Dosing Information

Dosing Information in Pediatric Patients Aged 2 Years and Older

The recommended starting and maximum VESIcare LS oral suspension doses are shown in mL in Table 1. VESIcare LS oral suspension has a concentration of 1 mg/1 mL. The recommended doses are weight-based and are administered once daily. After administration of the recommended starting dose, the dose may be increased to the lowest effective dose but should not exceed the maximum recommended dose.

Evaluate patients periodically for potential dose adjustment.

VESIcare LS oral suspension should be taken once daily. Instruct patients or their caregivers that patients should take VESIcare LS orally followed by liquid (e.g., water or milk). Instruct patients to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.

Dosing Recommendations in Patients with Renal Impairment

Do not exceed the recommended VESIcare LS oral suspension starting dose in patients with severe renal impairment (CLcr < 30 mL/min/1.73 m2) [see Use in Specific Populations (8.6)].

Dosing Recommendations in Patients with Hepatic Impairment

Do not exceed the recommended VESIcare LS oral suspension starting dose in patients with moderate hepatic impairment (Child-Pugh B). Do not use VESIcare LS in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)].

Dosing Recommendations in Patients Taking CYP3A4 Inhibitors

Do not exceed the recommended VESIcare LS oral suspension starting dose when VESIcare LS is administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions (7.1)].