Solifenacin

DRUG INFORMATION

  ADULT
    - mg tablet taken once daily, and if well tolerated may be increased to 10 mg once
      daily (2.1).
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - mg tablet taken once daily, and if well tolerated may be increased to 10 mg once
      daily (2.1). Do not exceed 5 mg tablet once daily in patients with: severe renal
      impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic
      impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors
      (2.4). Use of solifenacin succinate tablet is not recommended in patients with
      severe hepatic impairment (Child-Pugh C) (2.3).
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of solifenacin succinate tablets in pediatric
      patients have not been established.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'pediatric
      use', retrieved 2026-08-29
    - mg tablet taken once daily, and if well tolerated may be increased to 10 mg once
      daily (2.1). Do not exceed 5 mg tablet once daily in patients with: severe renal
      impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic
      impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors
      (2.4). Use of solifenacin succinate tablet is not recommended in patients with
      severe hepatic impairment (Child-Pugh C) (2.3).
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - Do not exceed 5 mg tablet once daily in patients with: severe renal impairment
      [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment
      (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4).
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Do not exceed 5 mg tablet once daily in patients with: severe renal impairment
      [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment
      (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4).
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - Solifenacin succinate tablets can be administered with or without food. 2.2 Dose
      Adjustment in Patients with Renal Impairment For patients with severe renal
      impairment (CL cr <30 mL/min), a daily dose of solifenacin succinate tablets
      greater than 5 mg is not recommended [see Warnings and Precautions (5.7) and Use
      in Specific Populations (8.6)] .
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - Multiple dose studies of solifenacin succinate tablets in elderly volunteers (65
      to 80 years) showed that C max , AUC and t 1/2 values were 20 to 25% higher as
      compared to the younger volunteers (18 to 55 years). 8.6 Renal Impairment
      Solifenacin succinate tablets should be used with caution in patients with renal
      impairment.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Do not exceed 5 mg tablet once daily in patients with: severe renal impairment
      [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment
      (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4).
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - Use of solifenacin succinate tablet is not recommended in patients with severe
      hepatic impairment (Child-Pugh C) (2.3). 2.1 Dosing Information The recommended
      dose of solifenacin succinate tablet is 5 mg once daily.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29
    - Solifenacin succinate tablets can be administered with or without food. 2.2 Dose
      Adjustment in Patients with Renal Impairment For patients with severe renal
      impairment (CL cr <30 mL/min), a daily dose of solifenacin succinate tablets
      greater than 5 mg is not recommended [see Warnings and Precautions (5.7) and Use
      in Specific Populations (8.6)] .
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Category C There are no adequate and well-controlled studies in pregnant
      women.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy',
      retrieved 2026-08-29
    - Reproduction studies have been performed in mice, rats and rabbits.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy',
      retrieved 2026-08-29
    - After oral administration of 14 C-solifenacin succinate to pregnant mice, drug-
      related material was shown to cross the placental barrier.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - After oral administration of 14 C-solifenacin succinate to lactating mice,
      radioactivity was detected in maternal milk.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'nursing
      mothers', retrieved 2026-08-29
    - There were no adverse observations in mice treated with 1.2 times (30 mg/kg/day)
      the expected exposure at the maximum recommended human dose [MRHD].
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'nursing
      mothers', retrieved 2026-08-29
    - Pups of female mice treated with 3.6 times (100 mg/kg/day) the exposure at the
      MRHD or greater revealed reduced body weights, postpartum pup mortality or delays
      in the onset of reflex and physical development during the lactation period.
      Source: US FDA label for solifenacin (Solifenacin Succinate), section 'nursing
      mothers', retrieved 2026-08-29