FLUTICASONE PROPIONATE cream

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

fluticasone propionate (UNII: O2GMZ0LF5W) (fluticasone - UNII:CUT2W21N7U)

Beszerezhető a:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (nemzetközi neve):

fluticasone propionate

Összetétel:

fluticasone propionate 0.5 mg in 1 g

Az alkalmazás módja:

TOPICAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established. Fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Termék összefoglaló:

Fluticasone propionate cream USP, 0.05% is supplied in: 15 g tubes NDC 0168-0332-15 30 g tubes NDC 0168-0332-30 60 g tubes NDC 0168-0332-60 Store between 2° and 30° C (36° and 86° F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, NY 11747 46233142A R07/18 #91

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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FLUTICASONE PROPIONATE CREAM USP, 0.05%
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Fluticasone propionate cream USP, 0.05% contains fluticasone
propionate USP [(6α,11β,16α,17α)-6,9-
difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic
acid _S_-
fluoromethyl ester], a synthetic fluorinated corticosteroid, for
topical dermatologic use. The topical
corticosteroids constitute a class of primarily synthetic steroids
used as anti-inflammatory and
antipruritic agents.
Chemically, fluticasone propionate is C
H F O S. It has the following structural formula:
Fluticasone propionate USP has a molecular weight of 500.6. It is a
white to off-white powder and is
insoluble in water.
Each gram of fluticasone propionate cream USP, 0.05% contains
fluticasone propionate USP 0.5 mg in
a base of propylene glycol, mineral oil, cetostearyl alcohol,
Ceteth-20, isopropyl myristate, dibasic
sodium phosphate, citric acid, purified water and imidurea as
preservative.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, fluticasone propionate has
anti-inflammatory, antipruritic and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
Fluticasone propionate is lipophilic and has a strong affinity for the
glucocorticoid receptor. It has
weak affinity for the progesterone receptor, and virtually no affinity
for the mineralocorticoid,
25
31
3
5
2
2
estrogen, or androgen r