(al kloe MET a sone)
- Alclometasone Dipropionate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as dipropionate:
Aclovate: 0.05% (15 g, 60 g) [contains cetearyl alcohol, propylene glycol]
Generic: 0.05% (15 g, 45 g, 60 g)
Ointment, External, as dipropionate:
Generic: 0.05% (15 g, 45 g, 60 g)
Brand Names: U.S.
- Corticosteroid, Topical
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Alclometasone has low range potency.
Topical: ~3% absorbed systemically after 8 hours when applied to intact skin
Onset of Action
Initial response (Ruthven 1988): Eczema: 5.3 days; Psoriasis: 6.7 days
Time to Peak
Peak response (Ruthven 1988): Eczema: 13.9 days; Psoriasis: 14.8 days
Use: Labeled Indications
Treatment of inflammation of corticosteroid-responsive dermatosis (low to medium potency topical corticosteroid)
Hypersensitivity to alclometasone or any component of the formulation
Steroid-responsive dermatoses: Topical: Apply a thin film to the affected area 2-3 times/day. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Refer to adult dosing.
Steroid-responsive dermatoses: Topical: Children ≥1 year: Apply thin film to affected area 2-3 times/day. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Do not use for >3 weeks.
For external use only. Apply a thin film to clean, dry skin and rub in gently. Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area (including diapered area). Should not be used in the presence of open or weeping lesions. Wash hands thoroughly before and after use.
Store between 2°C and 30°C (36°F and 86°F).
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Frequency not always defined.
Central nervous system: Localized burning (1% to 2%)
Dermatologic: Local dryness (2%), papular rash (2%), erythema (1% to 2%), pruritus (1% to 2%), acne vulgaris, allergic dermatitis, atrophic striae, folliculitis, hypopigmentation, miliaria, perioral dermatitis, skin atrophy
Endocrine & metabolic: Cushing's syndrome, growth suppression, HPA-axis suppression
Infection: Secondary infection
Local: Local irritation (2%)
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Immunosuppression: Prolonged use may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
• Pediatric: Safety and efficacy have not been established in children <1 year of age. Not for the treatment of diaper dermatitis. Safety and efficacy for use >3 weeks has not been established. Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
• Appropriate use: Avoid use of topical preparations with occlusive dressings or on weeping or exudative lesions. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Avoid contact with eyes. Generally not for routine use on the face, underarms, or groin area (including diapered area).
If HPA axis suppression is suspected, evaluate patient using the following tests: ACTH stimulation test, AM plasma cortisol test, and urinary free cortisol test
Pregnancy Risk Factor
Some corticosteroids were found to be teratogenic following topical application in animal reproduction studies. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), skin discoloration, signs of skin changes (pimples, stretch marks, slow healing, or hair growth), or skin irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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Other brands: Aclovate