CLOBETASOL PROPIONATE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

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 gel 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. Clobetasol propionate gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Clobetasol Propionate Gel, 0.05% is supplied in 15-g tubes (NDC 50383-269-15), 30-g tubes (NDC 50383-269-30), and 60-g tubes (NDC 50383-269-60). Store between 15° and 30° C (59° and 86° F). Do not refrigerate. Rx only Rev. 269:02 2/13 Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE GEL
AKORN
----------
CLOBETASOL PROPIONATE GEL, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
Clobetasol Propionate Gel, 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
(11ß,16ß)-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 molecular formula C
H
CIFO and a molecular weight of
467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a
gel base
composed of carbomer 974P, propylene glycol, purified water, and
sodium hydroxide.
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
25
32
5
2
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 not been
demonstrated to increase
penetration; however, occlusion of hydrocortisone for 96 hours
markedly enhances
penetration. Topical corticos