Desocort (Desonide)




Topical Corticosteroid

Action And Clinical Pharmacology: Desonide, like all topical corticosteroids, exhibits anti-inflammatory, antipruritic and vasoconstrictive actions. tag_IndicationsIndications

Indications And Clinical Uses: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contra-Indications: Tuberculous, fungal and most viral lesions of the skin (including herpes simplex, vaccinia and varicella). Hypersensitivity to any of the components. Not for ophthalmic use.

Precautions: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Children).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: urinary free cortisol test and ACTH stimulation test.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of desonide.

Pregnancy: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Desonide has been shown to be teratogenic after dermal application in laboratory animals at doses similar to recommended human dose. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time.

Lactation: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk. Caution should be exercised when topical corticosteroids are administered to a nursing woman.

Children: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypo-pigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see Precautions).

Dosage And Administration: Cream: Apply a small amount to affected areas 2 or 3 times daily.

Lotion: Shake well before using. Apply a small amount to affected areas 2 or 3 times daily.

Ointment: Apply a small amount to affected areas 2 to 3 times daily.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Availability And Storage: Cream: Each tube contains: desonide 0.05% in a water base cream. Nonmedicinal ingredients: emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sorbic acid, stearic acid and synthetic beeswax. May contain citric acid and/or sodium hydroxide to adjust pH. Tubes of 15 and 60 g. Store at room temperature (15 to 30°C).

Lotion: Each bottle contains: desonide 0.05% in a water base lotion. Nonmedicinal ingredients: cetyl alcohol, glyceryl stearate SE, methyl paraben, mineral oil, propyl paraben, propylene glycol, purified water, sodium lauryl sulfate, sorbitan monostearate, stearyl alcohol and tetrasodium EDTA. May contain sodium hydroxide and/or citric acid to adjust pH. Bottles of 60 and 120 mL. Store at room temperature (15 to 30°C).

Ointment: Each tube contains: desonide 0.05%. Nonmedicinal ingredients: mineral oil and polyethylene. Tubes of 15 and 60 g. Store at room temperature (15 to 30°C).

DESOCORT® Galderma Desonide Topical Corticosteroid

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