DESCRIPTION

DesOwen® Cream 0.05%, Ointment 0.05%, and Lotion 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 [(1methylethylidene) bis(oxy)]-,(11β,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Chemically, desonide is C24H32O6. It has the following structural formula:

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water.

Each gram of DesOwen® Cream contains 0.5 mg of desonide in a base of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid, and synthetic beeswax.

Each gram of DesOwen® Ointment contains 0.5 mg of desonide in a base of mineral oil and polyethylene.

Each gram of DesOwen® Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with DesOwen® (desonide cream, ointment and lotion) Cream, Ointment, and Lotion indicate that they are in the low to medium range of potency as compared with other topical cortico-steroids.

 INDICATIONS AND USAGE

DesOwen® Cream, Ointment and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

 CONTRAINDICATIONS

DesOwen® Cream, Oi