Solifenacin

Angioedema involving the face, lips, tongue, and/or larynx have been reported; some cases have occurred after the first dose. May be life-threatening. Immediately discontinue and institute supportive care if tongue, hypopharynx, or larynx is involved.

CNS effects have been reported (eg, headache, confusion, hallucinations, somnolence); monitor for CNS effects, particularly at treatment initiation or dose increase; reduce dose or discontinue, if necessary. May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.

Anaphylactic reactions have been reported rarely; immediately discontinue therapy if anaphylactic reaction develops. Disease-related concerns:

Preliminary data suggest that long-term use of anticholinergics may potentially adversely affect the clinical course of Alzheimer disease in patients receiving cholinesterase inhibitors (Lu 2003, Sink 2008). Additional monitoring for decreases in cognition and functional abilities and increased problematic behaviors should be considered in patients with dementia receiving dual therapy with an anticholinesterase inhibitor and a bladder anticholinergic, such as solifenacin.

Use with caution in patients with bladder outflow obstruction (eg, BPH); may increase the risk of urinary retention.

Use with caution in patients with decreased GI motility (severe constipation, ulcerative colitis) or GI obstructive disorders (pyloric stenosis); may increase the risk of gastric retention.

Use with caution in patients with controlled (treated) narrow-angle glaucoma; use is contraindicated in uncontrolled narrow-angle glaucoma.

Use with caution in patients with moderate hepatic impairment (Child-Pugh class B); dosage adjustment required; use is not recommended in patients with severe hepatic impairment (Child-Pugh class C).

Use with caution in patients with a known history of QT prolongation or other risk factors for QT prolongation (eg, concomitant use of medications known to prolong QT interval, electrolyte abnormalities). The risk for QT prolongation is dose-related.

Use with caution in patients with renal impairment; dosage adjustment is required for severe renal impairment (CrCl Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.