CLOBETASOL PROPIONATE ointment 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:

Rebel Distributors Corp

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, cream and ointment are 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 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 gel, cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes as follows: Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes as follows: 30 g (NDC 21695-483-30) Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 Repackaged by: REBEL DISTRIBUTORS CORP THOUSAND OAKS, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
REBEL DISTRIBUTORS CORP
----------
CLOBETASOL PROPIONATE GEL, 0.05%
CLOBETASOL PROPIONATE CREAM USP, 0.05%
CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
(POTENCY EXPRESSED AS CLOBETASOL PROPIONATE)
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
DESCRIPTION
Clobetasol propionate gel, cream and ointment contain 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.
Clobetasol propionate is a white to cream-colored crystalline powder
insoluble in water. Chemically, it
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:
Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a
base of propylene glycol,
carbomer 934P, sodium hydroxide and purified water.
Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in
a cream base of propylene
glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate,
PEG 100 stearate, white wax,
chlorocresol, sodium citrate anhydrous, citric acid anhydrous, and
purified water.
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg
in a base of propylene glycol,
sorbitan sesquioleate, and white petrolatum.
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 thei