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.
Approval Status: Approved December 1998
Treatment Area: Urology
Treatment of overactive bladder with symptoms of urge urinary
incontinence, urgency and frequency.
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.
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