the first and only transdermal system for
Actavis Pharma, Inc., is proud to market OXYTROL, the first and
only transdermal matrix system for the treatment of overactive
OXYTROL, a unique transdermal matrix system, delivers
the proven efficacy of oxybutynin
for the treatment of overactive bladder with symptoms of urge urinary
urgency, and frequency.
In clinical trials, patients treated with OXYTROL experienced up
to a 75% reduction in incontinence episodes (placebo
group experienced a 50% reduction in incontinence episodes).
The transdermal delivery of OXYTROL provides a
favorable safety profile. Anticholinergic adverse events, such as
dry mouth, constipation ,
and dizziness were not significantly different than placebo in clinical.
trials No serious adverse events
related to treatment were reported. The most common adverse events
were application site reactions,
pruritis and erythema. Most treatment-related adverse events were
described as mild or moderate in intensity. Approximately
11% of patients discontinued treatment in clinical trials due to
most were secondary to application
site reactions. No patients discontinued due to dry mouth.
OXYTROL provides ALL-DAY and ALL-NIGHT delivery of oxybutynin for
up to 4 days, allowing for convenient twice-weekly dosing.
Because of its transdermal delivery, OXYTROL bypasses first-pass
and hepatic metabolism and delivers more oxybutynin with 80% less
N-desethyloxybutynin (N-DEO) metabolite at less than half the daily
dose of oral immediate-release oxybutynin.
OXYTROL is available as a 1-month supply
of 8 patches contained in a patient calendar box. Each OXYTROL
patch delivers 3.9 mg of
oxybutynin per day. Patients should select any 2-day combination
listed on the box as their schedule for changing the patch—and
then stick with it. Thin, flexible, and virtually transparent, OXYTROL
can be applied on the hip, abdomen, or buttock—absorption
is bioequivalent. Patients should be instructed to choose a new
site with each application and avoid reapplication to the same site
Thank you for your continued support.
Gary Kozloski, PharmD
Vice President, Medical Affairs
Actavis Laboratories, Inc.
is contraindicated in patients with urinary retention,
or uncontrolled narrow-angle glaucoma and in patients
who are at risk for these conditions. OXYTROL is also
contraindicated in patients who have demonstrated hypersensitivity
oxybutynin or other components of the product. OXYTROL
should be administered with caution in the following patients:
those with hepatic or renal impairment; clinically significant
bladder outflow obstruction; gastrointestinal obstructive
disorders because of the risk of gastric retention; patients
*Comparison significant if P<.05.
OXYTROL Prescribing Information.
Dmochowski RR, Davila GW, Zinner NR, et al, for the Transdermal Oxybutynin Study Group. Efficacy and safety of transdermal oxybutynin in patients with urge and mixed urinary incontinence. J Urol. 2002;168:580-586.
Data on file, Watson Pharma, Inc.