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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 Text Continues Below
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 H2 O to 33 cm H2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H2 O) from 60% to 28%. DITROPAN XL is not recommended in pediatric patients who can not 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: Gender). Page: << Prev | 1 | 2 | 3
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