What is the role of oxybutynin (Ditropan XL) in the treatment of overactive bladder (OAB) in children?

Updated: Apr 01, 2019
  • Author: Pamela I Ellsworth, MD; Chief Editor: Edward David Kim, MD, FACS  more...
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Currently, the most commonly used anticholinergic for the treatment of OAB in children is extended-release oxybutynin (Ditropan XL). This agent is a once-a-day formulation that is approved for use in children who can swallow a pill and who meet the drug’s age requirements. [29]

Historically, oxybutynin use has been limited by side effects, most notably dry mouth and constipation. In addition, the need for dosing 2 or 3 times daily may affect compliance. The extended-release preparation decreases such side effects. The risk of side effects appears to be dose-related. Both oral oxybutynin and intravesical oxybutynin may have side effects involving the central nervous system (CNS) and cognitive function. [30, 31]  However, such reports have not been documented with extended-release oxybutynin.

Extended-release oxybutynin is delivered via the osmotic release oral system (OROS). The tablet cannot be crushed, cracked, or chewed and must be swallowed whole. Oxybutynin is metabolized by the cytochrome P-450 (CYP-450) enzyme systems, particularly the CYP3A in the liver and gut wall. The pharmacokinetics of extended-release oxybutynin were evaluated in 19 children aged 5-15 years with neuropathic detrusor overactivity and were found to be consistent with those reported for adults.

The contraindications to the use of extended-release oxybutynin in children are the same as those in the adult population (ie, urinary retention, severe decreased gastrointestinal motility conditions, uncontrolled narrow angle glaucoma). Caution should be used in treating patients with severe hepatic impairment and those on potent CYP3A4 inhibitors.

A 24-week open-label trial that studied the safety and efficacy of extended-release oxybutynin in 60 children aged 6-15 years with neuropathic detrusor overactivity demonstrated that this agent, in doses ranging from 5 to 20 mg, yielded an increase from baseline in mean urine volume per catheterization and an increase from baseline in the mean percentage of catheterizations without a leaking episode.48 Urodynamic results were found to be consistent with clinical results.

The recommended initial starting dose of extended-release oxybutynin in children aged 6 years or older is 5 mg/d. The dosage may be increased in 5-mg increments up to a maximum of 20 mg/d to achieve a balance of efficacy and tolerability.

Adverse effects of extended-release oxybutynin are those commonly encountered with anticholinergic agents, including dry mouth, constipation, facial flushing, central nervous system effects (headache, dizziness, somnolence), and blurred vision. The incidence of side effects with extended-release oxybutynin is significantly lower than with other oxybutynin formulations, particularly with respect to dry mouth and constipation.

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