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Uses

Bronchospasm in Asthma

Long-term prevention of bronchospasm in patients with reversible obstructive airway disease (e.g., asthma) whose symptoms are not adequately managed with other controller therapy (e.g., low to medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies. Not indicated in patients whose asthma can be successfully managed with occasional use of inhaled, short-acting β₂-adrenergic agonists or in those whose asthma can be successfully managed by inhaled corticosteroids or other controller drugs accompanied by occasional use of an inhaled, short-acting β₂-adrenergic agonist. (See Increased Risk of Asthma-related Death under Cautions.)

Fixed combination of salmeterol and fluticasone propionate recommended in patients who have not responded adequately to low to medium dosages of inhaled corticosteroids without a long-acting β₂-adrenergic agonist or in patients who are already taking an inhaled corticosteroid and a long-acting β₂-adrenergic agonist separately. Fixed combination should not be used in patients whose asthma can be successfully managed by inhaled corticosteroids accompanied by occasional use of inhaled, short-acting β₂-adrenergic agonists.

Salmeterol should not be used as initial or sole therapy for asthma and is not a substitute for corticosteroids; corticosteroid therapy should not be stopped or reduced in dosage when salmeterol is initiated. (See Concomitant Anti-inflammatory Therapy under Cautions.)

Not to be used for immediate relief of bronchospasm or in patients with substantially worsening or acutely deteriorating asthma. (See Acute Exacerbations of Asthma or COPD under Cautions.)

Exercise-induced Bronchospasm

Prevention of exercise-induced bronchospasm.

Consider alternative therapy if twice-daily dosing is not effective.

Bronchospasm in COPD

Long-term symptomatic treatment of reversible bronchospasm associated with moderate to severe COPD (e.g., FEV₁ less than 80% of predicted), including chronic bronchitis and emphysema.

Fixed combination of salmeterol and fluticasone propionate for maintenance treatment of airflow obstruction in COPD associated with chronic bronchitis.

Benefit of therapy with fixed combination of salmeterol and fluticasone propionate for >6 months not established. Reevaluate patients receiving long-term therapy (>6 months) periodically to assess continuing benefits and risks.

Not to be used for immediate relief of acute exacerbations of COPD. Use a short-acting inhaled β₂-agonist intermittently (as needed) for acute symptoms of COPD. (See Acute Exacerbations of Asthma or COPD under Cautions.)

Dosage and Administration

General

• When salmeterol therapy is initiated, regular use of short-acting, inhaled β₂-agonists should be discontinued, and such agents should be used only for relief of acute symptoms of asthma or COPD that are not controlled by salmeterol.
• Failure to respond to a previously effective dosage may indicate seriously worsening asthma; extra/increased doses are not recommended. (See Acute Exacerbations of Asthma or COPD under Cautions.) Consult clinician.
• Therapy with salmeterol in fixed combination with fluticasone propionate should be initiated in asthmatic patients ≥12 years of age whose disease severity warrants treatment with 2 maintenance therapies, including those maintained on noncorticosteroid therapy.

Administration

Oral Inhalation

Administer by oral inhalation using a special oral inhaler (Diskus^® device) that delivers powdered salmeterol xinafoate alone (Serevent^® Diskus^®) or in fixed combination with fluticasone propionate (Advair^® Diskus^®) from foil-wrapped blisters.

Administer twice daily, approximately every 12 hours (morning and evening).

Oral Inhalation Powder

Hold the Diskus^® device in one hand, put the thumb of the other hand on the thumbgrip, and push the thumbgrip until the mouthpiece appears and snaps into position.

To release powdered drug into the exit port, hold the inhaler in a level, horizontal position and depress the lever on the Diskus^® in a direction away from the patient.

To avoid releasing and wasting additional doses of the drug, do not close the Diskus^® device, play with the lever, or advance the lever more than once. A dose counter will advance each time the lever is depressed.

Exhale completely, place the mouthpiece of the inhaler between the lips, and inhale deeply and rapidly through the inhaler with a steady, even breath. Remove the inhaler from the mouth and hold the breath for 10 seconds before slowly exhaling.

Do not exhale into the Diskus^® device.

Spacer devices are not recommended with the Serevent^® or Advair^® Diskus^® inhaler.

Close the inhalation device and reset for the next dose by sliding the thumbgrip toward the patient as far as it will go. Do not wash the inhaler. Do not take inhaler apart.

