ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis and Impairment of Fertility. Long-term animal studies for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Hydrocortisone has an anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that recognizable correlation exists between vasoconstrictor potency and the therapeutic efficacy in humans lodoquinol has both antifungal and antibacterial properties.. Pharmacokinetics. The extent of the percutaneous absorption of topical steroids 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 tissue to hydrogeneted and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with very small proportion of unchanged hydrocortisone. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as glucuronide.

DESCRIPTION SECTION.

DESCRIPTION. Contains hydrocortisone 1% and iodoquinol 1% in greaseless cream 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-, (11)-] with the molecular formula 21H 30O 5) and is represented by the following structural formula: and iodoquinol, 5, 7-diiodo-8-quinolinol (C 9H 5I 2NO) is represented by the following structural formula: Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent.. Chemical Structure. Chemical Structure.

INDICATIONS & USAGE SECTION.

INDICATIONS. Based on review of 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; 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.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. If irritation develops, the use of this product should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for the use on infants or under diapers of occlusive dressings. If extensive areas are treated or if the occlusive dressing 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 topical corticosteroids and thus be more susceptible to systemic toxicity.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 false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result on overgrowth of non-susceptible organisms requiring appropriate therapy.

PHARMACOKINETICS SECTION.

Pharmacokinetics. The extent of the percutaneous absorption of topical steroids 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 tissue to hydrogeneted and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with very small proportion of unchanged hydrocortisone. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as glucuronide.

PRECAUTIONS SECTION.

PRECAUTIONS. NOT FOR OPHTHALMIC USE.KEEP OUT OF REACH OF CHILDREN.Avoid contact with eyes, lips and mucous membranes.. Information for Patients. If irritation develops, the use of this product should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for the use on infants or under diapers of occlusive dressings. If extensive areas are treated or if the occlusive dressing 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 topical corticosteroids and thus be more susceptible to systemic toxicity.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 false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result on overgrowth of non-susceptible organisms requiring appropriate therapy.. Carcinogenesis, Mutagenesis and Impairment of Fertility. Long-term animal studies for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol.. Pregnancy. Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to pregnant woman. This product should be used by pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.. Nursing Mothers. 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 this product is administered to nursing woman.. Pediatric Use. Safety and effectiveness in pediatric patients under the age of 12 have not been established.

PREGNANCY SECTION.

Pregnancy. Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to pregnant woman. This product should be used by pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

STORAGE AND HANDLING SECTION.

STORAGE. Store at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (between 59F to 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized. Keep container tightly closed.. NOTICE. Protect from freezing and excessive heat.

TERATOGENIC EFFECTS SECTION.

Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to pregnant woman. This product should be used by pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.