AIRDUO RESPICLICK- fluticasone propionate and salmeterol xinafoate powder, metered
Teva Respiratory, LLC
WARNING: ASTHMA-RELATED DEATH
Long‑acting beta2 ‑adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in AIRDUO RESPICLICK, increase the risk of asthma‑related death. Data from a large placebo‑controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long‑term asthma control drugs mitigates the increased risk of asthma‑related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma‑related hospitalization in pediatric and adolescent patients.
Therefore, when treating patients with asthma, physicians should only prescribe AIRDUO RESPICLICK 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 AIRDUO RESPICLICK) 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 AIRDUO RESPICLICK for patients whose asthma is adequately controlled on low‑ or medium‑dose inhaled corticosteroids [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
AIRDUO� RESPICLICK� is indicated for the treatment of asthma in patients aged 12 years and older.
LABAs, such as salmeterol, one of the active ingredients in AIRDUO RESPICLICK, 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 AIRDUO RESPICLICK 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 AIRDUO RESPICLICK) 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 AIRDUO RESPICLICK for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Important Limitation of Use: AIRDUO RESPICLICK is NOT indicated for the relief of acute bronchospasm.
2 DOSAGE AND ADMINISTRATION
2.1 General
AIRDUO RESPICLICK should be administered as one inhalation twice daily by the orally inhaled route only. Advise the patient to rinse his/her mouth with water without swallowing after each dose.