Country: United States
Language: English
Source: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Medsource Pharmaceuticals
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE 50 ug
NASAL
PRESCRIPTION DRUG
Fluticasone Propionate Nasal Spray, USP is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of Fluticasone Propionate Nasal Spray, USP in children below 4 years of age have not been adequately established. Fluticasone Propionate Nasal Spray, USP is contraindicated in patients with a hypersensitivity to any of its ingredients.
Fluticasone Propionate Nasal Spray, USP 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, and transparent dust cap in a box of 1 (NDC 60432-264-15) with patient's instructions for use. Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used. Store between 4° and 30°C (39° and 86°F).
Abbreviated New Drug Application
FLUTICASONE- FLUTICASONE PROPIONATE SPRAY, METERED MEDSOURCE PHARMACEUTICALS ---------- FLUTICASONE PROPIONATE NASAL SPRAY, USP 50 MCG PER SPRAY PRESCRIBING INFORMATION RX ONLY 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 to off-white powder with a molecular weight of 500.6, and the molecular 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 microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol, 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. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Fluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. _In_ 25 31 3 5 _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 Read the complete document