HYDROCORTISONE IODOQUINOL- hydrocortisone and iodoquinol cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
06-05-2020

Aktiv bestanddel:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ), IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8)

Tilgængelig fra:

Syntenza Pharmaceuticals LLC

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Hydrocortisone 1% – Iodoquinol 1% Cream is contraindicated in those patients with a history of hypersensitivity to hydrocortisone, iodoquinol or any other components of the preparation.

Produkt oversigt:

Hydrocortisone 1% – Iodoquinol 1% Cream is available as follows: 1 oz. tube (NDC 72056-040-64) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Autorisation status:

unapproved drug other

Produktets egenskaber

                                HYDROCORTISONE IODOQUINOL- HYDROCORTISONE AND IODOQUINOL CREAM
SYNTENZA PHARMACEUTICALS 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 1%-IODOQUINOL 1% CREAM
Rx Only
DESCRIPTION
Each gram of Hydrocortisone 1% – Iodoquinol 1% Cream contains 10 mg
of hydrocortisone and 10 mg
of iodoquinol in a greaseless base of cetyl alcohol, glyceryl
monostearate SE, isopropyl myristate,
lanolin alcohol, mineral oil, polyoxyl 40 stearate, polysorbate 20,
polysorbate 60, propylene glycol,
purified water, sorbic acid, and sorbitan monostearate. Paraben free.
Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17,
21-trihydroxy-,(11ß)-] with the
molecular formula C
H O and is represented by the following structural formula:
and iodoquinol, 5,7-diiodo-8-quinolinol (C H I NO) is represented by
the following structure:
Hydrocortisone is an anti-inflammatory and antipruritic agent, while
iodoquinol is an antifungal and
antibacterial agent.
CLINICAL PHARMACOLOGY
Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictor
properties. The mechanism of
anti-inflammatory activity is unclear. There is some evidence to
suggest that a recognizable correlation
exists between vasoconstrictor potency and therapeutic efficacy in
man.
Iodoquinol has both antifungal and antibacterial properties.
PHARMACOKINETICS
21
30
5
9
5 2
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.
Hydrocortisone can be absorbed from normal intact skin. Inflammation
and/or other inflammatory disease
processes in the skin increase percutaneous absorption. Occlusive
dressings substantially increase the
percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, hydrocortisone is metabolized in the
liver and most body tissues
                                
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