ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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Asthma Long-acting beta 2 -adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR ® and ADVAIR ® DISKUS ® , increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of salmeterol (SEREVENT ® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related death in patients receiving salmeterol (see WARNINGS AND PRECAUTIONS and CLINICAL TRIALS: Salmeterol Multi-center Asthma Research Trial (SMART)). Post-hoc analysis of the SMART trial data suggests that the risks may be lower in patients who were using inhaled corticosteroids (ICS) at study entry. However, these post-hoc analysis results are not conclusive (see CLINICAL TRIALS: Salmeterol Multi-center Asthma Research Trial (SMART)). Currently available clinical data are inadequate to determine whether concurrent use of inhaled corticosteroids 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 (see WARNINGS AND PRECAUTIONS). ADVAIR ® DISKUS ® In clinical trials involving 1824 adult and adolescent patients, the most commonly reported adverse events with the combination salmeterol xinafoate/fluticasone propionate DISKUS ® were: hoarseness/dysphonia, throat irritation, headache, candidiasis of mouth and throat and palpitations as detailed in the table below: July 29, 2014 Page 16 of 67
Table 2 Number (and percentage) of patients with drug-related adverse events (incidence ≥ 1%1) (Safety Population) Adverse events Salmeterol xinafoate/fluticaso ne propionate combination product Salmeterol xinafoate and Fluticasone propionate concurrent therapy Fluticasone propionate alone Salmeterol xinafoate alone Placebo Number of patients 644 486 339 180 175 Any event 110 (17%) 81 (17%) 50 (15%) 9 (5%) 5 (3%) Hoarseness/dysphonia 15 (2%) 11 (2%) 8 (2%) 1 (
Page 1 and 2: Pr ADVAIR ® DISKUS ® salmeterol x
Page 3 and 4: Pr ADVAIR ® DISKUS ® salmeterol x
Page 5 and 6: WARNINGS AND PRECAUTIONS General In
Page 7 and 8: Endocrine And Metabolism Systemic S
Page 9 and 10: The results of a drug interaction s
Page 11 and 12: Ophthalmologic (Glaucoma and Catara
Page 13 and 14: Since there is no experience with u
Page 15: MedDRA preferred term Musculoskelet
Page 19 and 20: The following table includes all ev
Page 21 and 22: Other COPD Clinical Trial Adverse D
Page 23 and 24: Very rare: Anaphylactic shock or an
Page 25 and 26: Drug-Drug Interactions Table 5 Esta
Page 27 and 28: Recommended Dose And Dosage Adjustm
Page 29 and 30: trauma, surgery or infection or any
Page 31 and 32: significant increase in plasma salm
Page 33 and 34: ADVAIR ® inhalation aerosol compri
Page 35 and 36: Partition Coefficient: The partitio
Page 37 and 38: In a randomized, double-blind, acti
Page 39 and 40: ADVAIR ® / ADVAIR ® DISKUS ® are
Page 41 and 42: Study Demographics and Trial Design
Page 43 and 44: consistent with the recommended use
Page 45 and 46: Clinical Studies in COPD Clinical s
Page 47 and 48: There was no evidence that the syst
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Page 53 and 54: 11. Greening AP, Ind PW, Northfield
Page 55 and 56: IMPORTANT: PLEASE READ WARNINGS AND
Page 57 and 58: IMPORTANT: PLEASE READ Then go on a
Page 59 and 60: IMPORTANT: PLEASE READ SERIOUS SIDE
Page 61 and 62: IMPORTANT: PLEASE READ PART III: CO
Page 63 and 64: IMPORTANT: PLEASE READ INTERACTIONS
Page 65 and 66: IMPORTANT: PLEASE READ SIDE EFFECTS
Page 67:
IMPORTANT: PLEASE READ This is not
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ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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