Diflorasone Diacetate

Description

DESCRIPTION PSORCON ® (diflorasone diacetate cream USP), 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use. Chemically, diflorasone diacetate is 6α, 9α-difluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical formula C 26 H 32 F 2 O 7 , a molecular weight of 494.5, and the following structural formula: Each gram of PSORCON ® (diflorasone diacetate cream USP), 0.05% contains 0.5 mg diflorasone diacetate in a cream base consisting of butylated hydroxytoluene, cetyl alcohol, citric acid, glyceryl stearate/PEG 100 stearate, isopropyl myristate, lanolin alcohol, mineral oil, monobasic sodium phosphate, polyoxyl 40 stearate, polysorbate 60, propylene glycol, purified water, sorbitan monostearate and vegetable oil. Chemical Structure

What Is Diflorasone Diacetate Used For?

INDICATION AND USAGE PSORCON ® (diflorasone diacetate cream USP), 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage and Administration

DOSAGE AND ADMINISTRATION PSORCON ® (diflorasone diacetate cream USP), 0.05% should be applied to the affected area twice daily.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria.

Contraindications

CONTRAINDICATIONS PSORCON ® (diflorasone diacetate cream USP), 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Pregnancy and Breastfeeding

Pregnancy Teratogenic effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Diflorasone diacetate has been shown to be teratogenic (cleft palate) in rats when applied topically at a dose of approximately 0.001 mg/kg/day to the shaven thorax of pregnant animals. This is approximately 0.3 times the human topical dose of PSORCON ® (diflorasone diacetate cream USP), 0.05%. When pregnant rats were treated topically with approximately 0.5 mg/kg/day, uterine deaths were higher in the treated animals than in control animals. In rabbits, cleft palate was seen when diflorasone diacetate was applied in topical doses as low as 20 mg/kg/day. In addition, fetal weight was depressed and litter sizes were smaller. There are no adequate and well-controlled studies of the teratogenic potential of diflorasone diacetate in pregnant women. PSORCON ® (diflorasone diacetate cream USP), 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when diflorasone diacetate cream USP is administered to a nursing woman.

Overdosage

OVERDOSAGE Topically applied PSORCON ® (diflorasone diacetate cream USP), 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

How Supplied

HOW SUPPLIED PSORCON ® (diflorasone diacetate cream USP), 0.05% is available in a 60 g (51672-5292-3) tube. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.