CLOBETASOL PROPIONATE- clobetasol propionate cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Actavis Pharma, Inc.

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Clobetasol Propionate Cream, USP 0.05% 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 per 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. Safety and effectiveness of clobetasol propionate cream in pediatric patients has not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of skin

Descriptif du produit:

Clobetasol Propionate Cream, USP 0.05% is supplied in: 15 g tubes (NDC 0472-0400-15) 30 g tubes (NDC 0472-0400-30) 45 g tubes (NDC 0472-0400-45) 60 g tubes (NDC 0472-0400-60) Store at 20°– 25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 08/2019 8-0665ACT4

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE CREAM
ACTAVIS PHARMA, INC.
REFERENCE LABEL SET ID: A188664A-8FA1-479F-9493-0DA4A6C592F7
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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, 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 molecular formula C
H
ClFO and a molecular weight of
466.97. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base of
propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl
stearate SE, PEG
100 stearate, white wax, chlorocresol, sodium citrate, 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
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32
5
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
dressings with