Overactive bladder/enuresis:

Indications for: TOVIAZ

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

Adult Dosage:

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 Dosage:

<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:

Urinary or gastric retention. Uncontrolled narrow angle glaucoma.

TOVIAZ 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 Classification:

Muscarinic antagonist.

TOVIAZ Interactions:

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

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).

Generic Drug Availability:

NO

How Supplied:

Tabs—30