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.
| 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.
| 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