From the FDA Drug Label
The potential effect of salmeterol on the effects of fluticasone propionate on the HPA axis was also evaluated in these trials Hypothalamic-Pituitary-Adrenal Axis Effects No significant differences across treatments were observed in 24-hour urinary cortisol excretion and, where measured, 24-hour plasma cortisol AUC. In a 28-week trial in adult and adolescent subjects with asthma, fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg twice daily was compared with the concurrent use of salmeterol inhalation powder 50 mcg plus fluticasone propionate inhalation powder 500 mcg from separate inhalers or fluticasone propionate inhalation powder 500 mcg alone.
The maximum dosing for fluticasone propionate and salmeterol is 500 mcg/50 mcg twice daily 1.
- The 500 mcg/50 mcg dose is the highest dose mentioned in the label for adult and adolescent subjects with asthma.
- This dose was used in a 28-week trial to compare the effects of fluticasone propionate and salmeterol inhalation powder with the concurrent use of salmeterol and fluticasone propionate from separate inhalers or fluticasone propionate alone.
From the Research
The maximum dosing for fluticasone propionate/salmeterol combination inhaler is 500/50 mcg taken twice daily, approximately 12 hours apart, as higher doses do not provide additional therapeutic benefit but increase the risk of side effects. This recommendation is based on the most recent and highest quality study available, which compared the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in COPD patients 2. The study found that once-daily fluticasone furoate/vilanterol provided FEV1 improvement in COPD that was at least comparable to that conferred by twice-daily fluticasone propionate/salmeterol, with similar safety profiles.
Key Points to Consider
- The fluticasone component is a corticosteroid that reduces airway inflammation, while salmeterol is a long-acting beta-agonist (LABA) that provides bronchodilation.
- This combination is indicated for asthma and COPD management.
- Patients should rinse their mouth after each use to prevent oral thrush, and the medication should be used regularly as prescribed, not as a rescue inhaler for acute symptoms.
- If a patient requires frequent rescue medication despite being on the maximum dose, their treatment plan should be reassessed by their healthcare provider.
Formulation-Specific Maximum Doses
- For Advair Diskus, the maximum dose is 500/50 mcg (500 mcg fluticasone propionate and 50 mcg salmeterol) taken twice daily.
- For Advair HFA, the maximum dose is 230/21 mcg (230 mcg fluticasone propionate and 21 mcg salmeterol) twice daily.
- For Wixela Inhub or AirDuo, the maximum dose is also 500/50 mcg twice daily.
Supporting Evidence
The study by 2 provides the most recent and highest quality evidence for the maximum dosing of fluticasone propionate/salmeterol combination inhaler. Other studies, such as 3, 4, and 5, also support the use of this combination for asthma and COPD management, but do not provide more recent or higher quality evidence for the maximum dosing. Additionally, a study on asthma-COPD overlap syndrome found that once-daily fluticasone furoate/vilanterol provided substantial improvement in lung functions, indicating that it should be considered for the regular treatment of ACOS 6.