CLOBETASOL PROPIONATE aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, 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 foam, 0.05% is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid- responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis on non-scalp regions excluding the face and intertriginous areas. 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. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of clobetasol propionate foam, 0.05% therapy (See ADVERSE REACTIONS ). Use in children under 12 years of age is not recommended. Clobetasol propionate foam, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

Product summary:

Clobetasol propionate foam, 0.05% is supplied in 50 g (NDC 54868-6291-0) aluminum cans. Store at controlled room temperature 68-77ºF (20-25ºC).

Authorization status:

New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE AEROSOL, FOAM
PHYSICIANS TOTAL CARE, INC.
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CLOBETASOL PROPIONATE FOAM, 0.05%
Rx only
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Clobetasol propionate foam, 0.05% contains 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.
Clobetasol propionate is pregna-1,4-diene-3,20-dione,
21-chloro-9-fluoro-11-hydroxy-16-methyl-17-
(1-oxopropoxy)-, (11β, 16β)-, with the empirical formula C
H ClFO , a molecular weight of 466.97.
The following is the chemical structure:
CLOBETASOL PROPIONATE
Clobetasol propionate is a white or almost white, odorless,
crystalline powder and is insoluble in
water.
Clobetasol propionate foam, 0.05% contains 0.5 mg clobetasol
propionate, USP, per gram in a
thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol,
citric acid, ethanol (60%),
polysorbate 60, potassium citrate, propylene glycol, purified water,
and stearyl alcohol pressurized
with a hydrocarbon (propane/butane) propellant.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate foam has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The precise mechanism of the
anti-inflammatory activity of topical steroids
in the treatment of steroid-responsive dermatoses, in general, is
uncertain. 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
25
32
5
2
2
Topical corticosteroids can be absorbed from intact healthy skin. The
extent of percutaneous absorption
of topical cort