Generic Name and Formulations:
Solifenacin succinate 5mg, 10mg; tabs.
Astellas Pharma US, Inc.
Indications for VESICARE:
Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Swallow whole with water. Initially 5mg once daily; if well tolerated, may increase to 10mg once daily. Severe renal impairment (CrCl<30mL/min), moderate hepatic impairment, or concomitant potent CYP3A4 inhibitors (eg, ketoconazole): max 5mg once daily.
GI or urinary retention. Uncontrolled narrow-angle glaucoma.
Severe hepatic impairment: not recommended. Bladder outflow obstruction. GI obstructive disorders. Decreased GI motility. Controlled narrow-angle glaucoma. History of QT prolongation. Renal or hepatic insufficiency. Monitor for signs of CNS effects esp. after initiating treatment or dose increases; consider dose reduction or discontinue if occurs. Exposure to high environmental temperature. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid drugs known to prolong the QT interval. Additive anticholinergic effects with other anticholinergics. Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole). May be antagonized by CYP3A4 inducers.
Anticholinergic effects (eg, dry mouth, constipation, blurred vision), urinary tract infection, nausea, dyspepsia; CNS effects (eg, headache, confusion, somnolence), angioedema (discontinue if occurs); rare: anaphylactic reactions.
Hepatic (CYP3A4). 98% protein bound.
Renal (major), fecal (minor).
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