Product Description.:
Aerosol , white
White to off-whiteOdorless
SEREVENT DISKUS (salmeterol xinafoate inhalation powder) contains salmeterol xinafoate as the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The active component of the formulation is salmeterol base, a highly selective beta2-adrenergic bronchodilator.
SEREVENT DISKUS is a specially designed plastic inhalation delivery system containing a double-foil blister strip of a powder formulation of salmeterol xinafoate intended for oral inhalation only. The DISKUS?, which is the delivery component, is an integral part of the drug product. Each blister on the double-foil strip within the unit contains 50 mcg of salmeterol administered as the salmeterol xinafoate salt in 12.5 mg of formulation containing lactose (which contains milk proteins). After a blister containing medication is opened by activating the DISKUS, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece.
Under standardized in vitro test conditions, SEREVENT DISKUS delivers 47 mcg when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean forced expiratory volume in 1 second [FEV1] 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS was 82.4 L/min (range, 46.1 to 115.3 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
INDICATIONS
Asthma: SEREVENT DISKUS is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.
Long-acting beta2-adrenergic agonists, such as salmeterol, the active ingredient in SEREVENT DISKUS, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, SEREVENT DISKUS should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including SEREVENT DISKUS. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled, short-acting beta2-agonists.
SEREVENT DISKUS is also indicated for prevention of exercise-induced bronchospasm in patients 4 years of age and older.
SIDE EFFECTS
Data from a large, 28-week, placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (see WARNINGS and Clinical Trials: Asthma: Salmeterol Multi-center Asthma Research Trial).
WARNINGS
* Long-acting beta2-adrenergic agonists, such as salmeterol, the active ingredient in SEREVENT DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SEREVENT DISKUS should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including SEREVENT DISKUS.
o A large 28-week, placebo-controlled US study comparing the safety of salmeterol (SEREVENT Inhalation Aerosol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (see Clinical Trials: Asthma: Salmeterol Multi-center Asthma Research Trial). Given the similar basic mechanisms of action of beta2-agonists, it is possible that the findings seen in the SMART study represent a class effect.
o A 16-week clinical study performed in the United Kingdom, the Salmeterol Nationwide Surveillance (SNS) study, showed results similar to the SMART study. In the SNS study, the rate of asthma-related death was numerically, though not statistically significantly, greater in patients with asthma treated with salmeterol (42 mcg twice daily) than those treated with albuterol (180 mcg 4 times daily) added to usual asthma therapy.
* The SNS and SMART studies enrolled patients with asthma. No studies have been conducted that were adequate to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists.
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