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.
There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk. However, fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low [see Clinical Pharmacology ()] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Flovent HFA and any potential adverse effects on the breastfed child from Flovent HFA or from the underlying maternal condition.