Trospium Chloride in the Treatment of Overactive Bladder: ADVERSE DRUG REACTIONS

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8 May 2010

Overactive BladderAnticholinergic ADEs are common with trospium (Table 4). More than half of the patients in the clinical trials experienced one or more ADEs. The most commonly reported ADEs were dry mouth, constipation, abdominal pain (upper), constipation (aggravated), headache, and fatigue.

CONTRAINDICATIONS AND PRECAUTIONS

Risk of Urinary Retention, Decreased Gastrointestinal Motility, and Controlled Narrow-Angle Glaucoma
Trospium chloride is contraindicated in patients with urinary retention, uncontrolled narrow-angle glaucoma, or gastric retention and in patients who are at risk for the development of these conditions. Patients who have developed a hypersensitivity to trospium or its ingredients should not take it.

Table 4 Incidence (Percent) of Adverse Drug Events Reported by 1% or More of Patients Taking Trospium Chloride for Overactive Bladder

Placebo

Trospium Chloride

Side Effect

(n = 590)

20 mg Twice Daily

Dry mouth

5.8%

20.l%

Constipation

4.6%

9.6%

Abdominal pain, upper

1.2%

l.5%

Constipation aggravated

0.8%

l.4%

Headache

2.0%

4.2%

Fatigue

l.4%

l.9%

Data from Sanctura™ prescribing information. Lexington, MA: Odyssey/Indevus; July 2004.

Urinary retention, decreased gastrointestinal (GI) motility, and abnormal vision (mydriasis) are commonly associated with trospium. Therefore, this drug should be administered with caution in patients with clinically significant bladder outflow obstruction, GI obstructive disorders, ulcerative colitis, intestinal atony, and myasthenia gravis.

Patients who are being treated for narrow-angle glaucoma should use trospium only if the potential benefits outweigh the risks. In such instances, careful monitoring is essential. canadian pharmacy online

Renal and Hepatic Insufficiency

Before they begin therapy with tros-pium, patients should be assessed for renal insufficiency and hepatic impairment. Patients with severe renal insufficiency (a creatinine clearance below 30 ml/minute) have experienced a 4.5-fold and two-fold increase in the mean AUC concentration and Cmax, respectively, as well as an additional elimination phase with a long half-life (approximately 33 hours). Because the Cmax is significant, patients with severe renal insufficiency should receive a single dose of 20 mg/day at bedtime. The pharmaco-kinetics of trospium has not been studied in patients with mild-to-moderate renal impairment (a creatinine clearance of 30 to 80 ml/minute).

Table 5 Dosage and Cost of Agents Currently Used to Treat Overactive Bladder

Drug Dosage Cost*
chloride: average generic price 5 mg PO twice daily or three times daily $22.20
Drug Oxybutynin chloride (Ditropan canadian, Ortho-McNeil) 5 mg PO twice daily or three times daily $60.60
Tolterodine canadian tartrate (Detrol tablet, Pharmacia) 1-2 mg PO twice daily $102.60
Trospium chloride (Sanctura™, Indevus/Odyssey) 20 mg PO twice daily $89.33j
PO = by mouth.
*Cost of treatment for one month with the lowest recommended adult dosage, according to the most recent data (June 30, 2004) from retail
pharmacies nationwide available from NDC Health, a health care information service company.
j Average wholesale price from the manufacturer.
Data from Med Lett 2004;46(ll88):63-64.

After exposure, patients with mild and moderate hepatic impairment experienced increased Cmax concentrations of 12% and 63%, respectively, with an AUC concentration comparable to that of healthy subjects. Clinicians should take precautions when administering tros-pium to patients with moderate and severe hepatic dysfunction.

CONCLUSION

Trospium chloride is the newest anti-spasmodic, anticholinergic agent to be approved by the FDA for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. As shown in Table 5, the recommended dose is 20 mg twice daily to be taken one hour before meals or on an empty stomach. Dosage modifications should be made for patients who have severe renal impairment with a dose of 20 mg once daily at bedtime. For geriatric patients 75 years of age or older, the dose may be titrated downward to 20 mg once daily, based on tol-erability.
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Like other available antispasmodic anti-cholinergic agents, trospium is effective for treating OAB and its symptoms; however, its side-effect profile proves more advantageous than that of older agents.


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