ALA QUIN- hydrocortisone and iodochlorhydroxyquin cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ), CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5)

Dostępny od:

Crown Laboratories

INN (International Nazwa):

HYDROCORTISONE

Skład:

HYDROCORTISONE 5 mg in 1 g

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications 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. Hypersensitivity to lodochlorhydroxyquin-Hydrocortisone, or any of its ingredients or related compounds: lesions of the eye, tuberculosis of the skin; most viral skin lesions (including herpes simplex, vaccinia, and varicella). Patients sensitive to chloroxine, iodine, or iodi

Podsumowanie produktu:

ALA-QUIN (Hydrocortisone USP, 0.5% and Iodochlorhydroxyquin USP, 3%) Cream is supplied in 1 ounce tube NDC 0316-0123-01 80 grams tube NDC 0316-0123-80 Revised: Oct. 2015 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 PRINTED IN USA P8001.04

Status autoryzacji:

unapproved drug other

Charakterystyka produktu

ALA QUIN- HYDROCORTISONE AND IODOCHLORHYDROXYQUIN CREAM
CROWN LABORATORIES
_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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ALA QUIN, 0.5% HYDROCORTISONE AND 3% IODOCHLORHYDROXYQUIN CREAM
RX ONLY
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DES CRIPTION
Iodochlorhydroxyquin (Clioquinol) is an antifungal agent and a member
of a family of drugs called
hydroxyquinolines. Chemically, Iodochlorhydroxyquin is
5-chloro-7-iodo-quinolin-8-ol. Its structural
formula is:
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents. Hydrocortisone is a member of this class.
Chemically hydrocortisone is pregn-
4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11β)-. Its structural
formula is:
Each gram of ALA-QUIN contains 5 mg Hydrocortisone USP and 30 mg
Iodochlorhydroxyquin USP in
a cream base consisting of purified water, glycerin, cetyl alcohol,
polysorbate 80, stearyl alcohol,
sodium lauryl sulfate, cetyl palmitate and sorbic acid.
CLINICAL PHARMACOLOGY
Iodochlorhydroxyquin is a broad-spectrum antibacterial and antifungal.
Its precise mechanism of action
is unknown. Topical corticosteroids share anti-inflammatory,
antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear. Various
laboratory methods, including vasoconstrictor assays, are used to
compare and predict potencies that a
recognizable correlation exists between vasoconstrictor potency and
therapeutic efficacy in man.
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. Occlusi