FLUTICASONE PROPIONATE spray, metered

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

Beschikbaar vanaf:

Unit Dose Services

INN (Algemene Internationale Benaming):

FLUTICASONE PROPIONATE

Samenstelling:

FLUTICASONE PROPIONATE 50 ug in 0.1 g

Toedieningsweg:

NASAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
UNIT DOSE SERVICES
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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