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Ditropan (Oxybutynin Chloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

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, 10 mg (pink), and 15 mg (gray) and are imprinted with "10 XL", or "15 XL". DITROPAN XL® Extended Release Tablets are supplied in


10 mg 10 count bottle NDC 54868-4502-1

30 count bottle NDC 54868-4502-0



15 mg
10 count bottle
NDC 54868-4835-1

30 count bottle
NDC 54868-4835-0

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

10192603

Revised December 2011

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

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