OXYTROL Highlights Prescribe OXYTROL as your first-line drug therapy for...
Power to calm their symptoms
61% and 75% reduction in incontinence episodes in 2 major clinical trials [1*†‡]
Proven safety and tolerability profiles
Dry mouth, constipation, and dizziness were not significantly different than placebo [1,3*†] — No patients discontinued due to dry mouth [1,3§]
Continuous relief
Delivers the power to treat overactive bladder through innovative transdermal technology
— Provides ALL-DAY, ALL-NIGHT delivery for up to 4 days [1] — Bypasses first-pass gastric and hepatic metabolism to provide more parent drug with less metabolite [1]
The most commonly reported adverse events were application site
reactions, dry mouth, constipation, diarrhea, dysuria, and abnormal vision.
OXYTROL is contraindicated in patients with urinary retention, gastric 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 to oxybutynin or other components of the product.
Please see full prescribing information for OXYTROL
Oxytrol Highlight References: * Study 1 was a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trial of OXYTROL (1.3, 2.6, and 3.9 mg/day). Median weekly baseline and end point values were 31 and 12, respectively, for OXYTROL (n=120) and 30 and 15, respectively, for placebo (n=127).
† Study 2 was a phase 3, 12-week, multicenter, randomized, double-blind, placebo- and active-controlled trial of OXYTROL (3.9 mg/day). Median daily baseline and end point values were 4 and 1, respectively, for OXYTROL (n=121) and 4 and 2, respectively, for placebo (n=117). All patients had a prior beneficial response to pharmacologic treatment for overactive bladder.
‡ Throughout both studies, patients were instructed to continue nonpharmacologic treatment measures (eg, pelvic floor exercise, timed voiding, or other behavioral techniques) consistent with standard practices.
§ The safety of OXYTROL was evaluated in a total of 417 patients from 2 clinical efficacy and safety studies and an open-label extension. Includes all patients receiving OXYTROL 3.9 mg/day.
ll Comparison significant if P<.05.
[1] OXYTROL® Prescribing Information. February 2003.
[2] 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.
[3] Data on file, Watson Pharma, Inc.
[4] Dmochowski RR, Sand PK, Zinner NR, et al. Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Urology. 2003;62:237-242.
[5] Appel RA, Chancellor MB, Zobrist RH, Thomas H, Sanders SW. Pharmacokinetics, metabolism, and saliva output during transdermal and extended-release oral oxybutynin administration in healthy subjects. Mayo Clin Proc. 2003;78:696-702.
[6] Zobrist RH, Schmid B, Feick A, Quan D, Sanders SW.Pharmacokinetics of the R- and S-enantiomers of oxybutynin and N-desethyloxybutynin following oral and transdermal administration of the racemate in healthy volunteers. Pharm Res. 2001;18:1029-1034.
[7] OXYTROL® Patient Prescribing Information.