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Carmol HC (Hydrocortisone Acetate Topical) - Description and Clinical Pharmacology

 
 



CARMOL® HC
(Hydrocortisone Acetate Cream USP, 1%)

Rx Only

DESCRIPTION

CARMOL® HC is intended for topical administration. The active component is the corticosteroid hydrocortisone acetate, which has the chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11β)-. It has the following chemical structure.

Each gram of the cream contains 10 mg Hydrocortisone Acetate USP, in a water-washable vanishing cream base containing urea (10%), purified water, stearic acid, propylene glycol, isopropyl myristate, isopropyl palmitate, PPG-26 oleate, sodium laureth sulfate, triethanolamine, xanthan gum, sodium metabisulfite, cetyl alcohol, edetate disodium, carbomer with hypoallergenic perfume. It is nonocclusive, and contains no mineral oil, petrolatum, lanolin, or parabens.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, anti-pruritic 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/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest 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.

The 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 topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION .)

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.

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