TROSPIUM CHLORIDE ER - Warnings CAPSULE

The FDA requires all potential medication risks for TROSPIUM CHLORIDE ER (capsule) be disclosed to consumers, no matter how rare. Here are the warnings and precautions for TROSPIUM CHLORIDE ER.

Warnings & 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. ( 5.2)

In patients with narrow angle glaucoma, Trospium Chloride Extended-Release Capsules should be used only with careful monitoring. ( 5.4)

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 affects them. ( 5.5)

Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). ( 5.6)

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

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 [see contraindications ( 4)].

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.

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 [ see Contraindications (4) ]. 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.

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 (4) ].

central nervous system effects

Trospium Chloride Extended-Release and Trospium Chloride Immediate Release Capsules are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2 ) ]. 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.

patients with severe renal impairment

Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Dosage and Administration (2) Use in Specific Populations (8.6), and Clinical Pharmacology (12.3 ) ].

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.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Search Drugs and Medication

Or Browse by Name