which can make the patch come off.
What should my patients do if the patch comes off?
If the patch starts
to lift off, they should apply a little bit of pressure using the
fingertips. OXYTROL is designed to restick. Very
rarely will the patch come off completely. If it does, they should
try putting the same patch on the same spot. If it sticks firmly
all over, they should leave it on. If not, they should take it off
and put a new patch on a new spot. No matter what day this happens,
patients should continue with the twice-a-week schedule that they
have marked on their OXYTROL box.
What if my patients forget to change the patch after 3-4 days?
As soon as they remember, they should remove
the old patch and apply a new one to a new spot on their abdomen,
hip, or buttock. No matter what day this happens, they should continue
with the same twice-a-week schedule for the next patch, even if
it means changing the new one before 3-4 days have elapsed.
How do my patients remove adhesive that is left on their skin after
they remove a patch?
They should gently soak the affected area
with warm water and mild soap, or use a small amount of baby oil
to remove
any residue. If
the rings of adhesive become soiled, they may need to use a medical
adhesive removal pad that should be available from a pharmacist.
Alcohol or other dissolving liquids (nail polish remover or other
solvents) may cause skin irritation and should not be used.
How do my patients store OXYTROL?
They should store OXYTROL at room
temperature, 25° C (77° F). Temporary storage between 15°-30° C
(59°-86° F) is also permitted. They should also keep OXYTROL and all medications
in a safe, secure place out of the reach of children.
Where can my patients find additional information about OXYTROL?
Additional information may be obtained by calling 1-888-OXYTROL (1-888-699-9765) or
visiting the About OXYTROL section of this site.
How are OXYTROL patches disposed of?
The old patch should be removed slowly and
carefully to avoid skin damage. The patch will still contain some
oxybutynin, so the
sticky edges should be folded together and the patch thrown away where
children or pets cannot retrieve it.
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