Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Clinical Solutions Wholesale
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE 50 ug in 0.1 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED CLINICAL SOLUTIONS WHOLESALE ---------- FLUTICASONE PROPIONATE NASAL SPRAY, USP, 50 MCG FOR INTRANASAL USE ONLY. SHAKE GENTLY BEFORE USE. DESCRIPTION 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 powder with a molecular weight of 500.6, and the empirical formula is C H F O S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. 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 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 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. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Fluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. 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, respec Baca dokumen lengkap