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----------Desonide Lotion 0.05%
DESCRIPTIONDesonide Lotion 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 -[(1-melhylethylidene)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 anti-pruritic agents.
Chemically, desonide is C24H3206. 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 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.
CLINICAL PHARMACOLOGYLike 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.
PharmacokineticsThe 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 Lotion indicate that it is in the low to medium range of potency as compared with other topical corticosteroids.
INDICATION AND USAGEDesonide Lotion is low to medium potency corticosteroids indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
CONTRAINDICATIONSDesonide lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
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. 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
Information for patientsPatients using topical corticosteroids should receive the following information and Instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.
Laboratory testsThe following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
Carcinogenesis, mutagenesis, and impairment or fertilityLong-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of Desonide Lotion.
PregnancyTeratogenic effects: Pregnancy category C:
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relativity 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 Lotion. It is also not known whether Desonide Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Desonide Lotion should be given to a pregnant woman only if clearly needed.
Nursing mothersSystemically 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 Lotion is administered to a nursing woman.
Pediatric useSafety 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.
ADVERSE REACTIONSIn 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.
OVERDOSAGETopically applied Desonide Lotion can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS)
DOSAGE AND ADMINISTRATIONDesonide 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.
Desonide Lotion should not be used with occlusive dressings.
HOW SUPPLIEDDesonide Lotion 0.05% is supplied as follows:
Store between 2° and 30°C (36° and 86°F).
325097-0209 Revised: February 2009
Relabeling of "Additional" barcode label by:
Revised: 06/2009 Physicians Total Care, Inc.
Reproduced with permission of U.S. National Library of Medicine
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