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Advair Diskus

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Advair Diskus

Advair Diskus

INDICATIONS

Treatment of Asthma

ADVAIR DISKUS (fluticasone propionate) is indicated for the treatment of asthma in patients aged 4 years and older.

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in ADVAIR DISKUS (fluticasone propionate) , increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS].Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS (fluticasone propionate) for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue ADVAIR DISKUS (fluticasone propionate) ) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS (fluticasone propionate) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Important Limitation of Use
  • ADVAIR DISKUS (fluticasone propionate) is NOT indicated for the relief of acute bronchospasm.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease

ADVAIR DISKUS (fluticasone propionate) 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS (fluticasone propionate) 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS (fluticasone propionate) 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS (fluticasone propionate) 500/50 over ADVAIR DISKUS (fluticasone propionate) 250/50 has not been demonstrated.

Important Limitation of Use

ADVAIR DISKUS (fluticasone propionate) is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

ADVAIR DISKUS (fluticasone propionate) should be administered twice daily every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see PATIENT INFORMATION].

More frequent administration or a higher number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of ADVAIR DISKUS (fluticasone propionate) is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using ADVAIR DISKUS (fluticasone propionate) should not use additional long-acting beta2-agonists for any reason. [See WARNINGS AND PRECAUTIONS.]

Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2­agonist should be taken for immediate relief.

Adult and Adolescent Patients Aged 12 Years and Older

For patients aged 12 years and older, the dosage is 1 inhalation twice daily (morning and evening, approximately 12 hours apart).

The recommended starting dosages for ADVAIR DISKUS (fluticasone propionate) for patients aged 12 years and older are based upon patients' asthma severity.

The maximum recommended dosage is ADVAIR DISKUS (fluticasone propionate) 500/50 twice daily.

Improvement in asthma control following inhaled administration of ADVAIR DISKUS (fluticasone propionate) can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week 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 2 weeks of therapy, replacing the current strength of ADVAIR DISKUS (fluticasone propionate) with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen of ADVAIR DISKUS (fluticasone propionate) 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 DISKUS (fluticasone propionate) with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

Pediatric Patients Aged 4 to 11 Years

For patients with asthma aged 4 to 11 years who are not controlled on an inhaled corticosteroid, the dosage is 1 inhalation of ADVAIR DISKUS 100/50 (fluticasone propionate) twice daily (morning and evening, approximately 12 hours apart).

Chronic Obstructive Pulmonary Disease

The recommended dosage for patients with COPD is 1 inhalation of ADVAIR DISKUS (fluticasone propionate) 250/50 twice daily (morning and evening, approximately 12 hours apart).

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2­agonist should be taken for immediate relief.

HOW SUPPLIED

Dosage Forms And Strengths

Disposable purple device with 60 blisters containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as an oral inhalation powder formulation. An institutional pack containing 14 blisters is also available.

Storage And Handling

ADVAIR DISKUS 100/50 (fluticasone propionate) is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture­protective foil pouch (NDC 0173-0695-00). ADVAIR DISKUS 100/50 (fluticasone propionate) is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173­0695-04).

ADVAIR DISKUS (fluticasone propionate) 250/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0696-00). ADVAIR DISKUS (fluticasone propionate) 250/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0696-04).

ADVAIR DISKUS (fluticasone propionate) 500/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). ADVAIR DISKUS (fluticasone propionate) 500/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 0173-0697-04).

Store at controlled room temperature (see USP), 20° to 25° C (68° to 77° F), in a dry place away from direct heat or sunlight. Keep out of reach of children. The DISKUS inhalation device is not reusable. The device should be discarded 1 month after removal from the moisture-protective foil overwrap pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the device apart.

GlaxoSmithKline, Research Triangle Park, NC 27709.

Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.

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