1. Dosage

Because asthma is comprised of both inflammatory and bronchoconstrictive components, asthma treatment plans include routine use of inhaled corticosteroids (ICS) to manage inflammatory processes in asthma patients requiring chronic treatment. Higher ICS doses may contribute to a decrease in linear growth velocity in children, but adult height does not appear to be significantly inhibited following ICS use in childhood. All ICS doses may contribute to decreased bone formation in children and bone mineral density in adults. Close monitoring of growth and bone formation markers in children and fracture risk in adults is warranted with long-term ICS use. The lowest effective ICS dose should be utilized for the shortest required time period.

1.1. Adults

Maximum recommended adult orally inhaled doses for available aerosolized corticosteroids as individual agents are summarized in Table 1. Prescribed dosages exceeding these recommendations will be reviewed.

Table 1: Maximum Daily Recommended Adult Doses for ICS as Monotherapy in Asthma 1-11
Drug Name Dosage Form/Strength Maximum Recommended Dosage
beclomethasone dipropionate HFA (QVAR Redihaler) inhalation aerosol: 40 mcg/actuation 16 actuations/day in divided doses (8 actuations twice daily); total dose = 640 mcg/day
  inhalation aerosol: 80 mcg/actuation 8 actuations/day in divided doses (4 actuations twice daily); total dose = 640 mcg/day
budesonide (Pulmicort Flexhaler) inhalation powder: 90 mcg/actuation 16 actuations/day in divided doses (8 actuations twice daily); total dose = 1440 mcg/day
  inhalation powder: 180 mcg/actuation 8 actuations/day in divided doses (4 actuations twice daily); total dose = 1440 mcg/day
ciclesonide (Alvesco) inhalation aerosol: 80 mcg/actuation 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 (4 actuations twice daily); total dose = 640 mcg/day
  inhalation aerosol: 160 mcg/actuation 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: 160 mcg/actuation: 4 (2 actuations twice daily); total dose = 640 mcg/day
fluticasone furoate (Arnuity Ellipta) dry powder inhaler: 100 mcg/actuation 1 actuation once daily; total dose = 100 mcg/day*
  dry powder inhaler: 200 mcg/actuation 1 actuation once daily; total dose = 200 mcg/day*
fluticasone propionate HFA (Flovent HFA) inhalation aerosol: 44 mcg/actuation no previous ICS: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 176 mcg/day
  inhalation aerosol: 110 mcg/actuation

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 prior therapy with bronchodilators alone, ICS: 8 actuations/day in divided doses (4 actuations twice daily); total dose = 1760 mcg/day
    prior therapy with oral corticosteroids: 8 (4 actuations twice daily); total dose = 1760 mcg/day
fluticasone propionate (Flovent Diskus) inhalation powder: 100 mcg/actuation total dose = 2000 mcg/day
  inhalation powder: 250 mcg/actuation 8 actuations/day in divided doses (4 actuations twice daily); total dose = 2000 mcg/day
fluticasone propionate (ArmonAir Digihaler) inhalation powder: 55 mcg/actuation 2 actuations/day in divided doses (1 actuation twice daily); total dose = 110 mcg
  inhalation powder: 113 mcg/actuation 2 actuations/day in divided doses (1 actuation twice daily); total dose = 226 mcg
  inhalation powder: 232 mcg/actuation 2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg
mometasone HFA (Asmanex HFA) inhalation aerosol: 100 mcg/actuation prior therapy with medium-dose ICS: 4 actuations/day (2 actuations twice daily); total dose = 400 mcg/day
  inhalation aerosol: 200 mcg/actuation

prior therapy 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 prior therapy with bronchodilators alone, ICS: 4 actuations/day (4 actuations once daily in evening or 2 actuations twice daily); total dose = 440 mcg/day
    prior therapy with oral corticosteroids: 8 actuations/day in divided doses (4 actuations twice daily); total dose = 880 mcg/day
  inhalation powder: 220 mcg/actuation prior therapy with bronchodilators alone, ICS: 2 actuations/day (2 actuations once daily in evening or 1 actuation twice daily); total dose = 440 mcg/day
    prior therapy with oral corticosteroids: 4 actuations/day in divided doses (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/day
  • ^ prednisone should be tapered slowly, beginning at least one week after mometasone use

ICS combined with LABAs are FDA-approved for use in adults and children as asthma maintenance therapy: fluticasone propionate/salmeterol metered aerosol (Advair HFA) is approved for patients 12 years of age and older, mometasone/formoterol inhalation aerosol (Dulera) is FDA-approved for use as maintenance therapy for asthma in patients 5 years of age and older, and fluticasone propionate/salmeterol inhalation powder (Advair Diskus) is FDA-approved for use in asthma maintenance in patients 4 years of age and older1,2,12-14. Advair Diskus is also FDA-approved for use in adults as COPD maintenance therapy.1,2.14 Fluticasone/salmeterol inhalation powder (AirDuo RespiClick) is approved for use in patients with asthma who are 12 years of age and older1,2,15. Budesonide/formoterol inhalation aerosol (Symbicort) is approved for the treatment of asthma in patients 6 years of age and older and in adults as COPT maintenance therapy1,2,16. Fluticasone/vilanterol (Breo Ellipta), is indicated for use in adults as maintenance therapy for COPD and maintenance therapy for asthma1,2,17. Additionally, a triple therapy inhaler containing fluticasone, umeclidinium and vilanterol (Trelegy Ellipta) is approved for COPD and asthma management.1,2,18 Advair Diskus 250 mcg/50 mcg is the only fluticasone/salmeterol dose approved for use in adult patients with COPD, while budesonide/formoterol (Symbicort) 160 mcg/4.5 mcg is the only recommended strength for COPD1,2,14,16.

