Desonide

Desonide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Desonide is a Corticosteroid that is FDA approved for the treatment of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Common adverse reactions include Contact dermatitis, Dry skin, Pruritus, Stinging of skin, Burning sensation, Irritation symptom.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dermatoses

• Dosing information

• Desonide cream or ointment should be applied to the affected areas as a thin film two or 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 and ointment should not be used with occlusive dressings.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Desonide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Desonide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients have not been established

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Desonide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Desonide in pediatric patients.

Contraindications

Desonide cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Warnings

General

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. No specific studies relevant to potential HPA suppression have been conducted with Desonide Ointment, 0.05%. 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 PRECAUTIONS - Pediatric Use). If irritation develops, desonide cream or ointment 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 or ointment should be discontinued until the infection has been adequately controlled. Desonide Cream, 0.05% and Ointment, 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% and Ointment, 0.05% should not be used in the eyes. FOR EXTERNAL USE ONLY.

Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression:

• ACTH stimulation test

• A.M. plasma cortisol test

• Urinary free cortisol test

Adverse Reactions

Clinical Trials Experience

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Desonide Cream, 0.05% was approximately 1% and Desonide Ointment, 0.05% was approximately 6%. The adverse reactions for Desonide Cream, 0.05% 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 adverse reactions for Desonide Ointment, 0.05% were erythema, induration, pruritus, irritation, oiliness, and peripheral edema. The following additional local adverse reactions have been reported infrequently with other 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.

Postmarketing Experience

FDA Package Insert for Desonide contains no information regarding Postmarketing experience .

Drug Interactions

FDA Package Insert for Desonide contains no information regarding Drug Interaction.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C 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 or ointment. It is also not known whether desonide cream or ointment 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 or ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Desonide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Desonide during labor and delivery.

Nursing Mothers

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 or ointment is administered to a nursing woman.

Pediatric Use

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 pediatric patients include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatic Use

There is no FDA guidance on the use of Desonide in geriatric settings.

Gender

There is no FDA guidance on the use of Desonide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Desonide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Desonide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Desonide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Desonide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Desonide in patients who are immunocompromised.

Administration and Monitoring

Administration

Applied to the affected area.

Monitoring

FDA Package Insert for Desonide contains no information regarding Drug Monitoring.

IV Compatibility

There is limited information about the IV Compatibility.

Overdosage

Topically applied desonide cream and ointment can be absorbed in sufficient amounts to produce systemic effects.

Pharmacology

There is limited information regarding Desonide Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Desonide Mechanism of Action in the drug label.

Structure

There is limited information regarding Desonide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Desonide Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Desonide Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Desonide Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Desonide Clinical Studies in the drug label.

How Supplied

There is limited information regarding Desonide How Supplied in the drug label.

Storage

There is limited information regarding Desonide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Desonide Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Desonide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Desonide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Desonide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.