To help address these issues, FDA engages with industry through Our report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts that the GDUFA Science and Research program awarded in FY 2019. LaForce CF, Pearlman DS, Ruff ME et al. SLGA5011: a double-blind, randomized, placebo-controlled surveillance study of asthma event outcomes in subjects receiving either usual pharmacotherapy of asthma or usual pharmacotherapy plus salmeterol 42 mcg twice daily. When used in fixed combination with salmeterol, consider interactions associated with salmeterol.Potent inhibitors of CYP3A4: potential pharmacokinetic interaction (increased fluticasone propionate plasma concentrations).Increased plasma fluticasone concentrations resulting in reduced plasma cortisol AUCIncreased plasma fluticasone concentrations and AUC, resulting in systemic corticosteroid effects (e.g., Cushing’s syndrome, adrenal suppression)Concomitant use not recommended unless the potential benefit outweighs the risk of systemic corticosteroid adverse effectsEfficacy of orally inhaled fluticasone appears to result from local action rather than systemic absorption.Fluticasone: Substantial relief usually is evident within 1–2 days; however, may require ≥1–2 weeks of continuous therapy for optimum effectiveness.Fluticasone in fixed combination with salmeterol: Initial improvement in asthma control may occur within 30 minutes following oral inhalation; optimal benefit occurs ≥1 week of continuous therapy.When corticosteroids are discontinued, asthma control remains stable for several days or longer.Gender does not affect the systemic exposure of fluticasone in patients with asthma.Glucocorticoids, including fluticasone, cross the placenta and may be distributed into milk.Excreted in feces (approximately 95%) as unchanged drug and metabolites and in urine (<5%) as metabolites.Following IV administration, approximately 7.8 hours.In patients with hepatic impairment, plasma concentrations of the drug may be increased.Fixed combination with salmeterol: 25°C (may be exposed to 15–30°C) with mouthpiece down.Potent glucocorticoid activity and minimal mineralocorticoid activity.Reduces the inflammatory asthmatic response by inhibiting multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, neutrophils).Inhibits macrophage accumulation in inflamed areas.Inhibits mediator production or secretion (e.g., eicosanoids, leukotrienes, cytokines, histamine) involved in the asthmatic response.When used in fixed combination with salmeterol, importance of informing patients of important cautionary information about salmeterol.Provide a copy of the manufacturer's patient information (medication guide) for fluticasone in fixed combination with salmeterol with each prescription.Importance of informing patients receiving the fixed combination of fluticasone and salmeterol that monotherapy with long-acting βImportance of instructing patients in the use of the oral inhaler and DiskusImportance of children receiving fluticasone oral inhalation therapy under adult supervision.Importance of adequate understanding of proper storage, disposal, preparation, and inhalation techniques, including use of the inhalation delivery systems.Importance of rinsing the mouth after oral inhalation.Importance of advising patients that fluticasone oral inhalation must be used at regular intervals to be therapeutically effective.Importance of not exceeding the recommended dosage and of contacting a clinician immediately if symptoms of asthma or COPD occur that are not responsive to bronchodilators.Importance of advising patient that if a dose of fluticasone alone or in fixed combination with salmeterol is missed, the next dose should be taken at the regularly scheduled time; the dose should not be doubled.Importance of not discontinuing therapy with fluticasone in fixed combination with salmeterol without clinician’s guidance, as symptoms may recur.Importance of availability of a short-acting, inhaled βImportance of contacting a clinician if decreased effectiveness of a short-acting βImportance of advising patients that although substantial improvement may occur within the first day of therapy with fluticasone propionate, ≥1–2 weeks of continuous therapy may be required for optimum effects to be achieved.Importance of advising patients using fixed combination of fluticasone with salmeterol that ≥1 week of therapy may be required for Importance of informing patients receiving therapy with fixed combination of fluticasone and salmeterol regarding common adverse effects associated with βImportance of informing patients that corticosteroids may decrease BMD.Importance of informing patients that long-term use of inhaled corticosteroids may increase the risk for development of cataracts or glaucoma.Importance of informing clinician of heart problems, hypertension, seizures, thyroid disorders, diabetes mellitus, liver disorders, osteoporosis, or immune disorders prior to initiation of therapy.Importance of advising patients that orally inhaled fluticasone should not be used as a bronchodilator and that the drug is not indicated for emergency use (e.g., relief of acute bronchospasm).Importance of obtaining emergency medical care if breathing problems worsen quickly.Importance of advising patients that additional salmeterol or other long-acting inhaled βImportance of advising patients being transferred from systemic corticosteroid to fluticasone oral inhalation therapy to carry special identification (e.g., card, bracelet) indicating the need for supplementary systemic corticosteroids during periods of stress.Importance of avoiding exposure to chickenpox or measles, and, if exposed, of immediately consulting their clinician.Importance of informing patients with COPD receiving fluticasone in fixed combination with salmeterol oral inhalation powder (AdvairImportance of informing clinicians of existing or contemplated concomitant therapy, including therapy with prescription drugs, particularly other orally inhaled corticosteroids or ritonavir, and OTC drugs, vitamins, or herbal supplements.Importance of informing clinicians of allergies to fluticasone, salmeterol (in fixed combination), other drugs, or food.Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of informing patients of other important precautionary information.45 mcg with Salmeterol Xinafoate 21 mcg (of salmeterol) per metered spray (from the actuator)115 mcg with Salmeterol Xinafoate 21 mcg (of salmeterol) per metered spray (from the actuator)230 mcg with Salmeterol Xinafoate 21 mcg (of salmeterol) per metered spray (from the actuator)100 mcg with Salmeterol Xinafoate 50 mcg (of salmeterol) per inhalation250 mcg with Salmeterol Xinafoate 50 mcg (of salmeterol) per inhalation500 mcg with Salmeterol Xinafoate 50 mcg (of salmeterol) per inhalation3.
Recommended starting dosages: Nasal spray: 50 mcg of fluticasone propionate in each 100-mg spray.
Fluticasone propionate nasal spray given as 200 mcg once daily or 400 mcg twice daily was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. Wash the applicator and translucent cap under warm tap water.
Prime fluticasone propionate nasal spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face.