CLOBETASOL PROPIONATE ointment

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Preferred Pharmaceuticals Inc.

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

Clobetasol Propionate Gel, 0.05% is supplied in tamper-evident tubes as follows: Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes as follows: 15 g (NDC 68788-8238-1) 30 g (NDC 68788-8238-3) 60 g (NDC 68788-8238-6) Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Relabeled By: Preferred Pharmaceuticals Inc. I2162H R08/12 #202

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
PREFERRED PHARMACEUTICALS INC.
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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 their common precursor, arachidonic acid. Ar