DESONIDE

Desonide cream, 0.05% contains desonide (Pregna-1, 4-diene-3, 20-dione, 11, 21-dihydroxy-16, 17-[(1- methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide cream, 0.05% is C 24 H 32 O 6 . It has the following structural formula: The molecular weight of desonide is 416.51. It is a white to almost white crystalline powder. It is insoluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%), slightly soluble in ethyl ether. Each gram of desonide cream, 0.05% contains 0.5 milligram of desonide micro dispersed in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. Desonide cream, 0.05% is preserved with methylparaben and buffered to pH 4.2 to 5.0.

Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.

Desonide cream, 0.05% should be applied to the affected area as a thin film two to four times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Desonide cream, 0.05% should not be used with occlusive dressings.

Desonide cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide cream, 0.05% was approximately 1%. These adverse reactions were pruritus, pain, folliculitis, rash, peripheral edema, pustular rash, sweating, erythema, irritation, and burning. Laboratory abnormalities were found in 3% of the patients. These were hyperglycemia (2%) and liver function abnormality (1%). The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.