n chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility or harm to the animal fetus. The safety of DITROPAN XL® administration to women who are or who may become pregnant has not been established. Therefore, DITROPAN XL® should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.
Nursing Mothers
It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DITROPAN XL® is administered to a nursing woman.
Pediatric Use
The safety and efficacy of DITROPAN XL® were studied in 60 children in a 24-week, open-label trial. Patients were aged 6–15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that administration of DITROPAN XL® 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%.
Urodynamic results were consistent with clinical results. Administration of DITROPAN XL® resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H2O to 33 cm H2O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H2O) from 60% to 28%.
DITROPAN XL® is not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6 (See DOSAGE AND ADMINISTRATION).
Geriatric Use
The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations: Geriatric).
ADVERSE REACTIONS
Adverse Events with DITROPAN XL®
The safety and efficacy of DITROPAN XL® (oxybutynin chloride) were eva luated in a total of 580 participants who received DITROPAN XL® in 4 clinical trials (429 patients) and four pharmacokinetic studies (151 healthy volunteers). The 429 patients were treated with 5–30 mg/day for up to 4.5 months. Three of the 4 clinical trials allowed dose adjustments based on efficacy and adverse events and one was a fixed-dose escalation design. Safety information is provided for 429 patients from these three controlled clinical studies and one open-label study in the first column of Table 3 below.
Adverse events from two additional fixed-dose, active-controlled, 12-week treatment duration, postmarketing studies, in which 576 patients were treated with DITROPAN XL® 10 mg/day, are also listed in Table 3 (second column). The adverse events are reported regardless of causality.
Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using DITROPAN XL® (5–30 mg/day) and % of Corresponding Adverse Events in Two Fixed-Dose (10 mg/day) Studies DITROPAN XL® DITROPAN XL®
Body System Advers
