CLOBETASOL PROPIONATE- clobetasol propionate cream cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clobetasol propionate cream USP, 0.05% 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 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 USP, 0.05% 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 45 g tube (NDC 68071-1596-4) Store cream between 15° and 30°C (59°-86°F). Clobetasol propionate cream should not refrigerated. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 00 Sep 2020

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM CREAM
NUCARE PHARMACEUTICALS,INC.
----------
RX ONLY
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, 0.05% contains clobetasol propionate
0.5 mg/g in a
cream base of propylene glycol, mono- and di-glycerides, cetostearyl
alcohol, stearoyl
macrogolglycerides, white wax, chlorocresol, sodium citrate, anhydrous
citric acid, and
purified water.
CLINICAL PHARMACOLOGY:
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
25
32
5
activity of the topical steroids, in general, is unclear. However,
corticosteroids are
thought to act by the induction of phospholipase A2 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 A2.
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
dressings with hydrocortisone for up to 24 hours has not been
demonstrated to
increase p