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These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000
Medication labelWhy this: Advisory · dailymed-prescription
ADVAIR DISKUS is indicated for the treatment of asthma in patients aged 4 years and older. Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions (5.1)].Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS 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 a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) 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 for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. Important Limitation of Use: ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. ADVAIR DISKUS 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 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated. Important Limitation of Use: ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.
- generic_name
- fluticasone propionate and salmeterol
- product_names
- fluticasone propionate and salmeterol
- ndc
- 54868-4518, 0173-0695, 54868-4518-0, 54868-4517, 0173-0696, 54868-4517-0, 54868-4516, 0173-0697, 54868-4516-0
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en