VERDESO- desonide aerosol, foam
Stiefel Laboratories Inc
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 Foam for the minimum amount of time necessary to achieve the desired results because of the potential for VERDESO Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.
2 DOSAGE AND ADMINISTRATION
VERDESO Foam is not for oral, ophthalmic, or intravaginal use.
A thin layer of VERDESO Foam should be applied to the affected area(s) twice daily. Shake the can before use. VERDESO 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 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 Foam has not been established beyond 4 weeks of use. Treatment should not exceed 4 consecutive weeks.
Unless directed by a physician, VERDESO Foam should not be used with occlusive dressings.
3 DOSAGE FORMS AND STRENGTHS
Foam, 0.05%. Each gram of VERDESO Foam contains 0.5 mg of desonide in a white to off-white petrolatum-based emulsion aerosol foam.
OVERDOSAGE
Topically applied VERDESO 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.
11 DESCRIPTION
VERDESO Foam is a white to off-white 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.
Desonide has a molecular formula of C24 H32 O6 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 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 Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatitis is unknown.
The contribution to efficacy by individual components of the vehicle has not been established.
