CUTIVATE- fluticasone propionate cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

PharmaDerm a division of Fougera Pharmaceuticals Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

CUTIVATE® (fluticasone propionate cream) Cream 0.05% is supplied in: Store between 2° and 30°C (36° and 86° F). PharmaDerm® A division of Fougera Pharmaceuticals Inc. Melville, NY 11747 US www.pharmaderm.com I8332E Rev. 06/12 #142

Berechtigungsstatus:

New Drug Application

Fachinformation

CUTIVATE - FLUTICASONE PROPIONATE CREAM
PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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CUTIVATE
(FLUTICASONE PROPIONATE CREAM)
CREAM, 0.05%
RX ONLY
FOR DERMATOLOGIC USE ONLY—NOT FOR OPHTHALMIC USE.
DESCRIPTION
CUTIVATE (fluticasone propionate cream) 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 CUTIVATE Cream 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 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 .
®
®
25
31
3
5
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2
2
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 the