The maximum recommended orally inhaled doses for available aerosolized corticosteroids as combination therapy is summarized in Table 2. Prescribed dosages exceeding these recommendations will be reviewed.

Table 2. Maximum Adult Daily Recommended Doses for ICS as Combination Therapy for Asthma and COPD12,12-21
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
budesonide/ formoterol (Symbicort, generics) inhalation aerosol:  80 mcg/4.5 mcg/ actuation Asthma 4 actuations/day (2 actuations twice daily); total dose = 320 mcg/18 mcg/day
  inhalation aerosol: 160 mcg/4.5 mcg/ actuation Asthma 4 actuations/day (2 actuations twice daily); total dose = 640 mcg/18 mcg/day
    Chronic obstructive pulmonary disease (COPD) 4 actuations/day (2 actuations twice daily); total dose = 640 mcg/18 mcg/day
budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) inhalation aerosol: 160 mcg/9 mcg/4.8 mcg/inhalation COPD 4 actuations/day (2 actuations twice daily); total dose = 640 mcg/ 36 mcg/ 19.2 mcg/ day
fluticasone propionate/salmeterol xinafoate (Advair HFA, generics) inhalation aerosol: 45 mcg fluticasone/21 mcg salmeterol/actuation Asthma 4 actuations/day (2 actuations twice daily); total dose = 180 mcg/84 mcg/day
  inhalation aerosol: 115 mcg fluticasone/21 mcg salmeterol/actuation   4 actuations/day (2 actuations twice daily); total dose = 460 mcg/84 mcg/day
  inhalation aerosol: 230 mcg fluticasone/21 mcg salmeterol/actuation   4 actuations/day (2 actuations twice daily); total dose = 920 mcg/84 mcg/day
fluticasone propionate/salmeterol (Advair Diskus, Wixela Inhub, generics) inhalation powder: 100 mcg fluticasone/50 mcg salmeterol/actuation Asthma 2 actuations/day in divided doses (1 actuation twice daily); total dose = 200 mcg/100 mcg/day
  inhalation powder: 250 mcg fluticasone/50 mcg salmeterol/ actuation Asthma 2 actuations/day in divided doses (1 actuation twice daily); total dose = 500 mcg/100 mcg/day
    COPD 2 actuations/day in divided doses (1 actuation twice daily); total dose =500 mcg/100 mcg/day
  inhalation powder: 500 mcg fluticasone/50 mcg salmeterol/ actuation Asthma 2 actuations/day in divided doses (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 Asthma 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/ actuation   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/ actuation   2 actuations/day in divided doses (1 actuation twice daily);  total dose = 464 mcg/28 mcg/day
fluticasone propionate/salmeterol (AirDuo Digihaler) inhalation powder: 55 mcg fluticasone/ 14 mcg salmeterol/ inhalation Asthma 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   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   2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg/28 mcg/day
fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) inhalation powder: 100 mcg/ 62.5 mcg/ 25 mcg/inhalation Asthma 1 actuation/day; total dose = 100 mcg/62.5 mcg/ 25 mcg/day
    COPD 1 actuation/day; total dose = 100 mcg/62.5 mcg/ 25 mcg/day
  inhalation powder: 200 mcg/ 62.5 mcg/ 25 mcg/inhalation Asthma 1 actuation/day; total dose = 200 mcg/62.5 mcg/ 25 mcg/day 
fluticasone furoate/vilanterol (Breo Ellipta, generics) inhalation powder: 100 mcg fluticasone/25 mcg vilanterol/actuation Asthma 1 actuation/day; total dose = 100 mcg/25 mcg/day
  200 mcg fluticasone/25 mcg vilanterol/actuation   1 actuation/day; total dose = 200 mcg/25 mcg/day
  inhalation powder: 100 mcg fluticasone/25 mcg vilanterol/ actuation COPD 1 actuation/day; total dose = 100 mcg/25 mcg/day
mometasone/formoterol (Dulera) inhalation aerosol: 100 mcg mometasone/5 mcg formoterol/actuation Asthma patients on medium-dose inhaled corticosteroids: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 400 mcg/20 mcg/day
  inhalation aerosol: 200 mcg mometasone/5 mcg formoterol/actuation   patients on high-dose inhaled corticosteroids: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 800 mcg/20 mcg/day

Legend:

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

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.