CLOBETASOL PROPIONATE 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 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, 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 available as a white to off-white cream. It is supplied as follows: 15 g Tubes NDC 68071-2764-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Clobetasol Propionate Cream, USP should not be refrigerated. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2018-00

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

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
RX ONLY
DESCRIPTION
Clobetasol propionate cream, USP 0.05% contains the active compound
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.
Chemically, clobetasol propionate, USP, is pregna-1, 4-diene-3,
20-dione, 21-chloro-9-
fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11ß,16ß) and it has
the following
structural formula:
Clobetasol propionate, USP has the empirical formula C
H
CIFO
and a molecular
weight of 466.97. It is a white to almost white crystalline powder
insoluble in water.
Clobetasol propionate cream, USP, contains clobetasol propionate 0.5
mg/g in a cream
base of anhydrous citric acid, cetyl alcohol, glycol stearate, lanolin
oil, methylparaben,
PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben,
purified water, sodium
citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide
pellets may be used to
adjust pH.
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
.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors, including the vehicle and