ions
AirDuo Digihaler, like all medicines containing sympathomimetic amines, should be used withcaution in patients with convulsive disorders or thyrotoxicosis and in those who are unusuallyresponsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonistalbuterol, when administered intravenously, have been reported to aggravate preexisting diabetesmellitus and ketoacidosis.
5.17 Hypokalemia and Hyperglycemia
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients,possibly through intracellular shunting, which has the potential to produce adversecardiovascular effects [see Clinical Pharmacology (12.2)]. The decrease in serum potassium isusually transient, not requiring supplementation. Clinically significant changes in blood glucoseand/or serum potassium were seen infrequently during clinical trials with fluticasonepropionate/salmeterol multidose dry powder inhaler (AIRDUO RESPICLICK hereafter referredto as fluticasone propionate/salmeterol MDPI) at recommended doses.
6 ADVERSE REACTIONS
Use of LABA may result in the following:
Serious asthma-related events – hospitalizations, intubations, death [see Warnings andPrecautions (5.1)]
Cardiovascular and central nervous system effects [see Warnings and Precautions (5.11)]
Systemic and local corticosteroid use may result in the following:
Candida albicans infection [see Warnings and Precautions (5.4)]
Immunosuppression [see Warnings and Precautions (5.5)]
Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7)]
Reduction in bone mineral density [see Warnings and Precautions (5.12)]
Growth effects in pediatrics [see Warnings and Precautions (5.13)]
Glaucoma and cataracts [see Warnings and Precautions (5.14)]
6.1 Clinical Trials Experience in Asthma
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinical trialsof another drug and may not reflect the rates observed in practice.
The safety of AirDuo Digihaler has been established from adequate and well-controlled studiesof fluticasone propionate and salmeterol MDPI .
In two placebo-controlled, 12-week, clinical studies (Trials 1 and 2) [see Clinical Studies (14)], atotal of 1,364 adolescent and adult patients with persistent symptomatic asthma despite ICS orICS/LABA therapy were treated twice daily with either placebo; fluticasone propionate MDPI 55mcg, 113 mcg, or 232 mcg (ARMONAIR RESPICLICK, hereafter referred to as fluticasonepropionate MDPI); or fluticasone propionate/salmeterol MDPI 55/14 mcg, 113/14 mcg, or232/14 mcg. Sixty percent ofpatients were female and 80% of patients were white. The averageduration of exposure was 82 to 84 days in the fluticasone propionate MDPI andfluticasonepropionate/salmeterol MDPI treatment groups compared with 75 days in the placebo group.
Table 2 displays the incidence of most common adverse reactions in pooled Trials 1 and 2.
Table 2: Adverse Reactions with ≥3% Incidence with Fluticasone
Propionate/Salmeterol MDPI, and More Common than Placebo in Subjects
with Asthma (Trials 1 and 2)
Adverse
Reaction
fluticasone
propionate
MDPI
55 mcg
(n=129)
%
fluticasone
propionate
MDPI
113 mcg
(n=274)
%
fluticasone
propionate
MDPI
2 |
