CLOBETASOL PROPIONATE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NuCare Pharmaceuticals,Inc.

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Clobetasol propionate cream USP is 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 50g/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 USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Produktsammanfattning:

Clobetasol propionate cream USP, 0.05% is supplied in 15-g (NDC 68071-4706-1) Store between 15º to 30ºC (59º to 86ºF). Clobetasol propionate cream should not be refrigerated. Rx only. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India February 2018

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
CLOBETASOL PROPIONATE CREAM USP, 0.05%
FOR TOPICAL DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION
Clobetasol propionate cream USP, 0.05% contain 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
21-chloro-9-fluoro,11β,17-dihydroxy-16β-
methylpregna-1,4-diene-3,20-dione 17-propionate, 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 almost white crystalline powder insoluble in
water.
Clobetasol propionate cream USP contains clobetasol propionate USP 0.5
mg/g in a
cream base of cetostearyl alcohol, chlorocresol, citric acid
monohydrate, glyceryl
monostearate, glyceryl stearate/ polyethylene glycol 100 stearate,
propylene glycol,
purified water, sodium citrate, and white wax.
CLINICAL PHARMACOLOGY
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32
5
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
.
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
dressing with hydrocortisone for up to 24 hours has