CLOBETASOL PROPIONATE- clobetasol propionate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol propionate ointment 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 grams 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 ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Product: 50090-3197 NDC: 50090-3197-0 30 g in a TUBE / 1 in a CARTON

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
A-S MEDICATION SOLUTIONS
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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, 0.05% contains the active compound
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.
Chemically, clobetasol propionate USP 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 USP has the empirical formula of C
H ClFO and a molecular weight of
466.97. It is a white to almost white, crystalline powder, practically
insoluble in water, slightly soluble
in benzene and diethyl ether; sparingly soluble in ethanol; freely
soluble in acetone, in
dimethylsulfoxide, in chloroform, in methanol and in dioxane.
Clobetasol Propionate Ointment USP, 0.05% contains clobetasol
propionate USP 0.5 mg/g in a base of
propylene glycol, sorbitan sesquioleate, and white petrolatum.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory, antipruritic, and
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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 th