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trospium chloride er 60 mg cap

In stock Manufacturer PERRIGO CO. 00574011830
$4.92 / Capsule

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Uses

Overactive Bladder

Trospium chloride is used in the management of overactive bladder for the relief of symptoms associated with voiding such as urge urinary incontinence, urgency, and frequency. In two 12-week randomized, placebo-controlled clinical studies in adults 19-94 years of age with overactive bladder, trospium chloride 20 mg twice daily was more effective than placebo in reducing the number of micturitions per 24 hours and the number of urge incontinence episodes per week and increased the volume of urine voided per micturition. In the first clinical study of 523 adults 21-90 years of age with overactive bladder receiving trospium chloride 20 mg twice daily or placebo, urinary frequency decreased from baseline by a mean of 2.4 or 1.3 micturitions per 24 hours, urge incontinence episodes decreased from baseline by a mean of 15.4 or 13.9 occurrences per week, and urine volume voided per micturition was increased by a mean of 32.1 or 7.7 mL per micturition, respectively. In the second nearly identical study of 658 adults 19-94 years of age receiving trospium or placebo, urinary frequency decreased from baseline by a mean of 2.7 or 1.8 micturitions per 24 hours, urge incontinence episodes decreased from baseline by a mean of 16.1 or 12.1 occurrences per week, and urine volume voided per micturition was increased by a mean of 35.6 or 9.4 mL per micturition, respectively. The differences in outcomes (number of micturitions per 24 hours, number of urge incontinence episodes per week, urine volume voided per micturition) between trospium and placebo cohorts were statistically significant for both studies.

Trospium appears to be as effective as immediate-release preparations of oxybutynin or tolterodine in decreasing urinary frequency, and limited information indicates the drug may be more effective than immediate-release preparations of tolterodine in decreasing urgency incontinence compared with placebo. However, some clinicians state that trospium appears to offer no advantage over extended-release anticholinergic preparations for the treatment of overactive bladder.

Dosage and Administration

General

Trospium chloride is administered orally at least 1 hour before meals or on an empty stomach. For the management of overactive bladder, the usual dosage of trospium chloride in adults is 20 mg twice daily.

Special Populations

For patients with severe renal impairment (creatinine clearance less than 30 mL/minute), the recommended dosage is 20 mg once daily at bedtime.

In geriatric patients 75 years of age or older, dosage may be reduced to 20 mg once daily based on patient tolerance.

Cautions

Contraindications

Urinary retention, gastric retention, or uncontrolled angle-closure glaucoma or risk of these conditions.

Known hypersensitivity to trospium chloride or any ingredient in the formulation.

Warnings/Precautions

General Precautions

Urinary Retention

Because of the risk of urinary retention, use with caution in patients with clinically important bladder outflow obstruction.

Decreased GI Motility

May decrease GI motility; use with caution in patients with ulcerative colitis, intestinal atony, and myasthenia gravis. Because of the risk of gastric retention, trospium should be used with caution in patients with obstructive GI disorders.

Controlled Narrow-angle Glaucoma

In patients being treated for angle-closure glaucoma, trospium should be used only if the potential benefits outweigh the risks and then only with careful monitoring.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in small amounts in rats; not known whether trospium is distributed into human milk. Use with caution in nursing women and only if potential benefit justifies the risk to the infant.

Pediatric Use

Safety and efficacy not established in pediatric patients.

Geriatric Use

In patients 75 years of age and older, an increased incidence of adverse anticholinergic effects unrelated to drug exposure was observed; therefore, dosage may be reduced in such patients depending on patient tolerance. (See Dosage and Administration: Special Populations.)

Hepatic Impairment

Use with caution in patients with moderate or severe hepatic impairment.

Renal Impairment

Pharmacokinetics were substantially altered in patients with severe renal impairment (creatinine clearance less than 30 mL/per minute). Dosage reduction is recommended in such patients. (See Dosage and Administration: Special Populations.) Pharmacokinetics not studied in patients with mild or moderate renal impairment.

Common Adverse Effects

Adverse effects occurring in 5% or more of patients receiving trospium include dry mouth and constipation.

Drug Interactions

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of cytochrome P-450 (CYP) isoenzymes: pharmacokinetic interactions unlikely.

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP isoenzymes 1A2, 3A4, 2A6, 2C9, 2C19, 2D6, or 2E1: pharmacokinetic interactions unlikely at clinically relevant concentrations.

Drugs Affected by GI motility

Potential pharmacokinetic interaction (altered absorption because of decreased GI motility).

Alcohol

Potential pharmacologic interaction (additive sedative effects).

Anticholinergic Agents

Potential pharmacologic interaction (additive anticholinergic effects).

Digoxin

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or digoxin).

Metformin

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or metformin).

Morphine

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or morphine).

Pancuronium

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or pancuronium).

Procainamide

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or procainamide).

Tenofovir

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or tenofovir).

Vancomycin

Potential pharmacokinetic interaction (decreased renal elimination and increased serum concentrations of trospium and/or vancomycin).

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