Desonide Cream

Name: Desonide Cream

Desonide Cream 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 C24H32O6. It has the following structural formula:

The molecular weight of desonide is 416.51. It is a white powder and practically insoluble in water; sparingly soluble in ethanol and in acetone; soluble in chloroform.

Each gram of Desonide Cream, 0.05% contains 0.5 mg of desonide micronized in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, diethylene glycol monoethyl ether, glycerin, light mineral oil, propylene glycol, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. Desonide Cream, 0.05% is preserved with methyl paraben.

Desonide Cream - 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 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 the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Desonide Cream, 0.05% indicate that it is in the low range of potency as compared with other topical corticosteroids.

Contraindications

Desonide Cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Desonide Cream 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.

Package/Label Display Panel

DESONIDE 
Desonide Cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-252
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESONIDE (DESONIDE) DESONIDE 0.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE  
CALCIUM ACETATE  
ICODEXTRIN  
GLYCERIN  
WATER  
YELLOW WAX  
PETROLATUM  
LIGHT MINERAL OIL  
METHYLPARABEN  
SODIUM LAURYL SULFATE  
CETOSTEARYL ALCOHOL  
DIETHYLENE GLYCOL MONOETHYL ETHER  
PROPYLENE GLYCOL  
Packaging
# Item Code Package Description
1 NDC:68462-252-17 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:68462-252-65 1 TUBE in 1 CARTON
2 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209729 07/24/2017
Labeler - Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 676115028 MANUFACTURE(68462-252), ANALYSIS(68462-252)
Revised: 07/2017   Glenmark Pharmaceuticals Inc., USA
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