HYDROCORTISONE ACETATE PRAMOXINE HCL- hydrocortisone acetate, pramoxine hcl cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Padagis Israel Pharmaceuticals Ltd

DCI (Denominação Comum Internacional):

HYDROCORTISONE ACETATE

Composição:

HYDROCORTISONE ACETATE 2.5 g in 100 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Resumo do produto:

Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 45802-124 -64) 2 oz tube (NDC 45802-124 -16) Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

Status de autorização:

unapproved drug other

Características técnicas

HYDROCORTISONE ACETATE PRAMOXINE HCL- HYDROCORTISONE ACETATE,
PRAMOXINE HCL CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
_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._
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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, 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
the active
ingredients are presented below.
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.
O