DETROL®LA (tolterodine tartrate extended release capsules) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Important Safety Information
DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL LA is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate.
Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL LA. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, DETROL LA should be discontinued and appropriate therapy promptly provided.
DETROL LA capsules should be used with caution in patients with clinically significant bladder outflow obstruction, gastrointestinal obstructive disorders, controlled narrow-angle glaucoma, myasthenia gravis, and QTc prolongation.
DETROL LA is associated with anticholinergic central nervous system (CNS) effects including dizziness and somnolence. Advise patients not to drive or operate heavy machinery until DETROL LA effects have been determined. Consider dose reduction or drug discontinuation if a patient experiences anticholinergic CNS effects.
The recommended dose of DETROL LA capsules is 4 mg once daily swallowed whole. For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B), or severe renal impairment (CCr 10-30 mL/min), the recommended starting dose is 2 mg once daily. DETROL LA is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr <10 mL/min have not been studied and use of DETROL LA is not recommended.
The most frequently reported adverse events (≥4%) for DETROL LA were: dry mouth (placebo, 8%; DETROL LA, 23%), headache (placebo, 4%; DETROL LA, 6%), constipation (placebo, 4%; DETROL LA, 6%), and abdominal pain (placebo, 2%; DETROL LA, 4%).