HYDROCORTISONE ACETATE PRAMOXINE HCL- hydrocortisone acetate, pramoxine hcl cream

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

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Download Vara einkenni (SPC)
15-06-2022

Virkt innihaldsefni:

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

Fáanlegur frá:

TRUPHARMA, LLC

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 52817-817-01) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Leyfisstaða:

unapproved drug other

Vara einkenni

                                HYDROCORTISONE ACETATE PRAMOXINE HCL- HYDROCORTISONE ACETATE,
PRAMOXINE HCL CREAM
TRUPHARMA, 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 2.5%
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 cetosteryl alcohol,
glycerin, isopropyl
myristate, poloxamer 407, polyoxyl 40 stearate, potassium sorbate,
propylene glycol,
purified water, sorbic acid, stearic acid and white petrolatum.
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.
Occlusive
dressings sub
                                
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