CLOBETASOL PROPIONATE cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Zydus Pharmaceuticals USA Inc.

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Clobetasol propionate cream is 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/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 cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Proizvod sažetak:

Clobetasol Propionate Cream USP, 0.05% is white to off-white cream supplied in: NDC 70710-1456-1 in tube of 15 g NDC 70710-1456-2 in tube of 30 g NDC 70710-1456-4 in tube of 45 g NDC 70710-1456-3 in tube of 60 g

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE CREAM
ZYDUS PHARMACEUTICALS USA INC.
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CLOBETASOL PROPIONATE CREAM USP, 0.05%
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION
Clobetasol propionate cream USP, 0.05% 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.
Chemically, clobetasol propionate is
(11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-
methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the
following
structural formula:
Clobetasol propionate has the molecular formula C
H
ClFO and a molecular weight of
467. It is a white to cream crystalline powder and soluble in acetone,
in dimethyl
sulfoxide, in chloroform, in methanol, and in dioxane; sparingly
soluble in ethanol; slightly
soluble in benzene and diethyl ether and practically insoluble in
water.
Clobetasol propionate cream USP, 0.05% contains clobetasol propionate,
USP 0.5 mg/g
in a cream base of propylene glycol, cetyl alcohol, stearyl alcohol,
citric acid
monohydrate, sodium citrate anhydrous, methylparaben, propylparaben,
ethylene glycol
stearate, PEG-400 monostearate, polysorbate 60, lanolin oil, white
petrolatum, and
purified water.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
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5
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