Version May 2024
Overactive bladder: Oral:
Immediate release: 20 mg twice daily
Extended release: 60 mg once daily in the morning
CrCl ≥30 mL/minute: No dosage adjustment provided in manufacturer's labeling. However, renal impairment increases systemic exposure to trospium. Monitor for increased adverse effects.
CrCl <30 mL/minute:
Immediate release: 20 mg once daily at bedtime
Extended release: Use not recommended
Mild impairment: No dosage adjustment provided in manufacturer's labeling.
Moderate to severe impairment: No dosage adjustment provided in manufacturer's labeling; use with caution.
Elderly ≥75 years: Immediate release: Consider initial dose of 20 mg once daily (based on tolerability); Extended release: Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Xerostomia (9% to 22%)
1% to 10%:
Cardiovascular: Tachycardia (<2%)
Central nervous system: Headache (4% to 7%), fatigue (2%)
Dermatologic: Skin rash (<2%), xeroderma
Gastrointestinal: Constipation (9% to 10%), abdominal pain (1% to 3%), dyspepsia (1% to 2%), flatulence (1% to 2%), abdominal distention (<2%), nausea (1%), dysgeusia, vomiting
Genitourinary: Urinary tract infection (1% to 7%), urinary retention (≤1%)
Infection: Influenza (2%)
Ophthalmic: Dry eye syndrome (1% to 2%), blurred vision (1%)
Respiratory: Nasopharyngitis (3%), dry nose (1%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, back pain, chest pain, confusion, delirium, dizziness, drowsiness, fecal impaction, gastritis, hallucination, heat intolerance, hypertensive crisis, inversion T wave on ECG, palpitations, rhabdomyolysis, Stevens-Johnson syndrome, supraventricular tachycardia, syncope, visual disturbance
Hypersensitivity to trospium or any component of the formulation; patients with or at risk of urinary retention, gastric retention, uncontrolled narrow-angle glaucoma
Concerns related to adverse effects:
• Angioedema: Cases of angioedema involving the face, lips, tongue, and/or larynx have been reported. Immediately discontinue if tongue, hypopharynx, or larynx are involved.
• CNS effects: May cause drowsiness, confusion, dizziness, hallucinations, and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns:
• Alzheimer's disease: Use with caution in patients with Alzheimer's disease.
• Bladder flow obstruction: Use with caution in patients with bladder flow obstruction; may increase the risk of urinary retention.
• Gastrointestinal obstructive disorders: Use with caution in patients with gastrointestinal obstructive disorders (ie, pyloric stenosis); may increase the risk of gastric retention.
• Glaucoma: Use with caution in patients with controlled (treated) narrow-angle glaucoma.
• Hepatic impairment: Use with caution in patients with moderate or severe hepatic impairment.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis due to decreased GI motility.
• Renal impairment: Use immediate release formulation with caution in patients with renal impairment; dosage adjustment is required. Use of the extended release formulation is contraindicated in patients with severe renal impairment (CrCl <30 mL/minute).
• Ulcerative colitis: Use with caution in patients with ulcerative colitis due to decreased GI motility.
Concurrent drug therapy issues:
• Medications eliminated by active tubular secretion (ATS): ATS is a route of elimination; use caution with other medications that are eliminated by ATS (eg, procainamide, pancuronium, vancomycin, morphine, metformin, and tenofovir).
• Sedatives: Effects with other sedative drugs or ethanol may be potentiated.
Dosage form specific issues:
• Extended release: Ethanol should not be ingested within 2 hours of the administration of the extended release formulation; may increase incidence of drowsiness.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule Extended Release 24 Hour, Oral, as chloride:
Generic: 60 mg
Tablet, Oral, as chloride:
Generic: 20 mg
Yes
Capsule ER 24 Hour Therapy Pack (Trospium Chloride ER Oral)
60 mg (per each): $6.74 - $10.77
Tablets (Trospium Chloride Oral)
20 mg (per each): $0.50 - $6.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as chloride:
Trosec: 20 mg
Generic: 20 mg
Immediate release: Administer with water on an empty stomach at least 1 hour prior to meals.
Extended release: Administer in the morning with water on an empty stomach at least 1 hour before a meal.
Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. ER capsules should be swallowed whole. Do not crush or chew. IR formulation is available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery.
Overactive bladder: Treatment of overactive bladder with symptoms of urgency, incontinence, and urinary frequency
Beers Criteria: Trospium is identified in the Beers Criteria as a potentially inappropriate medication in patients 65 years and older due to its strong anticholinergic properties (Beers Criteria [AGS 2023]).
Substrate of OCT1, OCT2
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Alcohol (Ethyl): May enhance the CNS depressant effect of Trospium. Management: Avoid consuming any alcohol within 2 hours of taking a dose of trospium XR. Alcohol may increase sedation and CNS depressant effects of trospium XR. Risk D: Consider therapy modification
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy
Chlorprothixene: Anticholinergic Agents may enhance the anticholinergic effect of Chlorprothixene. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Ethanol: Ethanol may increase the peak (maximum) serum concentration of trospium when consumed within 2 hours of taking extended release trospium. Management: Avoid consuming any alcohol within 2 hours of taking a dose of extended release trospium.
Food: Administration with a fatty meal reduces the absorption and bioavailability of trospium. Management: Administer 1 hour prior to meals or an empty stomach. Administer extended release capsules in the morning with a full glass of water.
Adverse events were observed in animal studies.
It is not known if trospium is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Anticholinergic effects (eg, dry mouth, constipation, dizziness); renal function; postvoid residual urine volume at baseline and as clinically indicated thereafter (AUA [Lerner 2021]); urinary tract infection prior to initiation of therapy (ACOG 2015).
Trospium antagonizes the effects of acetylcholine on muscarinic receptors in cholinergically innervated organs. It reduces the smooth muscle tone of the bladder.
Absorption: <10%; decreased with a high-fat meal
Distribution: Vd: 395 to >600 L, primarily in plasma
Protein binding: 48% to 85% in vitro
Metabolism: Hypothesized to be via esterase hydrolysis and conjugation; forms metabolites
Bioavailability: Immediate release formulation: ~10% (range: 4% to 16%)
Half-life elimination: Immediate release formulation: 20 hours
Severe renal insufficiency (CrCl <30 mL/minute): ~33 hours; extended release formulation: ~35 hours
Time to peak, plasma: 5-6 hours
Excretion: Feces (85%); urine (~6%; mostly as unchanged drug) primarily via active tubular secretion
Altered kidney function: In patients with severe renal function impairment, there is a 4.2- and 1.8-fold increase in mean AUC and Cmax, respectively, and prolonged elimination t½.
Hepatic function impairment: In patients with mild or moderate hepatic impairment, the Cmax increased 12% and 63%, respectively (immediate release).
Sex: Pharmacokinetic data are conflicting. In patients 60 to 75 years of age, exposure was 45% lower in females compared with males when a single 40 mg immediate-release dose was administered. AUC and Cmax were 26% and 68% higher, respectively, in females without hormone therapy compared with males.
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