TROSPIUM CHLORIDE

Manufacturer: Padagis US LLC

Score: 145.0

Quick Summary

Trospium chloride is a muscarinic antagonist used to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose is 20 mg twice daily, taken at least one hour before meals or on an empty stomach. Key clinical findings indicate that trospium chloride increases maximum cystometric bladder capacity and volume at first detrusor contraction, with a low incidence of adverse reactions such as dry mouth, constipation, and headache. Important safety information includes contraindications for patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and known hypersensitivity to the drug. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with dose adjustments recommended for patients with severe renal impairment or aged 75 years and older.

Key Clinical Findings and Indications

Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
Increases maximum cystometric bladder capacity and volume at first detrusor contraction
Low incidence of adverse reactions such as dry mouth, constipation, and headache

Important Safety Information

Warning

Contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and known hypersensitivity to the drug

Contraindications

Urinary retention
Gastric retention
Uncontrolled narrow-angle glaucoma
Known hypersensitivity to the drug

Adverse Reactions

Dry mouth
Constipation
Headache
Fatigue
Urinary retention
Dry eyes

Dosing Recommendations

General Guidance

Recommended dose is 20 mg once daily at bedtime for patients with severe renal impairment, and may be titrated down to 20 mg once daily based on tolerability for geriatric patients aged 75 years and older

Overactive bladder

Adult Dose

20 mg twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy only if potential benefit justifies potential risk to patient and fetus
Based on animal data, predicted to have low probability of increased risk of adverse developmental outcomes

Nursing Mothers

Excreted in human milk to a limited extent
Use during lactation only if potential benefit justifies potential risk to newborn

Pediatric Use

Safety and effectiveness not established in pediatric patients

Geriatric Use

Dose may be titrated down to 20 mg once daily based on tolerability for patients aged 75 years and older
Increased incidence of anticholinergic adverse reactions in patients aged 75 years and older

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