(TROSE pee um)
- Trospium Chloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule Extended Release 24 Hour, Oral, as chloride:
Sanctura XR: 60 mg [DSC]
Generic: 60 mg
Tablet, Oral, as chloride:
Sanctura: 20 mg [DSC]
Generic: 20 mg
Brand Names: U.S.
- Sanctura XR [DSC]
- Sanctura [DSC]
- Anticholinergic Agent
Trospium antagonizes the effects of acetylcholine on muscarinic receptors in cholinergically innervated organs. It reduces the smooth muscle tone of the bladder.
<10%; decreased with a high-fat meal
Vd: 395 - >600 L, primarily in plasma
Hypothesized to be via esterase hydrolysis and conjugation; forms metabolites
Feces (85%); urine (~6%; mostly as unchanged drug) primarily via active tubular secretion
Time to Peak
Immediate release formulation: 20 hours
Severe renal insufficiency (CrCl <30 mL/minute): ~33 hours; extended release formulation: ~35 hours
48% to 85% in vitro
Special Populations: Renal Function Impairment
In patients with severe renal function impairment, there is a 4.5- and 2-fold increase in mean AUC and Cmax, respectively, and prolonged elimination t½.
Special Populations: Hepatic Function Impairment
In patients with with severe renal function impairment, there is a 4.2- and 1.8-fold increase in mean AUC and Cmax, respectively, and prolonged elimination half-life.
Special Populations: Elderly
In patients with mild or moderate hepatic impairment, the Cmax increased 12% and 63%, respectively (immediate release).
Special Populations: Gender
Pharmacokinetic data are conflicting. Exposure was 45% lower in elderly women compared with elderly men when a single 40 mg immediate-release dose was administered. AUC and Cmax were 26% and 68% higher, respectively, in women without hormone replacement therapy compared with men.
Use: Labeled Indications
Treatment of overactive bladder with symptoms of urgency, incontinence, and urinary frequency
Hypersensitivity to trospium or any component of the formulation; urinary retention; gastric retention; uncontrolled narrow-angle glaucoma
Overactive bladder: Oral:
Immediate release: 20 mg twice daily
Extended release: 60 mg once daily
Elderly ≥75 years: Immediate release: Consider initial dose of 20 mg once daily (based on tolerability); Extended release: Refer to adult dosing.
Dosing: Renal Impairment
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
Dosing: Hepatic Impairment
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.
Administer 1 hour prior to meals or on an empty stomach. Administer extended release capsules in the morning with a full glass of water.
Take1 hour prior to meals or on an empty stomach.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Alcohol (Ethyl): May enhance the CNS depressant effect of Trospium. Alcohol (Ethyl) may increase the serum concentration of Trospium. Specifically, alcohol 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 trospium XR. Consider therapy modification
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
MetFORMIN: May decrease the serum concentration of Trospium. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. 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. Avoid combination
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. 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. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
>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% (Limited to important or life-threatening): Anaphylaxis, angioedema, confusion, delirium, drowsiness, fecal impaction, gastritis, hallucination, heat intolerance, hypertensive crisis, inversion T wave on ECG, palpitations, rhabdomyolysis, Stevens-Johnson syndrome, supraventricular tachycardia, syncope, visual disturbance
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).
• 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.
Pregnancy Risk Factor
Adverse events were observed in animal studies. There are no adequate or well-controlled studies in pregnant women; use only if clearly needed.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience dry mouth, headache, blurred vision, or fatigue. Have patient report immediately to prescriber severe dizziness, passing out, lack of sweat, confusion, hallucinations, difficult urination, severe constipation, vision changes, eye pain, severe eye irritation, angioedema, or painful urination (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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