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Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Nephrology

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Ditropan XL (oxybutynin chloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Alza
Approval Status: Approved December 1998
Treatment Area: Urology

General Information

Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Clinical Results

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 ³ 6 urge incontinence episodes per week and ³ 10 micturitions per day. Study 1 was a forced dose escalation design, whereas the other studies used a dose adjustment design in which each patient’s final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. Controlled studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks.

Side Effects

Ditropan ® XL is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.

Ditropan ® XL is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

The most common adverse events reported by patients receiving 5-30 mg/day Ditropan ® XL were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.