PRAMOSONE CREAM- hydrocortisone acetate and pramoxine hydrochloride cream

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Boleh didapati daripada:

Sebela Pharmaceuticals Inc.

INN (Nama Antarabangsa):

HYDROCORTISONE ACETATE

Komposisi:

HYDROCORTISONE ACETATE 10 mg in 1 g

Laluan pentadbiran:

TOPICAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 fontanels, headaches, and bilateral papilledema. Admi

Ringkasan produk:

HOW SUPPLIED:    Pramosone® Cream 1%       1 oz tube (NDC 54766-716-04)                                                                                    2 oz tube (NDC 54766-716-03) Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx Only. Manufactured for Sebela Ireland Ltd. By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A. Distributed by Sebela Pharmaceuticals Inc. 645 Hembree Parkway, Suite I Roswell, GA 30076 www.sebelapharma.com Toll Free 1-844-732-3521 Aquaphor® is a registered trademark of Beiersdorf AG. Pramosone® is a registered trademark of Sebela International Limited. #6988I PI716041014 ©2014 Reproduction prohibited

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

PRAMOSONE CREAM- HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE
CREAM
SEBELA PHARMACEUTICALS INC.
----------
PRAMOSONE ® (HYDROCORTISONE ACETATE 1% PRAMOXINE HYDROCHLORIDE 1%)
CREAM 1%
DESCRIPTION: PRAMOSONE ® CREAM 1% is a topical preparation containing
hydrocortisone acetate
1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base
containing stearic acid,
cetyl alcohol, Aquaphor
, 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 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 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. Occ