Desloratadine Use in 1-Year-Old Children
Desloratadine can be safely given to a 1-year-old child, as FDA labeling and clinical studies support its use in children aged 6 months to 11 months at a dose of 1.0 mg once daily. 1
FDA-Approved Dosing for Infants
For infants 6 to 11 months of age, desloratadine oral solution is dosed at 1.0 mg once daily, as established in controlled clinical trials involving 246 pediatric subjects. 1
For children 12 months to 23 months (which includes your 1-year-old patient), the same 1.0 mg once daily dosing applies, with clinical trial data demonstrating safety over 15 days of treatment. 1
The oral solution formulation (0.5 mg/mL) allows for precise dosing in this age group, making administration practical and accurate. 2
Safety Profile in Young Infants
In the 6-11 month age group clinical trials, adverse events reported at ≥2% frequency and greater than placebo included upper respiratory tract infections (21.2% vs 12.9%), diarrhea (19.7% vs 8.1%), fever (12.1% vs 1.6%), and irritability (12.1% vs 11.3%). 1
Critically, no clinically meaningful changes occurred in any electrocardiographic parameter, including the QTc interval, in pediatric subjects receiving desloratadine. 1
Only 1 of 246 pediatric subjects discontinued treatment due to an adverse event across all age groups studied, demonstrating excellent tolerability. 1
Clinical Advantages Over Alternatives
Desloratadine is one of the few second-generation antihistamines with established safety data extending down to 6 months of age, unlike most alternatives which only have approval starting at age 2 years. 3
The American Academy of Pediatrics recognizes that second-generation antihistamines such as desloratadine have been shown to be well tolerated with very good safety profiles in young children. 4
Desloratadine has superior binding affinity at the H1-receptor compared to other common antihistamines and is at least 10-fold more potent in vivo than its parent compound loratadine. 5
Critical Safety Considerations
Avoid first-generation antihistamines (diphenhydramine, hydroxyzine) in children under 6 years, as between 1969-2006, there were 69 fatalities associated with antihistamines in children under 6 years, with 41 deaths in children under 2 years. 6, 4
Desloratadine does not cross the blood-brain barrier, does not cause sedation, and has no clinically relevant drug-drug interactions or food interactions. 5
The medication achieves steady-state concentrations after approximately 5 doses with a mean half-life of 24-27 hours, supporting once-daily dosing. 5
Practical Administration
Use the oral solution formulation (0.5 mg/mL) rather than tablets for accurate dosing in infants. 1
Administer 2 mL of the oral solution to deliver the 1.0 mg dose for a 1-year-old child. 1
The medication can be given without regard to food intake, providing flexibility in administration timing. 5
When to Consider Alternatives
If desloratadine is unavailable, cetirizine is an alternative second-generation antihistamine with FDA approval for children 6 months and older at 0.25 mg/kg twice daily (approximately 2.5 mg twice daily for a 10 kg infant). 6
For allergic rhinitis specifically, intranasal corticosteroids are the most effective medication class for controlling all four major symptoms (sneezing, itching, rhinorrhea, nasal congestion) in children under 2 years, though they serve a different therapeutic role than antihistamines. 6