CLOBETASOL PROPIONATE cream

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Lupin Pharmaceuticals, Inc.

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Clobetasol propionate cream USP is 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 50g/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% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Prehľad produktov:

Clobetasol propionate cream USP, 0.05% is supplied in 15-g (NDC 68180-956-01), 30-g (NDC 68180-956-02), 45-g (NDC 68180-956-03), and 60-g (NDC 68180-956-04) tubes. Store between 15º to 30ºC (59º to 86ºF). Clobetasol propionate cream should not be refrigerated. Rx only. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India February 2018

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE CREAM
LUPIN PHARMACEUTICALS, 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
21-chloro-9-fluoro,11β,17-dihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17-propionate, and it has the following structural
formula:
Clobetasol propionate has the empirical formula C
H ClFO and a molecular weight of 467. It is a
white to almost white crystalline powder insoluble in water.
Clobetasol propionate cream USP contains clobetasol propionate USP 0.5
mg/g in a cream base of
cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl
monostearate, glyceryl stearate/
polyethylene glycol 100 stearate, propylene glycol, purified water,
sodium citrate, 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,
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5
2
2
including the vehicle and the integrity of the epidermal barrier.
Occlusive dressing with hydrocortisone
for up to 24 hour