Verdeso Information
Verdeso (Desonide) Indications And Usage
Verdeso (Desonide) Foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.
Patients should be instructed to use Verdeso (Desonide) Foam for the minimum amount of time necessary to achieve the desired results because of the potential for Verdeso (Desonide) Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.
Verdeso (Desonide) Dosage And Administration
Verdeso (Desonide) Foam is not for oral, ophthalmic, or intravaginal use.
A thin layer of Verdeso (Desonide) Foam should be applied to the affected area(s) twice daily. Shake the can before use. Verdeso (Desonide) Foam should be dispensed by inverting the can (upright actuation will cause loss of the propellant which may affect product delivery). Dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer.
The medication should not be dispensed directly on the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly onto the affected area. Take care to avoid contact with the eyes or other mucous membranes.
Patients should dispense the smallest amount of foam as necessary to adequately cover the affected area with a thin layer. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of Verdeso (Desonide) Foam has not been established beyond 4 weeks of use. Treatment should not exceed 4 consecutive weeks.
Unless directed by a physician, Verdeso (Desonide) Foam should not be used with occlusive dressings.
Verdeso (Desonide) Dosage Forms And Strengths
White to off-white petrolatum-based emulsion aerosol foam containing 0.05% desonide.
Verdeso (Desonide) Contraindications
Verdeso (Desonide) Warnings And Precautions
Verdeso (Desonide) Foam has been shown to reversibly suppress the HPA axis.
Topical application of Verdeso (Desonide) Foam may result in systemic absorption and effects including HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal, and growth retardation in children. Use of Verdeso (Desonide) Foam for longer than four weeks may suppress the immune system [].
Conditions that augment systemic absorption include the application of topical corticosteroids over large body surface areas, prolonged use, or the addition of occlusive dressings. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
The effect of Verdeso (Desonide) Foam on HPA axis function was investigated in pediatric patients in one study. In this study, patients with atopic dermatitis covering at least 25% of their body applied Verdeso (Desonide) Foam twice daily for 4 weeks. Three out of 75 patients (4%) displayed adrenal suppression after 4 weeks of use based on the cosyntropin stimulation test. The laboratory suppression was transient; all subjects had returned to normal when tested 4 weeks post treatment.
Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Verdeso (Desonide) Foam due to their larger skin surface to body mass ratios. [see ].
Concomitant therapy with topical corticosteroids should be used with caution because a cumulative effect may occur.
Verdeso (Desonide) Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a controlled clinical study of 581 patients 3 months to 17 years of age, adverse reactions occurred at the application site in 6% of subjects treated with Verdeso (Desonide) Foam and 14% of subjects treated with Vehicle Foam. Other commonly reported adverse reactions for Verdeso (Desonide) Foam and Vehicle Foam are noted in Table 1.
Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender.
The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Verdeso (Desonide) Use In Specific Populations
Teratogenic Effects: Pregnancy Category C:
There are no adequate and well-controlled studies of Verdeso (Desonide) Foam in pregnant women. Therefore, Verdeso (Desonide) Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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.
No long-term reproductive studies in animals have been performed with Verdeso (Desonide) Foam. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6–15) and pregnant rabbits (gestational days 6–18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species. The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and at a topical dose of 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits) are similar to the maximum recommended human dose based on body surface area comparisons.
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 Verdeso (Desonide) Foam is administered to a nursing woman.
If used during lactation, Verdeso (Desonide) Foam should not be applied on the chest to avoid accidental ingestion by the infant.
Safety and efficacy in pediatric patients below 3 months of age have not been established and therefore the use of Verdeso (Desonide) Foam is not recommended.
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 and/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 an 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.
The effect of Verdeso (Desonide) Foam on HPA axis function was investigated in pediatric patients, ages 6 months to 17 years, in one study. In this study, patients with atopic dermatitis covering at least 25% of their body applied Verdeso (Desonide) Foam twice daily for 4 weeks. Three out of 75 patients (4%) displayed adrenal suppression after 4 weeks of use based on the ACTH stimulation test. The suppression was transient; all subjects’ cortisol levels had returned to normal when tested 4 weeks post treatment.
Verdeso (Desonide) Overdosage
Topically applied Verdeso (Desonide) Foam can be absorbed in sufficient amounts to produce systemic effects.
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.
Verdeso (Desonide) Description
Verdeso (Desonide) Foam is a petrolatum-based emulsion aerosol foam containing the active ingredient desonide, a low-potency topical corticosteroid.
Chemically, desonide is (11β,16α)-11,21-dihydroxy-16,17-[(1-methylethylidene)-bis(oxy)]-pregna-1,4-diene-3,20-dione.
The structural formula of desonide is represented below:
Desonide has a molecular formula of CHO and a molecular weight of 416.51. Desonide is a white powder or crystal that is practically insoluble in water, sparingly soluble in ethanol and in acetone, and soluble in chloroform. Each gram of Verdeso (Desonide) Foam contains 0.5 mg desonide. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative.
Verdeso (Desonide) Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.
Verdeso (Desonide) Clinical Pharmacology
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatatis is unknown.
The contribution to efficacy by individual components of the vehicle has not been established.
Verdeso (Desonide) Clinical Studies
In a double-blind, randomized study of 581 patients ages 3 months to 17 years old, with mild to moderate atopic dermatitis, Verdeso (Desonide) Foam was applied twice daily for 4 weeks. Success was defined as the proportion of patients who had all of the following: an Investigator’s Static Global Assessment (ISGA) score of clear or almost clear, a minimum improvement in the 5 point ISGA score of 2 grades from Baseline to Week 4, and a score of absent or minimal for both erythema and induration/papulation at Week 4. The results of this study are presented in the following table.
Verdeso (Desonide) How Supplied/storage And Handling
Store at controlled room temperature 68–77°F (20–25°C).
Contents under pressure. Do not puncture or incinerate.
Avoid contact with eyes or other mucous membranes.
Keep out of reach of children.
Verdeso (Desonide) Patient Counseling Information
See FDA-Approved Patient Labeling
Verdeso (Desonide)
Verdeso (Desonide)
