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:

Proficient Rx LP

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. 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 prescribed Fluticasone Prop

Product summary:

Fluticasone Propionate Nasal Spray, USP, 50 mcg 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. (NDC 63187-021-16). 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. 700:03 4/11 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
PROFICIENT RX LP
----------
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
25
31 3
5
system involving binding and gene expression afforded 50% responses at
1.25 and 0.17
nM concentrations, respect