Vesicare (Solifenacin Succinate) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

Dosing Information

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 water and swallowed whole. VESIcare can be administered with or without food.

Dose Adjustment in Patients with 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 [see Warnings and Precautions (5.7); Use in Specific Populations (8.6)].

Dose Adjustment in Patients with 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 [see Warnings and Precautions (5.6); Use in Specific Populations (8.7)].

Dose Adjustment in Patients Taking CYP3A4 Inhibitors

When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of VESIcare greater than 5 mg is not recommended [see Drug Interactions (7.1)].

DOSAGE FORMS AND STRENGTHS

The 5 mg tablets are round, light yellow, debossed with 150.

The 10 mg tablets are round, light pink, debossed with 151.

HOW SUPPLIED/STORAGE AND HANDLING

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

Each 5 mg tablet is light yellow and debossed with a logo and “150” and is available as follows:

Bottle of 30	NDC 51248-150-01
Bottle of 90	NDC 51248-150-03
Unit Dose Pack of 100	NDC 51248-150-52

Each 10 mg tablet is light pink and debossed with a logo and “151” and is available as follows:

Bottle of 30	NDC 51248-151-01
Bottle of 90	NDC 51248-151-03
Unit Dose Pack of 100	NDC 51248-151-52

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