Generic name: fluticasone propionate and salmeterol xinafoate
Dosage form: HFA, inhalation aerosol
This dosage information does not include all the information needed to use Advair safely and effectively. See full prescribing information for Advair.
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ADVAIR HFA should be administered by the orally inhaled route only in patients aged 12 years and older. ADVAIR HFA should not be used for transferring patients from systemic corticosteroid therapy. ADVAIR HFA has not been studied in patients less than 12 years of age or in patients with COPD.
LABAs, such as salmeterol, one of the active ingredients in ADVAIR HFA, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients (see WARNINGS). Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR HFA for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR HFA) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR HFA for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
ADVAIR HFA is available in 3 strengths, ADVAIR HFA 45/21 Inhalation Aerosol, ADVAIR HFA 115/21 Inhalation Aerosol, and ADVAIR HFA 230/21 Inhalation Aerosol, containing 45, 115, and 230 mcg of fluticasone propionate, respectively, and 21 mcg of salmeterol per inhalation.
ADVAIR HFA should be administered as 2 inhalations twice daily every day. More frequent administration (more than twice daily) or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of ADVAIR HFA is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. The safety and efficacy of ADVAIR HFA when administered in excess of recommended doses have not been established.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Patients who are receiving ADVAIR HFA twice daily should not use additional salmeterol or other inhaled LABAs (e.g., formoterol) for prevention of EIB or for any other reason.
For patients aged 12 years and older, the dosage is 2 inhalations twice daily (morning and evening, approximately 12 hours apart).
The recommended starting dosages for ADVAIR HFA are based upon patients’ current asthma therapy.
The maximum recommended dosage is 2 inhalations of ADVAIR HFA 230/21 twice daily.
Improvement in asthma control following inhaled administration of ADVAIR HFA can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of ADVAIR HFA with a higher strength may provide additional improvement in asthma control.
If a previously effective dosage regimen of ADVAIR HFA fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options, e.g., replacing the current strength of ADVAIR HFA with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids, should be considered.
ADVAIR HFA should be primed before using for the first time by releasing 4 test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 test sprays into the air away from the face, shaking well for 5 seconds before each spray.
In studies where geriatric patients (aged 65 years or older, see PRECAUTIONS: Geriatric Use) have been treated with ADVAIR HFA, efficacy and safety did not differ from that in younger patients. Based on available data for ADVAIR HFA and its active components, no dosage adjustment is recommended.