warnings and cautions
5 WARNINGS AND PRECAUTIONS • Angioedema and Anaphylactic Reactions : Promptly discontinue VESIcare LS and provide appropriate therapy. ( 5.1 ) • Urinary Retention : VESIcare LS is not recommended for use in patients with clinically significant bladder outlet obstruction in the absence of clean intermittent catherization. ( 5.2 ) • Gastrointestinal Disorders : VESIcare LS is not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) • Central Nervous System Effects : Somnolence has been reported with solifenacin succinate. Advise patients not to drive or operate heavy machinery until they know how VESIcare LS affects them. ( 5.4 ) • Controlled Narrow-Angle Glaucoma : Use VESIcare LS with caution in patients being treated for narrow-angle glaucoma. ( 5.5 ) • QT Prolongation in Patients at High Risk of QT Prolongation : VESIcare LS is not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. ( 5.6 ) 5.1 Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate. Angioedema associated with upper airway swelling and anaphylactic reactions may be life-threatening. VESIcare LS oral suspension is contraindicated in patients with a known or suspected hypersensitivity to solifenacin succinate [see Contraindications ( 4 )] . If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue VESIcare LS oral suspension and provide appropriate therapy and/or measures necessary to ensure a patent airway. 5.2 Urinary Retention The use of VESIcare LS oral suspension, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction may result in urinary retention. The use of VESIcare LS oral suspension is not recommended in patients with clinically significant bladder outflow obstruction in the absence of clean intermittent catheterization because of the risk of urinary retention. 5.3 Gastrointestinal Disorders The use of VESIcare LS oral suspension, like other antimuscarinic drugs, in patients with conditions associated with decreased gastrointestinal motility may result in further decreased gastrointestinal motility. VESIcare LS oral suspension is contraindicated in patients with gastric retention [see Contraindications ( 4 )] . The use of VESIcare LS oral suspension is not recommended in patients with conditions associated with decreased gastrointestinal motility. 5.4 Central Nervous System Effects Solifenacin succinate is associated with antimuscarinic central nervous system (CNS) adverse reactions [see Adverse Reactions ( 6.2 )] . A variety of CNS antimuscarinic adverse reactions have been reported, including headache, confusion, hallucinations, and somnolence. Monitor patients for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how VESIcare LS affects them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation. 5.5 Controlled Narrow-Angle Glaucoma VESIcare LS should be used with caution in patients being treated for narrow-angle glaucoma [see Contraindications ( 4 )] . 5.6 QT Prolongation in Patients at High Risk of QT Prolongation In a study of the effect of solifenacin succinate on the QT interval conducted in 76 healthy adult women [see Clinical Pharmacology ( 12.2 )] , solifenacin succinate 30 mg (three times the largest maximum recommended dose in pediatric patients) was associated with a mean increase in the Fridericia-corrected QT interval of 8 msec (90% CI, 4, 13). The QT prolonging effect appeared less with solifenacin succinate 10 mg than with solifenacin succinate 30 mg, and the effect of solifenacin succinate 30 mg did not appear as large as that of the positive control moxifloxacin at its therapeutic dose. The use of VESIcare LS is not recommended in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients who are taking medications known to prolong the QT interval.