FLUTICASONE PROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluticasone Propionate Cream, USP 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, USP 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, USP 0.05% in pediatric patients below 3 months of age have not been established. Fluticasone Propionate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Product summary:

Fluticasone Propionate Cream, USP 0.05% is supplied in: 15 GRAM in a TUBE/1 TUBE in a CARTON (53217-164-01) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE CREAM
AIDAREX PHARMACEUTICALS LLC
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FLUTICASONE PROPIONATE CREAM, USP 0.05%
FOR DERMATOLOGIC USE ONLY-NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Fluticasone Propionate Cream, USP 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, USP 0.05% contains
fluticasone propionate 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 methylparaben 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,
estrogen, or androgen receptors. The therapeutic potency of
glucocorticoi