Levocetirizinedosage

levocetirizine dihydrochloride 0.5 MG/ML Oral Solution

Dosage and administration

XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption. Perennial Allergic Rhinitis Children 6 months to 2 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening Chronic Idiopathic Urticaria Adults and children 12 years of age and older: 5 mg once daily in the evening Children 6 to 11 years of age: 2.5 mg once daily in the evening Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function

2.1 Perennial

Allergic Rhinitis Children 6 months to 2 Years of Age The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg.

2.2 Chronic

Idiopathic Urticaria Adults and Children 12 Years of Age and Older The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. Children 6 to 11 Years of Age The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults. Children 6 months to 5 Years of Age The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg. Dose Adjustment for Renal and Hepatic Impairment In adults and children 12 years of age and older with: Mild renal impairment (creatinine clearance [CL CR ] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CL CR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CL CR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CL CR <10 mL/min) and patients undergoing hemodialysis should not receive XYZAL. No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 22, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

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