Important Safety Information
IMPORTANT SAFETY INFORMATION AND INDICATION
TOVIAZ® (fesoterodine fumarate) is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients with known hypersensitivity to the drug or its ingredients or to DETROL® (tolterodine tartrate) tablets or DETROL® LA (tolterodine tartrate extended release capsules).
Warnings and Precautions
Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine, in some cases after the first dose. Patients should be advised to promptly discontinue fesoterodine therapy and seek immediate medical attention if they experience edema of the tongue, laryngopharynx, or difficult breathing.
TOVIAZ tablets should be used with caution in patients with clinically significant bladder outlet obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or myasthenia gravis.
TOVIAZ is associated with anticholinergic central nervous system (CNS) effects including headache, dizziness and somnolence. Advise patients not to drive or operate heavy machinery until they know how TOVIAZ affects them. Consider dose reduction or drug discontinuation if a patient experiences anticholinergic CNS effects.
The recommended starting dose of TOVIAZ is 4 mg once daily swallowed whole. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. Doses greater than 4 mg are not recommended in patients with severe renal insufficiency (CLCR <30 mL/min), or in patients taking a potent CYP3A4 inhibitor, such as ketoconazole, itraconazole, and clarithromycin. TOVIAZ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).
The most frequently reported adverse events (≥4%) for TOVIAZ were: dry mouth (placebo, 7%; TOVIAZ 4 mg, 19%; TOVIAZ 8 mg, 35%) and constipation (placebo, 2%; TOVIAZ 4 mg, 4%; TOVIAZ 8 mg, 6%).
TOVIAZ® (fesoterodine fumarate) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
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