Trospium chloride
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Severe renal impairment (creatinine clearance less than 30 mL/minute) may significantly alter the disposition of trospium chloride extended-release capsules. In a study of immediate-release trospium chloride, 4.2-fold and 1.8-fold increases in mean AUC (0-∞) and C max , respectively, were detected in patients with severe renal impairment.
Use of trospium chloride extended-release capsules is not recommended in patients with severe renal impairment [see Warnings and Precautions and Clinical Pharmacology] . The pharmacokinetics of trospium chloride have not been studied in patients with creatinine clearance ranging from 30 to 80 mL/min. 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.
Dosing in liver impairment
Hepatic Impairment There is no information regarding the effect of severe hepatic impairment on exposure to trospium chloride extended-release capsules. In a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean C max increased 12% and 63%, respectively, and mean AUC (0-∞) decreased 5% and 15%, respectively, compared to healthy subjects.
The clinical significance of these findings is unknown. Caution is advised, however, when administering trospium chloride extended-release capsules to patients with moderate to severe hepatic impairment.
Drug interactions
Check trospium chloride against a medication listLabel text (6 paragraphs)
Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with trospium chloride extended-release capsules. However, some drugs which are actively secreted by the kidney may interact with trospium chloride extended-release capsules by competing for renal tubular secretion. The concomitant use of trospium chloride extended-release capsules with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic effects may increase the frequency and/or severity of such effects.
Trospium chloride extended-release capsules may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. Some drugs which are actively secreted by the kidney may interact with trospium chloride extended-release capsules by competing for renal tubular secretion. ( 7 ) Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) Exposure to trospium on average was comparable in the presence of and without antacid, however, some individuals demonstrated increases or decreases in trospium exposure in the presence of antacid. The clinical relevance of these findings is not known.
( 7.2 ) Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.3 )
7.1 Digoxin Concomitant use of trospium chloride 20 mg twice daily and digoxin did not affect the pharmacokinetics of either drug [see Clinical Pharmacology ( 12.3 )].
7.2 Antacid While the systemic exposure of trospium on average was comparable with and without antacid containing aluminum hydroxide and magnesium carbonate, 5 out of 11 individuals in a drug interaction study demonstrated either an increase or decrease in trospium exposure, in presence of antacid. The clinical relevance of these findings is not known [see Clinical Pharmacology ( 12.3 )].
7.3 Metformin Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC (0-24) and by 34% for mean C max . The effect of a decrease in trospium exposure on the efficacy of trospium chloride extended-release capsules is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg trospium chloride extended-release capsules once daily under fasted condition. The effect of metformin at higher doses on trospium PK is unknown [see Clinical Pharmacology ( 12.3 )].
Contraindications
Trospium Chloride Extended-Release Capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. Trospium Chloride Extended-Release Capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions ( 4 ) patients with known hypersensitivy ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Trospium is an antispasmotic and anticholinergic agent used to treat urinary incontinence and overactive bladder syndrome. Trospium has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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