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Halog-E (Halcinonide Topical) - Description and Clinical Pharmacology

 
 



HALOG-E® CREAM
(Halcinonide Cream, USP) 0.1%

For Topical Use Only.
Not For Ophthalmic Use.

DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide is designated chemically as 21-Chloro-9-fluoro-11β,16α, 17-trihydroxy-pregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula:

Each gram of 0.1% HALOG-E® CREAM (Halcinonide Cream, USP) contains 1 mg halcinonide in a hydrophilic vanishing cream base consisting of castor oil, ceteareth-20 (and) cetearyl alcohol, dimethicone 350, propylene glycol, propylene glycol stearate, purified water, and white petrolatum. This formulation is water-washable, greaseless, and nonstaining, with moisturizing and emollient properties.

CLINICAL PHARMACOLOGY

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/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.

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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