CLOBETASOL PROPIONATE- clobetasol propionate gel gel

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Direct RX

Podání:

Topical

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

- Clobetasol Propionate Gel, 0.05% 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/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. Clobetasol Propionate Gel, 0.05% 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/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. - Clobetasol Propionate Gel, 0.05% is contraindicated in those patients with a h

Přehled produktů:

Clobetasol Propionate Gel, 0.05% is available as follows: 15 g tube (NDC 45802-925-14) 30 g tube (NDC 45802-925-94) 60 g tube (NDC 45802-925-96)

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE GEL GEL
DIRECT RX
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CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE GEL
SPL UNCLASSIFIED SECTION
FOR TOPICAL DERMATOLOGIC USE ONLY –
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
Rx Only
DESCRIPTION
Clobetasol Propionate Gel, 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 empirical formula C25H32ClFO5 and a
molecular weight of 467. It is
a white to cream-colored crystalline powder insoluble in water.
Clobetasol Propionate Gel, 0.05% contains clobetasol propionate 0.5
mg/g in a base of carbomer
homopolymer type B, propylene glycol, purified water, and sodium
hydroxide.
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 A2 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 A2.
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 dressing with
hydrocortisone for up to 24 hours has not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 h