Desowen Information
Desowen (Desonide) Description
Desowen (Desonide) Cream 0.05%, Ointment 0.05%, and Lotion 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 [(1methylethylidene) bis(oxy)]-,(11β,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
Chemically, desonide is CHO. It has the following structural formula:
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.
Each gram of Desowen (Desonide) Cream contains 0.5 mg of desonide in a base of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid, and synthetic beeswax.
Each gram of Desowen (Desonide) Ointment contains 0.5 mg of desonide in a base of mineral oil and polyethylene.
Each gram of Desowen (Desonide) Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.
Desowen (Desonide) 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 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.
Desowen (Desonide) Indications And Usage
Desowen (Desonide) Cream, Ointment and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Desowen (Desonide) Contraindications
Desowen (Desonide) Cream, Ointment and Lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Desowen (Desonide) Precautions
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. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.
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. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See ).
If irritation develops, Desowen (Desonide) Cream, Ointment or Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing 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 Desowen (Desonide) (desonide cream, ointment and lotion) Cream, Ointment or Lotion should be discontinued until the infection has been adequately controlled.
The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
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.
Desowen (Desonide) Adverse Reactions
In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%, irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.
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.
Desowen (Desonide) Overdosage
Topically applied Desowen (Desonide) (desonide cream, ointment and lotion) Cream, Ointment and Lotion can be absorbed in sufficient amounts to produce systemic effects (See ).
Desowen (Desonide) Dosage And Administration
Desowen (Desonide) Cream, Ointment or Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.
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.
Desowen (Desonide) Cream, Ointment and Lotion should not be used with occlusive dressings.
Desowen (Desonide) How Supplied
Desowen (Desonide) (desonide cream) Cream 0.05% is supplied in tubes containing:
60 g 0299-5770-60
Desowen (Desonide) (desonide ointment) Ointment 0.05% is supplied in tubes containing:
60 g 0299-5775-60
Desowen (Desonide) (desonide lotion) Lotion 0.05% is supplied in bottles containing:
2 fl oz 0299-5765-02
4 fl oz 0299-5765-04
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177, USAMfd. by: DPT Laboratories, Ltd.San Antonio, Texas 78215, USAGALDERMA is a registered trademark.325007-0203Revised: April 2007
Desowen (Desonide) Package Label
For External Use Only. Not for Ophthalmic Use. Store between 2° and 30°C (35° and 86°F).
Usual dosage: Apply a small amount to affected areas 2 or 3 times daily. See package insert for complete prescribing information.
Each gram contains: desonide 0.5 mg in a cream base consisting of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid and synthetic beeswax.
Lot no. and exp. date on crimp.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAManufactured by:DPT Laboratories, Ltd.San Antonio, Texas 78215 USAGALDERMA is a registered trademark.303017-0402
For External Use Only. Not for Ophthalmic Use.
Store between 2° and 30°C (35° and 86°F).
Usual dosage: Apply a small amount to affected areas two or three times daily. See package insert for complete prescribing information.
Each gram contains: deconide 0.5 mg in an ointment base consisting of mineral oil and polyethylene.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth Texas, 76177 USAManufactured by:DPT Laboratories, Ltd.San Antonio, Texas 78215 USAGALDERMA is a registered trademark.310020-1102
See package insert for complete prescribing information.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAManufactured by:DPT Laboratories, Ltd.San Antonio, Texas 78215 USAGALDERMA is a registered trademark.326074-0702
