Trade Names:Vesicare- Tablets 5 mg- Tablets 10 mg
Competitive muscarinic receptor agonist.
Bioavailability 90%. Steady-state C max from 32.3 to 62.9 ng/mL for the 5 and 10 mg tablets, respectively. Plasma concentrations are proportional to the administered dose. C max reached in 3 to 8 h.
Plasma protein binding approximately 98%, principally to a 1 -acid glycoprotein. Vd is 600 L.
Primarily metabolized by CYP3A4; however, alternate pathways exist. Pharmacologically active metabolite, 4R-hydroxy solifenacin, occurs in low concentrations and is unlikely to be clinically important. Three pharmacologically inactive metabolites have been found.
Elimination t ½ is about 45 to 68 h. Approximately 69% of the administered dose is recovered in the urine and 22.5% in the feces. Less than 15% recovered in the urine as intact solifenacin.
Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, hypersensitivity to any component of the product.
PO 5 mg once daily. If 5 mg dose is well tolerated, the dose may be increased to 10 mg/day.Renal ImpairmentAdults
PO Do not administer more than 5 mg/day in patients with CrCl less than 30 mL/min.Hepatic ImpairmentAdults
PO Do not administer more than 5 mg/day in patients with moderate hepatic function impairment (Child-Pugh B). Use in patients with severe hepatic function impairment (Child-Pugh C) is not recommended.CYP3A4 InhibitorsAdults
PO Do not administer more than 5 mg/day in patients taking therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors.
Store tablets at controlled room temperature (59° to 86°F).
May elevate solifenacin plasma concentrations, increasing the risk of side effects.
None well documented.
Dizziness, fatigue (2%); depression (1%).
Blurred vision (5%); dry eyes (2%); pharyngitis (1%).
Dry mouth (28%); constipation (13%); dyspepsia (4%); nausea (3%); abdominal pain (2%); vomiting (1%).
UTI (5%); urinary retention (1%).
Influenza (2%); lower limb edema (1%).
Category C .
Safety and efficacy not established.
Use with caution.
Use with caution.
Use with caution in patients with decreased GI motility, narrow-angle glaucoma, clinically important bladder outflow obstruction.
Severe anticholinergic effects.Chronic
Fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors, and dry skin.
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