CLOBETASOL PROPIONATE ointment

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Clobetasol Propionate

Sammensætning:

Clobetasol Propionate 0.5 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Clobetasol Propionate Ointment 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 Ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Safety and effectiveness of Clobetasol Propionate Ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a higher rati

Produkt oversigt:

Clobetasol Propionate Ointment, USP 0.05% is supplied in: 15 g tubes (NDC 0713-0656-15) 30 g tubes (NDC 0713-0656-31) 45 g tubes (NDC 0713-0656-37) 60 g tubes (NDC 0713-0656-60) Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature].  Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 06/2022 8-0656CPLNC2 VC7642

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
CLOBETASOL PROPIONATE OINTMENT, USP 0.05%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
RX ONLY
DESCRIPTION
Clobetasol Propionate Ointment, 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.
Clobetasol propionate is a white to cream-colored crystalline powder
insoluble in water.
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 molecular formula C
H
ClFO
and a molecular weight
of 466.98.
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg
in a base of
propylene glycol, sorbitan sesquioleate, and white petrolatum.
25
32
5
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
dressing with hydrocortisone for up to 24 hours has not been
demonstrated to increase
penetration; however, occlusion of hydrocortisone for 96 hours
markedly enhances
p