HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride and hydrocortisone acetate cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Nivagen Pharmaceuticals Inc.

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream 2.5% 1 oz tube (NDC 75834-197-01) Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

Status autorizacije:

unapproved drug other

Svojstava lijeka

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- PRAMOXINE
HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM
NIVAGEN PHARMACEUTICALS 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._
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HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1% CREAM 2.5%
DESCRIPTION
HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1% CREAM 2.5% 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, petrolatum,
mineral oil, paraffin, microcrystalline wax, polyethylene wax, lanolin
alcohol, isopropyl
palmitate, polyoxyethylene 40 stearate, propylene glycol, potassium
sorbate, sorbic acid,
tea 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.
23
32
6
17
27
3
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