HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE- hydrocortisone acetate and pramoxine hydrochloride cream

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

AKRON PHARMA INC

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

INDICATIONS 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 intracranial 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. Administ

Огляд продуктів:

HOW SUPPLIED Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 71399-2501 -1) Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Manufactured for: Akron Pharma, Inc, Fairfield, NJ 07004 Rev. 03/19

Статус Авторизація:

unapproved drug other

Характеристики продукта

HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE- HYDROCORTISONE
ACETATE AND PRAMOXINE HYDROCHLORIDE CREAM
AKRON PHARMA INC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1% CREAM
RX ONLY
DESCRIPTION
HYDROCORTISONE ACETATE 2.5% AND PRAMOXINE HCL 1% CREAM is a topical
preparation containing
hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in
a hydrophilic cream base
containing stearic acid, cetyl alcohol, isopropyl palmitate, polyoxyl
40 stearate, propylene glycol,
potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and
purified water.
Topical corticosteroids are anti-inflammatory and anti-pruritic
agents. The structural formula, the
chemical name, molecular formula and molecular weight for the 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
pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
C
H
NO
.HCl; mol. wt.: 329.87
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.
Pramoxine hydrochloride is a topical anesthetic agent which provides
temporary relief from itching and
pain. It acts by stabilizing the neuronal membrane of nerve endings
with which it comes into contact.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the vehicle, the integrity of