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Diflorasone

Medically reviewed by Drugs.com. Last updated on Apr 20, 2020.

Pronunciation

(dye FLOR a sone)

Index Terms

  • Diflorasone Diacetate

Dosage Forms

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

Cream, External, as diacetate:

ApexiCon E: 0.05% (30 g, 60 g) [contains cetyl alcohol, propylene glycol]

Psorcon: 0.05% (60 g) [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, 60 g)

Brand Names: U.S.

  • ApexiCon E
  • Psorcon

Pharmacologic Category

  • Corticosteroid, Topical

Pharmacology

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

Use: Labeled Indications

Dermatoses: Treatment of inflammation and pruritic symptoms of corticosteroid-responsive dermatoses (high to very high potency topical corticosteroid)

Contraindications

Hypersensitivity to diflorasone or any component of the formulation

Dosing: Adult

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.

Dosing: Geriatric

Refer to adult dosing.

Administration

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.

Storage

Store at controlled room temperature 20°C to 25°C (68°F to 77°F).

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Adverse Reactions

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)

Warnings/Precautions

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'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.

• 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.

Monitoring Parameters

Adrenal suppression with extensive/prolonged use (ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test)

Pregnancy Considerations

Topical corticosteroids are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women.

Patient Education

What is this drug used for?

• It is used to treat skin irritation.

• It is used to treat skin rashes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin

• Itching

• Burning

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss.

• Cushing's disease like weight gain in upper back or abdomen; moon face; severe headache; or slow healing.

• Skin changes like acne, stretch marks, slow healing, or hair growth.

• Skin thinning

• Vision changes

• Eye pain

• Severe eye irritation

• Skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.