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  • CLASSES

    Plain Topical Corticosteroids

    DEA CLASS

    Rx

    DESCRIPTION

    Topical low-to-medium potency synthetic corticosteroid; modest antiinflammatory properties; equivalent in efficacy to desonide and hydrocortisone; however, it is much less effective than betamethasone ointment for severe dermatosis.

    COMMON BRAND NAMES

    Aclovate

    HOW SUPPLIED

    Aclovate/Alclometasone/Alclometasone Dipropionate Topical Cream: 0.05%
    Aclovate/Alclometasone/Alclometasone Dipropionate Topical Ointment: 0.05%

    DOSAGE & INDICATIONS

    For the treatment of mild to moderate inflammatory manifestations of corticosteroid-responsive dermatitis such as atopic dermatitis, 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, atopic dermatitis, 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 (cream or ointment)
    Adults, Adolescents, and Children >= 1 year

    Apply a thin film to the affected area 2—3 times/day; massage gently until the medication disappears. An initial response to eczema or psoriasis occurs in 5—7 days, with peak effects by 14 days. If no response is seen within 2 weeks, reassess treatment options. In children, the safety and efficacy of use for more than 3 weeks has not been established.

    MAXIMUM DOSAGE

    Adults

    Maximum dosage information not available.

    Elderly

    Maximum dosage information not available.

    Adolescents

    Maximum dosage information not available.

    Children

    Do not exceed 3 weeks of treatment.

    Infants

    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.
    Apply a thin film to the affected area and rub in gently but completely.
    Occlusive dressings may be used for the management of refractory or chronic dermatoses or more severe conditions. Do not apply to the diaper area if the child still requires diapers or plastic pants as these garments may constitute an occlusive dressing and increase the risk of toxicity.

    STORAGE

    Aclovate:
    - Store between 36 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

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

    Systemic absorption of topical preparations may result in hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing's syndrome in some patients. Alclometasone dipropionate has been shown to suppress the HPA axis in pediatric patients receiving twice daily applications for 3 weeks and in patients where 30% of body surface was treated using occlusive dressings. Conditions which increase systemic absorption include use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Patients receiving large doses of alclometasone applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence 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 substitute a less potent corticosteroid.

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

    The safety and efficacy of alclometasone ointment and cream in neonates and infants less than 1 year of age have not been established. Administration of alclometasone to children should be limited to the least amount compatible with an effective therapeutic regimen.  Children may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore, are more susceptible to developing systemic toxicity. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, growth inhibition (linear growth retardation and delayed weight gain), and increased intracranial pressure have been reported in children receiving topical corticosteroids. Pediatric patients applying alclometasone cream or ointment to more than 20% of the body surface area are at higher risk of HPA axis suppression. Alclometasone cream or ointment should not be used for the treatment of diaper dermatitis. 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

    Alclometasone is classified in FDA pregnancy risk category C. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in laboratory animals. There are no adequate and well-controlled studies of alclometasone in pregnant women. According to the manufacturer, it should only be used in pregnant patients if the potential benefit justifies the potential risk. Topical corticosteroids should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.

    Breast-feeding

    According to the manufacturer, it is not known whether topical administration of alclometasone could result in sufficient systemic absorption to produce detectable quantities in breast milk.  When used in low doses, systemically administered corticosteroids (e.g., prednisone) are distributed into breast milk in quantities not likely to have a deleterious effect on the nursing infant; the American Academy of Pediatrics (AAP) considers prednisone to be usually compatible with lactation. Topical corticosteroids should not be applied to the nipples during nursing. 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 alclometasone. 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 acne vulgaris, acne rosacea or perioral dermatitis as they may aggravated these conditions.

    Ocular exposure

    Care should be taken to avoid ocular exposure to alclometasone.

    Geriatric, skin atrophy

    Topical corticosteroids such as alclometasone 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 pre-existing 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.

    Diabetes mellitus

    Topical corticosteroids such as alclometasone 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.

    Corticosteroid hypersensitivity

    Alclometasone is contraindicated in any patient with a history of hypersensitivity to any ingredients in the preparation. Use with caution, if at all, in patients with a history of other corticosteroid hypersensitivity. True corticosteroid hypersensitivity is rare. It is possible, though also rare, that patients hypersensitive to alclometasone will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing to determine if hypersensitivity to another corticosteroid exists and should be carefully monitored following the administration of any corticosteroid.

    ADVERSE REACTIONS

    Severe

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

    Moderate

    erythema / Early / 1.0-2.0
    withdrawal / Early / Incidence not known
    growth inhibition / Delayed / Incidence not known
    hyperglycemia / Delayed / Incidence not known
    pseudotumor cerebri / Delayed / Incidence not known
    glycosuria / Early / Incidence not known
    hypertension / Early / Incidence not known
    adrenocortical insufficiency / Delayed / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known
    hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
    cataracts / Delayed / Incidence not known
    skin ulcer / Delayed / Incidence not known
    impaired wound healing / Delayed / Incidence not known
    tolerance / Delayed / Incidence not known
    contact dermatitis / Delayed / Incidence not known

    Mild

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

    DRUG INTERACTIONS

    Deferasirox: (Moderate) Because gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.
    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

    Alclometasone is classified in FDA pregnancy risk category C. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in laboratory animals. There are no adequate and well-controlled studies of alclometasone in pregnant women. According to the manufacturer, it should only be used in pregnant patients if the potential benefit justifies the potential risk. Topical corticosteroids should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.

    According to the manufacturer, it is not known whether topical administration of alclometasone could result in sufficient systemic absorption to produce detectable quantities in breast milk.  When used in low doses, systemically administered corticosteroids (e.g., prednisone) are distributed into breast milk in quantities not likely to have a deleterious effect on the nursing infant; the American Academy of Pediatrics (AAP) considers prednisone to be usually compatible with lactation. Topical corticosteroids should not be applied to the nipples during nursing. 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

    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

    Alclometasone is applied topically as a cream or ointment. Once in the systemic circulation, alclometasone is metabolized in the liver, but systemic metabolism has not been fully quantified. After hepatic metabolism, alclometasone metabolites are excreted by the kidney.

    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. In normal volunteers, approximately 3% of the alclometasone dose is absorbed during 8 hours of contact with intact skin. Absorption after topical application of alclometasone 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 alclometasone 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 alclometasone into the skin. Because alclometasone contains a substituted 17-hydroxyl group, it is not metabolized in the skin. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action and increased systemic absorption. Circulating levels of alclometasone are normally below the level of detection.