Desloratadine Use in 1-Year-Old Children
Desloratadine can be given to a 1-year-old child at a dose of 1.25 mg once daily, as this age group (12-23 months) has been studied and approved by the FDA for this indication. 1
FDA-Approved Dosing for Infants
- For children aged 12 months to 23 months, desloratadine oral solution is dosed at 1.25 mg once daily. 1
- The medication is available as an oral solution (0.5 mg/mL), making administration feasible in young children. 2
- Desloratadine has specific FDA approval and safety data for infants as young as 6 months of age, distinguishing it from most other second-generation antihistamines. 3
Safety Profile in Young Children
- In clinical trials of 12-23 month-old infants receiving desloratadine, the most common adverse events (occurring more frequently than placebo) included fever (16.9% vs 12.9%), diarrhea (15.4% vs 11.3%), and upper respiratory tract infections (10.8% vs 9.7%). 1
- No serious adverse events occurred in pediatric trials, and only 1 of 246 children discontinued treatment due to adverse events. 1
- Desloratadine does not cause clinically meaningful ECG changes, including QTc prolongation, in pediatric patients. 1
- The medication does not cross the blood-brain barrier significantly, resulting in minimal sedation compared to first-generation antihistamines. 4
Comparison to Other Antihistamines
- Most second-generation antihistamines (cetirizine, loratadine) only have FDA approval starting at age 2 years, though cetirizine extends down to 6 months in some formulations. 5
- Desloratadine is one of only three antihistamines (along with cetirizine and montelukast) with substantial safety data in infants under 2 years. 3
- The American Academy of Pediatrics recognizes second-generation antihistamines including desloratadine as well-tolerated with good safety profiles in young children. 5
Critical Safety Considerations
- First-generation antihistamines (diphenhydramine, hydroxyzine) should be avoided in children under 6 years due to serious safety concerns, including 41 reported fatalities in children under 2 years between 1969-2006. 5
- No dose adjustment is needed for desloratadine in young children based on renal function unless severe renal impairment is present. 1
- Desloratadine has been shown safe at doses up to 9 times the recommended dose without cardiovascular adverse effects. 6
Clinical Context
- For a 1-year-old with allergic rhinitis, intranasal corticosteroids remain the most effective first-line treatment according to guidelines, but desloratadine serves as an appropriate and safe second-line or adjunctive option. 5
- The oral solution formulation allows for accurate dosing in infants using an appropriate measuring device such as a 3-mL or 5-mL oral syringe. 1