DESONYX

A nonfluorinated corticosteroid anti-inflammatory agent used topically for dermatoses.

For the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatose.

Desonide is 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.

Topical corticosteroids can be absorbed from normal intact skin, inflammation and/or other disease processes in the skin may increase percutaneous absorption.

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Topically applied desonide cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects.

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

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.

Cream, 0.05% is supplied in 15 g (NDC 16714-729-01) tubes.

Cream, 0.05% is supplied in 60 g (NDC 16714-729-02) tubes.

Store at 20° to 25°C (68° to 77°F) .

Protect from freezing.

Store at 20° to 25°C (68° to 77°F) .

Protect from freezing.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Animal reproductive studies have not been conducted with desonide cream, 0.05%.

It is also not known whether desonide cream, 0.05% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

There are no adequate and well-controlled studies in pregnant women.

Desonide cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when desonide cream, 0.05% is administered to a nursing woman.

Safety and effectiveness in pediatric patients have not been established.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids.

They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.