Fesoterodine fumarate

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

General Guidance

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

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