MICORT HC- hydrocortisone acetate cream

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Доступна с:

Sebela Pharmaceuticals Inc.

ИНН (Международная Имя):

HYDROCORTISONE ACETATE

состав:

HYDROCORTISONE ACETATE 25 mg in 1 g

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

INIDCATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intra-cranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma Cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema

Обзор продуктов:

HOW SUPPLIED:

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MICORT HC- HYDROCORTISONE ACETATE CREAM
SEBELA PHARMACEUTICALS INC.
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MICORT™ HC (HYDROCORTISONE ACETATE CREAM USP) CREAM 2.5%
DESCRIPTION
MICORT™ HC CREAM 2.5% is a topical preparation containing
hydrocortisone acetate 2.5% w/w in a
water washable base containing cetostearyl alcohol, ceteth 20, light
mineral oil, petrolatum,
propylparaben, butylparaben, citric acid, sodium citrate, and purified
water. Topical corticosteroids are
anti-inflammatory and anti-pruritic agents.
The structural formula, the chemical name, molecular formula and
molecular weight for active
ingredients are presented below.
hydrocortisone acetate
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
C
H
O
; mol. wt.: 404.50
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of topical corticosteroids is
unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings. Topical corticosteroids can be absorbed from normal intact
skin. Inflammation and/or other
disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially
increase the percutaneous absorption of topical corticosteroids. Thus,
occlusive dressings may be a
valuable therapeutic adjunct for treatment of resistant dermatoses.
(See DOSAGE AND
ADMINISTRATION.)
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying de