Desonide Information
Desonide () Description
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 CHO. It has the following structural formula:
The molecular weight of Desonide () is 416.51. It is a white to off-white powder. The solubility of Desonide () in distilled water saturated with ether is 184 mg/L.
Each gram of Desonide () Cream, 0.05% contains 0.5 milligram of Desonide () microdispersed in a base of aluminum sulfate, calcium acetate, cetyl stearyl 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 - 5.0.
Desonide () 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 A 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 A.
Desonide () Indications And Usage
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 () Contraindications
Desonide () Cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Desonide () Precautions
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than two weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppressions.
One of ten patients treated for one week under occlusion (30% of body surface) with Desonide () Cream, 0.05% developed HPA axis suppression as determined by metapyrone testing.
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 corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see ).
If irritation develops, Desonide () Cream, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonide () Cream, 0.05% should be discontinued until the infection has been adequately controlled.
Desonide () Cream, 0.05% should not be used in the presence of infection at the treatment site, hypersensitivity to corticosteroids, or pre-existing skin atrophy.
Desonide () Cream, 0.05% should not be used in the eyes.
FOR EXTERNAL USE ONLY.
The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation testA.M. plasma cortisol testUrinary free cortisol test
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.
Desonide () Adverse Reactions
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.
Desonide () Overdosage
Topically applied Desonide () Cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see ).
Desonide () Dosage And Administration
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 () How Supplied
Desonide () Cream, 0.05% is available as follows:
15 g tube (NDC 45802--35)
60 g tube (NDC 45802--37)
Desonide () Storage
Store at 20-25°C (68-77°F)[see USP Controlled Room Temperature].
Desonide ()
Desonide () Principal Display Panel - Carton
Desonide () Cream, 0.05%
Rx Only
Desonide () Principal Display Panel - Tube
Desonide () Cream, 0.05%
Rx Only
