Sanctura (Trospium Chloride) - Indications and Dosage

INDICATIONS AND USAGE

Sanctura is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

DOSAGE AND ADMINISTRATION

The recommended dose is 20 mg twice daily. Sanctura should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:

For patients with severe renal impairment (CLcr < 30 mL/min), the recommended dose is 20 mg once daily at bedtime (See PRECAUTIONS: General).

In geriatric patients >/= 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability (See PRECAUTIONS: Geriatric Use).

HOW SUPPLIED

Sanctura™ tablets 20 mg (brownish yellow, biconvex, glossy coated tablets printed with black ink) are supplied as follows:

60 count HDPE bottle.............................................. NDC 65473-980-04

500 count HDPE bottle............................................ NDC 65473-980-02

14 count blister (PVC/Paper backed foil).................. NDC 65473-980-70

14 count blister (PVC-Aclar/Paper backed foil)........ NDC 65473-980-71

Store at controlled room temperature 20° to 25°C (68° to 77°F) (see USP).

Rx only

Manufactured for:

Odyssey Pharmaceuticals, Inc.

East Hanover, NJ 07936 USA

and

Indevus Pharmaceuticals, Inc.

Lexington, MA 02421 USA

Manufactured by:

Madaus AG

Troisdorf, Germany

Address Medical Inquiries to:

www.SANCTURA.com or (877)-427-9068