TROSPIUM CHLORIDE ER

Manufacturer: 35573

Score: 145.0

Quick Summary

Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dosage is one 60 mg capsule daily in the morning, dosed with water on an empty stomach, at least one hour before a meal. Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment. The most common adverse reactions are dry mouth and constipation. Special considerations are needed for pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Increases maximum cystometric bladder capacity and volume at first detrusor contraction

Important Safety Information

Warning

Not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute)

Contraindications

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

Adverse Reactions

Dry mouth
Constipation
Dry eye
Flatulence
Nausea
Abdominal pain
Dyspepsia
Urinary tract infection

Dosing Recommendations

General Guidance

Not recommended for use in patients with severe renal impairment

Overactive bladder

Adult Dose

One 60 mg capsule daily in the morning

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Trospium Chloride Extended-Release Capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus

Nursing Mothers

Trospium Chloride Extended-Release Capsules should be used during lactation only if the potential benefit justifies the potential risk

Pediatric Use

The safety and effectiveness of Trospium Chloride Extended-Release Capsules in pediatric patients have not been established

Geriatric Use

No overall differences in effectiveness were observed between those subjects aged 65 and over and younger subjects
Adverse reactions were reported at a higher incidence in subjects ages 65 and over

Similar Drugs