Dosetil

Desonide.

Each gram of cream contains: Desonide 0.5 mg.
Each gram of DESONIDE (DOSETIL) Cream contains 0.5 mg of desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)-) a synthetic non-fluorinated corticosteroid in a suitable vehicle for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents. Chemically, desonide is C₂₄H₃₂O₆.
Desonide has the molecular weight of 416.51. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water.

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.

DESONIDE (DOSETIL) Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DESONIDE (DOSETIL) Cream should be applied to the affected areas as a thin film two or three 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 2 weeks, reassessment of diagnosis may be necessary.
DESONIDE (DOSETIL) Cream should not be used with occlusive dressings.

Topically applied DESONIDE (DOSETIL) Cream can be absorbed in sufficient amounts to produce systemic effects.

DESONIDE (DOSETIL) Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.
If irritation to DESONIDE (DOSETIL) Cream develops, then it should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of DESONIDE (DOSETIL) Cream should be discontinued until the infection has been adequately controlled.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of DESONIDE (DOSETIL) Cream.
Use in Pregnancy: 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 reproduction studies have not been conducted with desonide. It is also not known whether desonide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DESONIDE (DOSETIL) Cream should be given to a pregnant woman only if clearly needed.
Use in Lactation: 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 DESONIDE (DOSETIL) Cream is administered to a nursing woman.
Use in Children: 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 when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on 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.

Pregnancy: 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 reproduction studies have not been conducted with desonide. It is also not known whether desonide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DESONIDE (DOSETIL) Cream should be given to a pregnant woman only if clearly needed.
Nursing Mothers: 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 DESONIDE (DOSETIL) Cream is administered to a nursing woman.

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning, irritation, contact dermatitis, condition worsened peeling of skin, itching, intense transient erythema, and dryness/scaliness. The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and 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.

Store at temperatures not exceeding 30°C. Do not freeze.

Topical Corticosteroids

D07AB08 - desonide ; Belongs to the class of moderately potent (group II) corticosteroids. Used in the treatment of dermatological diseases.

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