Apexicon E
(diflorasone diacetate)Apexicon E Prescribing Information
Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
ApexiCon® E Cream (diflorasone diacetate cream 0.05% [emollient]) should be applied to the affected areas as a thin film from one to three times daily depending on the severity or resistant nature of the condition.
For topical use only. Avoid contact with eyes.
Wash hands after each application.
Do not use with occlusive dressings, unless directed by a physician (see PRECAUTIONS).
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
The following adverse reactions have been identified from clinical trials or postmarketing surveillance. Because they are reported from a population from unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to topical corticosteroids exposure.
These adverse reactions may occur more frequently with the use of occlusive dressings or prolonged use of topical corticosteroids.
Skin and Subcutaneous Tissue Disorders: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria
Vision Disorders: cataract, glaucoma, central serous chorioretinopathy
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Each gram of ApexiCon® E Cream (diflorasone diacetate cream USP, 0.05% [emollient]) contains 0.5 mg diflorasone diacetate in a cream base for topical dermatological use.
Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate.
The structural formula is represented below:
Each gram of ApexiCon® E Cream (diflorasone diacetate cream USP, 0.05% [emollient]) contains: 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water.
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics:
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
ApexiCon® E Cream (diflorasone diacetate cream USP, 0.05% [emollient]) is available in the following size tubes:
NDC 62559-365-30 30 gram tube
NDC 62559-365-60 60 gram tube
Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].
Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
46291084A/46291087A
N6800 Rev 09/21
#56
Use of topical corticosteroids, including ApexiCon® E Cream (diflorasone diacetate 0.05% [emollient]) may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts have been reported in postmarketing experience with the use of topical diflorasone diacetate products.
Glaucoma, with possible damage to the optic nerve, and increased intraocular pressure have been reported in postmarketing experience with the use of topical dermal corticosteroids.
Avoid contact of ApexiCon® E Cream (diflorasone diacetate 0.05% [emollient]) with eyes. Advise patients to report any visual symptoms.