Generic Name and Formulations:
Solifenacin succinate 5mg, 10mg; tabs.

Company:
Astellas Pharma US, Inc.
Indications for VESICARE:
Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Adult:
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.

Children:
Not established.

Contraindications:
GI or urinary retention. Uncontrolled narrow-angle glaucoma.

Warnings/Precautions:
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.

Interactions:
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.

Pharmacological Class:
Antispasmodic/anticholinergic.

Adverse Reactions:
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.

Metabolism:
Hepatic (CYP3A4). 98% protein bound.

Elimination:
Renal (major), fecal (minor).

Generic Availability:
NO

How Supplied:
Tabs—30, 90