1.2. Pediatrics

ICS as individual agents are FDA-approved for use in pediatric asthma management in children as young as 4 years of age. Pediatric therapy initiation differs by age for individual agents and is summarized in Table 3. Prescribed dosages exceeding these recommendations will be reviewed.

Table 3: Maximum Recommended Pediatric Doses for ICS as Monotherapy in Asthma1-11
Drug Name Dosage Form/Strength Patient Age/Maximum Recommended Dosage
beclomethasone dipropionate HFA (QVAR Redihaler) inhalation aerosol: 40 mcg/actuation
  • children 4-11 years: 
    • 4 actuations/day in divided doses (2 actuations twice daily); total dose = 160 mcg/day
  • adolescents 12-17 years: 
    • 16 actuations/day in divided doses (8 actuations twice daily); total dose = 640 mcg/day
  inhalation aerosol: 80 mcg/actuation
  • children 4-11 years: 
    • 2 actuations/day in divided doses (1 actuation twice daily); total dose = 160 mcg/day 
  • adolescents 12-17 years: 
    • 8 actuations/day in divided doses (4 actuations twice daily); total dose = 640 mcg/day
budesonide (Pulmicort Flexhaler) inhalation powder: 90 mcg/actuation
  • children, adolescents 6-17 years: 
    • 8 actuations/day in divided doses (4 actuations twice daily); total dose = 720 mcg/day
  inhalation powder: 180 mcg/actuation
  • children, adolescents 6-17 years: 
    • 4 actuations/day in divided doses (2 actuations twice daily); total dose = 720 mcg/day
ciclesonide (Alvesco) inhalation aerosol:  80 mcg/actuation
  • adolescents 12-17 years:
    • prior therapy with bronchodilators alone: 
      • 4 actuations/day in divided doses(2 actuations twice daily); total dose = 320 mcg/day
    • prior therapy with ICS, oral corticosteroids: 
      • 8 actuations/day in divided doses(4 actuations twice daily); total dose = 640 mcg/day
  inhalation aerosol: 160 mcg/actuation
  • adolescents 12-17 years:
    • prior therapy with bronchodilators alone: 
      • 2 actuations/day in divided doses(1 actuation twice daily); total dose = 320 mcg/day
    • prior therapy with ICS, oral corticosteroids: 
      • 4 actuations/day in divided doses(2 actuations twice daily); total dose = 640 mcg/day
fluticasone furoate (Arnuity Ellipta) dry powder inhaler: 50 mcg/actuation
  • children 5-11 years: 
    • 1 actuation once daily; total dose = 50 mcg/day
  dry powder inhaler: 100 mcg/actuation
  • adolescents 12-17 years:
    • 1 actuation once daily; total dose = 100 mcg/day*
  dry powder inhaler: 200 mcg/actuation
  • adolescents 12-17 years: 
    • 1 actuation once daily; total dose = 200 mcg/day*
fluticasone propionate HFA (Flovent HFA, generics) inhalation aerosol: 44 mcg/actuation
  • children 4-11 years:
    • regardless of prior therapy:
      • 4 actuations/day in divided doses (2 actuations twice daily); total dose = 176 mcg/day
  inhalation aerosol: 110 mcg/actuation
  • adolescents 12-17 years:
    • prior therapy with bronchodilators alone, ICS:
      • 16 actuations/day in divided doses (8 actuations twice daily); total dose = 1760 mcg/day
  inhalation aerosol: 220 mcg/actuation
  • adolescents 12-17 years:
    • prior therapy with bronchodilators alone, ICS:
      • 8 actuations/day in divided doses (4 actuations twice daily); total dose = 1760 mcg/day
fluticasone propionate (Flovent Diskus) dry powder inhaler: 50 mcg/actuation
  • children 4-11 years: 
    • regardless of prior therapy:
      • 4 actuations/day in divided doses (2 actuations twice daily); total dose = 200 mcg/day 
  dry powder inhaler: 100 mcg/actuation
  • children 4-11 years: 
    • regardless of prior therapy:
      • 2 actuations/day in divided doses (1 actuation twice daily); total dose = 200 mcg/day 
  • adolescents 12-17 years:
    • total dose = 2000 mcg/day
  dry powder inhaler: 250 mcg/actuation
  • adolescents 12-17 years:
    • 8 actuations/day in divided doses (4 actuations twice daily); total dose = 2000 mcg/day
fluticasone propionate (ArmonAir Digihaler) dry powder inhaler:  55 mcg/actuation
  • adolescents 12-17 years: 
    • no current corticosteroid therapy:
    • 2 actuations/day in divided doses (1 actuation twice daily); total dose = 110 mcg
  dry powder inhaler: 113 mcg/actuation
  • adolescents 12-17 years: 
    • prior treatment with ICS:
      • 2 actuations/day in divided doses (1 actuation twice daily); total dose = 226 mcg
  dry powder inhaler: 232 mcg/actuation
  • adolescents 12-17 years: 
    • prior treatment with ICS:
      • 2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg
mometasone HFA (Asmanex HFA) inhalation aerosol: 50 mcg/actuation
  • children 5-11 years: 
    • regardless of prior therapy:
      • 4 actuations/day (2 actuations twice daily); total dose = 200 mcg/day
  inhalation aerosol: 100 mcg/actuation
  • adolescents 12-17 years: 
    • prior therapy with medium-dose ICS:
    • 4 actuations/day (2 actuations twice daily); total dose = 400 mcg/day
  inhalation aerosol: 200 mcg/actuation
  • adolescents 12-17 years:
    • prior therapy with high-dose ICS, oral corticosteroids:
      • 4 actuations/day (2 actuations twice daily); total dose = 800 mcg/day^
mometasone (Asmanex Twisthaler) inhalation powder: 110 mcg/actuation
  • children 4-11 years:
    • 1 actuation/day once daily in evening; total dose = 110 mcg/day
  inhalation powder: 220 mcg/actuation
  • adolescents 12-17 years:
    • prior therapy with bronchodilators alone, ICS:
      • 1 actuation twice daily or 2 actuations once daily; total dose = 440 mcg/day
    • prior therapy with oral corticosteroids:
      • 4 actuations/day (2 actuations twice daily); total dose = 880 mcg/day

