Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Unit Dose Services
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE 50 ug in 0.1 g
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. Please read this leaflet carefully before you start to take your medicine. It provides a summary of information on your medicine. For further information ask your doctor or pharmacist. Rhinitis is a word that means inflammation of the lining of the nose. If you suffer from rhinitis, your nose becomes stuffy and runny. Rhinitis can also make your nose itchy, and you may sneeze a lot. Rhinitis can be caused by allergies to pollen, animals, molds, or other materials-or it may have a nonallergic cause. Your doctor has
Abbreviated New Drug Application
FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED UNIT DOSE SERVICES ---------- 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 -(fluoromethyl) 6α,9-difluoro-11β-17-dihydroxy- 16α-methyl- 3-oxoandrosta-1,4- diene-17β-carbothioate, 17-propionate and the following chemical structure: _S_ 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, respectively. F Baca dokumen lengkap