Trospium - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS • Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. ( 5.1 , 5.3 ) • Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. • In patients with narrow-angle glaucoma, Trospium Chloride Extended-Release Capsules should be used only with careful monitoring. • Central Nervous System Effects: Somnolence has been reported with Trospium Chloride Extended-Release Capsules.

Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affect them. • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute). • Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration.

5.1 Risk of Urinary Retention Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [s ee CONTRAINDICATIONS ].

5.2 Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride.

In one case, angioedema occurred after the first dose of trospium chloride.

Angioedema associated with upper airway swelling may be life threatening.

If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.3 Decreased Gastrointestinal Motility Trospium Chloride Extended-Release Capsules should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [s ee CONTRAINDICATIONS ].

Trospium Chloride Extended-Release Capsules, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

5.4 Controlled Narrow-angle Glaucoma In patients being treated for narrow-angle glaucoma, Trospium Chloride Extended-Release Capsules should only be used if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring [ see CONTRAINDICATIONS ] .

5.5 Central Nervous System Effects Trospium Chloride Extended-Release Capsules and Trospium Chloride Immediate-Release Tablets are associated with anticholinergic central nervous system (CNS) effects [ see ADVERSE REACTIONS ].

A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations 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 Trospium Chloride Extended-Release Capsules affects them.

If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6 Patients with Severe Renal Impairment Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) [ see DOSAGE AND ADMINISTRATION , USE IN SPECIFIC POPULATIONS , and CLINICAL PHARMACOLOGY ] .

5.7 Alcohol Interaction Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration.

In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.