Version May 2024
Corticosteroid-responsive dermatosis: Topical: Apply sparingly 1 to 3 times daily. Therapy should be discontinued when control is achieved; if no improvement is seen, 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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Reactions listed are based on reports for other agents in this same pharmacologic class and may not be specifically reported for diflorasone. Diflorasone is classified as a potent topical steroid.
Central nervous system: Burning sensation
Dermatologic: Acneiform eruption, allergic contact dermatitis, atrophic striae, folliculitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, skin irritation, xeroderma
Endocrine & metabolic: HPA-axis suppression (children at greater risk)
Infection: Secondary infection
<1%, postmarketing and/or case reports: Acne rosacea (Hengge 2006), aggravation reaction (cutaneous candidiasis, herpes, dermodex) (Hengge 2006), cataract (Hengge 2006), dermal ulcer (Hengge 2006), glaucoma (Hengge 2006), hirsutism (Hengge 2006), hyperpigmentation (Hengge 2006), Kaposi's sarcoma (reactivation) (Hengge 2006), nonthrombocytopenic purpura (Hengge 2006), ocular hypertension (Hengge 2006), psoriasis flare (rebound) (Hengge 2006), purpura (Hengge 2006), skin photosensitivity (Hengge 2006), spontaneous star-shaped scar-like lesions (Hengge 2006), telangiectasia (Hengge 2006), tinea (tinea incognito) (Hengge 2006)
Hypersensitivity to diflorasone 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).
• Ocular effects: Subcapsular cataracts, glaucoma (with possible nerve damage), and increased intraocular pressure have been reported with topical use.
• Skin reactions: Local adverse effects (eg, atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria) may occur. Reactions may not be reversible and may be more likely to occur with prolonged use, higher potency corticosteroids, and occlusive dressings.
• 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.
Disease-related concerns:
• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue diflorasone if infection does not resolve promptly.
Special populations:
• 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's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients. Diflorasone is not FDA-approved for use in children.
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with eyes and mucous membranes. Do not use with occlusive dressing unless using for psoriasis or recalcitrant conditions. Do not use on the face, axillae, or groin or for the treatment of rosacea or perioral dermatitis.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as diacetate:
ApexiCon E: 0.05% (30 g, 60 g) [contains cetyl alcohol, propylene glycol]
Psorcon: 0.05% (60 g [DSC]) [contains cetyl alcohol, propylene glycol]
Generic: 0.05% (15 g, 30 g, 60 g)
Ointment, External, as diacetate:
Generic: 0.05% (15 g, 30 g, 45 g [DSC], 60 g)
Yes
Cream (ApexiCon E External)
0.05% (per gram): $25.53
Cream (Diflorasone Diacetate External)
0.05% (per gram): $13.98 - $16.46
Ointment (Diflorasone Diacetate External)
0.05% (per gram): $13.98 - $18.87
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.
Apply the smallest amount that will cover affected area. For topical use only; avoid contact with eyes and mucous membranes. Do not apply to face or intertriginous areas. Do not use if there is atrophy at the treatment site. Minimize contact to nonaffected areas of the body. Wash hands after use.
Dermatoses: Treatment of inflammation and pruritic symptoms of corticosteroid-responsive dermatoses (high to very high potency topical corticosteroid)
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
Florone [Germany, Greece] may be confused with Flogene brand name for piroxicam [Brazil]
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 diflorasone 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).
Adrenal suppression with extensive/prolonged use (ACTH stimulation test, morning plasma cortisol test, 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. Diflorasone has high range potency.
Absorption: Negligible, around 1% reaches dermal layers or systemic circulation; occlusive dressings increase absorption percutaneously
Metabolism: Primarily hepatic
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