Salmeterol Xinafoate

1 INDICATIONS AND USAGE SEREVENT DISKUS is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. ( 1.1 ) • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. ( 1.2 ) • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). ( 1.3 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.3 ) 1.1 Treatment of Asthma SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with an ICS in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.

6 ADVERSE REACTIONS LABA, including salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death. Data from a large 28-week placebo-controlled U.S. trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions ( 5.1 ), Clinical Studies ( 14.1 )] .

8.1 Pregnancy Risk Summary The available data from published epidemiological studies and case reports with use of SEREVENT DISKUS in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Beta‑agonists may interfere with uterine contractility. There are clinical considerations in pregnant women with asthma (see Clinical Considerations) .

WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. 5 WARNINGS AND PRECAUTIONS • LABA as monotherapy (without ICS) for asthma increase the risk of asthma-related death and asthma-related hospitalizations. Prescribe for asthma only as concomitant therapy with an inhaled corticosteroid. ( 5.1 ) • Do not initiate in acutely deteriorating asthma or COPD. Do not use to treat acute symptoms. ( 5.2 ) • Not a substitute for corticosteroids. Patients with asthma must take a concomitant ICS. ( 5.3 ) • Do not use in combination with an additional medicine containing a LABA because of risk of overdose. ( 5.4 ) • If paradoxical bronchospasm occurs, discontinue SEREVENT DISKUS and institute alternative therapy. ( 5.5 ) • Use with caution in patients with cardiovascular or central nervous system disorders because of beta-adrenergic stimulation. 4 CONTRAINDICATIONS Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated [see Warnings and Precautions ( 5.1 )] .