Version May 2024
Acute and chronic skin disease: Topical: Apply a thin layer using only enough to cover affected area 1 to 2 times daily. Lack of improvement or worsening of condition after 2 to 4 weeks of therapy may necessitate further evaluation. Maximum duration of therapy: 4 weeks
There are no specific dosage adjustments provided in the manufacturer’s labeling; however, the manufacturer recommends applying the least amount for the shortest period of time required to achieve desired therapeutic effect.
There are no specific dosage adjustments provided in the manufacturer’s labeling; however, the manufacturer recommends applying the least amount for the shortest period of time required to achieve desired therapeutic effect.
Acute and chronic skin disease: Topical: Apply the least amount for the shortest duration of time needed to achieve desired therapeutic effect. Refer to adult dosing.
Acute and chronic skin disease: Children >1 year and Adolescents: Topical: Apply the least amount for the shortest duration of time needed to achieve desired therapeutic effect. May apply a thin layer using only enough to cover affected area 1 to 2 times daily. Lack of improvement or worsening of condition after 2 to 4 weeks of therapy may necessitate further evaluation Maximum duration of therapy: 4 weeks
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Reactions listed are based on reports from other topical steroids and may not be specifically reported for diflucortolone.
Cardiovascular: Hypertension
Central nervous system: Localized burning, steroid withdrawal syndrome
Dermatologic: Acneiform eruption, alopecia, atrophic striae, contact dermatitis, dermatitis, dyschromia, epidermal thinning, erythema, folliculitis, hair breakage, hypertrichosis, miliaria, perioral dermatitis, pruritus, pustular psoriasis, skin atrophy, skin pain, skin rash, telangiectasia, urticaria, wrinkling of skin, xeroderma
Endocrine & metabolic: Cushingoid appearance, decreased plasma cortisol, glycosuria, hpa-axis suppression, hyperglycemia, obesity, weight gain
Hypersensitivity: Local hypersensitivity reaction
Immunologic: Immunosuppression (underlying symptom exacerbation)
Infection: Secondary infection
Local: Application site irritation, application site pain
Neuromuscular & skeletal: Decreased linear skeletal growth rate, osteoporosis
Ophthalmic: Cataract, glaucoma
Miscellaneous: Failure to thrive
Hypersensitivity to diflucortolone, any component of the formulation, or other corticosteroids; infants <1 year of age; viral (eg, herpes, varicella, vaccinia) lesions of the skin, bacterial or fungal skin infections, parasitic infections, skin manifestations relating to tuberculosis or syphilis, eruptions following vaccinations; rosacea; pruritus without inflammation; perianal and genital pruritus; perioral dermatitis; acne vulgaris; ophthalmic application
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. Patients receiving large doses of potent topical steroids should be periodically evaluated for HPA axis suppression using urinary free cortisol and ACTH stimulation tests. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully by reducing the frequency of application or substitution of a less potent steroid. Recovery is usually prompt and complete upon drug discontinuation, but may require supplemental systemic corticosteroids if signs and symptoms of steroid withdrawal occur.
• Contact dermatitis: Allergic contact dermatitis may occur; it is usually diagnosed by failure to heal rather than clinical exacerbation. Patch testing may be used to confirm the diagnosis.
• Hypersensitivity: Localized hypersensitivity reactions may occur; discontinue use if hypersensitivity occurs and treat appropriately. Allergic contact dermatitis is usually diagnosed by failure to heal rather than clinical exacerbation. Patch testing may be used to confirm the diagnosis.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Discontinue use if concomitant skin infection occurs and treat appropriately. Exposure to varicella zoster (chickenpox) should be avoided; corticosteroids should not be used to treat ocular herpes simplex.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports) (Goedert 2002); if noted, discontinuation of therapy should be considered.
• 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.
Disease-related issues:
• Psoriasis: Use with caution and monitor carefully; rebound relapses, development of tolerances, risk of generalized pustular psoriasis, and development of localized or systemic toxicity due to impaired skin barrier have been observed. Discontinue use with significant irritation and treat appropriately.
Special populations:
• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.
• Pediatric: 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 of occlusive dressings; may increase systemic exposure and risk of adrenal suppression and other systemic effects. Use with caution in patients with stasis dermatitis or other skin diseases associated with impaired circulation. Application near chronic leg ulcers may increase risk of localized hypersensitivity reactions and infection. Use with caution near the eyes (do not apply to the eyes), and on the face, groin and axilla. Monitor for skin atrophy and discontinue use if observed.
Not available in the US
No
For topical use only. Rub a thin layer in gently using only enough to cover affected area. Avoid use of occlusive dressings. Do not apply in or near the eye or on other mucous membranes.
Topical: For external use only. Rub a thin layer in gently using only enough to cover affected area. Avoid use of occlusive dressings. Do not apply in or near the eye or on other mucous membranes.
Acute and chronic skin disease: Treatment of acute and chronic skin diseases responsive to the anti-inflammatory, antipruritic, and antiallergic effects of topical corticosteroids.
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 (eg, integrity of skin, use of occlusion) 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 diflucortolone are absorbed following topical administration to produce detectable amounts in breast milk. However, systemic corticosteroids are present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
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).
Adrenal suppression with extensive/prolonged use (ACTH stimulation test); response to treatment; growth in children
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. Diflucortolone has intermediate range potency.
Absorption: Percutaneous absorption is variable and dependent upon many factors including vehicle used, integrity and thickness of epidermis, surface area of application, and use of occlusive dressings (not recommended)
Metabolism: Hepatic
Excretion: Urine and feces
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