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Pronunciation
(TROSE pee um)
Generic Available (U.S.)
Yes: Tablet
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of overactive bladder with symptoms of urgency, incontinence, and urinary frequency
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.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to trospium or any component of the formulation; urinary retention; gastric retention; uncontrolled narrow-angle glaucoma
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 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).
• Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.
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: Avoid use of extended release formulation in severe renal impairment (Clcr <30 mL/minute). Use immediate release formulation with caution in patients with renal impairment; dosage adjustment is required.
• 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).
Special populations:
• Elderly: Use with caution in the elderly ≥65 years of age; increased anticholinergic side effects are seen.
Dosage form specific issues:
• Extended release: Ethanol should not be ingested within 2 hours of the administration of the extended release formulation.
Adverse Reactions
>10%: Gastrointestinal: Xerostomia (9% to 22%)
1% to 10%:
Cardiovascular: Tachycardia
Central nervous system: Headache (4% to 7%), fatigue (2%)
Dermatologic: Dry skin
Gastrointestinal: Constipation (9% to 10%), abdominal pain (1% to 3%), dyspepsia (1% to 2%), flatulence (1% to 2%), nausea (1%), abdominal distention (<2%), taste abnormal, vomiting
Genitourinary: Urinary tract infection (1% to 7%), urinary retention (≤1%)
Ocular: Dry eyes (1% to 2%), blurred vision (1%)
Respiratory: Nasopharyngitis (3%), nasal dryness (1%)
Miscellaneous: Influenza (2%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, back pain, chest pain, delirium, feces hard, gastritis, hallucinations, hypertensive crisis, palpitation, rash, rhabdomyolysis, somnolence, Stevens-Johnson syndrome, supraventricular tachycardia, syncope, T-wave inversion
Metabolism/Transport Effects
None known.
Drug Interactions
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapy
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy
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. Risk D: Consider therapy modification
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy
Cannabinoids: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoids. Risk C: Monitor therapy
MetFORMIN: May decrease the serum concentration of Trospium. Risk C: Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Risk D: Consider therapy modification
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Ethanol: Ethanol may enhance the sedative effects of trospium. Ethanol may increase the peak (maximum) serum concentration of trospium when consumed within 2 hours of taking extended release trospium. Management: Avoid use of ethanol. 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.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Mechanism of Action
Trospium antagonizes the effects of acetylcholine on muscarinic receptors in cholinergically innervated organs. It reduces the smooth muscle tone of the bladder.
Pharmacodynamics/Kinetics
Absorption: <10%; decreased with food
Distribution: Vd: 395 - >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 (Clcr <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
Dosage
Oral:
Adults: Immediate release formulation: 20 mg twice daily; extended release formulation: 60 mg once daily
Elderly ≥75 years: Immediate release formulation: Consider initial dose of 20 mg once daily (based on tolerability) at bedtime
Dosage adjustment in renal impairment: Clcr ≤30 mL/minute: Immediate release formulation: 20 mg once daily at bedtime; Extended release formulation: Use not recommended
Administration: Oral
Administer 1 hour prior to meals or an empty stomach. Administer extended release capsules in the morning with a full glass of water.
Dietary Considerations
Give 1 hour prior to meals or on an empty stomach.
Patient Education
Take tablets on an empty stomach. Take extended release capsules in the morning with a full glass of water 1 hour before eating. Avoid alcohol for 2 hours before or after taking extended release capsules. May cause dry or sore mouth, constipation, headache or blurred vision, or decreased sweating. Report rapid heart beat.
Geriatric Considerations
In studies, the incidence of anticholinergic side effects was higher in patients ≥65 years of age as compared to younger adults. The extended release formulation should be avoided in patients with Clcr <30 mL/minute.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Significant xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause delirium and hallucinations
Mental Health: Effects on Psychiatric Treatment
Dry mouth and other anticholinergic effects are common; concurrent use with psychotropics may produce additive effects; use caution in patients with Alzheimer's disease
Nursing: Physical Assessment/Monitoring
Use with caution in presence of narrow-angle glaucoma, bladder flow or gastrointestinal obstruction, renal or hepatic impairment, or Alzheimer's. Evaluate voiding patterns at baseline and periodically during therapy.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, extended release, oral, as chloride:
Sanctura® XR: 60 mg
Tablet, oral, as chloride: 20 mg
Sanctura®: 20 mg
Pricing: U.S. (www.drugstore.com)
Capsule, 24-hour (Sanctura XR)
60 mg (30): $171.99
Tablets (Sanctura)
20 mg (30): $99.99
Tablets (Trospium Chloride)
20 mg (30): $82.99
References
Chancellor M and de Miguel F, “Treatment of Overactive Bladder Selective Use of Anticholinergic Agents With Low Drug-Drug Interaction Potential,” Geriatrics, 2007, 62(5):15-24.
Staskin D, Sand P, Zinner N, et al, “Once Daily Trospium Chloride is Effective and Well Tolerated for the Treatment of Overactive Bladder: Results From a Multicenter Phase III Trial,” J Urol, 2007, 178(3 Pt 1): 978-84.
Zinner N, Gittelman M, Harris R, et al, “Trospium Chloride Improves Overactive Bladder Symptoms: A Multicenter Phase III Trial,” J Urol, 2004, 171(6 Pt 1):2311-15.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
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