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OXYTROL Highlights
Prescribe OXYTROL — a first-line drug therapy with a favorable safety profile

Low incidence of troublesome anticholinergic adverse events [1,3*†]

No patients discontinued due to dry mouth. [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. 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 with gastroesophageal reflux.

Predominantly mild-to-moderate topical adverse events [1,3*]

• Other topical adverse events occurring in Study 1 and Study 2, respectively, in >2% of OXYTROL-treated patients included rash (0.0%; 3.3%), vesicles (3.2%; 0.0%), and macules (0.0%; 2.5%) [1#**]
• All application-site reactions were investigator observed (erythema) or patient reported (pruritus) and study protocol involved only 1 application site with multiple patches utilized to achieve a 3.9 mg/dose[3]

Favorable safety profile in a wide range of ages

• No serious treatment-related adverse events reported with OXYTROL [1*]
  — 49% of patients enrolled in clinical safety studies were 65 years of age [1]
  — 19% were 75 years of age [3]
  — Patients' ages ranged from 18 to 89 years [3]
• Most treatment-related adverse events were mild or moderate in intensity [1]
  — Severe application-site reactions were reported by 6.4% and 5.0% of OXYTROL-treated patients in Studies 1 and 2, respectively
• Only 11% discontinued treatment due to adverse events [1]
  — No patients discontinued due to dry mouth

Please see full prescribing information for OXYTROL

Oxytrol Highlight References:
* Comparison significant if P<.05.
† 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.
‡ 78% of patients in Study 1 had no prior pharmacologic treatment for overactive bladder.
§ 100% of patients in Study 2 had a prior beneficial response to pharmacologic treatment for overactive bladder.
* 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.
† Some patients experienced more than 1 severity type.
‡ 100% of patients in Study 2 had a prior beneficial response to pharmacologic treatment for overactive bladder.
§ 78% of patients in Study 1 had no prior pharmacologic treatment for overactive bladder.
ll 1.6%, 1.6%, and 3.2% of OXYTROL®-treated patients had mild, moderate, and severe application site erythema, respectively.
¶ 12.0%, 5.6%, and 0.8% of OXYTROL®-treated patients had mild, moderate, and severe application site pruritus, respectively.
# In Study 1, the incidence of topical adverse events occurring in the placebo group were pruritus (6.1%) and erythema (2.3%).
** In Study 2, the incidence of topical adverse events occurring in the placebo group were pruritus (4.3%), erythema (1.7%), and rash (0.9%).
†† Proportion of patients continuing to open-label extensions of the 2 studies. Following week 12 of the studies, all eligible patients were allowed to continue treatment for an additional 12 weeks in open-label extensions.

	[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.