HALOBETASOL PROPIONATE ointment

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

HALOBETASOL PROPIONATE (UNII: 91A0K1TY3Z) (HALOBETASOL - UNII:9P6159HM7T)

Disponible desde:

Cosette Pharmaceuticals, Inc.

Designación común internacional (DCI):

Halobetasol Propionate

Composición:

Halobetasol Propionate .5 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Halobetasol Propionate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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 children 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. Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Resumen del producto:

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes: 15 g (NDC 0713-0339-15) 50 g (NDC 0713-0339-86) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 VC7643 Rev. 06/2022 8-0339CPLNC3

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
HALOBETASOL PROPIONATE OINTMENT, 0.05%
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Halobetasol Propionate Ointment, 0.05% contains halobetasol
propionate, a synthetic
corticosteroid for topical dermatological use. The corticosteroids
constitute a class of
primarily synthetic steroids used topically as an anti-inflammatory
and antipruritic agent.
Chemically halobetasol propionate is 21-chloro-6α,
9-difluoro-11β,17-dihydroxy-16β-
methylpregna-1,4-diene-3-20-dione,17-propionate, C
H
ClF
O
. It has the following
structural formula:
Halobetasol propionate has the molecular weight of 485. It is a white
crystalline powder
insoluble in water.
Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of
halobetasol
propionate in a base of aluminum stearate, beeswax, pentaerythritol
cocoate, propylene
glycol, sorbitan sesquioleate, stearyl citrate, and white petrolatum.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, halobetasol propionate has
anti-inflammatory,
antipruritic and vasoconstrictive actions. The mechanism of the
anti-inflammatory
activity of the topical corticosteroids, in general, is unclear.
However, corticosteroids are
thought to act by the induction of phospholipase A
inhibitory proteins, collectively called
25
31
2
5
2
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 have not been
demonstrated to
increase penetration; however, occlusion of hydrocortisone for 96
hours markedly
enhances p