Ditropan XL

[Oxybutynin]

Excretion

Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin.

Dose Proportionality

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Pharmacokinetic parameters of oxybutynin and desethyloxybutynin (Cmax and AUC) following administration of 5-20 mg of DITROPAN XL are dose proportional.

Special Populations

Geriatric:

The pharmacokinetics of DITROPAN XL were similar in all patients studied (up to 78 years of age).

Pediatric

The pharmacokinetics of DITROPAN XL were evaluated in 19 children aged 5-15 years with detrusor overactivity associated with a neurological condition (e. g., spina bifida). The pharmacokinetics of DITROPAN XL in these pediatric patients were consistent with those reported for adults (see Tables 1 and 2, and Figures 1 and 2 above).

Gender

There are no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following administration of DITROPAN XL.

Race

Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of DITROPAN XL.

Renal Insufficiency

There is no experience with the use of DITROPAN XL in patients with renal insufficiency.

Hepatic Insufficiency

There is no experience with the use of DITROPAN XL in patients with hepatic insufficiency.

Drug-Drug Interactions

See PRECAUTIONS: Drug Interactions.

Clinical Studies

DITROPAN XL was evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled studies and one open label study. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by 6 urge incontinence episodes per week and 10 micturitions per day.

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