Table 2 Drugs used for treatment of asthma in children and 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# | |||
Inhaled corticosteroids | Budesonide (DPI; MDI) | Asthma prophylactic treatment | 2 years | 6 years | 400 μg/day – 2 to 6 years | 800 μg/day |
|  |  |  |  |  | 800 μg/day – 6 to 18 years |  |
|  | Budesonide (INH) |  | 6 months | 12 months | 2000 μg/day | 500 μg/day |
|  | Fluticasone (DPI; MDI) |  | 12 months | 4 years | 200 μg/day – 1 to 4 years; | 200 μg/day (DPI) or 176 μg/day (MDI)– 4 to 11 years; |
|  |  |  |  |  | 400 μg/day – 4 to 16 years | 2000 μg/day (DPI) or 1760 μg/day (MDI) ≥ 12 years |
|  |  |  |  |  | 2000 μg/day > 16 years |  |
|  | Mometasone furoate (DPI) |  | 12 years | 4 years | 800 μg/day | 110 μg/day – 4 to 11 years; |
|  |  |  |  |  |  | 880 μg/day ≥ 12 years |
|  | Beclomethasone Dipropionate |  | 4 years | 5 years | 400 μg/day – 4 to 12 years; | 160 μg/day – 5 to 11 years; |
|  |  |  |  |  | 2000 μg/day ≥ 12 years | 640 μg/day ≥ 12 years |
Oral anti-leukotrienes | Montelukast |  | 6 months | 6 months | 4 mg/day – 6 months to 5 years; |  |
|  |  |  |  |  | 5 mg/day – 6 to 14 years |  |
|  |  |  |  |  | 10 mg/day ≥15 years |  |
Short-acting β2 agonists | Salbutamol or Albuterol | Asthma reliever treatment | None | 4 years (MDI) | 800 μg/day <12 years (MDI) | 1080 μg/day (MDI) |
|  |  |  |  | 2 years(INH) | 10 mg/day < 12 years (INH) | 5 mg/day- 2 to 12 years (INH) |
|  |  |  |  |  | 20 mg/day ≥ 12 years(INH) | 10 mg/day ≥ 12 years (INH) |
|  | Terbutaline (DPI) |  | 3 years | --- | 4 mg/day – 3 to 12 years | --- |
|  |  |  |  |  | 6 mg/day ≥ 12 years |  |
Long-acting β2 agonists | Salmeterol | Asthma prophylactic treatment | 4 years (MDI; DPI) | 4 years (DPI) | 100 μg/day |  |
|  | Formoterol (DPI) |  | 6 years | 5 years | 24 μg/day – 5 to 12 years | 24 μg/day |
|  |  |  |  |  | 48 μg/day ≥ 12 years |  |
Combination long-acting β2 agonists with inhaled corticosteroids | Budesonide/Formoterol (DPI) |  | 6 years | 12 years | 320/18 μg/day – 6 to 12 years | 640/18 μg/day |
|  |  |  |  |  | 640/18 μg/day ≥ 12 years |  |
|  | Fluticasone/Salmeterol |  | 4 years(DPI) | 4 years (DPI) | 200/100 μg/day (DPI; MDI)- 4 to 11years | 200/100 μg/day (DPI)- 4 to 11years |
|  |  |  | 4years(MDI) | 12 years (MDI) | 1000 μg/100day (DPI; MDI)- ≥12 years | 1000 μg/100day (DPI)- ≥12 years |
|  |  |  |  |  |  | 460/42 μg/day (MDI) |