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The safety and effectiveness of VESIcare in pediatric patients have not been established.
8.5 Geriatric Use
In placebo-controlled clinical studies, similar safety and effectiveness were observed between older
(623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger patients (1188 patients < 65 years)
treated with VESIcare.
Multiple dose studies of VESIcare in elderly volunteers (65 to 80 years) showed that Cmax, AUC and t1/2
values were 20-25% higher as compared to the younger volunteers (18 to 55 years).
8.6 Renal Impairment
VESIcare should be used with caution in patients with renal impairment. There is a 2.1-fold increase in
AUC and 1.6-fold increase in t1/2 of solifenacin in patients with severe renal impairment. Doses of
VESIcare greater than 5 mg are not recommended in patients with severe renal impairment (CLcr
< 30 mL/min) [see Warnings and Precautions (5.7); Dosage and Administration (2.2)].
8.7 Hepatic Impairment
VESIcare should be used with caution in patients with reduced hepatic function. There is a 2-fold increase
in the t1/2 and 35% increase in AUC of solifenacin in patients with moderate hepatic impairment. Doses of
VESIcare greater than 5 mg are not recommended in patients with moderate hepatic impairment (ChildPugh B). VESIcare is not recommended for patients with severe hepatic impairment (Child-Pugh C) [see
Warnings and Precautions (5.6); Dosage and Administration (2.3)].
The pharmacokinetics of solifenacin is not significantly influenced by gender.
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