CLOBETASOL PROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

Clobetasol Propionate

Composition:

Clobetasol Propionate 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 children 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 sk

Product summary:

Clobetasol Propionate Cream, USP 0.05% is supplied in: 15 g (0.53 oz) tubes                 30 g (1.1 oz) tubes 45 g (1.59 oz) tubes                 60 g (2.2 oz) tubes Store at 20°– 25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: G&W Laboratories, Inc. 111 Coolidge St. South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 08/2013 8-0665ACT1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
ACTAVIS PHARMA, INC.
REFERENCE LABEL SET ID: 550D6CBD-88D0-C82B-F7C9-927064F2BA36
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CLOBETASOL PROPIONATE CREAM, USP 0.05%
FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC,
ORAL, OR INTRAVAGINAL USE
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
CIFO
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,
25
32
5
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
dressings with hydrocortisone for up