What is the recommended dose of Levocetrizine (levocetirizine) for pediatric patients?

Levocetirizine Dosing in Pediatric Patients

Levocetirizine dosing in children is strictly age-based: children 6-11 years receive 2.5 mg once daily in the evening, children 12 years and older receive 5 mg once daily in the evening, and the drug is contraindicated in children under 6 years of age per FDA labeling. 1

FDA-Approved Dosing by Age Group

Children 6-11 Years

• Dose: 2.5 mg (½ tablet) once daily in the evening 1
• Do not exceed 2.5 mg in 24 hours 1

Children and Adolescents 12-64 Years

• Dose: 5 mg (1 tablet) once daily in the evening 1
• For less severe symptoms, 2.5 mg once daily may be appropriate 1
• Do not exceed 5 mg in 24 hours 1

Children Under 6 Years

• Do not use 1
• This represents an absolute FDA contraindication for over-the-counter formulations 1

Critical Safety Contraindications

Renal Impairment

• Any child with kidney disease is absolutely contraindicated for levocetirizine 2
• In moderate renal impairment, the dose must be halved 2
• In severe renal impairment, avoid the drug entirely 2

Drug Interactions

• Never combine levocetirizine with other antihistamine-containing products to prevent overdosage 2, 3

Formulation Considerations

• Liquid formulations (oral drops) are strongly preferred for infants and young children when used under medical supervision for easier administration and better absorption 4, 2
• Levocetirizine has minimal sedative effects at recommended doses, unlike first-generation antihistamines 2, 3

Research Evidence for Younger Children (Off-Label Use)

While FDA labeling contraindicates use under 6 years, research studies have evaluated safety and efficacy in younger populations under medical supervision:

Ages 1-5 Years (Off-Label)

• Research studies used 1.25 mg twice daily in children aged 1-5 years with good tolerability 5
• This dosing showed similar adverse event profiles to placebo over 2-week periods 5

Ages 6-11 Months (Off-Label)

• Research studies used 1.25 mg once daily in infants aged 6-11 months 5
• Population pharmacokinetics suggest 0.125 mg/kg twice daily may be appropriate for children 12-24 months under medical supervision 6, 7

Important Caveat

These younger age dosing regimens are research-based only and contradict FDA labeling 1. The FDA explicitly states "do not use" in children under 6 years for over-the-counter products 1. Any use in younger children should only occur under direct specialist supervision with appropriate monitoring.

Clinical Pearls

• Levocetirizine is a second-generation antihistamine with superior safety profile compared to first-generation agents like diphenhydramine 4
• Evening dosing is recommended to maximize symptom control during typical peak allergy hours 1
• The drug has been studied for up to 18 months in young atopic children with excellent long-term safety profile in research settings 8
• No clinically relevant changes in vital signs, ECG parameters (including QT interval), or laboratory values have been observed in pediatric studies 5, 8