HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- hydrocortisone acetate and pramoxine hydrochloride cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Scite Pharma, LLC

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 2.35% and Pramoxine HCl 1% Cream Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status autorizacije:

unapproved drug other

Svojstava lijeka

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- HYDROCORTISONE
ACETATE AND PRAMOXINE HYDROCHLORIDE CREAM
SCITE PHARMA, LLC
_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 2.35%
PRAMOXINE HCL 1% CREAM
RX ONLY
FOR EXTERNAL USE ONLY – NOT FOR OPHTHALMIC USE
DESCRIPTION
Hydrocortisone Acetate 2.35% and Pramoxine HCl 1% Cream is a topical
preparation
containing hydrocortisone acetate 2.35% w/w and pramoxine
hydrochloride 1% w/w in a
cream base containing Aloe Barbadensis Leaf Juice, Cetyl Alcohol,
Glycerin, Glyceryl
Stearate SE, Menthol, Mineral Oil, PEG-100 Stearate, Phenoxyethanol,
Purified Water,
Stearyl Alcohol, White Petrolatum, Xanthan Gum.
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
23
32
6
17
27
3
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 corticosteroid