CLOBETASOL PROPIONATE- clobetasol propionate ointment usp, 0.05% ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol propionate ointment USP, 0.05%  is super-high potency corticosteroid formulations 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 ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Clobetasol Propionate Ointment USP, 0.05% is supplied in: 15 g tube (NDC 63629-2458-1) Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE OINTMENT USP,
0.05% OINTMENT
BRYANT RANCH PREPACK
----------
CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY -
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION
Clobetasol propionate ointment USP 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 (11β,
16β)-21-chloro-9-fluoro-11-hydroxy-16-
methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the
following
structural formula:
Clobetasol propionate has the empirical formula C
H
ClFO
and a molecular weight
of 467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate ointment USP, 0.05% contains clobetasol
propionate 0.5 mg/g in a
base of propylene glycol, sorbitan sesquioleate, and white petrolatum.
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32
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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 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 m