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Alclometasone

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MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Aclovate® may be confused with Accolate®

U.S. BRAND NAMES — Aclovate®

PHARMACOLOGIC CATEGORY
Corticosteroid, Topical

DOSING: ADULTS — 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.

DOSING: PEDIATRIC — 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 additional information see “Alclometasone: Pediatric drug information”)

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, as dipropionate: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 60 g)

Ointment, as dipropionate: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 45 g, 60 g)

DOSAGE FORMS: CONCISE
Cream: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 60 g)

Ointment: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 45 g, 60 g)

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — For external use only. Do not use on open wounds. Should not be used in the presence of open or weeping lesions. Apply sparingly to occlusive dressings.

USE — Treatment of inflammation of corticosteroid-responsive dermatosis (low to medium potency topical corticosteroid)

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

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Dermatologic: Acne, allergic dermatitis, hypopigmentation, maceration of the skin, perioral dermatitis, skin atrophy, striae, miliaria, telangiectasia

Endocrine & metabolic: HPA suppression, Cushing’s syndrome, growth retardation

Local: Burning, erythema, itching, irritation, dryness, folliculitis, hypertrichosis, papular rash

Miscellaneous: Secondary infection

CONTRAINDICATIONS — Hypersensitivity to alclometasone or any component of the formulation; viral, fungal, or tubercular skin lesions

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible) particularly in younger children. HPA axis suppression may lead to adrenal crisis. Risk is increased when used over large surface areas, for prolonged periods, or with occlusive dressings. Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation. 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. Systemic effects: Adverse systemic effects including hyperglycemia, glycosuria, fluid and electrolyte changes, and HPA suppression may occur when used on large surface areas, for prolonged periods, or with an occlusive dressing.

Special populations: Pediatrics: Safety and efficacy have not been established in children <1 year of age. Chronic use of corticosteroids in children may interfere with growth and development. Not for the treatment of diaper dermatitis. DRUG INTERACTIONS
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. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

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PREGNANCY IMPLICATIONS — Teratogenic effects have been observed in animals administered topical corticosteroids.

PRICING — (data from drugstore.com)
Cream (Aclovate)
0.05% (45): $73.99

Cream (Alclometasone Dipropionate)
0.05% (45): $38.99
0.05% (60): $52.99

Ointment (Aclovate)
0.05% (15): $44.99

Ointment (Alclometasone Dipropionate)
0.05% (15): $16.99
0.05% (60): $35.99

INTERNATIONAL BRAND NAMES — Aclosone (NL); Almeta (JP); Cloderm (ID); Delonal (DE); Demiderm (VE); Legederm (IT); Logoderm (NZ); Lomesone (GR); Miloderme (PT); Modraderm (BE); Modrasone (GB); Perderm (AE, BH, CY, EG, HK, HN, ID, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)

MECHANISM OF ACTION — Stimulates the synthesis of enzymes needed to decrease inflammation, suppress mitotic activity, and cause vasoconstriction

PHARMACODYNAMICS / KINETICS
Absorption: Topical: ~3% absorbed systemically after 8 hours when applied to intact skin

PATIENT INFORMATION — Before applying, gently wash area to reduce risk of infection. Apply a thin film to cleansed area and rub in gently and thoroughly until medication vanishes. Avoid exposure to sunlight; severe sunburn may occur.

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