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Table 3 Drugs used for treatment of allergic rhinitis, urticaria and atopic eczema in children and their authorizations for their use according to age, dose and indication

From: Off-label prescribing for allergic diseases in children

Category

Drug

Indication

Age lower limit

Maximum allowed dose

Europe

USA

Europe*

US#

Nasal inhaled corticosteroids

Budesonide

Allergic Rhinitis

6 years

6 years

400 μg/day

400 μg/day

Fluticasone furoate

4 years

4 years

50 μg/day – 4 to 12 years

200 μg/day

   

200 μg/day ≥ 12 years

 

Mometasone

6 years

2 years

100 μg/day

100 μg/day -2 to 11 years;

      

200 μg/day ≥ 12 years

Oral antihistamines

Cetirizine

Allergic rhinitis; Urticaria

2 years

6 months

5 mg/day – 2 to 6 years;

2.5 mg/day- 6 months to 1year

    

10 mg/day > 6 years

5 mg/day- >1 year to 5 years

     

10 mg ≥ 6 years

 

Levocetirizine

2 years

6 months

2.5 mg/day – 2 to 6 years;

1.25 mg 6 months to 5 years

    

5 mg/day – older than 6 years

2.5 mg- 6 years to 11 years

     

5 mg ≥ 12 years

 

Loratadine

2 years

2 years

5 mg/day – 2 to 6 years;

    

10 mg/day > 6 years

 

Desloratadine

12 months

6 months

1.25 mg/day – 1 to 5 years;

1 mg – 6 to 11 months

    

2.5 mg/day – 6 to 12 years;

1.25 mg/day – 1 to 5 years;

    

5 mg/day ≥ 12 years;

2.5 mg/day – 6 to 11 years;

     

5 mg/day ≥ 12 years

 

Fexofenadine

 

6 years

6 years

60 mg/day – 6 to 11 years

30 mg/day- 6 months to < 2 years

    

180 mg/day ≥ 12 years

60 mg/day – 2 to 11 years

     

180 mg/day ≥ 12 years

 

Diphenhydramine

6 years

2 years

75 mg/day – 6 to 12 years;

37.5 mg/day – 2 to 5 years

    

150 mg/day > 12 years

150 mg/day – 6 to 11 years

     

300 mg/day ≥ 12 years

Topical immunomodulators

Pimecrolimus

Atopic Dermatitis

2 years

2 years

Twice daily, intermittent treatment 12 months

Twice daily, intermittent treatment 12 months

 

Tacrolimus

 

2 years

2 years

0.03%- 2 to 15 years

0.03% – 2 to 15 years

     

0.1% ≥ 16 years

0.1% ≥ 16 years

     

(twice daily for 3 weeks then once daily, intermittent use)

(twice daily for intermittent use)

  1. *Data obtained in the Summaries of Product Characteristics (SPC) of one European country (Portugal, Infarmed[47]) #Data obtained in the FDA approved Drugs Database [48].
  2. Comparison between an European country (regulated by EMA and the national authority) and the United States of America (regulated by FDA).