warnings and cautions
5 WARNINGS AND PRECAUTIONS • Angioedema : Promptly discontinue fesoterodine fumarate and provide appropriate therapy. (5.1) • Urinary Retention : Fesoterodine fumarate is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2) • Decreased Gastrointestinal Motility : Fesoterodine fumarate is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3) • Worsening of Narrow Angle Glaucoma : Use fesoterodine fumarate with caution in patients being treated for narrow-angle glaucoma. (5.4) • Central Nervous System Effects : Somnolence has been reported with fesoterodine fumarate. Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate affects them. (5.5) • Worsening of Myasthenia Gravis Symptoms : Use Fesoterodine fumarate with caution in patients with myasthenia gravis. (5.6) 5.1 Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. 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. Angioedema associated with upper airway swelling may be life-threatening. Fesoterodine fumarate is contraindicated in patients with a known or suspected hypersensitivity to fesoterodine fumarate or any of its ingredients [see Contraindications (4)] . If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine fumarate should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided. 5.2 Urinary Retention in Adult Patients with Bladder Outlet Obstruction The use of fesoterodine fumarate, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury. The use of fesoterodine fumarate is not recommended in patients with clinically significant bladder outlet obstruction, and is contraindicated in patients with urinary retention [see Contraindications (4) and Adverse Reactions (6.1)]. 5.3 Decreased Gastrointestinal Motility Fesoterodine fumarate is associated with decreased gastric motility. Fesoterodine fumarate is contraindicated in patients with gastric retention [see Contraindications (4)]. The use of fesoterodine fumarate is not recommended in patients with decreased gastrointestinal motility, such as those with severe constipation. 5.4 Worsening of Narrow-Angle Glaucoma Fesoterodine fumarate can worsen controlled narrow-angle glaucoma. Fesoterodine fumarate is contraindicated in patients with uncontrolled narrow-angle glaucoma [see Contraindications (4)] . Fesoterodine fumarate should be used with caution in patients being treated for narrow-angle glaucoma. 5.5 Central Nervous Systems Effects Fesoterodine fumarate is associated with anticholinergic central nervous system (CNS) adverse reactions [see Adverse Reactions (6.1)] . A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate affects them. If a patient experiences anticholinergic CNS effects, fesoterodine fumarate dose reduction or discontinuation should be considered. 5.6 Worsening of Myasthenia Gravis Symptoms Fesoterodine fumarate should be used with caution in patients with myasthenia gravis due to the risk of worsening of symptoms of the disease.