Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.

Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.

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.

Adults
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).

HOW SUPPLIED
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

Storage
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

Manufactured by:
ALZA Corporation, Vacaville, CA 95688

An ALZA OROS® Technology Product

DITROPAN XL® and OROS® are registered trademarks of ALZA Corporation.

Manufactured for:
Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, NJ 08869

Placeholder for Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Logo

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 1998

Revised December 2011

PRINCIPAL DISPLAY PANEL - 5 mg 100 tablet bottle
NDC 50458-805-01
100 tablets

DITROPAN XL®
(oxybutynin chloride)
Extended-release tablets

5 mg

Rx only

Ditropan XL®and OROS®are registered
trademarks of ALZA Corporation.

PRINCIPAL DISPLAY PANEL - 10 mg 100 tablet bottle
NDC 50458-810-01
100 tablets

DITROPAN XL®
(oxybutynin chloride)
Extended-release tablets

10 mg

Rx only

Ditropan XL®and OROS®are registered
trademarks of ALZA Corporation.

PRINCIPAL DISPLAY PANEL - 15 mg 100 tablet bottle
NDC 50458-815-01
100 tablets

DITROPAN XL®