VESIcare
INDICATIONS
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 (CLcr < 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 B | NDC 51248-150-01 | NDC 51248-151-01 |
| Bottle of 90 | NDC 51248-150-03 | NDC 51248-151-03 |
| Unit Dose Pack of 100 | NDC 51248-150-52 | NDC 51248-151-52 |
Store at 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F -86°F) [see USP Controlled Room Temperature]
Manufactured by: Astellas Pharma Technologies Inc. Norman, Oklahoma
73072. Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015-2548. Marketed
and Distributed by: GlaxoSmithKline Research Triangle Park North Carolina 27709.
Revised: January 2008
FDA Rev date: 1/23/2008
Generic Name: Solifenacin Succinate
Report Problems to the Food and Drug Administration
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VESIcare
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