Ditropan XL (oxybutynin chloride)

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

Company:

Approval Status:

Approved June 1999

Specific Treatments:

Urology

Therapeutic Areas

General Information

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.

Clinical Results

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.

Side Effects

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.

Additional Information

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).