DRUGS & SUPPLEMENTS
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 Dermasorb AF contains 5mg Hydrocortisone USP and 30mg Iodochlorhydroxyquin USP in a cream base consisting of water, cetyl alcohol, stearyl alcohol, cetyl palmitate, sorbic acid, sodium lauryl sulfate, glycerin, and polysorbate-80.
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 and some evidence suggests a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
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 substantially increase the percutaneous absorption of the topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses..
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
INDICATIONS AND USAGE:
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.
Risk-benefit should be considered when the following medical problems exist:
- Intolerance to iodochlorhydroxyquin, hydrocortisone, chloroxine, iodine, iodine-containing preparations, or related compounds
- Herpes simplex, vaccinia, eczema vaccinia, varicella, or other viral infections of the skin
Staining of skin and fabrics may occur. Additionally, there are rare reports of discoloration (yellowing) of hair and nails. Iodochlorhydroxyquin-Hydrocortisone may prove irritating to sensitized skin in rare cases. If irritation occurs, discontinue therapy. Check with physician if no improvement within 1 to 2 weeks.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Signs and symptoms of systemic toxicity, electrolyte imbalance, or adrenal suppression have not been reported with Iodochlorhydroxyquin-Hydrocortisone. Nevertheless, the possibility of suppression of the HPA axis during therapy should be kept in mind, especially when the drug is used under occlusive dressings, for a prolonged period, or for treating extensive cutaneous areas since significant absorption of corticosteroid may occur under these conditions, particularly in children and infants.
Patients receiving a large dose of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Iodochlorhydroxyquin may be absorbed through the skin and interfere with thyroid function test. Iodochlorhydroxyquin may cause significant elevation of protein-bound iodine (PBI) or butanol-extractable iodine (BEI) and a decrease in radioactive iodine (RAI) uptake. If such tests are contemplated, wait at least one month between discontinuation of therapy and performance of these tests.
Prolonged use may result in overgrowth of nonsusceptible organisms requiring appropriate therapy. In the
presence of systemic infections, appropriate systemic antibiotics should be used.
Information for the Patient
Patients using Iodochlorhydroxyquin-Hydrocortisone should receive the following information and instructions:
1. This medication is to be used as directed by the physician.
2. This medication is for external use only. Do not use in or around the eyes. This product is not for ophthalmic use.
3. Patients should be advised not to use this medication for any disorder other than for which it is prescribed.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
The following tests may be helpful in evaluating HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy Category C
Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnant women has not been absolutely established. Use of large amounts or for prolonged periods of time is not recommended since systemic absorption may occur. In laboratory animals, increases in incidence of fetal abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some cases at rather low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Therefore, drugs of this class should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
It is not known whether topical administration of this drug could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when this class of drug is administered to a nursing woman.
Use is not recommended for infants or children up to 2 years of age. Iodochlorhydroxyquin may produce false-positive ferric chloride test results for phenylketonuria (PKU) if iodochlorhydroxyquin is present in the neonate’s diaper or urine.
Special care must be exercised in using this drug in a pediatric patient. It is recommended that only low-potency topical corticosteroids that are not fluorinated and that have a free 17-hydroxyl group be used in children unless there is a very specific indication for one of the other topical corticosteroids.
As a general rule, pediatric therapy continuing for longer than 2 weeks and consisting of doses in excess of 2 daily applications (with low-potency corticosteroids) should be carefully evaluated by the physician. This is especially important if medication is applied to more than 5-10% of the body surface or if an occlusive dressing is used. A tight-fitting diaper or one covered with plastic pants may constitute an occlusive dressing. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
There have been a few reports of rash and hypersensitivity as well as thinning of the skin with easy bruising. The following local adverse reactions have also been reported with topical corticosteroids and iodochlorhydroxyquin especially under occlusive dressings; burning; itching; irritation; dryness; folliculitis; blistering, peeling, redness, swelling; hypertrichosis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; maceration of the skin, secondary infection; skin atrophy; striae; miliaria or other signs of irritation not present before therapy.
Discontinue therapy if any untoward reaction occurs.
DOSAGE AND ADMINISTRATION:
Apply a thin layer to the affected area 3 or 4 times daily.
PACKAGING AND STORAGE:
Store at room temperature 15°C- 30°C (59°F - 86°F) in original container.
Protect from freezing.
DERMASORB AF (Hydrocortisone USP, 0.5%, Iodochlorhydroxyquin USP, 3%) Cream is supplied in:
1 ounce tube NDC 0316-1025-01
PRINTED IN USA
Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN, 37604
Dermasorb AF Trade Carton
Iodo-Cortifair pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Iodo-Cortifair available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Iodo-Cortifair destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Iodo-Cortifair Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Iodo-Cortifair pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Iodo-Cortifair?
Depending on the reaction of the Iodo-Cortifair after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Iodo-Cortifair not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Iodo-Cortifair addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Iodo-Cortifair, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Iodo-Cortifair consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
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The information was verified by Dr. Arunabha Ray, MD Pharmacology