NURSING MOTHERS SECTION.

Nursing mothers. Systemicallyadministered corticosteroids appearin human milk and could suppress growth, interfere with endogenouscorticosteroidproduction, or cause other untoward effects. It is not known whethertopical administration of corticosteroids could result in sufficientsystemic absorption to produce detectable quantities in human milk.Because many drugs are excreted in human milk, caution should beexercised when Desonide Lotion is administered to nursing woman.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Incontrolled clinical trials, the totalincidence of adverse reactions associated with the use of desonide wasapproximately 8%.These were: stinging and burning approximately 3%. Irritation, contactdermatitis, condition worsened, peeling of skin, itching, intensetransient erythema, and dryness/scaliness, each less than 2%. Thefollowing additional local adverse reactions have been reportedinfrequently with other topical corticosteroids, and they may occurmore frequently with the use of occlusive dressings, especially withhigherpotency corticosteroids. These reactions are listed in an approximatedecreasing order of occurrence: folliculitis, acneiform eruptions,hypopigmentation, perioral dermatitis, secondary infection, skinatrophy, striae, and miliaria.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Like other topical corticosteroids, desonide has anti-inflammatory,antipruritic and vasoconstrictive properties. The mechanism of theanti-inflammatory activity of the topical steroids, in general, isunclear. However, corticosteroids are thought to act by the inductionof phospholipase A2 inhibitory proteins,collectively called lipocortins. It is postulated that these proteinscontrol the biosynthesis of potent mediators of inflammation such asprostaglandins and leukotrienes by inhibiting the release of theircommon precursor arachidonic acid. Arachidonic acid is released frommembrane phospholipids by phospholipase A2.

DESCRIPTION SECTION.

DESCRIPTION. Desonide Lotion 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 -[(1-melhylethylidene)bis(oxy)]-,(11, 16)- synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute 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 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 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.. desonide-lotion-01.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. DesonideLotion should be applied to the affected areas as thin film two orthree times daily depending on the severity of the condition. SHAKELOTION WELL BEFORE USING.As with other corticosteroids, therapy should be discontinued whencontrol is achieved. If no improvement is seen within weeks,reassessment ofdiagnosis may be necessary.Desonide Lotion should not be used with occlusive dressings.

INFORMATION FOR PATIENTS SECTION.

Information for patients. Patients 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 orwrapped so as to be occlusive unless directed by the physician.4. Patients should report to their physician any signs of local adverse reactions.

PEDIATRIC USE SECTION.

Pediatric use. Safety and effectiveness in pediatric patientshave not been established. Because of higher ratio of skin surface area tobody mass, pediatric patients are at greater risk than adults of HPA axissuppression when they are treated with topical corticosteroids. They aretherefore also at greater risk of glucocorticosteroid insufficiency afterwithdrawal of treatment and of Cushings syndrome while on treatment. Adverse effectsincluding striae have been reported with inappropriate use of topicalcorticosteroids in infants and children. HPA axis suppression, Cushings syndrome, linear growth retardation, delayedweight gain and intracranial hypertension have been reported in childrenreceiving topical corticosteroids. Manifestations of adrenal suppression inchildren include low plasma cortisol levels, and absence of response to ACTHstimulation. Manifestations of intracranial hypertension include bulgingfontanelles, headaches, and bilateral papilledema.

PHARMACOKINETICS SECTION.

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 Lotion indicate that it is in the low to medium range of potency as compared with other topical corticosteroids.

PRECAUTIONS SECTION.

PRECAUTIONS. General: Systemic absorption of topicalcorticosteroids can produce reversible hypothalamic-pituitary-adrenal(HPA) axis suppression with the potential for glucocorticosteroidinsufficiency after withdrawal of treatment. Manifestations ofCushings syndrome, hyperglycemia, and glucosuria can also beproduced in some patients by systemic absorption of topicalcorticosteroids while on treatment. Patients applying topical steroidto large surface area or to areas under occlusion should be evaluatedperiodically for evidence of HPA axis suppression. This may be done byusing the ACTH stimulation, A.M. plasma cortisol, and urinary freecortisol tests. Patients receiving superpotent corticosteroids shouldnot be treated for more than weeks at time and only small areasshould be treated at any one time due to the increased risk of HPA axissuppression. If HPA axis suppression is noted, an attempt shouldbe made to withdraw the drug, to reduce the frequency of application,or to substitute less potent corticosteroid. Recovery of HPA axisfunction is generally prompt and complete upon discontinuation oftopical corticosteroids. Infrequently, signs and symptoms ofglucocorticosteroid insufficiency may occur requiring supplementalsystemic corticosteroids. For information on systemic supplementation,see prescribing information for those products.Pediatric patientsmay be more susceptible to systemic toxicity from equivalent doses dueto their larger skin surface to body mass ratios. (See PRECAUTIONS: Pediatric Use). Ifirritation develops, Desonide Lotion should be discontinued andappropriate therapy instituted. Allergic contact dermatitis withcorticosteroids is usually diagnosed by observing failure to healrather than noting clinical exacerbation as with most topicalproducts not containing corticosteroids. Such an observation should becorroborated with appropriate diagnostic patch testing.Ifconcomitant skin infections are present or develop, an appropriateantifungal or antibacterial agent should be used. If favorableresponse does not occur promptly, use of Desonide Lotion should bediscontinued until the infection has been adequately controlled.

PREGNANCY SECTION.

Pregnancy. Teratogenic effects: Pregnancy category C:Corticosteroids have been shown to be teratogenic in laboratory animalswhen administered systemically at relativity low dosage levels. Somecorticosteroids have been shown to be teratogenic after dermalapplication in laboratory animals. Animal reproduction studies have notbeen conducted with Desonide Lotion. It is also not known whetherDesonide Lotion can cause fetal harm when administered to pregnantwoman or can affect reproduction capacity. Desonide Lotion should begiven to pregnant woman only if clearly needed.