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 (Child-Pugh B), or concomitant potent CYP3A4 inhibitors: max 5mg once daily.
Gastric or urinary retention. Uncontrolled narrow-angle glaucoma.
Severe hepatic impairment: not recommended. Bladder outflow obstruction. Decreased GI motility. Controlled narrow-angle glaucoma. History of QT prolongation. Monitor for CNS effects esp. after initiation or dose increases; consider reducing dose or discontinue if occurs. Renal or hepatic impairment. Exposure to high environmental temperature. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole); see Adult. May be antagonized by CYP3A4 inducers. Avoid drugs known to prolong the QT interval. Additive anticholinergic effects with other anticholinergics.
Dry mouth, constipation, UTI, blurred vision; angioedema (discontinue if occurs), CNS effects (eg, headache, confusion, hallucination, somnolence); rare: anaphylactic reactions.
Hepatic (CYP3A4). 98% protein bound.
Renal (major), fecal (minor).