1.2. Pediatrics

Oral non-sedating antihistamines are FDA-approved for use in pediatric patients for allergic rhinitis and chronic urticaria. Cetirizine and levocetirizine are FDA-approved for use in children 6 months of age and older with urticaria and seasonal allergic rhinitis. Desloratadine is FDA-approved for use in children 6 months of age and older with chronic idiopathic urticaria and perennial allergic rhinitis and 2 years of age and older for seasonal allergic rhinitis, and fexofenadine and loratadine are FDA-approved for use in children 2 years and older for allergic rhinitis. The nasal non-sedating antihistamine, azelastine 0.1% solution, is FDA-approved for use in children 2 years and older for seasonal allergic rhinitis treatment, while olopatadine, another nasal non-sedating antihistamine, is indicated for use in children 6 years and older for seasonal allergic rhinitis therapy. Azelastine 0.15% solution is approved for use in children 5 years and older for perennial allergic rhinitis; azelastine 0.1% is FDA-approved for perennial allergic rhinitis treatment in children 6 months to 11 years. Azelastine 0.1% solution is also indicated for use in pediatric patients 12 years and older with vasomotor rhinitis. Safety and efficacy of oral non-sedating antihistamine/decongestant combination products have not been established in children less than 12 years of age. Maximum recommended pediatric dosages for available non-sedating antihistamines are summarized in Tables 3 and 4. Dosages identified in Texas Medicaid patients exceeding these recommendations will be reviewed.

Table 3. Pediatric Maximum Recommended Dosages for Non-sedating Antihistamines – Monotherapy1-11
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
azelastine (Astepro®, Astepro Allergy®, generics)
  • **0.15% nasal solution – 205.5 mcg/spray
 seasonal and perennial allergic rhinitis
  • 6 years to 11 years:
    • 1 spray per nostril twice daily
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily
azelastine (Astepro ® generics)
  • 0.1% nasal solution – 137 mcg/spray
 perennial allergic rhinitis
  • 6 months to 11 years:
    • 1 spray per nostril twice daily
azelastine (Astepro ® generics)   seasonal allergic rhinitis
  • 2 years to 11 years:
    • 1 spray per nostril twice daily
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily
azelastine (generics)   vasomotor rhinitis
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily
cetirizine (Zyrtec®, generics)
  • **tablets, chewable tablets – 5 mg, 10 mg
  • **orally disintegrating tablets - 10 mg
  • **liquid filled capsule – 10 mg
  • **solution – 1 mg/mL
  • syrup – 1 mg/ mL
 perennial or seasonal allergic rhinitis    
  • 6 months to 11 months:
    • 2.5 mg once daily (oral solution only)
  • 12 months to 5 years:
    • 5 mg once daily
  • 6 years to 17 years:
    • 10 mg once daily
cetirizine (Zyrtec®, generics)
  • **tablets, chewable tablets – 5 mg, 10 mg
  • **liquid filled capsule – 10 mg
  • **solution – 1 mg/mL
  • syrup – 1 mg/ mL
 chronic urticaria
  • 6 months to 11 months:
    • 2.5 mg once daily (oral solution only)
  • 12 months to 5 years:
    • 5 mg once daily
  • 6 years to 17 years:
    • 10 mg once daily
desloratadine (Clarinex®, generics)
  • tablets – 5 mg
  • rapidly disintegrating tablets - 2.5 mg, 5 mg
 chronic idiopathic urticaria; seasonal and perennial allergic rhinitis    
  • 6 years to 11 years:
    • 2.5 mg once daily
  • 12 years to 17 years:
    • 5 mg once daily
fexofenadine (Children’s Allegra® Allergy suspension, generics)
  • **suspension – 30 mg/5 mL
 allergic rhinitis
  • 2 years to 11 years:
    • 30 mg (1 teaspoon) every 12 hours
  • 12 years to 17 years:
    • 60 mg twice daily
fexofenadine (Children’s Allegra® Allergy suspension, generics)
  • **suspension – 30 mg/5 mL
 allergic rhinitis
  • 2 years to 11 years:
    • 30 mg (1 teaspoon) every 12 hours
  • 12 years to 17 years:
    • 60 mg twice daily
fexofenadine (Children’s Allegra® Allergy suspension, generics)   chronic idiopathic urticaria
  • 6 months to 2 years:
    • 15 mg twice daily
  • 2 years to 11 years:
    • 30 mg twice daily
  • 12 years to 17 years:
    • 60 mg twice daily or 180 mg once daily
fexofenadine (Children’s Allegra® Allergy ODT, generics)
  • **orally disintegrating tablets - 30 mg
 allergic rhinitis
  • 6 years to 11 years:
    • 30 mg (1 ODT) on tongue every 12 hours
  • 12 years to 17 years:
    • 60 mg (2 ODTs) on tongue every 12 hours
fexofenadine (Children’s Allegra® Allergy ODT, generics)   chronic idiopathic urticaria
  • 6 years to 11 years:
    • 30 mg (1 ODT) on tongue every 12 hours
  • 12 years to 17 years:
    • 60 mg (2 ODTs) on tongue every 12 hours
fexofenadine (Allegra®, generics)
  • **tablets – 30 mg, 60 mg, 180 mg
 allergic rhinitis
  • 12 years to 17 years:
    • 60 mg twice daily or 180 mg once daily
fexofenadine (Allegra®, generics)   chronic idiopathic urticaria
  • 6 years to 11 years:
    • 30 mg twice daily
  • 12 years to 17 years:
    • 60 mg twice daily or 180 mg once daily
levocetirizine (Xyzal®, generics)
  • **tablet – 5 mg
  • **oral solution – 2.5 mg/5 mL
 allergic rhinitis
  • 6 months to 5 years:*
    • 1.25 mg once daily in the evening (oral solution only)
  • 6 years to 11 years:
    • 2.5 mg once daily in evening
  • 12 years to 17 years:
    • 5 mg once daily in evening
levocetirizine (Xyzal®, generics)   chronic idiopathic urticaria
  • 6 months to 5 years:*
    • 1.25 mg once daily in the evening (oral solution only)
  • 6 years to 11 years:
    • 2.5 mg once daily in evening
  • 12 years to 17 years:
    • 5 mg once daily in evening
loratadine (Claritin®, Alavert®, Claritin Children’s®, Claritin RediTabs®, generics)
  • **tablets – 10 mg
  • **chewable tablets (Claritin®) – 5 mg
  • **rapidly disintegrating tablets (Claritin RediTabs®) – 5 mg, 10 mg
  • **liquid-gel capsule – 10 mg
  • **solution - 5 mg/5 mL
 perennial or seasonal allergic rhinitis
  • 2 years to 5 years:
    • 5 mg once daily (chewable tablets, solution)
  • 6 years to 17 years:
    • 10 mg once daily or 5 mg every 12 hours
  loratadine oral solution 5mg/5mL chronic idiopathic urticaria
  • 6 years to 17 years:
    • 10 mg once daily or 5 mg every 12 hours
olopatadine (Patanase®, generics) 0.6% nasal solution seasonal allergic rhinitis
  • 6 years to 11 years:
    • 1 spray per nostril twice daily
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily

