Home » Drug Information » FDA Approved Drugs » 1999
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 June 1999
Treatment Area: Urology
A new 15 mg tablet formulation of Ditropan XL has been approved
for the treatment for overactive bladder. The new 15 mg tablet
provides once-daily convenience in the treatment of overactive
bladder. The recommended starting dose of Ditropan is 5 mg once
daily. This dose may be adjusted in 5 mg increments, up to a
maximum of 30 mg per day, to achieve the optimal balance of
efficacy and tolerability.
The efficacy and safety of Ditropan were demonstrated in 429
adult overactive bladder patients with incontinence episodes in
three controlled studies and one open-label study. In a controlled
study, Ditropan demonstrated efficacy superior to placebo in the
reduction of urge incontinence episodes. Patients treated with
Ditropan experienced a decrease in incontinence episodes from 18.6
episodes per week to 1.5 episodes per week.
In clinical trials, Ditropan XL was demonstrated to be generally
well-tolerated by patients. The most common adverse events included
dry mouth, constipation, drowsiness, diarrhea, blurred vision, dry
eyes, dizziness, and runny nose.
Overactive bladder is a common and chronic urologic disorder
that affects an estimated 17 million Americans. Symptoms of
overactive bladder include urge urinary incontinence (sudden and
involuntary loss of bladder control resulting in wetting
accidents), urgency (the urgent need to empty the bladder), and
frequency (frequent urination).