DITROPAN XL® (oxybutynin chloride) is a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
DITROPAN XL® is also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
DOSAGE AND ADMINISTRATION
DITROPAN XL® (oxybutynin chloride) must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.
DITROPAN XL® may be administered with or without food.
The recommended starting dose of DITROPAN XL® is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.
Pediatric Patients Aged 6 Years of Age and Older
The recommended starting dose of DITROPAN XL® is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).
DITROPAN XL® (oxybutynin chloride) Extended Release Tablets are available in three dosage strengths, 5 mg (pale yellow), 10 mg (pink), and 15 mg (gray) and are imprinted with “5 XL”, “10 XL”, or “15 XL”. DITROPAN XL® Extended Release Tablets are supplied in bottles of 100 tablets.
|5 mg||100 count bottle||NDC 50458-805-01|
|10 mg||100 count bottle||NDC 50458-810-01|
|15 mg||100 count bottle||NDC 50458-815-01|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity. For more information call 1-888-395-1232 or visit www.DITROPANXL.com Product of France
Manufactured by: ALZA Corporation, Vacaville, CA 95688. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Revised November 2012
Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.
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