Legend:

  • **now over-the-counter
  • *OTC use only indicated in patients 2 years and older
Table 4. Pediatric Maximum Recommended Dosages for Non-sedating Antihistamines – Combination Therapy1,2,12-19
Drug Name Treatment Indication Dosage Form/Strength Maximum Recommended Dosage
azelastine/fluticasone (Dymista®) seasonal allergic rhinitis nasal suspension – 137 mcg/ 50 mcg per actuation
  • 6 years to 17 years:
    • 1 spray per nostril twice daily
**cetirizine/ pseudoephedrine (Zyrtec-D®, generics) perennial or seasonal allergic rhinitis 12-hour tablets (cetirizine 5 mg/ pseudoephedrine 120 mg/ tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**fexofenadine/ pseudoephedrine (Allegra-D®, generics) seasonal allergic rhinitis 12-hour tablets (fexofenadine 60 mg/ pseudoephedrine 120 mg/ tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**fexofenadine/ pseudoephedrine (Allegra-D®, generics) seasonal allergic rhinitis 24-hour tablets (fexofenadine 180 mg/ pseudoephedrine 240 mg/ tablet)
  • 12 years to 17 years:
    • 1 tablet once daily
desloratadine/ pseudoephedrine (Clarinex-D® 12 hour, generics) seasonal allergic rhinitis 12-hour tablets (2.5 mg desloratadine/ 120 mg pseudoephedrine/ tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**loratadine/pseudoephedrine (Claritin D® 12 Hour, Alavert Allergy and Congestion D®- 12 Hour, generics) seasonal allergic rhinitis 12-hour tablets
(loratadine 5mg/pseudoephedrine 120 mg/tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**loratadine/pseudoephedrine extended release (Claritin D® 24 Hour, generics) seasonal allergic rhinitis 24-hour tablets (loratadine 10 mg/pseudoephedrine 240 mg/tablet)
  • 12 years to 17 years:
    • 1 tablet once daily

Legend:

  • **now over-the-counter