Zuellig Pharma
Concise Prescribing Info
Fesoterodine fumarate
Overactive bladder w/ symptoms of urge urinary incontinence, urgency & frequency.
Dosage/Direction for Use
Adult & elderly Recommended dose: 4 mg once daily, may be increased to 8 mg once daily. Max: 8 mg once daily. Duration of treatment: 2-8 wk. Patient receiving potent CYP3A4 inhibitors Max: 4 mg once daily. Mild & moderate renal impairment 4-8 mg. Severe renal impairment 4 mg. Mild & moderate renal impairment w/ concomitant use of moderate CYP3A4 inhibitor 4 mg. Mild hepatic impairment 4-8 mg. Moderate hepatic impairment 4 mg. Mild hepatic impairment w/ concomitant use of moderate CYP3A4 inhibitor 4 mg.
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Hypersensitivity to peanut or soya. Urinary &/or gastric retention; uncontrolled narrow angle glaucoma; myasthenia gravis; severe ulcerative colitis; toxic megacolon. Concomitant use of potent CYP3A4 inhibitors in moderate to severe hepatic or renal impairment. Severe hepatic impairment (Child-Pugh C).
Special Precautions
Discontinue use if angioedema occurs. Risk of urinary retention & decreased GI motility; controlled narrow-angle glaucoma; myasthenia gravis; autonomic neuropathy; GI obstructive disorders eg, pyloric stenosis; GERD &/or taking drugs that cause or exacerbate oesophagitis eg, oral bisphosphanates; UTI; risk for QT-prolongation & preexisting cardiac diseases. Monitor for signs of anticholinergic effects. Concomitant use w/ CYP3A4 inhibitors, potent CYP3A4 inducers & CYP2D6 inhibitors. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in severe hepatic impairment. Severe renal impairment. May affect ability to drive or operate machinery. Pregnancy. Not recommended during lactation. Childn <18 yr.
Adverse Reactions
Dry mouth, eyes & throat; constipation, dyspepsia, nausea, upper abdominal pain, UTI, upper resp tract infection, dysuria, urinary retention, cough, peripheral edema, back pain, insomnia; increased alanine aminotransferase & γ-glutamyltransferase; skin rash.
Drug Interactions
Increased frequency &/or severity of AR & other anticholinergic effects w/ antimuscarinic agents. Altered absorption w/ anticholinergic agents. Increased Cmax & AUC w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, miconazole & clarithromycin & CYP2D6 metabolizers.
ATC Classification
G04BD11 - fesoterodine ; Belongs to the class of urinary antispasmodics.
Toviaz prolonged-release tab 4 mg
Toviaz prolonged-release tab 8 mg
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