FLUTICASONE PROPIONATE spray metered

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Clinical Solutions Wholesale

INN (International ime):

FLUTICASONE PROPIONATE

Sastav:

FLUTICASONE PROPIONATE 50 ug in 0.1 g

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
CLINICAL SOLUTIONS WHOLESALE
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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 _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