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  • CLASSES

    Plain Topical Corticosteroids

    DEA CLASS

    Rx

    DESCRIPTION

    Topical low-potency synthetic corticosteroid
    Used for corticosteroid-responsive dermatoses
    Topical efficacy similar to hydrocortisone

    COMMON BRAND NAMES

    Desonate, DesOwen, LoKara, Tridesilon, Verdeso

    HOW SUPPLIED

    Desonate Topical Gel: 0.05%
    Desonide/DesOwen/LoKara Topical Lotion: 0.05%
    Desonide/DesOwen/Tridesilon Topical Cream: 0.05%
    Desonide/DesOwen/Tridesilon Topical Ointment: 0.05%
    Verdeso Topical Foam: 0.05%

    DOSAGE & INDICATIONS

    For the treatment of mild to moderate inflammatory manifestations of corticosteroid-responsive dermatitis such as contact dermatitis, exfoliative dermatitis, Rhus dermatitis due to plants like poison ivy, or seborrheic dermatitis (facial and intertriginous areas), discoid lupus erythematosus (facial and intertriginous areas), eczema, granuloma annulare, intertrigo, cutaneous lichen planus, lichen simplex chronicus, polymorphous light eruption, anogenital or senilis pruritus, psoriasis (facial and intertriginous areas), or xerosis (inflammatory phase).
    NOTE: Occlusive dressings may be required for chronic or severe cases of lichen simplex chronicus, psoriasis, eczema, or chronic hand eczema. More potent topical corticosteroids and/or occlusive dressings may be necessary for the treatment of discoid lupus erythematosus, lichen planus, granuloma annulare, psoriatic plaques, and psoriasis of the palms, soles, elbows, or knees.
    Topical dosage (topical cream, ointment, or lotion)
    Adults

    Apply sparingly to affected areas. Cream or ointment may be used 2 to 4 times per day; lotion may be used 2 to 3 times per day.

    Children†

    A multicenter, randomized trial using 0.05% desonide ointment twice daily for dermatitis (atopic) in children (10 months to 12 years of age) demonstrated improved efficacy, and equivalent safety, compared to 1% hydrocortisone ointment.

    For the treatment of mild to moderate atopic dermatitis.
    NOTE: Occlusive dressings may be required for chronic or severe cases of atopic dermatitis.
    Topical dosage (topical cream, ointment, or lotion)
    Adults

    Apply sparingly to affected areas. Cream or ointment may be used 2 to 4 times per day; lotion may be used 2 to 3 times per day.

    Children†

    A multicenter, randomized trial using 0.05% desonide ointment twice daily for atopic dermatitis in children (10 months to 12 years of age) demonstrated improved efficacy, and equivalent safety, compared to 1% hydrocortisone ointment.

    Topical dosage (Verdeso Foam 0.05% or Desonate Gel 0.05%)
    Adults, Adolescents, Children, and Infants >= 3 months

    Apply sparingly to affected areas twice daily. Treatment should be limited to 4 consecutive weeks.

    MAXIMUM DOSAGE

    While in general corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease and on patient age and response, the area of skin where desonide is applied should be limited.

    Adults

    Cream or ointment 4 applications/day topically; Lotion 3 applications/day topically; Foam or gel 2 applications/day topically.

    Elderly

    Cream or ointment 4 applications/day topically; Lotion 3 applications/day topically; Foam or gel 2 applications/day topically.

    Adolescents

    Cream or ointment 4 applications/day topically; Lotion 3 applications/day topically; Foam or gel 2 applications/day topically.

    Children

    Foam or gel 2 applications/day topically.

    Infants

    >= 3 months: Foam or gel 2 applications/day topically.
    < 3 months: Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration

    For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use.
    Do not use with occlusive dressings.

    Cream/Ointment/Lotion Formulations

    Cream or ointment:
    Apply a thin film to the affected areas.
    Lotion:
    Shake well before using.
    Apply to the affected areas and massage lightly until the lotion disappears.
    For the most effective and economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze.

    Other Topical Formulations

    Foam: 
    Shake well before using. 
    Turn the can upside down to dispense. 
    For application to the face, dispense into the hands and gently massage into the affected areas until the foam disappears. For areas other than the face, the foam may be dispensed directly onto the affected area. 
    Rub in gently until the foam disappears. 
    Use only enough medication to cover the affected areas. 
    This product is flammable. Keep away from fire, flame, and smoking during and immediately after use.
    Gel:
    Apply a thin film to the affected areas and rub in gently.

    STORAGE

    Desonate:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    DesOwen:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    LoKara:
    - Store between 36 to 86 degrees F
    Tridesilon:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Verdeso:
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    - Flammable, keep away from heat and flame
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to desonide should not receive any form of desonide. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.

    Corticosteroid hypersensitivity

    Desonide is contraindicated in any patient with a history of desonide hypersensitivity or hypersensitivity to any ingredients in the preparation. In addition, desonide should be used with caution in patients with a history of corticosteroid hypersensitivity.

