FLUTICASONE spray, metered

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Direct RX

INN (Διεθνής Όνομα):

FLUTICASONE PROPIONATE

Σύνθεση:

FLUTICASONE PROPIONATE 50 ug

Οδός χορήγησης:

NASAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FLUTICASONE- FLUTICASONE SPRAY, METERED
DIRECT RX
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FLUTICASONE PROPIONATE SPRAY
DESCRIPTION SECTION
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 C25H31F3O5S. 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 SECTION
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. Fluticasone
propionate was 3-fold to 5-fold more potent than dexamethasone in
these assays. Data fr