there are two form of fluticasone that is fluticasone propionate and fluticasone furoate. The mechanisms of action described below for the individual components apply to this combination product.
However, fluticasone propionate and salmeterol concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low Subcutaneous administration of tritiated fluticasone propionate at a dose in lactating rats approximately 0.2 times the MRHDID for adults (on a mcg/mThe safety and effectiveness of Fluticasone Propionate/Salmeterol MDPI in the treatment of asthma in pediatric patients aged 12 years and older whose asthma (1) is inadequately controlled on a long term asthma control medication or (2) warrants initiation of treatment with both an ICS and a LABA has been established. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Other corticosteroids have been detected in human milk.
To minimize the systemic effects of orally inhaled corticosteroids, including Fluticasone Propionate/Salmeterol MDPI, titrate each patient’s dosage to the lowest dosage that effectively controls his/her symptoms Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including fluticasone propionate, a component of Fluticasone Propionate/Salmeterol MDPI.
Meta-analysis of Serious Asthma-Related Events in Subjects with Asthma Aged 12 Years and OlderSalmeterol Multicenter Asthma Research Trial (SMART)Systemic and local corticosteroid use may result in the followingTable 2: Adverse Reactions with ≥3% Incidence with Fluticasone Propionate/Salmeterol MDPI, and More Common than Placebo in Subjects with Asthma (Trials 1 and 2)Musculoskeletal, Connective Tissue, and Bone DisordersDisease‑Associated Maternal and/or Embryo/Fetal RiskSalmeterol xinafoate crossed the placenta following oral administration to mice and rats.Cardiovascular Effects and Effects on Potassium and GlucoseOther Fluticasone Propionate and Salmeterol Dry Powder Inhaler (DPI) Products in Healthy SubjectsConcomitant Use of Fluticasone Propionate/SalmeterolDrug Interaction Studies with Another Fluticasone Propionate/Salmeterol MDPI ProductFigure 1: Baseline Adjusted Least Square Mean Change in Trough Morning FEVAdult and Adolescent Patients Aged 12 Years and OlderTwo 12-week randomized, double-blind, placebo-controlled, parallel-group, global Phase 3 clinical trials (Trials 1 and 2) were conducted in 1375 adult and adolescent patients (aged 12 years and older, with baseline FEVFigure 4: Serial Spirometry: Mean Change from Baseline in FEVFigure 5: Serial Spirometry: Mean Change from Baseline in FEVFigure 7: Serial Spirometry: Mean Change from Baseline in FEVFigure 8: Serial Spirometry: Mean Change from Baseline in FEVInstruct patients to not open their inhaler unless they are taking a dose.Never wash or put any part of the inhaler in water.Advise patients to immediately replace inhaler if mouthpiece cover is damaged or broken.Fluticasone Propionate and Salmeterol inhalation powder 55 mcg/14 mcgFluticasone Propionate and Salmeterol inhalation powder 113 mcg/14 mcgFluticasone Propionate and Salmeterol inhalation powder 232 mcg/14 mcgWhat is fluticasone propionate/salmeterol inhalation powder?Do not use Fluticasone Propionate/Salmeterol inhalation powder:Tell your healthcare provider about all of your medical conditions, including if you:Tell your healthcare provider about all the medicines you take,How should I use Fluticasone Propionate/Salmeterol inhalation powder?● Read the step-by-step instructions for using Fluticasone Propionate/Salmeterol inhalation powder at the end of this Patient Information leaflet.Do not use other medicines that contain a LABA for any reason.Fluticasone Propionate/Salmeterol inhalation powder does not relieve sudden asthma symptoms.
The primary safety endpoint for all 4 trials was serious asthma-related events (hospitalizations, intubations, death). Take your next dose at your usual time. The AQLQ for patients age ≥ 18 years or the PAQLQ for patients aged 12-17 were assessed in Trial 2. Patients should taper slowly from systemic corticosteroids if transferring to Fluticasone Propionate/Salmeterol MDPIAdvise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Fluticasone Propionate/Salmeterol MDPI. In the nose it is used for hay fever and nasal polyps.
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