Vesicare (Solifenacin Succinate) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

The recommended dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.

VESIcare should be taken with liquids and swallowed whole. VESIcare can be administered with or without food.

Dose Adjustment in Renal Impairment

For patients with severe renal impairment (CL_cr <30 mL/min), a daily dose of VESIcare greater than 5 mg is not recommended.

Dose Adjustment in Hepatic Impairment

For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of VESIcare greater than 5 mg is not recommended. Use of VESIcare in patients with severe hepatic impairment (Child-Pugh C) is not recommended.

Dose Adjustment CYP3A4 Inhibitors

When administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors, a daily dose of VESIcare greater than 5 mg is not recommended.

HOW SUPPLIED

VESIcare is supplied as round, film-coated tablets, available in bottles and unit dose blister packages as follows:

strength color debossed	5 mg light yellow logo, 150	10 mg light pink logo, 151
Bottle of 30 Bottle of 90 Unit Dose Pack of 100	NDC 51248-150-01 NDC 51248-150-03 NDC 51248-150-52	NDC 51248-151-01 NDC 51248-151-03 NDC 51248-151-52

Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F-86ºF) [see USP Controlled Room Temperature]

Rx Only