CLOBETASOL PROPIONATE gel CLOBETASOL PROPIONATE cream 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:

Taro Pharmaceuticals U.S.A., Inc.

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 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 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 Gel, 0.05% is supplied in tamper-evident tubes:15 g (NDC 51672-1294-1), 30 g (NDC 51672-1294-2), and 60 g (NDC 51672-1294-3). Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes: 15 g (NDC 51672-1258-1), 30 g (NDC 51672-1258-2), 45 g (NDC 51672-1258-6), and 60 g (NDC 51672-1258-3). Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes: 15 g (NDC 51672-1259-1), 30 g (NDC 51672-1259-2), 45 g (NDC 51672-1259-6), and 60 g (NDC 51672-1259-3). Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE GEL
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
TARO PHARMACEUTICALS U.S.A., INC.
REFERENCE LABEL SET ID: 48707910-7F65-465B-810E-238F985FD63E
REFERENCE LABEL SET ID: D43C1251-806A-4CEA-8EFB-05D3AF2CCD43
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CLOBETASOL PROPIONATE GEL, 0.05%
CLOBETASOL PROPIONATE CREAM USP, 0.05%
CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
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:
C
H
CIFO MOLECULAR WEIGHT: 467
Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a
base of
carbomer 934P, propylene glycol, purified water, and sodium hydroxide.
Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in
a cream base
of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate,
glyceryl
stearate/polyethylene glycol 100 stearate, propylene glycol, purified
water, sodium
citrate, stearyl alcohol, and white wax.
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg
in a base of
propylene glycol, sorbitan sesquioleate, and white petrolatum.
25 32
5
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
l