Fexofenadine Oral Dosing for Babies
Fexofenadine is not recommended for infants under 6 months of age, and for babies 6 months to 2 years old, the recommended dose is 15 mg twice daily.
Age-Based Dosing Recommendations
Infants Under 6 Months
- No established dosing recommendations exist
- Safety and efficacy have not been established in this age group
- Alternative treatments should be considered for allergic symptoms
Infants 6 Months to 2 Years
- Recommended dose: 15 mg twice daily 1
- Available as oral suspension (6 mg/mL) for easier administration
- Mean treatment duration in safety studies was 8 days
- Maximum studied dose: 30 mg twice daily (also shown to be safe but not necessary for efficacy) 1
Children 2-5 Years
- Recommended dose: 30 mg twice daily 2, 3
- Available as oral suspension (6 mg/mL) or tablet formulation
Administration Considerations
- Oral suspension (6 mg/mL) is preferred for babies and young children 3, 4
- For the 15 mg dose, administer 2.5 mL of the suspension
- Can be given without regard to meals
- If suspension is unavailable, capsule/tablet contents may be mixed with approximately 10 mL of applesauce 2
Safety Profile
The safety profile of fexofenadine in babies 6 months to 2 years has been specifically studied:
- Treatment-emergent adverse events were comparable between fexofenadine and placebo groups 1
- Most common side effect was vomiting (14.1% with 15 mg dose vs. 13.6% with placebo) 1
- No clinically significant differences in vital signs, ECG results, or physical examination findings 1
- Most adverse events were mild to moderate in intensity and unrelated to the medication 1
Clinical Efficacy
- Fexofenadine is effective for allergic rhinitis symptoms including sneezing, rhinorrhea, and itchy nose/eyes 5
- Unlike first-generation antihistamines, fexofenadine does not cause significant sedation or anticholinergic effects 6
- Second-generation antihistamines like fexofenadine are preferred over first-generation options due to better safety profile 6
Important Considerations and Precautions
- Always use weight-appropriate dosing for babies
- Monitor for any adverse reactions, particularly with initial doses
- Avoid first-generation antihistamines in babies due to risk of sedation and anticholinergic effects 6
- If symptoms persist or worsen despite appropriate dosing, consult a pediatrician
- The pharmacokinetic profile of the 30 mg suspension in children 2-5 years is similar to that seen with the same dose in older children and comparable to 60 mg in adults 3
Remember that while fexofenadine has been studied and found safe in babies as young as 6 months, always consult with a pediatrician before initiating treatment in very young children, especially those under 1 year of age.