FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Adı):

FLUTICASONE PROPIONATE

Kompozisyon:

FLUTICASONE PROPIONATE 50 ug in 0.1 g

Uygulama yolu:

NASAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

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. 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

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
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.