Trospium/xanomeline Disease Interactions

The use of trospium is contraindicated in patients with gastric retention. Trospium reduces the tonus of smooth muscle and may decrease gastrointestinal motility, hence it should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis. Caution should be exercised when using this drug in patients with gastrointestinal obstructive disorders as it increases the risk of gastric retention.

The use of trospium is contraindicated in patients with uncontrolled narrow-angle glaucoma. In those patients being treated for narrow-angle glaucoma, trospium should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring.

Use of trospium is contraindicated in patients with urinary retention. Administer trospium with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

Use of xanomeline, a component of xanomeline-trospium, is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C). Use is not recommended in patients with mild hepatic impairment (Child-Pugh A). Xanomeline was not studied in patients with severe hepatic impairment. Assess liver enzymes prior to therapy, and as clinically indicated.

The use of alcohol may enhance the drowsiness caused by anticholinergic agents. It is recommended that alcohol should not be consumed within 2 hours of trospium administration. Caution should be exercised when using this agent in alcoholic patients.

Caution is advised when administering trospium to patients with moderate to severe hepatic impairment. There is no information regarding the effect of severe hepatic impairment on exposure to trospium.

Trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. A reduced dose is recommended in patients with severe renal impairment (CrCl less than 30 mL/minute). The pharmacokinetics of trospium have not been studied in patients with CrCl 30 to 80 mL/min.