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Uses

Asthma

Long-term prevention of bronchospasm in patients with asthma.

In corticosteroid-dependent patients, may permit a substantial reduction in the daily maintenance dosage of the systemic corticosteroid and gradual discontinuance of corticosteroid maintenance dosages.

Used in fixed combination with salmeterol in asthmatic patients whose disease is inadequately controlled with other anti-asthma therapy (e.g., low to medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.

Fixed combination with salmeterol should not be used in patients whose asthma can be successfully managed with inhaled corticosteroids and occasional use of inhaled short-acting β₂ adrenergic agonists.

COPD

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

Reevaluate patients receiving long-term therapy (>6 months) periodically to assess continuing benefits and risks.

Dosage and Administration

General

• Adjust dosage carefully according to individual requirements and response.
• After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response. Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth.

Asthma

• Recommended initial and maximum dosages of oral inhalation are based on previous asthma therapy. After 2 weeks of therapy at the initial dosage, if asthma is inadequately controlled, replace the current strength with a higher strength.

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• When switching from systemic corticosteroids to orally inhaled fluticasone propionate, asthma should be reasonably stable before initiating treatment with the oral inhalation.
• Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid. After at least 1 week, gradually withdraw the systemic corticosteroid.
• Decrements usually should not exceed 2.5–5 mg of prednisone (or its equivalent) each week in patients receiving the oral inhalation. Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate the dosage to the lowest effective level.
• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly. (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

Chronic Obstructive Pulmonary Disease

• In patients receiving long-term therapy (>6 months) for chronic bronchitis, reevaluate periodically to assess continuing benefits and risks.

Administration

Administer by oral inhalation.

Oral Inhalation

Administer microcrystalline suspension by oral inhalation using a metered-dose inhaler. Administer inhalation powder in fixed combination with salmeterol using a special oral inhaler (Advair^® Diskus^®) that delivers the drug from foil-wrapped blisters.

Following each treatment, rinse the mouth thoroughly with water without swallowing.

Inhalation Powder

Administer fluticasone propionate in fixed combination with salmeterol using a special oral inhaler (Advair^® Diskus^®). Administer twice daily (morning and evening), about 12 hours apart.

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. Depress the lever away from the body until a click is heard; the lever pierces the foil blister and releases the powdered drug into an exit port. Do not tilt or close the Diskus^® device, play with the lever, or advance the lever more than once at this point. A dose counter will advance each time the lever is depressed.

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with lips closed around it. After inhaling dose through the mouth, hold the breath for 10 seconds, and exhale slowly. Do not breathe out into the Diskus^® device.

Rinse the mouth after inhalation of fluticasone propionate in fixed combination with salmeterol. Slide the thumbgrip toward the body to close the Diskus^® device and reset the device for the next dose. Do not wash the inhaler. Do not take apart the inhaler.

Do not use fluticasone propionate in fixed combination with salmeterol xinafoate with a spacer device.

Inhalation Aerosol

Shake well (5 seconds) immediately prior to use. Actuate aerosol inhaler 4 times prior to the initial use. Actuate inhaler once prior to use if it has not been used for >1 week or if the inhaler has been dropped.

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with lips closed around it. Inhale slowly and deeply through the mouth while actuating the inhaler. Hold the breath for 10 seconds, withdraw the mouthpiece, and exhale slowly.

Allow 30 seconds to elapse between subsequent inhalations from the aerosol inhaler.

Following each treatment, rinse the mouth thoroughly.

Clean inhaler at least once a week by removing canister from the inhaler and washing plastic cap and case in warm water; allow the actuator to air-dry.

Dosage

Unless otherwise stated, the dose of fluticasone propionate administered as an aerosol via metered-dose inhaler is expressed as the amount delivered from the actuator of the inhaler per metered spray.

Oral inhalation aerosol delivers 50, 125, or 250 mcg from the valve, and 44, 110, or 220 mcg, respectively, from the actuator per metered spray. The 10.6- or 12-g canister (labeled as containing 44, 110, or 220 mcg of fluticasone propionate) delivers 120 metered sprays of fluticasone propionate.

Doses of fluticasone propionate and salmeterol in the combination preparation (Advair^® inhalation powder) are expressed as the nominal (labeled) doses contained in each foil-wrapped blister. The amount of drug powder delivered to the lungs depends on factors such as the patient’s inspiratory flow.