Discard the inhaler when every blister of salmeterol alone or in fixed combination with fluticasone propionate has been used. Alternatively, discard the inhaler 6 or 4 weeks after removal of salmeterol alone or in fixed combination with fluticasone propionate, respectively, from its foil overwrap pouch.

Rinse the mouth without swallowing after inhalation of salmeterol in fixed combination with fluticasone propionate.

Dosage

Available as salmeterol xinafoate; dosage expressed in terms of salmeterol.

Each blister in the Serevent^® or Advair^® Diskus^® device contains 50 mcg of salmeterol as salmeterol xinafoate inhalation powder. However, the precise amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.

Pediatric Patients

Asthma

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) twice daily in children ≥4 years of age.

Fixed combination of salmeterol and fluticasone propionate in children 4–11 years of age: Initially, 50 mcg of salmeterol and 100 mcg of fluticasone propionate twice daily in those inadequately controlled with an inhaled corticosteroid.

Fixed combination of salmeterol and fluticasone propionate in children ≥12 years of age: Initially, 50 mcg of salmeterol and 100 mcg of fluticasone propionate (1 inhalation) twice daily, for children not currently receiving an orally inhaled corticosteroid; after 2 weeks, if asthma control is inadequate, increasing the dosage of fluticasone propionate may provide additional asthma control. In patients currently receiving inhaled corticosteroid, salmeterol 50 mcg twice daily and a fluticasone propionate dosage based on the dosage of the inhaled corticosteroid currently in use. (see Table 1.)

Exercise-induced Bronchospasm

Oral Inhalation

50 mcg (1 inhalation) administered via the Serevent^® Diskus^® device at least 30 minutes before exercise for children ≥4 years of age.

Adults

Asthma

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) twice daily.

Fixed combination of salmeterol and fluticasone propionate: Initially, 50 mcg of salmeterol and 100 mcg of fluticasone propionate (1 inhalation) twice daily, in patients not currently receiving an orally inhaled corticosteroid; after 2 weeks, if asthma control is inadequate, increasing the dosage of fluticasone propionate may provide additional asthma control. In patients currently receiving inhaled corticosteroid, salmeterol 50 mcg twice daily and a fluticasone proprionate dosage based on the dosage of the inhaled corticosteroid currently in use. (see Table 2.)

If control of asthma is inadequate 2 weeks after initiation of therapy at the initial dosage, a higher strength may provide additional asthma control.

Exercise-induced Bronchospasm

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) administered at least 30 minutes before exercise.

COPD

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) twice daily.

Fixed combination of salmeterol and fluticasone propionate: 50 mcg (1 inhalation) of salmeterol with 250 mcg of fluticasone propionate twice daily administered via the Advair^® Diskus^® device.

Use of dosages higher than those recommended (50 mcg of salmeterol and 250 mcg of fluticasone propionate twice daily) produces no additional improvement in lung function.

Prescribing Limits

Pediatric Patients

Asthma

Oral

Children ≥4 years of age receiving Serevent^® Diskus^®: Maximum 50 mcg (1 inhalation) twice daily.

Children 4–11 years of age receiving fixed combination of salmeterol and fluticasone propionate: Maximum 50 mcg of salmeterol and 100 mcg of fluticasone propionate twice daily.

Children or adolescents ≥12 years of age receiving fixed combination of salmeterol and fluticasone propionate: Maximum 50 mcg of salmeterol and 500 mcg of fluticasone propionate (1 inhalation) twice daily.

Exercise-induced Bronchospasm

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) twice daily (every 12 hours) in children ≥4 years of age.

Adults

Asthma

Oral Inhalation

Serevent^® Diskus^®: Maximum 50 mcg (1 inhalation) twice daily.

Fixed combination of salmeterol and fluticasone propionate: Maximum 50 mcg of salmeterol and 500 mcg of fluticasone propionate (1 inhalation) twice daily.

Exercise-induced Bronchospasm

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) twice daily (every 12 hours).

COPD

Oral Inhalation

Serevent^® Diskus^®: 50 mcg (1 inhalation) twice daily.

Fixed combination of salmeterol and fluticasone propionate: 50 mcg of salmeterol (1 inhalation) twice daily in fixed combination with fluticasone propionate (250 mcg).

Special Populations

Dosage in Hepatic Impairment

Decreased clearance.

Monitor patients closely; however, dosage adjustments not required.

Dosage in Renal Impairment

Pharmacokinetics have not been studied; dosage adjustments not required.

Geriatric Patients

Salmeterol in fixed combination with fluticasone propionate: Dosage adjustments not recommended solely because of age in geriatric patients.