Version May 2024
Steroid-responsive dermatoses: Topical: Apply a thin film to the affected area(s) 2 to 3 times daily. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Alclometasone: Pediatric drug information")
Steroid-responsive dermatoses: Children and Adolescents: Topical: Apply thin film to affected area 2 to 3 times daily. 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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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%)
Hypersensitivity to alclometasone or any component of the formulation.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism 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 sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
• 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 syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
• Pediatric: 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 syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
• Appropriate use: Avoid use with occlusive dressings. Discontinue use if irritation occurs. 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).
The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to HPA axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as dipropionate:
Generic: 0.05% (15 g, 45 g, 60 g)
Ointment, External, as dipropionate:
Generic: 0.05% (15 g, 45 g, 60 g)
Yes
Cream (Alclometasone Dipropionate External)
0.05% (per gram): $2.17
Ointment (Alclometasone Dipropionate External)
0.05% (per gram): $0.66
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For external use only. Apply a thin film to clean, dry skin and rub in gently. Avoid contact with eyes; generally not for use on the face, underarms, or groin area (including diapered area). Use of occlusive dressings is not recommended. Wash hands thoroughly before and after use.
Topical: Cream, Ointment: Apply sparingly in a thin film to clean, dry skin; rub in lightly; for external use only; avoid contact with the eyes; generally not for routine use on the face, underarms, or groin area (including diapered area). Do not use on open wounds or weeping lesions. The treated skin area should not be bandaged or covered unless directed by the prescriber. Wash hands thoroughly before and after use.
Steroid-responsive dermatosis: Treatment of inflammation and pruritic manifestations of corticosteroid-responsive dermatosis in adults and pediatric patients ≥1 year.
Aclovate® may be confused with Accolate®
Cloderm: Brand name for alclometasone [Indonesia], but also brand name for clobetasol [China, India, Malaysia, Singapore, Thailand]; clocortolone [U.S., Canada]; clotrimazole [Germany]
None known.
There are no known significant interactions.
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
Systemic bioavailability of topical corticosteroids is variable (integrity of skin, use of occlusion, etc) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
It is not known if sufficient quantities of alclometasone are absorbed following topical administration to produce detectable amounts in breast milk. However, systemic corticosteroids are present in breast milk.
Although the manufacturer recommends that caution be used, topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019).
Growth in pediatric patients, signs/symptoms of HPA axis suppression/adrenal insufficiency; bacterial or fungal skin infection.
If HPA axis suppression is suspected, evaluate patient using the following tests: ACTH stimulation test, AM plasma cortisol test, and urinary free cortisol test
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.
Onset of action: Initial response (Ruthven 1988): Eczema: 5.3 days; Psoriasis: 6.7 days
Absorption: Topical: ~3% absorbed systemically after 8 hours when applied to intact skin
Time to peak: Peak response (Ruthven 1988): Eczema: 13.9 days; Psoriasis: 14.8 days
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
