Solifenacindosage

5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily.

Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with:

Severe renal impairment creatinine clearance <30 mL/min/1.73 m 2.

Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended in patients with severe hepatic impairment (Child- Pugh C).

Concomitant use of strong CYP3A4 inhibitors.

2.1 Dosing Information

The recommended oral dose of solifenacin succinate tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin succinate tablets should be taken with water and swallowed whole. Solifenacin succinate tablets can be administered with or without food.

2.2 Dosing Recommendations in

Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ).

2.3 Dosing Recommendations in

Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use of solifenacin succinate tablets in patients with severe hepatic impairment (Child-Pugh C).

2.4 Dosing Recommendations in

Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when solifenacin succinate tablets are administered with strong CYP3A4 inhibitors such as ketoconazole.