FLUTICASONE PROPIONATE cream

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Padagis Israel Pharmaceuticals Ltd

INN (Algemene Internationale Benaming):

Fluticasone Propionate

Samenstelling:

Fluticasone Propionate 0.5 mg in 1 g

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 ).

Product samenvatting:

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)

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
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.
25
31 3
5
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
glucoc