CLOBETASOL PROPIONATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Glasshouse Pharmaceuticals Limited Canada

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clobetasol Propionate Cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol Propionate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Produkt oppsummering:

Clobetasol Propionate Cream USP, 0.05% is supplied in 15-g (NDC 71428-005-15), 30-g (NDC 71428-005-30), 45-g (NDC 71428-005-45), and 60-g (NDC 71428-005-60) tubes. Store between 15° and 30°C (59° and 86°F). Clobetasol Propionate Cream USP should not be refrigerated.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
GLASSHOUSE PHARMACEUTICALS LIMITED CANADA
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CLOBETASOL PROPIONATE CREAM USP, 0.05%
FOR TOPICAL DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION
Clobetasol Propionate Cream USP contains the active compound
clobetasol propionate,
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.
Chemically, clobetasol propionate is (11β,
16β)-21-chloro-9-fluoro-11-hydroxy-16-
methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the
following
structural formula:
Clobetasol propionate has the empirical formula C
H
ClFO
and a molecular weight
of 467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol Propionate Cream USP contains clobetasol propionate 0.5
mg/g in a cream
base of cetyl alcohol, citric acid anhydrous, glycol stearate, lanolin
anhydrous,
methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol,
propylparaben,
purified water, sodium citrate dihydrate, stearyl alcohol, and white
petrolatum.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol 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
.
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32
5
2
2
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors, including the vehicle and the integrity of the epidermal
barrier. Occlusive