CLOBETASOL PROPIONATE cream

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Bryant Ranch Prepack

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Clobetasol propionate cream is a super-high potency corticosteroid formulation 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 Cream, USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Резиме производа:

Clobetasol Propionate Cream, USP, 0.05% is supplied in 45-g tubes (NDC: 63629-2330-1). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Clobetasol propionate cream should not be refrigerated. Rx only

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
BRYANT RANCH PREPACK
----------
CLOBETASOL PROPIONATE CREAM, USP, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
Clobetasol Propionate Cream USP, 0.05% contains 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
CIFO and a molecular weight of
467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base
composed of cetyl alcohol, citric acid monohydrate, glycol stearate,
lanolin liquid,
methylparaben, PEG-400 stearate, polysorbate 60, propylene glycol,
propylparaben,
purified water, stearyl alcohol, and white petrolatum. Sodium
hydroxide may be used to
adjust pH.
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
25
32
5
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 .
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors, including the vehicle and the integrity of the epidermal
ba