Legend:

  • * initial fluticasone furoate dose in patients not on ICS is 100 mcg once/day; if 100 mcg not effective, dose should be increased to 200 mcg once daily
  • ^ prednisone should be tapered slowly, beginning at least one week after mometasone use

Combined therapy with aerosolized inhaled ICS and long-acting beta2-agonists is only FDA-approved for use in asthma treatment in children greater than or equal to 5 years of age; combined ICS/ long-acting beta2-agonist therapy as inhalation powder is FDA-approved for use in asthma management in children 4 years of age and older. Maximum recommended orally inhaled doses for available aerosolized corticosteroids as combination therapy are summarized in Table 4. Prescribed dosages exceeding these recommendations will be reviewed.

Table 4: Maximum Pediatric Recommended Doses for ICS as Combination Therapy for Asthma 1,2,12-16,20,21
Drug Name Dosage Form/Strength Patient Age/Maximum Recommended Dosage
budesonide/ formoterol (Symbicort) inhalation aerosol: 80 mcg/4.5 mcg/ actuation 6 to 11 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 320 mcg/18 mcg/day
    12-17 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 320 mcg/18 mcg/day
  inhalation aerosol: 160 mcg/4.5 mcg/actuation 12-17 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 640 mcg/18 mcg /day
fluticasone propionate/ salmeterol xinafoate (Advair HFA, generics) inhalation aerosol: 45 mcg/21 mcg/ actuation 12-17 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 180 mcg/84 mcg/day
  inhalation aerosol: 115 mcg/21 mcg/ actuation 12-17 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 460 mcg/84 mcg/day
  inhalation aerosol: 230 mcg/21 mcg/ actuation 12-17 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 920 mcg /84 mcg/day
fluticasone propionate/salmeterol (Advair Diskus, generics) inhalation powder: 100 mcg/50 mcg/ actuation 4-11 years of age: 2 actuations/day (1 actuation twice daily); total dose = 200 mcg/100 mcg/day
  inhalation powder: 100 mcg/50 mcg/actuation 12-17 years of age: 2 actuations/day (1 actuation twice daily); total dose = 200 mcg/100 mcg/day
  inhalation powder: 250 mcg/50 mcg/actuation 12-17 years of age: 2 actuations/day (1 actuation twice daily); total dose = 500 mcg/100 mcg/day
  inhalation powder: 500 mcg/50 mcg/actuation 12-17 years of age: 2 actuations/day (1 actuation twice daily); total dose = 1000 mcg/100 mcg/day
fluticasone propionate/salmeterol (AirDuo RespiClick) inhalation powder: 55 mcg fluticasone/14 mcg salmeterol/ actuation 12-17 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 110 mcg/28 mcg/day
  113 mcg fluticasone/14 mcg salmeterol/actuation 12-17 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 226 mcg/28 mcg/day
  232 mcg fluticasone/14 mcg salmeterol/actuation 12-17 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg/28 mcg/day
fluticasone propionate/salmeterol (AirDuo Digihaler) 55 mcg fluticasone/ 14 mcg salmeterol/inhalation Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 110 mcg/28 mcg/day
  inhalation powder: 113 mcg fluticasone/14 mcg salmeterol/inhalation Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 226 mcg/28 mcg/day
  inhalation powder: 232 mcg fluticasone/14 mcg salmeterol/inhalation Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg/28 mcg/day
mometasone/formoterol (Dulera) inhalation aerosol: 50 mcg/5 mcg/ actuation 5-11 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 200 mcg/ 20 mcg/ day 
  inhalation aerosol: 100 mcg/5 mcg/ actuation 12-17 years of age: patients on medium-dose inhaled corticosteroids: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 400 mcg/20 mcg/day
  200 mcg/5 mcg/actuation 12-17 years of age: patients on high-dose inhaled corticosteroids: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 800 mcg/20 mcg/day

Number of maximum actuations per day based on dose of salmeterol and formoterol, and independent of inhaled corticosteroid dose.