    Cushing's syndrome, hypothalamic-pituitary-adrenal (HPA) suppression, occlusive dressing, skin abrasion

    Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing's syndrome in some patients. Conditions which increase systemic absorption include application of more potent corticosteroids, use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of occlusive dressings. Desonide preparations should not be used with occlusive dressings. Patients receiving large doses of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression and manifestations Cushing's syndrome. If these effects are noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

    Diabetes mellitus

    Topical corticosteroids should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.

    Children, growth inhibition, increased intracranial pressure, infants, neonates

    The safety and efficacy of desonide cream, lotion, and ointment in neonates, infants, children, and adolescents have not been established. The safety and efficacy of desonide foam and gel have not been established in neonates and infants less than 3 months of age. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and therefore are more susceptible to developing systemic toxicity. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and increased intracranial pressure have been reported in pediatric patients receiving topical corticosteroids. Chronic corticosteroid therapy in pediatric patients may interfere with growth and development, resulting in growth inhibition. Administration of topical corticosteroids should be limited to the least amount compatible with an effective therapeutic regimen. If children are being treated in the diaper area, tight-fitting diapers or plastic pants should be avoided as these garments may act as an occlusive dressing and increase systemic absorption of the drug.

    Pregnancy

    There are no adequate and well-controlled studies of topical application of desonide during pregnancy. Topical corticosteroids, including desonide, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents, such as desonide, over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

    Breast-feeding

    According to the manufacturer, it is not known whether topical administration of desonide could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Acne rosacea, acne vulgaris, fungal infection, herpes infection, infection, measles, perioral dermatitis, tuberculosis, varicella, viral infection

    The normal inflammatory response to local infections can be masked by desonide. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Topical corticosteroids should not be used to treat perioral dermatitis, acne vulgaris, or acne rosacea as they may aggravate these conditions.

    Ocular exposure, ophthalmic administration

    Desonide is not indicated for ophthalmic administration. If unintended ocular exposure occurs, the patient should rinse the exposed area well with water. Visual impairment, glaucoma, and posterior subcapsular cataracts have been reported with other topical corticosteroids. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.[62797]

    Geriatric, skin atrophy

    Topical corticosteroids should be used for brief periods, or under close medical supervision in patients with evidence of pre-existing skin atrophy. Geriatric patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients.

    ADVERSE REACTIONS

    Severe

    skin atrophy / Delayed / Incidence not known
    papilledema / Delayed / Incidence not known
    increased intracranial pressure / Early / Incidence not known
    visual impairment / Early / Incidence not known
    ocular hypertension / Delayed / Incidence not known

    Moderate

    erythema / Early / 0-2.0
    withdrawal / Early / Incidence not known
    pseudotumor cerebri / Delayed / Incidence not known
    hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
    growth inhibition / Delayed / Incidence not known
    adrenocortical insufficiency / Delayed / Incidence not known
    glycosuria / Early / Incidence not known
    hyperglycemia / Delayed / Incidence not known
    hypertension / Early / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known
    blurred vision / Early / Incidence not known
    cataracts / Delayed / Incidence not known
    impaired wound healing / Delayed / Incidence not known
    skin ulcer / Delayed / Incidence not known
    tolerance / Delayed / Incidence not known
    contact dermatitis / Delayed / Incidence not known

    Mild

    maculopapular rash / Early / 1.0-10.0
    skin irritation / Early / 0-3.0
    xerosis / Delayed / 0-2.0
    pruritus / Rapid / 0-2.0
    infection / Delayed / Incidence not known
    hypertrichosis / Delayed / Incidence not known
    purpura / Delayed / Incidence not known
    striae / Delayed / Incidence not known
    folliculitis / Delayed / Incidence not known
    skin hypopigmentation / Delayed / Incidence not known
    miliaria / Delayed / Incidence not known
    telangiectasia / Delayed / Incidence not known
    acneiform rash / Delayed / Incidence not known
    headache / Early / Incidence not known

    DRUG INTERACTIONS

    Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate and well-controlled studies of topical application of desonide during pregnancy. Topical corticosteroids, including desonide, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents, such as desonide, over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

    According to the manufacturer, it is not known whether topical administration of desonide could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.

    PHARMACOKINETICS

    Desonide is administered topically to the skin as a cream, lotion, foam, or ointment. Circulating levels of desonide are below the level of detection. Once in the systemic circulation, desonide is metabolized in the liver. Excretion is primarily via the urine.

    Topical Route

    The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the pharmaceutical vehicle and the integrity of the epidermis. Absorption after topical application of desonide is increased in areas that have skin damage, inflammation, or occlusion, or in areas where the stratum corneum is thin such as the eyelids, genitalia, axillae, and face. The use of occlusive dressings with the application of desonide enhances penetration into the skin, and may increase the chance of systemic absorption. Ointments have a hydrating effect, are lipophilic, and enhance the penetration of desonide into the skin. Because desonide contains a substituted 17-hydroxyl group, it is not metabolized in the skin. Repeated application of desonide results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action, increased adverse effects, and increased systemic absorption.