Oxytrol (Oxybutynin Transdermal) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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Urinary Incontinence »

Urinary incontinence (UI) in men facts

*Urinary incontinence (UI) in men facts Medically Edited by: Melissa Conrad Stöppler, MD

The definition of urinary incontinence in men is the unintentional loss of urine. Weak bladder muscles, overactive bladder muscles, certain prostate conditions, and nerve damage are just some of the possible underlying causes of urinary incontinence in men.
There are different types of urinary incontinence in men, including stress incontinence, urge incontinence, and overflow incontinence.
Diagnosis of urinary incontinence in men may involve a physical exam, an ultrasound, urodynamic testing, and tests including an electroencephalogram (EEG) and an electromyogram (EMG). The doctor will also take a medical history and may recommend keeping a bladder diary.
Treatment of urinary incontinence in men may include behavioral treatments, like bladder training and Kegel exercises, medication, surgery, or...

Read the Urinary Incontinence article »

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SIDE EFFECTS

The safety of OXYTROL (oxybutynin transdermal) was evaluated in a total of 417 patients who participated in two Phase 3 clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in Phase 1 and Phase 2 trials. In the two pivotal studies, a total of 246 patients received OXYTROL (oxybutynin transdermal) during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL (oxybutynin transdermal) for at least 24 weeks and at least 36 weeks, respectively.

No deaths were reported during treatment. No serious adverse events related to treatment were reported.

Adverse events reported in the pivotal trials are summarized in Tables 4 and 5 below.

Table 4: Number (%) of adverse events occurring in ≥ 2% of OXYTROL (oxybutynin transdermal) -treated patients and greater in OXYTROL (oxybutynin transdermal) group than in placebo group (Study 1).

Adverse Event*	Placebo (N=132)		OXYTROL (3.9 mg/day) (N=125)
Adverse Event*	N	%	N	%
Application site pruritus	8	6.1%	21	16.8%
Dry mouth	11	8.3%	12	9.6%
Application site erythema	3	2.3%	7	5.6%
Application site vesicles	0	0.0%	4	3.2%
Diarrhea	3	2.3%	4	3.2%
Dysuria	0	0.0%	3	2.4%
*includes adverse events judged by the investigator as possibly, probably or definitely treatment-related.

Table 5: Number (%) of adverse events occurring in ≥ 2% of OXYTROL (oxybutynin transdermal) -treated patients and greater in OXYTROL (oxybutynin transdermal) group than in placebo group (Study 2).

Adverse Event*	Placebo (N=117)		OXYTROL (3.9 mg/day) (N=121)
Adverse Event*	N	%	N	%
Application site pruritus	5	4.3%	17	14.0%
Application site erythema	2	1.7%	10	8.3%
Dry mouth	2	1.7%	5	4.1%
Constipation	0	0.0%	4	3.3%
Application site rash	1	0.9%	4	3.3%
Application site macules	0	0.0%	3	2.5%
Abnormal vision	0	0.0%	3	2.5%
*includes adverse events judged by the investigator as possibly, probably or definitely treatment-related.

Other adverse events reported by > 1% of OXYTROL (oxybutynin transdermal) -treated patients, and judged by the investigator to be possibly, probably or definitely related to treatment include: abdominal pain, nausea, flatulence, fatigue, somnolence, headache, flushing, rash, application site burning and back pain.

Most treatment-related adverse events were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL (oxybutynin transdermal) -treated patients in Study 1 and by 5.0% of OXYTROL (oxybutynin transdermal) -treated patients in Study 2.

Treatment-related adverse events that resulted in discontinuation were reported by 11.2% of OXYTROL (oxybutynin transdermal) -treated patients in Study 1 and 10.7% of OXYTROL (oxybutynin transdermal) -treated patients in Study 2. Most of these were secondary to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL (oxybutynin transdermal) treatment due to dry mouth.

In the open-label extension, the most common treatment-related adverse events were: application site pruritus, application site erythema and dry mouth.

Post Marketing Surveillance

The following event has been reported in association with OXYTROL (oxybutynin transdermal) use in clinical practice: dizziness. Because spontaneously reported events are from worldwide post marketing experiences, the frequency of events and the role of OXYTROL (oxybutynin transdermal) in their causation cannot be reliably determined.

DRUG INTERACTIONS

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents that produce dry mouth, constipation, somnolence, and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. Pharmacokinetic studies have not been performed with patients concomitantly receiving cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g. ketoconazole, itraconazole, and miconazole) or macrolide antibiotics (e.g. erythromycin and clarithromycin). No specific drug-drug interaction studies have been performed with OXYTROL (oxybutynin transdermal) .

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.