HYDROCORTISONE IODOQUINOL- hydrocortisone, iodoquinol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Perrigo New York Inc

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: “Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; infantile eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis, bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis, intertrigo. Final classification of the less-than-effective indications requires further investigation. 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.

Product summary:

Hydrocortisone 1%−Iodoquinol 1% Cream is available as follows: 1 oz. tube (NDC 45802-930 -64)

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE IODOQUINOL- HYDROCORTISONE, IODOQUINOL CREAM
PERRIGO NEW YORK 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 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
21
30
5
9
5 2
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 −
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 to
hydr