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Trospium

Pronunciation

Pronunciation

(TROSE pee um)

Index Terms

  • Trospium Chloride

Dosage Forms

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]

Pharmacologic Category

  • Anticholinergic Agent

Pharmacology

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 - >600 L, primarily in plasma

Metabolism

Hypothesized to be via esterase hydrolysis and conjugation; forms metabolites

Excretion

Feces (85%); urine (~6%; mostly as unchanged drug) primarily via active tubular secretion

Time to Peak

5-6 hours

Half-Life Elimination

Immediate release formulation: 20 hours

Severe renal insufficiency (CrCl <30 mL/minute): ~33 hours; extended release formulation: ~35 hours

Protein Binding

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

Contraindications

Hypersensitivity to trospium or any component of the formulation; urinary retention; gastric retention; uncontrolled narrow-angle glaucoma

Dosing: Adult

Overactive bladder: Oral:

Immediate release: 20 mg twice daily

Extended release: 60 mg once daily

Dosing: Geriatric

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.

Administration

Administer 1 hour prior to meals or on an empty stomach. Administer extended release capsules in the morning with a full glass of water.

Dietary Considerations

Take1 hour prior to meals or on an empty stomach.

Storage

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).

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. 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

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

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

Adverse Reactions

>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

Warnings/Precautions

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.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal studies. There are no adequate or well-controlled studies in pregnant women; use only if clearly needed.

Patient Education

• 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 constipation, dry mouth, blurred vision, or fatigue. Have patient report immediately to prescriber severe dizziness, passing out, lack of sweat, confusion, hallucinations, urinary retention, 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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