Trospium

Pronunciation

(TROSE pee um)

U.S. Brand Names

Sanctura™

Synonyms

Trospium Chloride

Generic Available

No

Use

Treatment of overactive bladder with symptoms of urgency, incontinence, and urinary frequency

Pregnancy Risk Factor

C

Pregnancy Implications

Maternal toxicity and decreased fetal survival was seen in animal studies when given 10 times the expected clinical exposure. 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; myasthenia gravis

Warnings/Precautions

Use with caution in patients with bladder flow obstruction, may increase the risk of urinary retention. Use with caution in patients with gastrointestinal obstructive disorders (eg, pyloric stenosis); may increase the risk of gastric retention. Use with extreme caution in patients with controlled (treated) narrow-angle glaucoma. Use with caution in renal dysfunction; dosage adjustment is required. Monitor closely when used concurrently with other medications that are eliminated by active tubular secretion (eg, digoxin, procainamide, pancuronium, morphine vancomycin, metformin, tenofovir); may increase levels of trospium and/or the coadministered drug. Use caution in Alzheimer's patients. Use caution in patients with moderate-to-severe hepatic dysfunction. Use caution in the elderly (75 years); increased anticholinergic side effects are seen. Safety and efficacy in pediatric patients have not been established.

Adverse Reactions

>10%: Gastrointestinal: Xerostomia (20%)

1% to 10%:

Cardiovascular: Tachycardia, heart rate increase

Central nervous system: Headache (4%), fatigue (2%)

Dermatologic: Dry skin

Gastrointestinal: Constipation (10%), abdominal pain (2%), dyspepsia (1%), flatulence (1%), abdominal distention, vomiting, dysgeusia

Genitourinary: Urinary retention (1%)

Ocular: Dry eyes (1%), blurred vision

<1%: Angioneurotic edema

Postmarketing and/or case reports: Anaphylaxis, chest pain, delirium, gastritis, hallucinations, hypertensive crisis, palpitation, rhabdomyolysis, Stevens-Johnson syndrome, supraventricular tachycardia, syncope, T-wave inversion

Overdosage/Toxicology

ECG monitoring is recommended. Treatment is symptom-directed and supportive.

Drug Interactions

Cationic drugs (eg, amiloride, digoxin, morphine, metformin, procainamide, quinidine, quinine, ranitidine, tenofovir, triamterene, trimethoprim, and vancomycin), which are eliminated by renal tubular secretion, could have the potential for interaction with trospium by competing for common renal tubular transport systems.

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid use.

Food: Administration with a fatty meal reduced absorption 70% to 80%.

Stability

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%

Distribution: Vd: 395 L, primarily in plasma

Protein binding: 50% to 85% in vitro

Metabolism: Hypothesized to be via esterase hydrolysis and conjugation; forms metabolites

Bioavailability: ~10%

Half-life elimination: 20 hours; severe renal insufficiency (Clcr<30 mL/minute): ~33 hours

Time to peak, plasma: 5-6 hours

Excretion: Feces primarily (85%); urine (~6%; mostly as unchanged drug)

Dosage

Oral:

Adults: 20 mg twice daily

Elderly 75 years: Consider initial dose of 20 mg once daily (based on tolerability) at bedtime

Dosage adjustment in renal impairment: Clcr 30 mL/minute: 20 mg once daily at bedtime

Administration

Administer 1 hour before meals or on an empty stomach.

Dietary Considerations

Give 1 hour prior to meals or on an empty stomach. Avoid alcohol.

Patient Education

Take prescribed oral dose 1 hour prior to or 2 hours after a meal. Avoid alcohol. Void prior to taking medication. May cause dry mouth (frequent mouth care, sucking lozenges, or chewing gum may help); constipation (increased exercise, fluids, fruit, or fiber may help); headache (consult prescriber for analgesic if necessary); dry eyes or blurred vision (use caution when driving or engaging in high risk activity until response to drug is known); decreased sweating (use caution in hot weather, avoid extreme exercise or activity). Report rapid heart beat or persistent adverse effects. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Note breast-feeding caution.

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

Dosage Forms

Tablet, as chloride: 20 mg

International Brand Names

Ceris® (FR); Regurin® (GB, IE); Rekont® (AT); Spasmex® (AR, CZ, DE, HR, RU, SI, YU); Spasmolyt® (AT); Spasmo-lyt® (DE, DK, FI, LU, TH); Spasmoplex® (PT); Spasmo-Rhoival TC® (DE); Spasmo-Urgenin® (EG, KW); Spasmo-Urgenin Neo® (CH); Spasmo-Urgenin TC® (DE, LU); Trospi® (DE); Uraplex® (ES, IT); Uraton® (DE)