Desonate™ (desonide) Gel 0.05%
(desonide)Desonate™ (desonide) Gel 0.05% Prescribing Information
Desonate Gel 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 Desonate Gel for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate Gel to suppress the hypothalamic-pituitary-adrenal (HPA) axis (see PRECAUTIONS). Treatment should not exceed 4 consecutive weeks.
Desonate Gel should be applied as a thin layer to the affected areas two times daily and rubbed in gently. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.
Desonate Gel should not be used with occlusive dressings.
Desonate Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
In controlled clinical studies of 425 Desonate Gel treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate Gel and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonate Gel- treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425) .
Adverse events that resulted in premature discontinuation of study drug in Desonate Gel treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonate Gel included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.
The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Desonate Gel contains desonide (pregna-1,4-diene-3, 20-dione,11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-, (11ß,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C24H32O6. It has the following structural formula:
Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water.
Each gram of Desonate Gel contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium dihydrate, methylparaben, propylparaben, sodium hydroxide, and Carbopol® 981.
Topical corticosteroids share 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 A2 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 A2.
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Topical corticosteroids can be absorbed from normal intact skin. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
In a controlled pharmacokinetic study, one of 37 (3%) pediatric subjects with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonate Gel experienced suppression of the adrenal glands following 4 weeks of therapy (see PRECAUTIONS: General and Pediatric Use). A follow-up evaluation of the subject’s adrenal axis was not performed; it is unknown whether the suppression was reversible.