R01AD12 fluticasone furoate

1 INDICATIONS AND USAGE Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important Limitation of Use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inhalation powder should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg over fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg has not been demonstrated. Important Limitation of Use Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.