Treatment of overactive bladder with symptoms of urge urinary incontinence, urinary frequency and urgency.

Solifenacin is a competitive muscarinic receptor antagonist.

Bioavailability: ∼90%, in the elderly (65-80 y/o): 20-25% increase in Cmax and AUC; Time to peak plasma levels: 3 to 8 hours. Protein binding: ∼98%. Extensively metabolized in the liver, primarily by CYP3A4. Excretion: 69.2% excreted in the urine with less than 15% in unchanged form, 22.5% excreted in the feces. Elimination half-life: 45-68 hours, 20-25% higher in the elderly.

Hypersensitivity to the active substance or to any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma

C

avoided, infant risk cannot be ruled out

Dry mouth (most common), constipation, blurred vision (accommodation abnormalities), urinary retention, urinary tract infectious disease

5 mg orally once daily. May be administered with or without food. Should be taken with liquids and swallowed whole. Dose adjustment: with concomitant CYP3A4 inhibitors: MAX dose: 5 mg/day; in hepatic impairment: moderate (Child-Pugh class B): MAX dose: 5 mg/day, severe (Child-Pugh class C): use is not recommended

in renal impairment: Clcr< 30 ml/min: MAX dose: 5 mg/day

in hepatic impairment: moderate (Child-Pugh class B): MAX dose: 5 mg/day, severe (Child-Pugh class C): use is not recommended