CLOBETASOL PROPIONATE- clobetasol propionate cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals,Inc.

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Clobetasol Propionate Gel, 0.05% is supplied in tamper-evide in boxes. NDC 68071-4234-1 Box of 15g Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
REFERENCE LABEL SET ID: D43C1251-806A-4CEA-8EFB-05D3AF2CCD43
REFERENCE LABEL SET ID: 48707910-7F65-465B-810E-238F985FD63E
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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:
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.
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