Pediatric Patients

Asthma

Inhalation Aerosol

Children 4–11 years of age: Initial and maximal dosage is 88 mcg twice daily.

Children ≥12 years of age previously receiving bronchodilators alone: Initially, 88 mcg twice daily. If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher strength may provide additional asthma control. If required, dosage may be increased to a maximum of 440 mcg twice daily. Consider initial dosages >88 mcg twice daily in children with inadequate asthma control.

Children ≥12 years of age previously receiving inhaled corticosteroids: Initially, 88–220 mcg twice daily. If required, dosage may be increased to a maximum of 440 mcg twice daily. Consider initial dosages >88 mcg twice daily in those who were receiving inhaled corticosteroids at the higher end of the dosage range.

Children ≥12 years of age previously receiving oral corticosteroids: Initially, 440 mcg twice daily and maximum dosage is 880 mcg twice daily.

Inhalation Powder

Fixed combination of fluticasone propionate and salmeterol in children 4–11 years of age inadequately controlled with an inhaled corticosteroid: Initial and maintenance dosage is 100 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily.

Fixed combination of fluticasone propionate and salmeterol in children ≥12 years of age not currently receiving an orally inhaled corticosteroid: Initially, 100 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily.

The dosage of fluticasone propionate and salmeterol in fixed combination in adolescents receiving inhaled corticosteroids depends on the dosage of the inhaled corticosteroid currently in use.

Adults

Asthma

Inhalation Aerosol

Previously receiving bronchodilators alone: Initially, 88 mcg twice daily. If required, dosage may be increased to a maximum of 440 mcg twice daily. Consider initial dosages >88 mcg twice daily in adults with inadequate asthma control.

Previously receiving inhaled corticosteroids: Initially, 88–220 mcg twice daily. If required, dosage may be increased to a maximum of 440 mcg twice daily. Consider initial dosages >88 mcg twice daily in those who were receiving inhaled corticosteroids at the higher end of the dosage range.

Previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg twice daily.

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

Inhalation Powder

Fixed combination of fluticasone propionate and salmeterol in patients not currently receiving an orally inhaled corticosteroid: Initially, 100 or 250 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily.

The dosage of fluticasone propionate and salmeterol in fixed combination in patients currently receiving inhaled corticosteroids depends on the dosage of the inhaled corticosteroid currently in use.

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

COPD

Oral Inhalation

Fixed combination of fluticasone propionate and salmeterol: Initial and maintenance dosage is 250 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily given approximately every 12 hours (morning and evening).

Prescribing Limits

Pediatric Patients

Asthma

Inhalation Aerosol

Children 4–11 years of age: Maximum 88 mcg twice daily.

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg twice daily.

Children ≥12 years of age previously receiving oral corticosteroids: Maximum 880 mcg twice daily.

Inhalation Powder

Fixed combination of fluticasone propionate and salmeterol in children 4–11 years of age: Maximum 100 mcg of fluticasone propionate and 50 mcg salmeterol (1 inhalation) twice daily.

Fixed combination of fluticasone propionate and salmeterol in children ≥12 years of age: Maximum 500 mcg of fluticasone propionate and 50 mcg salmeterol (1 inhalation) twice daily.

Adults

Asthma

Inhalation Aerosol

Previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg twice daily.

Previously receiving oral corticosteroids: Maximum 880 mcg twice daily.

Inhalation Powder

Fixed combination of fluticasone propionate and salmeterol: Maximum 500 mcg of fluticasone propionate and 50 mcg salmeterol (1 inhalation) twice daily. Use of higher than recommended dosage (500 mcg of fluticasone propionate and 50 mcg of salmeterol twice daily) does not improve lung function compared with recommended dosages.

COPD

Oral Inhalation

Fixed combination of fluticasone propionate and salmeterol: Maximum 250 mcg fluticasone propionate and 50 mcg salmeterol (1 inhalation) twice daily. Use of higher than recommended dosage (250 mcg of fluticasone propionate and 50 mcg of salmeterol twice daily) does not improve lung function compared with the recommended dosage.

Special Populations

Geriatric Patients

Inhalation aerosol: Select dosage with caution, reflecting the greater frequency of decreased hepatic function, presence of coexisting conditions, or other drug therapies.

Inhalation powder of fluticasone propionate in fixed combination with salmeterol: Dosage adjustments not recommended solely because of age.