HYDROCORTISONE ACETATE PRAMOXINE HCL cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 2.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 45802-472 -64) Carton of 12 4-gram tubes (NDC 45802-472 -53) Carton of 30 4-gram tubes (NDC 45802-472 -65)

Authorization status:

unapproved drug other

Summary of Product characteristics

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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PERRIGO 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.
hydrocortisone acetate
Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,
17-dihydroxy-, (11-beta)-
C
H
O ; mol. wt: 404.50
pramoxine hydrchloride
4-(3-(butoxyphenoxy)propyl)morpholine hydrochloride
23
32
6
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, t