FLUTICASONE PROPIONATE cream

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Fluticasone Propionate (UNII: O2GMZ0LF5W) (Fluticasone - UNII:CUT2W21N7U)

Dostupné s:

Physicians Total Care, Inc.

INN (Mezinárodní Name):

Fluticasone Propionate

Složení:

Fluticasone Propionate 0.5 mg in 1 g

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 (see PRECAUTIONS ).

Přehled produktů:

Fluticasone Propionate Cream, 0.05% is available as follows: 30 g tube (NDC 54868-5337-0) 60 g tube (NDC 54868-5337-1)

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

FLUTICASONE PROPIONATE - FLUTICASONE PROPIONATE CREAM
PHYSICIANS TOTAL CARE, INC.
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FLUTICASONE PROPIONATE CREAM, 0.05%
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Fluticasone Propionate Cream, 0.05% contains fluticasone propionate
[(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 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, 0.05% contains fluticasone
propionate 0.5 mg in a base of
ceteth-20, cetostearyl alcohol, citric acid, dibasic sodium phosphate,
isopropyl myristate, mineral oil,
propylene glycol, and purified water, with imidurea as a 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
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5
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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,
estrogen, or androgen receptors. The therapeutic potency of
glucocor