CLASSES
Plain Topical Corticosteroids
DESCRIPTION
High-potency fluorinated topical corticosteroid
Used for moderate-severe corticosteroid-responsive dermatoses, including psoriasis
Generally use for short durations due to potential for systemic effects
COMMON BRAND NAMES
Halog, Halog -E
HOW SUPPLIED
Halcinonide/Halog/Halog -E Topical Cream: 0.1%
Halog Topical Ointment: 0.1%
Halog Topical Sol: 0.1%
DOSAGE & INDICATIONS
For the treatment of corticosteroid-responsive dermatoses, including atopic dermatitis, localized vitiligo, eczema, phimosis, lichen planus, and localized bullous pemphigoid.
Topical dosage
Adults
Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily.
Children and Adolescents
Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily.
For the treatment of psoriasis.
Topical dosage
Adults
Apply a thin layer to the affected skin area(s) 2 to 3 times daily.
Children and Adolescents
Apply a thin layer to the affected skin area(s) 2 to 3 times daily.
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
Halog -E:
- Avoid excessive heat (above 104 degrees F)
- Store at room temperature
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
There are no adequate and well-controlled studies of topical application of halcinonide during pregnancy. Topical corticosteroids, including halcinonide, 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 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
It is not known whether topical administration of halcinonide 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.
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
There are no adequate and well-controlled studies of topical application of halcinonide during pregnancy. Topical corticosteroids, including halcinonide, 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 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.
It is not known whether topical administration of halcinonide 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
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.