Dermazene
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Questions & Answers
Side Effects & Adverse Reactions
For external use only. Keep away from eyes. If irritation develops, the use of Dermazene Cream should be discontinued and appropriate therapy instituted. Staining of the skin and fabrics may occur. If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of the corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tightfitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine.
Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy. Keep out of reach of children.
Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of hydrocortisone or Iodoquinol.
In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been conducted with iodoquinol.
Animal reproductive studies have not been conducted with Dermazene Cream. It is not known whether Dermazene Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Dermazene Cream should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dermazene Cream is administered to a nursing woman.
Safety and effectiveness in children under the age of 12 have not been established.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
| INDICATIONS AND USAGE |
| 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 declatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis, intertrigo. Final classification of the less-than-effective indications requires further investigation. |
History
There is currently no drug history available for this drug.
Other Information
Each gram of Dermazene® Cream 1% contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a cream base of purified water, propylene glycol, cerasynt SE, amerchol L101, isopropyl palmitate, cetyl alcohol, arlacel 60, myrj 52, tween 60, sorbic acid, methyl paraben and propyl paraben.
Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-(11β)-] with the molecular formula (C21H30O5) and is represented by the following structural formula:
and iodoquinol, 5,7-diiodo-8-quinolinol (C9H5I2NO) is represented by the following structure:
Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent.
Sources
Dermazene Manufacturers
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Stratus Pharamceuticals, Inc
![Dermazene (Hydrocortisone And Iodoquinol) Cream [Stratus Pharamceuticals, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dermazene | Stratus Pharamceuticals, Inc
Apply to affected area 3 to 4 times daily in accordance with physician's directions.
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