FLUTICASONE PROPIONATE cream

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cosette Pharmaceuticals, Inc.

INN (mednarodno ime):

Fluticasone Propionate

Sestava:

Fluticasone Propionate 0.5 mg in 1 g

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Fluticasone Propionate Cream, USP 0.05% is supplied in: 15 g tubes (NDC 0713-0631-15) 30 g tubes (NDC 0713-0631-31) 60 g tubes (NDC 0713-0631-60)

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
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
25
31
3
5
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