FLUTICASONE PROPIONATE ointment

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Physicians Total Care, Inc.

INN:

FLUTICASONE PROPIONATE

composition:

FLUTICASONE PROPIONATE 0.05 mg in 1 g

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Fluticasone propionate ointment, 0.005% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. Fluticasone propionate ointment, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

leaflet_short:

Fluticasone Propionate Ointment, 0.005% is available as follows: 30 g tube (NDC 54868-5458-1) 60 g tube (NDC 54868-5458-0) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 Manufactured by: Perrigo Bronx, NY  10457 Rev. 07/09 0A300 RC J4

authorization_status:

Abbreviated New Drug Application

SPC

FLUTICASONE PROPIONATE - FLUTICASONE PROPIONATE OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
FOR DERMATOLOGIC USE ONLY—NOT FOR OPHTHALMIC USE.
DESCRIPTION
Fluticasone propionate ointment, 0.005% 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 ointment, 0.005% contains
fluticasone propionate 0.05 mg in a
base of liquid paraffin, microcrystalline wax, propylene glycol, and
sorbitan sesquioleate.
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
glucocorticoids is related to the half-life
of the glucocorticoid-receptor complex. The half-life of the
fluticasone propionate-glucocor