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  • CLASSES

    Plain Topical Corticosteroids

    DEA CLASS

    Rx

    DESCRIPTION

    High-potency fluorinated topical corticosteroid used for corticosteroid-responsive dermatologic disorders.

    COMMON BRAND NAMES

    Halog

    HOW SUPPLIED

    Halog Topical Cream: 0.1%
    Halog Topical Ointment: 0.1%

    DOSAGE & INDICATIONS

    For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as alopecia areata, atopic dermatitis, contact dermatitis, exfoliative dermatitis, Rhus dermatitis due to plants like poison ivy, seborrheic dermatitis (facial and intertriginous areas), discoid lupus erythematosus (facial and intertriginous areas), eczema, granuloma annulare, intertrigo, keloids (reduction of associated itching), cutaneous lichen planus, lichen simplex chronicus, lichen striatus, polymorphous light eruption, pompholyx (dyshidrosis), necrobiosis lipoidica diabeticorum, pemphigus, pityriasis rosea, nodular prurigo, anogenital or senilis pruritus, psoriasis (facial and intertriginous areas), sarcoidosis, or xerosis (inflammatory phase).
    NOTE: Acute exudative inflammation, as occurs with poison ivy, may be best treated with the cream formulation, which is drying. Dry, scaly dermatoses, as occur with eczema or psoriasis, may be best treated with the ointment formulation.
    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 (ointment, cream or topical solution)
    Adults

    Apply sparingly to the affected area 2—3 times per day, depending on the severity of the condition. In hairy parts, the hair should be parted to allow direct contact with the lesion. Occlusive dressings may be used for the management of recalcitrant conditions.

    Children

    Apply sparingly to affected area 2—3 times per day. NOTE: Pediatric patients may absorb greater amounts of topical corticosteroids thus increasing their susceptibility to HPA axis suppression and Cushing's syndrome. Therefore, administration should be limited to the least amount compatible with effective therapy.

    MAXIMUM DOSAGE

    NOTE: In general, corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease, dosage form selected, and patient age and response.

    DOSING CONSIDERATIONS

    Hepatic Impairment

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

    Renal Impairment

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

    ADMINISTRATION

    Halcinonide products are for external application to the skin only. Not for ophthalmic or intravaginal use.

    Topical Administration

    Occlusive Dressing Technique:
    For the solution or ointment, apply to the lesion leaving a thin film.
    For the cream, gently rub a small amount into the lesion until it disappears then reapply, leaving a thin coating on the lesion.
    After application cover the lesion with a pliable, nonporous film and seal the edges.
    If additional moisture is needed, apply a dampened clean cotton cloth before the nonporous film is applied or briefly wet the affected area with water immediately prior to applying the medication.
    The frequency of dressing changes is best determined on an individual basis. It may be convenient to apply halcinonide under an occlusive dressing in the evening and remove the dressing in the morning (i.e. 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional halcinonide should be applied, without occlusion, during the day.
    Reapplication is essential at each dressing change.
    If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

    Cream/Ointment/Lotion Formulations

    Cream and ointment:
    Apply halcinonide cream or ointment sparingly in a thin film and rub gently.
    When applying to hairy areas, part the hair and apply a small amount to the affected area; rub in gently.
    Until the medication has dried, do not wash or rub the treated area or apply clothing.
    Hair may be washed as usual during the treatment period but not immediately after applying the medication.

    Other Topical Formulations

    Solution:
    Apply halcinonide solution sparingly in a thin film and rub gently.
    When applying to hairy areas, part the hair and apply a small amount to the affected area; rub in gently.
    Until the medication has dried, do not wash or rub the treated area or apply clothing.
    Hair may be washed as usual during the treatment period but not immediately after applying the medication.

    STORAGE

    Halog:
    - Avoid excessive heat (above 104 degrees F)
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Corticosteroid hypersensitivity

    Halcinonide is contraindicated in any patient with a history of severe hypersensitivity to other corticosteroids or any ingredients in the preparation. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to halcinonide should not receive any form of halcinonide. 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.

