Generic Name and Formulations:
Fesoterodine fumarate 4mg, 8mg; ext-rel tabs.
Indications for TOVIAZ:
Overactive bladder (OAB) with urge urinary incontinence, urgency, and frequency.
Swallow whole. 4mg once daily; max 8mg once daily. Severe renal insufficiency (CrCl<30mL/min) or concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): max 4mg/day.
Urinary or gastric retention. Uncontrolled narrow angle glaucoma.
Severe hepatic impairment: not recommended. Discontinue promptly if angioedema with upper airway swelling occurs. Bladder outlet obstruction. Controlled narrow angle glaucoma. Hepatic or renal dysfunction. Myasthenia gravis. Decreased gastric motility. Monitor for CNS effects after treatment initiation or dose increases; consider dose reduction or discontinuation if occur. Exposure to high environmental temperatures. Pregnancy (Cat.C). Nursing mothers.
See Adult dose. Increased levels with potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). Additive effects with other antimuscarinic or anticholinergic agents. Monitor with warfarin.
Dry mouth, constipation, urinary retention/UTI, blurred vision, dry eyes, back pain, insomnia, dyspepsia, cough; CNS effects (eg, dizziness, headache, somnolence).
Hepatic (CYP2D6, CYP3A4).
Renal (primarily), fecal.