SPL Set ID: d781dd49-ed8d-4204-99ac-a3b632d7640a

Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray USP, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate is a white or almost white, crystalline powder with a molecular weight of 500.6, and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and in dichloromethane and slightly soluble in ethanol (95%). Fluticasone 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 Nasal Spray USP also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water, and has a pH between 5 and 7. It is necessary to prime the pump before first use or after a period of non-use (1 week or more). After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each 16 g bottle of Fluticasone Propionate Nasal Spray USP provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded. fluticasone-01