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

    Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which increase systemic absorption include application of very high-potency 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 an occlusive dressing. 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 using ACTH stimulation, AM plasma cortisol and urinary free-cortisol tests. 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 the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids. Due to the potential for glucose alterations, halcinonide should be used cautiously in patients with diabetes mellitus.

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

    Administration of halcinonide to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Neonates, infants, and 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, especially with very-high-potency products. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and increased intracranial pressure have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy in children may also interfere with growth and development, resulting in growth inhibition. 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

    Halcinonide is classified in FDA pregnancy risk category C. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in laboratory animals. Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. There are no adequate and well-controlled studies of teratogenic effects from topical application of halcinonide in pregnant women. Halcinonide has greater potency, and thus greater teratogenic potential, than other less potent topical corticosteroids. It may be prudent to consider using a lower potency topical corticosteroid during pregnancy. If halcinonide must be used, the potential risks should be discussed with the patient. Topical corticosteroids, including halcinonide, 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 halcinonide 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 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.

    Fungal infection, herpes infection, infection, measles, varicella, viral infection

    The normal inflammatory response to local infections can be masked by halcinonide. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (i.e., herpes infection, measles or varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. Herpes infections may be transmitted to other sites, including the eye. 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.

    Acne rosacea, acne vulgaris, ocular exposure, ophthalmic administration, perioral dermatitis

    As with other potent fluorinated topical corticosteroids, halcinonide should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis. Halcinonide may aggravate these conditions. Halcinonide preparations should not be applied to the face, groin, or axillae. Care should be taken to avoid use around the eyes; use caution to avoid ophthalmic administration. Visual impairment and ocular hypertension have been reported with ocular exposure to other high potency topical corticosteroids. High potency corticosteroids have been noted to promote progression of cataracts. Preexisting glaucoma may be aggravated if halcinonide is used in the periorbital area.

    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. Use halcinonide preparations cautiously in patients with markedly impaired circulation or peripheral vascular disease due to the potential for skin ulcer. Use of lower potency topical corticosteroids also may be necessary in some patients.

    ADVERSE REACTIONS

    Severe

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

    Moderate

    erythema / Early / 1.0-10.0
    withdrawal / Early / Incidence not known
    hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known
    pseudotumor cerebri / Delayed / Incidence not known
    hypertension / Early / Incidence not known
    glycosuria / Early / Incidence not known
    adrenocortical insufficiency / Delayed / Incidence not known
    growth inhibition / Delayed / Incidence not known
    hyperglycemia / 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

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

    DRUG INTERACTIONS

    There are no drug interactions associated with Halcinonide products.

    PREGNANCY AND LACTATION

    Pregnancy

    Halcinonide is classified in FDA pregnancy risk category C. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in laboratory animals. Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. There are no adequate and well-controlled studies of teratogenic effects from topical application of halcinonide in pregnant women. Halcinonide has greater potency, and thus greater teratogenic potential, than other less potent topical corticosteroids. It may be prudent to consider using a lower potency topical corticosteroid during pregnancy. If halcinonide must be used, the potential risks should be discussed with the patient. Topical corticosteroids, including halcinonide, 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 halcinonide 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 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

    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

    Halcinonide is applied topically as cream, ointment or solution. Because halcinonide is fluorinated and also 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. Halcinonide is metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

    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 halcinonide 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 halcinonide enhances penetration into the skin, and may increase the chance of systemic absorption. Ointments have a hydrating effect, are lipophilic, and may enhance the penetration of halcinonide into the skin. Halcinonide solutions also have enhanced topical penetration versus cream preparations. Anti-inflammatory effects are usually not seen for hours after halcinonide application, since the mechanism of action requires alterations in synthesis of proteins. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action and increased systemic absorption.