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 with liquid. 4mg once daily; may increase to max 8mg once daily. Severe renal impairment (CrCl<30mL/min) or concomitant potent CYP3A4 inhibitors: max 4mg/day.
Urinary or gastric retention. Uncontrolled narrow angle glaucoma.
Severe hepatic impairment: not recommended. Bladder outlet obstruction. Decreased GI motility (eg, severe constipation). Controlled narrow-angle glaucoma. Myasthenia gravis. Monitor for CNS effects esp. after initiation or dose increases; consider reducing dose or discontinue if occurs. Renal or hepatic impairment. Exposure to high environmental temperatures. Pregnancy. Nursing mothers.
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin); see Adult. Additive effects with other antimuscarinic or anticholinergic agents.
Dry mouth, constipation, urinary retention/UTI, dyspepsia, dry eyes; angioedema (discontinue if occurs), CNS effects (eg, headache, dizziness, somnolence).
Hepatic (CYP2D6, CYP3A4).
Renal (primarily), fecal.
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