FLUTICASONE PROPIONATE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

FLUTICASONE PROPIONATE

Composition:

FLUTICASONE PROPIONATE 50 ug in 0.1 g

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Read the complete instructions carefully and use only as directed. 1. Shake the bottle gently and then remove the cap (Figure 1). Figure 1 2. It is necessary to prime the pump into the air the first time it is used, or when you have not used it for a week or more. To prime the pump, hold the bottle as shown with the nasal applicator pointing away from you and

Product summary:

Fluticasone Propionate Nasal Spray, USP, 50 mcg NDC 21695-704-16 is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, in a box of 1 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). Manufactured by Hi-Tech Pharmacal Co., Inc Amityville, NY 11701 Made in USA MG #19577 Rev. 700:02 09/09

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
REBEL DISTRIBUTORS CORP
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FLUTICASONE PROPIONATE NASAL SPRAY, USP
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
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 (0.025%
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 the 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, res