CLOCORTOLONE PIVALATE- clocortolone pivalate cream
Dr. Reddy�s Laboratories Inc
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Rx Only
FOR TOPICAL DERMATOLOGIC USE ONLY-
NOT FOR OPTHALMIC, ORAL, OR INTRAVAGINAL USE.
WARNING: KEEP OUT OF REACH OF CHILDREN
DESCRIPTION
Clocortolone Pivalate Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate,carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.
Chemically, clocortolone pivalate is 9-chloro-6?-fluoro-11?,21-dihydroxy-16? methylpregna-1,4-diene-3, 20-dione 21-pivalate.Its structure is as follows:?-fluoro-11?,21-dihydroxy-16? methylpregna-1,4-diene-3, 20-dione 21-pivalate.Its structure is as follows:? methylpregna-1,4-diene-3, 20-dione 21-pivalate.Its structure is as follows:
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CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroidsis 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 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 increasepercutaneous 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.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
