Alclometasone is a topical low-to-medium potency synthetic corticosteroid. It is used to relieve the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Low-potency topical corticosteroids have modest antiinflammatory properties and are usually effective in treating acute inflammatory conditions involving areas of thin skin. Since the stratum corneum is thin on the face and intertriginous areas, low-potency topical corticosteroids are preferred. Low potency topical corticosteroids are also considered the safest for chronic use and are favored in elderly or pediatric patients. Alclometasone is equivalent in efficacy to desonide and hydrocortisone. Alclometasone ointment has been shown to be at least as effective as hydrocortisone 1% for the treatment of eczema in children. The FDA approved alclometasone in 1982.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific 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.
The following adverse reactions (listed in decreasing order of occurrence) are reported with topical corticosteroids such as alclometasone and may occur more often when used with an occlusive dressing: skin irritation (including burning, 1-2%), pruritus (1-2%), xerosis (dry skin, 2%), folliculitis, hypertrichosis, acneiform rash/eruptions, skin hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Erythema (1-2%),telangiectasia, purpura, and maculopapular rash (2%) may also occur. Although skin atrophy usually occurs after prolonged use of alclometasone, this effect may occur even with short-term use of alclometasone on intertriginous or flexor areas, or on the face. If irritation develops, discontinue topical corticosteroids and institute appropriate therapy. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection. In the presence of dermatological infections, institute the use of an appropriate antifungal or antibacterial agent. If a favorable response does not promptly occur, discontinue the corticosteroid until the infection has been adequately controlled.
Signs and symptoms of corticosteroid withdrawal may occur with alclometasone dose reduction or discontinuation, and supplemental systemic corticosteroids may be needed. For example, disease flare may occur and HPA axis suppression may be present.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency after withdrawal of treatment. In some patients, systemic absorption can produce manifestations of Cushing's syndrome, hypertension, hyperglycemia, and glycosuria. Percutaneous absorption of alclometasone is dependent on many factors including the vehicle, the integrity of the epidermal barrier, duration of use, and use of an occlusive dressing. HPA axis suppression was suggested by about a 10% decrease in average plasma and urinary free cortisol levels and urinary levels of 17-hydroxysteroids in adults who received the cream to 30% of their body twice daily for 7 days with or without occlusive dressings and to patients who received the cream to 80% of their body twice daily for 21 days with daily 12-hour periods of whole body occlusion. HPA axis suppression and increased intracranial pressure have been reported in children receiving topical corticosteroids. Manifestations of adrenocortical insufficiency in children include linear growth inhibition, delayed weight gain, low plasma cortisol concentrations, and absence of response to ACTH stimulation. Clinical signs of increased intracranial pressure include bulging fontanelles, headache, and bilateral papilledema (i.e., pseudotumor cerebri). Plasma cortisol levels have been shown to decrease in pediatric patients treated twice daily for 3 weeks without occlusive dressings. Also, pediatric patients applying alclometasone dipropionate cream to > 20% of the body surface area are at higher risk for HPA axis suppression. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Patients applying alclometasone to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (using the ACTH stimulation test and urinary free cortisol test). To minimize risk of HPA axis suppression, discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid.
Case reports describe visual impairment in patients using topical corticosteroids for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Any patient who develops changes in vision during topical corticosteroid therapy, such as alclometasone, should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone, dexamethasone) have been reported to be safer for short-term use around the eye area.
In general, excessive use of corticosteroids can lead to impaired wound healing. Alclometasone should not be applied directly on or near healing wounds. Skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Tolerance may occur with the prolonged use of topical corticosteroids such as alclometasone. Tolerance is usually described as a decreased acute vasoconstrictive response to the agent after a period of days to weeks. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application (e.g., alclometasone is given twice daily for 2-3 weeks, followed by a 1-week intermission).
Allergic contact dermatitis with corticosteroids such as alclometasone is usually diagnosed by observing a failure to heal. Appropriate diagnostic patch testing may help with the diagnosis.
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.
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.
There are no adequate and well-controlled studies of topical application of alclometasone during pregnancy. Topical corticosteroids, including alclometasone, 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.
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 during breast-feeding. However, most dermatologists stress that topical corticosteroids can be safely used during lactation. 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.
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.
Care should be taken to avoid ocular exposure to alclometasone.
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.
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.
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.
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. If no response is seen within 2 weeks, reassess treatment options.
Children and Adolescents: Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily. If no response is seen within 2 weeks, reassess treatment options.
Maximum Dosage Limits:
-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.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
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.
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.
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.
-Route-Specific Pharmacokinetics
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.