Salmeterol

1 INDICATIONS AND USAGE Wixela Inhub ® 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 Wixela Inhub ® is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub ® 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 Wixela Inhub ® is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Wixela Inhub ® 250/50 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. Wixela Inhub ® 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Wixela Inhub ® 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength Wixela Inhub ® 500/50 over Wixela Inhub ® 250/50 has not been demonstrated. Important Limitation of Use Wixela Inhub ® is NOT indicated for the relief of acute bronchospasm.