40 mcg inhaled twice daily, approximately 12 hours apart, is the recommended starting dose. For patients who do not respond adequately to 40 mcg after 2 weeks of therapy, increasing the dosage to 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage is 80 mcg twice daily. The starting dosage is based on the severity of asthma, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. Improvement in asthma symptoms can occur within 24 hours of the beginning of treatment and should be expected within the first or second week, but maximum benefit should not be expected until 3 to 4 weeks of therapy. Improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 160 mcg/day, medium dose as 161 to 320 mcg/day, and high dose therapy as more than 320 mcg/day for children ages 5 to 11 years. The Global Initiative for Asthma (GINA) guidelines define low dose therapy as 100 mcg/day in this age group. Titrate to the lowest effective dose once asthma stability is achieved.
Plasma levels of salmeterol, a component of Fluticasone Propionate and Salmeterol Inhalation Powder, after inhaled therapeutic doses are very low. In rats, salmeterol xinafoate is excreted in the milk. There are no data from controlled trials on the use of salmeterol by nursing mothers. It is not known whether fluticasone propionate, a component of Fluticasone Propionate and Salmeterol Inhalation Powder, is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Subcutaneous administration to lactating rats of tritiated fluticasone propionate resulted in measurable radioactivity in milk.
Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ADVAIR HFA. Prednisone reduction can be accomplished by reducing the daily prednisone dose by mg on a weekly basis during therapy with ADVAIR HFA. Lung function (mean forced expiratory volume in 1 second [FEV 1 ] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.