Desonide is a human prescription drug labeled by 'Viona Pharmaceuticals Inc'. National Drug Code (NDC) number for Desonide is 72578-086. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Desonide drug includes Desonide - .5 mg/g . The currest status of Desonide drug is Active.

Desonide desonide desonide desonide aluminum sulfate calcium acetate cetostearyl alcohol glycerin icodextrin light mineral oil methylparaben petrolatum sodium lauryl sulfate water yellow wax white to off-white

Indications and usage desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician.

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.

Contraindications desonide cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse reactions in controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide cream, 0.05% was approximately 1%. these adverse reactions 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 following additional local adverse reactions have been reported infrequently with 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. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-f Read more...

Pregnancy teratogenic effects pregnancy category 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, 0.05%. it is also not known whether desonide cream, 0.05% 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, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 children include low plasma cortisol levels and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Overdosage topically applied desonide cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see precautions ).

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 c 24 h 32 o 6 . it has the following structural formula: the molecular weight of desonide is 416.51. it is a white to almost white crystalline powder. it is insoluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%), slightly soluble in ethyl ether. each gram of desonide cream, 0.05% contains 0.5 milligram of desonide micro dispersed in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. desonide cream, 0.05% is preserved with methylparaben and buffered to ph 4.2 to 5.0. 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 a 2 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 a 2 . 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 mar Read more...

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.

How supplied desonide cream, 0.05% is white to off white cream and is available as follows: ndc 72578-086-01 in tube of 15 g ndc 72578-086-02 in tube of 60 g storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. call your doctor for medical advice about side effects. you may report side effects to viona pharmaceuticals inc. at 1-888-304-5011 or fda at 1-800-fda-1088.

Information for patients patients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. this medication should not be used for any disorder other than that for which it was prescribed. the treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. patients should report to their physician any signs of local adverse reactions.

Package label.principal display panel ndc 72578-086-01 desonide cream, 0.05% 15 g rx only desonide cream desonide cream