Similarly, when corticosteroids are discontinued, symptoms may not return for several days.įluticasone propionate is a substrate of cytochrome P450 3A4.

Maximum benefit may not be reached for several days. A decrease in nasal symptoms has been noted in some patients 12 hours after initial treatment with Fluticasone Propionate Nasal Spray, USP. The direct relationship of these finding to long-term symptom relief is not known.įluticasone Propionate Nasal Spray, USP, like other corticosteroids, is an agent that does not have an immediate effect on allergic symptoms. In 7 trials in adults, Fluticasone Propionate Nasal Spray,USP, has decreased nasal mucosal eosinophils in 66% (35% for placebo) of patients and basophils in 39% (28% for placebo) of patients. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

The precise mechanism through which fluticasone propionate affects allergic rhinitis symptoms is not known. However, the clinical significance of these findings in relation to the low plasma levels (see ) is not known. In preclinical studies, fluticasone propionate revealed progesterone-like activity similar to the natural hormone. Data from the McKenzie vasoconstrictor assay in man also support its potent glucocorticoid activity. Fluticasone propionate was 3-fold to 5-fold more potent than dexamethasone in these assays. In vitro dose response studies on a cloned human glucocorticoid receptor system involving binding and gene expression afforded 50% responses at 1.25 and 0.17 nM concentrations, respectively. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded.įluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. Each 16-g bottle of Fluticasone Propionate Nasal Spray, USP, provides 120 metered sprays. After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. It is necessary to prime the pump before first use or after a period of non-use (1 week or more). Fluticasone Propionate Nasal Spray, USP, also contains benzalkonium chloride (0.02% w/w), carboxymethylcellulose sodium,dextrose, microcrystalline cellulose, phenylethyl alchol (0.25% w/w), polysorbate 80, and purified water and has a pH between 5.8 and 6.8. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.įluticasone Propionate Nasal Spray, USP, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray, USP, is a synthetic corticosteroid having the chemical name -(fluoromethyl) 6α,9-difluoro-11β-17-dihydroxy- 16α-methyl-3-oxoandrosta-1,4- diene-17β-carbothioate, 17-propionate and the following chemical structure:įluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C H F O S.

Fluticasone 50 mcg