Levocetirizine Safety in 8-Month-Old Infants
Levocetirizine is NOT approved for use in infants under 6 months of age according to FDA labeling, and the FDA-approved formulation specifically states "do not use" for children under 6 years of age for the over-the-counter tablet formulation. 1 However, prescription formulations and clinical research demonstrate safety and efficacy in infants as young as 6 months.
FDA-Approved Age and Dosing
- The FDA drug label for over-the-counter levocetirizine tablets explicitly states "children under 6 years of age: do not use" 1
- However, prescription levocetirizine oral solution has been studied and used safely in infants starting at 6 months of age 2
- For an 8-month-old infant, levocetirizine 1.25 mg once daily is the appropriate dose based on clinical trial data 2
Clinical Evidence Supporting Safety in Infants 6-11 Months
- A multicenter, double-blind, randomized trial specifically evaluated levocetirizine 1.25 mg once daily in 69 infants aged 6-11 months with allergic rhinitis or chronic urticaria 2
- The overall incidence of treatment-emergent adverse events was similar between levocetirizine and placebo 2
- Most adverse events were mild or moderate in intensity 2
- No clinically relevant changes in vital signs, laboratory parameters, or ECG parameters (including QT interval) were observed 2
- Only 3 patients discontinued therapy due to adverse events in the levocetirizine group 2
Dosing Recommendations for 8-Month-Old Infants
The evidence-based dose for infants 6-11 months is 1.25 mg once daily 2
- Alternative dosing studied in toddlers 12-24 months used 0.125 mg/kg twice daily, which showed excellent pharmacokinetic and pharmacodynamic profiles 3
- Young children have rapid oral clearance of levocetirizine compared to older patients, which is why twice-daily dosing may be necessary in very young children 4, 5
- The recommended volume per dose is 2.5-3.5 mL twice daily (morning and evening) when using oral solution 4
Safety Profile Compared to Other Antihistamines
- Second-generation antihistamines like levocetirizine have been shown to be well tolerated with a very good safety profile in young children 6, 7
- This contrasts sharply with first-generation antihistamines and over-the-counter cough/cold medications, which have been associated with 54 fatalities in children under 6 years (43 under age 1 year) between 1969-2006 6
- The FDA's advisory committees recommended against OTC cough and cold medications for children under 6 years due to safety concerns, but specifically noted that second-generation antihistamines like levocetirizine have demonstrated good safety profiles 6
Important Safety Considerations
- Cetirizine (the racemic mixture) may cause sedation at recommended doses, with counseling needed about this risk 4, 7
- However, no cardiac effects such as QT prolongation have been observed in infants receiving levocetirizine 4, 7
- For infants with renal impairment, reduce the dose by 50% in moderate renal impairment 4, 7
- Avoid use in severe renal impairment (creatinine clearance <10 mL/min) 7
Long-Term Safety Data
- An 18-month safety study in 510 atopic children aged 12-24 months receiving levocetirizine 0.125 mg/kg twice daily showed no significant differences from placebo in adverse events, growth parameters, developmental milestones, or laboratory tests 8
- Long-term use (18 months) showed no clinically relevant adverse effects on physical and psychomotor development 9, 8
Clinical Bottom Line
For an 8-month-old infant, levocetirizine 1.25 mg once daily is safe and appropriate based on clinical trial evidence in infants 6-11 months old. 2 This must be prescribed as a prescription oral solution, not the over-the-counter tablet formulation which is not approved for this age group. 1 Monitor for sedation as the primary potential adverse effect, though the incidence is similar to placebo in this age group. 2