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Advair HFA (Fluticasone Propionate / Salmeterol Xinafoate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ADVAIR HFA is indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR HFA 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. ADVAIR HFA is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

ADVAIR HFA is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

ADVAIR HFA should be administered by the orally inhaled route only in patients 12 years of age and older. ADVAIR HFA should not be used for transferring patients from systemic corticosteroid therapy. ADVAIRHFA has not been studied in patients under 12 years of age or in patients with COPD.

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR HFA 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. ADVAIR HFA is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

ADVAIR HFA is available in 3 strengths, ADVAIRHFA 45/21 Inhalation Aerosol, ADVAIR HFA 115/21 Inhalation Aerosol, and ADVAIR HFA 230/21 Inhalation Aerosol, containing 45, 115, and 230mcg of fluticasone propionate, respectively, and 21 mcg of salmeterol per inhalation.

ADVAIR HFA should be administered as 2 inhalations twice daily every day. More frequent administration (more than twice daily) or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of ADVAIR HFA is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. The safety and efficacy of ADVAIR HFA when administered in excess of recommended doses have not been established.

If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Patients who are receiving ADVAIR HFA twice daily should not use additional salmeterol or other inhaled, long-acting beta2-agonists (e.g., formoterol) for prevention of EIB or for any other reason.

For patients 12years of age and older, the dosage is 2 inhalations twice daily (morning and evening, approximately 12hours apart).

The recommended starting dosages for ADVAIR HFA are based upon patients' current asthma therapy.

  • For patients not adequately controlled on an inhaled corticosteroid, Table 5 provides the recommended starting dosage.
  • For patients not currently on inhaled corticosteroids, whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, the recommended starting dosage is 2 inhalations of ADVAIR HFA 45/21 or ADVAIR HFA 115/21 twice daily (see INDICATIONS AND USAGE).

The maximum recommended dosage is 2 inhalations of ADVAIR HFA 230/21 twice daily.

For all patients it is desirable to titrate to the lowest effective strength after adequate asthma stability is achieved.

Table 5. Recommended Dosages of ADVAIR HFA Inhalation Aerosol for Patients Not Adequately Controlled on Inhaled Corticosteroids

Current Daily Dose of Inhaled Corticosteroid

Recommended Strength

of ADVAIR HFA

(2 inhalations twice daily)

Beclomethasone dipropionate HFA inhalation aerosol

≤160mcg

320mcg

640mcg

45/21

115/21

230/21

Budesonide inhalation powder

≤400mcg

800-1,200mcg

1,600mcg*

45/21

115/21

230/21

Flunisolide CFC inhalation aerosol

≤1,000mcg

1,250-2,000mcg

45/21

115/21

Flunisolide HFA inhalation aerosol

≤320mcg

640mcg

45/21

115/21

Fluticasone propionate HFA inhalation aerosol

≤176mcg

440mcg

660-880mcg*

45/21

115/21

230/21

Fluticasone propionate inhalation powder

≤200mcg

500mcg

1,000mcg*

45/21

115/21

230/21

Mometasone furoate inhalation powder

220 mcg

440 mcg

880 mcg

45/21

115/21

230/21

Triamcinolone acetonide inhalation aerosol

≤1,000mcg

1,100-1,600mcg

45/21

115/21

*ADVAIR HFA should not be used for transferring patients from systemic corticosteroid therapy.

Improvement in asthma control following inhaled administration of ADVAIR HFA can occur within 30minutes of beginning treatment, although maximum benefit may not be achieved for 1week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dosage after 2weeks of therapy, replacing the current strength of ADVAIR HFA with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen of ADVAIR HFA fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options, e.g., replacing the current strength of ADVAIR HFA with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

ADVAIR HFA should be primed before using for the first time by releasing 4 test sprays into the air away from the face, shaking well for 5seconds before each spray. In cases where the inhaler has not been used for more than 4weeks or when it has been dropped, prime the inhaler again by releasing 2 test sprays into the air away from the face, shaking well for 5 seconds before each spray.

Geriatric Use

In studies where geriatric patients (65years of age or older, see PRECAUTIONS: Geriatric Use) have been treated with ADVAIR HFA, efficacy and safety did not differ from that in younger patients. Based on available data for ADVAIR HFA and its active components, no dosage adjustment is recommended.

HOW SUPPLIED

Each strength of ADVAIR HFA Inhalation Aerosol is supplied in a 12-g pressurized aluminum canister containing 120 metered actuations in a box of 1.* Each canister is fitted with a counter, supplied with a purple actuator with a light purple strapcap, and sealed in a plastic-coated, moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each canister is packaged with a Medication Guide leaflet.

*NDC 0173-0715-20 ADVAIR HFA 45/21 Inhalation Aerosol

*NDC 0173-0716-20 ADVAIR HFA 115/21 Inhalation Aerosol

*NDC 0173-0717-20 ADVAIR HFA 230/21 Inhalation Aerosol

The purple actuator supplied with ADVAIR HFA Inhalation Aerosol should not be used with any other product canisters, and actuators from other products should not be used with an ADVAIR HFA Inhalation Aerosol canister.

The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000.

Keep out of reach of children. Avoid spraying in eyes.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120F may cause bursting. Never throw container into fire or incinerator.

Store at 25C (77F); excursions permitted to 15-30C (59-86F). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL FOR 5 SECONDS BEFORE USING.

ADVAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

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