Trospium Chloride

Trade Names:
Sanctura
- Tablets 20 mg

Pharmacology

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Antagonizes effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. Its parasympatholytic action reduces tonus of smooth muscle in the bladder.

Pharmacokinetics

Absorption

Less than 10% absorbed after oral dose (bioavailability 9.6%). C _max occurs 5 to 6 h postdose. Dose increases from 20 to 40 mg or 60 mg result in an increase in C _max of 3- or 4-fold, respectively. There is a diurnal variability with a decrease in C _max and AUC of up to 59% and 33%, respectively, for evening compared with morning doses. Because high-fat meals reduce absorption, it is recommended that trospium be taken at least 1 h before meals or on an empty stomach.

Distribution

Vd is 395 L after a 20 mg dose. Protein binding is 50% to 85%.

Metabolism

Of 10% absorbed, metabolites account for about 40% of excreted dose. Hypothesized metabolic pathway is ester hydrolysis with subsequent conjugation of benzylic acid.

Elimination

Plasma t _½ is approximately 20 h. Majority of dose (85.2%) recovered in feces and 5.8% in urine.

Indications and Usage

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

Contraindications

Patients with or at risk of urinary retention; gastric retention; uncontrolled narrow-angle glaucoma; hypersensitivity to any component of product.

Dosage and Administration

PO 20 mg twice daily on an empty stomach or at least 1 h before meals.

PO 20 mg once daily at bedtime.

PO Titrate dose down to 20 mg once daily based on tolerability.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

Additive effects, leading to increased dry mouth, constipation, and other anticholinergic effects.

Serum concentrations of these agents as well as trospium may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Tachycardia; palpitations, supraventricular tachycardia, chest pain, syncope, hypertensive crisis (postmarketing).

CNS

Headache (4%); fatigue (2%); hallucinations, delirium (postmarketing).

Dermatologic

Stevens-Johnson syndrome (postmarketing).

EENT

Dry eyes (1%); abnormal vision (postmarketing).

GI

Dry mouth (20%); constipation (10%); upper abdominal pain (2%); aggravated constipation, dyspepsia, flatulence (1%); gastritis (postmarketing).

Hypersensitivity

Anaphylactic reactions (postmarketing).

Musculoskeletal

Rhabdomyolysis (postmarketing).

Renal

Urinary retention (1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

May have increased sensitivity to effects of anticholinergic agents.

Renal Function

In patients with severe renal function impairment, there is a 4.5- and 2-fold increase in mean AUC and C _max , respectively, and prolonged elimination t _½ . Dose modification is recommended with CrCl less than 30 mL/min.

Special Risk Patients

Use with caution in patients with GI obstruction (risk of gastric retention), hepatic function impairment, or clinically important bladder overflow obstruction (risk of urinary retention).

Controlled narrow-angle glaucoma

Use only if benefits outweigh risks.

Overdosage

Symptoms

Severe anticholinergic effects.

Patient Information

• Advise patient to take prescribed dose on an empty stomach at least 1 h before or 2 h after a meal.
• Advise patient if a dose is missed to skip that dose and take the next dose at least 1 h before the next meal.
• Advise patient to contact health care provider if urinary symptoms do not improve or worsen while taking this medication.
• Advise patient to take sips of water, chew sugarless gum, or suck on sugarless candy to relieve symptoms of dry mouth.
• Advise patient to avoid strenuous activity during periods of high temperature or humidity.
• Advise patient to avoid alcoholic beverages and sedatives (eg, diazepam) while taking trospium.
• Advise patient that drug may cause dizziness or blurred vision and to use caution while driving or performing other tasks requiring coordination and mental alertness until tolerance is determined.

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Urinary Incontinence, Overactive Bladder

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