CLOBETASOL PROPIONATE aerosol foam

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Tilgjengelig fra:

DPT Laboratories, Ltd.

INN (International Name):

CLOBETASOL PROPIONATE

Sammensetning:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE AEROSOL, FOAM
DPT LABORATORIES, LTD.
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CLOBETASOL PROPIONATE FOAM, 0.05%
Rx Only
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Clobetasol propionate foam, 0.05% contains clobetasol propionate, USP,
a synthetic corticosteroid, for
topical dermatologic use. Clobetasol, an analog of prednisolone, has a
high degree of glucocorticoid
activity and a slight degree of mineralocorticoid activity.
Clobelasol propionate is is pregna-1,4-diene-3,20-dione,
21-chloro-9-fluoro-11-hydroxy-16-methyl-
17-(1-oxopropoxy)-, (11β,16β)-, with the empirical formula C
H CIF0 , a molecular weight of
466.97. The following is the chemical structure:
Clobetasol propionate is a white or almost white, odorless,
crystalline powder and is insoluble in
water.
Clobetasol propionate foam, 0.05% contains 0.5 mg clobetasol
propionate, USP, per gram in a
thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol,
citric acid, ethanol (60%),
polysorbate 60, potassium citrate, propylene glycol, purified water,
and stearyl alcohol pressurized
with a hydrocarbon (propane/butane) propellant.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate foam has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The precise mechanism of the
anti-inflammatory activity of topical steroids
in the treatment of steroid-responsive dermatoses, in general, is
uncertain. 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 .
PHARMACOKINETICS
Topical corticosteroids can be absorbed from intact healthy skin. The
extent of percutaneous absorption
25
32
5
2
2
of topical corticosteroids is determined