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.

Chronic Obstructive Pulmonary Disease: SEREVENT DISKUS is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).

SEREVENT DISKUS should be administered by the orally inhaled route only (see Instructions for Using SEREVENT DISKUS in the Medication Guide accompanying the product). The patient must not exhale into the DISKUS and the DISKUS should only be activated and used in a level, horizontal position.

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.

For maintenance of bronchodilatation and prevention of symptoms of asthma, including the symptoms of nocturnal asthma, the usual dosage for adults and children 4 years of age and older is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart). If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of asthma. Under these circumstances, the therapeutic regimen should be reevaluated. If symptoms arise in the period between doses, an inhaled, short-acting beta₂-agonist should be taken for immediate relief.

Chronic Obstructive Pulmonary Disease: For maintenance treatment of bronchospasm associated with COPD (including chronic bronchitis and emphysema), the usual dosage for adults is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart). For both asthma and COPD, adverse effects are more likely to occur with higher doses of salmeterol, and more frequent administration or administration of a larger number of inhalations is not recommended.

To gain full therapeutic benefit, SEREVENT DISKUS should be administered twice daily (morning and evening) in the treatment of reversible airway obstruction.

Geriatric Use: Based on available data for SEREVENT DISKUS, no dosage adjustment is recommended.

Prevention of Exercise-Induced Bronchospasm: One inhalation of SEREVENT DISKUS at least 30 minutes before exercise has been shown to protect patients against EIB. When used intermittently as needed for prevention of EIB, this protection may last up to 9 hours in adolescents and adults and up to 12 hours in patients 4 to 11 years of age. Additional doses of SEREVENT should not be used for 12 hours after the administration of this drug. Patients who are receiving SEREVENT DISKUS twice daily should not use additional SEREVENT for prevention of EIB. If regular, twice-daily dosing is not effective in preventing EIB, other appropriate therapy for EIB should be considered.

SEREVENT DISKUS is supplied as a disposable teal green unit containing 60 blisters. The drug product is packaged within a teal green, plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00).

SEREVENT DISKUS is also supplied in an institutional pack of 1 disposable teal green unit containing 28 blisters. The drug product is packaged within a teal green, plastic-coated, moisture-protective foil pouch (NDC 0173-0520-00).

Store at controlled room temperature (see USP), 20º to 25ºC (68º to 77ºF) in a dry place away from direct heat or sunlight. Keep out of reach of children. SEREVENT DISKUS should be discarded 6 weeks after removal from the moisture-protective foil pouch or after all blisters have been used (when the dose indicator reads "0"), whichever comes first. The DISKUS is not reusable. Do not attempt to take the DISKUS apart.

GlaxoSmithKline, Research Triangle Park, NC 27709. March 2008. FDA rev date: 3/20/2008

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