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Ditropan XL - Indications & Dosage

[Oxybutynin]

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.

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Adults:

The recommended starting dose of DITROPAN XL is 5 mg once daily. 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. 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 ExtendedRelease Tablets are supplied in bottles of 100 tablets. 5 mg 100 count bottle NDC 17314-8500-1 10 mg 100 count bottle NDC 17314-8501-1

15 mg 100 count bottle NDC 17314-8502-1

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.

Rx only

For more information call 1-888-395-1232 or visit www. DITROPANXL. com

Manufactured by ALZA Corporation, Mountain View, CA 94043

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

Distributed and Marketed by Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ 08869

631-10-800-1 Revised June 2003