FLUTICASONE PROPIONATE cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

H J Harkins Company, Inc.

INN (International Nazwa):

FLUTICASONE PROPIONATE

Skład:

FLUTICASONE PROPIONATE 0.5 mg

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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).

Podsumowanie produktu:

Fluticasone Propionate Cream, 0.05% is available as follows: 15 g tube (NDC 45802-222-35) 30 g tube (NDC 45802-222-11) 60 g tube (NDC 45802-222-37)

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE CREAM
H J HARKINS COMPANY, INC.
----------
SPL UNCLASSIFIED
For Dermatologic Use Only. Not for Ophthalmic Use.
Rx Only
DES CRIPTION
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 C25H31F3O5S. 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
A2inhibitory 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 A2.
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
glucocorticoids is related to the half-l