Fesoterodine Fumarate

FESOTERODINE FUMARATE

Manufacturer: Ascend Laboratories, LLC

Score: 145.0

Quick Summary

Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. The recommended starting dosage is 4 mg orally once daily, which can be increased to 8 mg once daily based on individual response and tolerability. Fesoterodine fumarate extended-release tablets are contraindicated in patients with known or suspected hypersensitivity to the drug, urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. The most commonly reported adverse events include dry mouth, constipation, and dry eyes.

Key Clinical Findings and Indications

Treatment of overactive bladder (OAB) in adults
Symptoms of urge urinary incontinence, urgency, and frequency

Important Safety Information

Warning

Angioedema, urinary retention, gastric retention, and uncontrolled narrow-angle glaucoma

Contraindications

Known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets
Urinary retention
Gastric retention
Uncontrolled narrow-angle glaucoma

Adverse Reactions

Dry mouth
Constipation
Dry eyes
Dyspepsia
Abdominal pain

Dosing Recommendations

General Guidance

Doses greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors

Overactive bladder (OAB)

Adult Dose

4 mg orally once daily, increased to 8 mg once daily as needed

Pediatric Dose

Not established for pediatric patients younger than 6 years of age or weighing 25 kg or less

Special Population Considerations

Pregnancy

No available data on use in pregnant women
Fetotoxicity observed in animal studies at maternal exposures 6 and 3 times the maximum recommended human dose

Nursing Mothers

No information on presence in human milk
Developmental and health benefits of breastfeeding should be considered

Pediatric Use

Not established for pediatric patients younger than 6 years of age or weighing 25 kg or less
Safety and effectiveness not established in pediatric patients

Geriatric Use

No dose adjustment recommended for elderly patients
Incidence of antimuscarinic adverse reactions higher in patients 75 years of age and older

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