What is the recommended dose of fexofenadine (Allegra) for pediatric patients?

Fexofenadine Dosing in Pediatric Patients

For pediatric patients with seasonal allergic rhinitis or chronic idiopathic urticaria, fexofenadine 30 mg twice daily is recommended for children ages 6-11 years, with dose reduction to 30 mg once daily in those with renal impairment. 1

Age-Based Dosing Recommendations

Children 6-11 Years

• Standard dose: 30 mg twice daily with water 1
• For renal impairment: 30 mg once daily as starting dose 1
• This dosing produces comparable drug exposure to the adult 60 mg dose 2

Children 2-5 Years

• Dose: 30 mg once daily (administered as oral suspension) 3
• The 30 mg dose in this age group achieves similar plasma exposures to 30-60 mg doses in older children and adults, respectively 3
• Oral suspension formulation (6 mg/mL) improves ease of administration and compliance 3

Children 6 Months to 2 Years

• Dose: 15 mg for children weighing ≤10.5 kg 2
• Dose: 30 mg for children weighing >10.5 kg 2
• Safety and effectiveness have not been formally established by FDA in children under 6 years 1

Adolescents ≥12 Years

• Dose: 60 mg twice daily OR 180 mg once daily 1
• For renal impairment: 60 mg once daily as starting dose 1

Indications

Seasonal Allergic Rhinitis

• Fexofenadine significantly reduces total symptom scores including sneezing, rhinorrhea, itchy nose/palate/throat, and itchy/watery/red eyes 4
• Does not effectively treat nasal congestion, as antihistamines have limited effect on nasal blockage 4

Chronic Idiopathic Urticaria

• Same dosing regimen as for allergic rhinitis 1
• Efficacy in children 6-11 years is extrapolated from adult data and pharmacokinetic comparisons 1

Safety Profile

Adverse Events

• Fexofenadine is exceptionally well-tolerated with adverse event rates comparable to placebo 5, 6
• Headache is the most common adverse event (6.6-9.4% across all groups including placebo) 5
• No dose-related increase in adverse events observed even at 60 mg twice daily (double the recommended dose) 5
• Treatment discontinuation due to adverse events is rare (approximately 1%) and not attributed to the medication 5

Key Safety Advantages

• No sedation at any dose, including supratherapeutic doses 7, 6
• Fexofenadine, loratadine, and desloratadine do not cause sedation at recommended doses, unlike cetirizine which may cause mild drowsiness 7
• No cardiotoxicity or QT prolongation 6, 4
• No anticholinergic effects 7
• No performance impairment on driving or psychomotor testing 6

Special Populations

• Renal impairment: Reduce to once-daily dosing 1
• Hepatic impairment: No dose adjustment required; well-tolerated 6
• Elderly: Generally well-tolerated, though dose selection should consider renal function 1

Clinical Considerations

Timing and Administration

• Administer with water 1
• Avoid concurrent fruit juices (particularly grapefruit, orange, apple) as they may reduce absorption 1
• Can be taken without regard to meals 1

Comparison to Other Antihistamines

• Second-generation antihistamines (fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine) are well-tolerated in young children with excellent safety profiles 7
• Fexofenadine is preferred when complete absence of sedation is critical, as it shows no sedative properties even at doses exceeding recommendations 7, 6
• First-generation antihistamines should be avoided in children due to sedation, anticholinergic effects, and performance impairment 7

Common Pitfalls to Avoid

• Do not use fexofenadine as monotherapy for nasal congestion; it has minimal effect on this symptom 4
• Ensure parents understand to avoid all OTC cold medications containing other antihistamines to prevent duplication 8
• Do not assume all second-generation antihistamines are non-sedating; cetirizine and intranasal azelastine may cause sedation 7