CLOBETASOL PROPIONATE cream

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

clobetasol propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

متاح من:

IPG PHARMACEUTICALS, INC.

INN (الاسم الدولي):

clobetasol propionate

تركيب:

clobetasol propionate 0.5 mg in 1 g

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

ملخص المنتج:

Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes: 60 g (NDC 71085-007-60). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
IPG PHARMACEUTICALS, INC.
----------
CLOBETASOL PROPIONATE
CREAM USP, 0.05%
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
DESCRIPTION
Clobetasol propionate cream 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.
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% 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.
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. 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 barrier.
Occlusive dressings with
hydrocortisone for up to 24 hours has not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 9