What is the recommended dose of levocetrizine (antihistamine) for infants?

Levocetirizine Dosing in Infants

Levocetirizine is contraindicated in infants under 6 months of age, and for infants 6-11 months, the recommended dose is 1.25 mg once daily. 1

Age-Specific Dosing Guidelines

Infants 6-11 Months

• 1.25 mg once daily is the FDA-approved dose for this age group 1, 2
• This dosing was validated in clinical trials showing good safety and tolerability in 69 infants over 2 weeks 2
• Do not exceed the recommended daily dose 1

Children 12-24 Months (Toddlers)

• 0.125 mg/kg twice daily (equivalent to approximately 1.25 mg twice daily for most toddlers) 3, 4, 5
• This weight-based dosing accounts for the more rapid clearance of levocetirizine in very young children 3, 4
• Twice-daily dosing is necessary in this age group because the elimination half-life is only 4.1 hours, significantly shorter than in adults 4
• Long-term safety has been confirmed for up to 18 months of continuous use at this dose 5

Children 1-5 Years

• 1.25 mg twice daily (total 2.5 mg/day) 2
• Clinical trials demonstrated this dose was well-tolerated with no clinically significant adverse effects 2

Children 6-11 Years

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

Critical Contraindications

Absolute contraindications include: 1

• Infants under 6 months of age
• Any child with kidney disease (renal impairment)
• The dose must be halved in children with moderate renal impairment, and the drug should be avoided entirely in severe renal impairment 6

Important Clinical Considerations

Pharmacokinetic Differences in Infants

• Infants and young children have significantly higher weight-normalized clearance compared to adults, requiring relatively higher mg/kg doses 3, 7
• Oral clearance increases by 0.044 L/h/kg with each kilogram of body weight 3, 7
• Peak plasma levels occur within 1 hour of administration 4

Safety Profile

• The most common adverse events are mild and include upper respiratory tract infections and transient gastroenteritis symptoms, with no significant difference from placebo 5, 2
• No clinically relevant changes in vital signs, ECG parameters (including QT interval), or laboratory values were observed in pediatric studies 2
• Levocetirizine has minimal sedative effects at recommended doses, unlike older first-generation antihistamines 8

Administration Guidance

• Never combine levocetirizine with other antihistamine-containing products to prevent overdosage 8
• Liquid formulations (oral drops) are preferred for infants and young children for easier administration and better absorption 9
• Compliance with dosing should be documented, as bioavailability can be significantly reduced (to 28%) with noncompliance 7

Common Pitfalls to Avoid

• Do not use adult tablet formulations in infants - use only the oral liquid drops formulation for precise weight-based dosing 2
• Do not assume once-daily dosing is adequate in children under 2 years - twice-daily dosing is necessary due to rapid clearance 3, 4
• Do not use levocetirizine in any infant with renal impairment without dose adjustment or specialist consultation 6, 1
• Do not extrapolate adult dosing to infants - pharmacokinetic differences require specific pediatric dosing regimens 3, 7