Toviaz

— THERAPEUTIC CATEGORIES —
  • Overactive bladder/enuresis

Toviaz Generic Name & Formulations

General Description

Fesoterodine fumarate 4mg, 8mg; ext-rel tabs.

Pharmacological Class

Muscarinic antagonist.

How Supplied

Tabs—30

Manufacturer

Generic Availability

NO

Toviaz Indications

Indications

Overactive bladder (OAB) in adults with urge urinary incontinence, urgency, and frequency. Neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥6yrs and weighing >25kg.

Toviaz Dosage and Administration

Adult

Swallow whole with liquid. Initially 4mg once daily; may increase to max 8mg once daily. Severe renal impairment (CrCl<30mL/min) or concomitant strong CYP3A4 inhibitors: max 4mg/day.

Children

<6yrs or ≤25kg: not established. Swallow whole with liquid. ≥6yrs (>25–35kg): 4mg once daily, may increase to 8mg once daily if needed; (>35kg): initially 4mg once daily, then increase to 8mg once daily after 1 week. Mild to moderate renal impairment (eGFR 30–89mL/min/1.73m2): (>25–35kg): max 4mg/day; (>35kg): no change (same as above). Severe renal impairment (eGFR 15–29mL/min/1.73m2) or concomitant strong CYP3A4 inhibitors: (>25–35kg): not recommended; (>35kg): max 4mg/day.

Toviaz Contraindications

Contraindications

Urinary or gastric retention. Uncontrolled narrow angle glaucoma.

Toviaz Boxed Warnings

Not Applicable

Toviaz Warnings/Precautions

Warnings/Precautions

Significant bladder outlet obstruction, decreased GI motility (eg, severe constipation), severe hepatic impairment: not recommended. Controlled narrow-angle glaucoma. Risk of worsening myasthenia gravis symptoms. 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.

Toviaz Pharmacokinetics

See Literature

Toviaz Interactions

Interactions

Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). Additive effects with other antimuscarinic or anticholinergic agents.

Toviaz Adverse Reactions

Adverse Reactions

Dry mouth, constipation; in children: also diarrhea, UTI, abdominal pain, nausea, weight increased, headache; angioedema (discontinue if occurs), CNS effects (eg, headache, dizziness, somnolence).

Toviaz Clinical Trials

See Literature

Toviaz Note

Not Applicable

Toviaz Patient Counseling

See Literature

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