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DIFLORASONE DIACETATE CREAM
USP, 0.05%

Rx only

FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE

DESCRIPTION

Diflorasone diacetate cream, 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid 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, with the molecular formula C26H32F2O7, a molecular weight of 494.54, and the following structural formula:

Each gram of diflorasone diacetate cream, 0.05% contains: 0.5 mg diflorasone diacetate in a cream base consisting of cetyl alcohol, glyceryl stearate SE (nonionic), isopropyl myristate, mineral oil (and) lanolin alcohol, monobasic sodium phosphate, monoglyceride citrate, polyoxyl 40 stearate, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, vegetable oil, butylated hydroxytoluene and citric acid.

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, diflorasone diacetate has anti-inflammatory, anti-pruritic, and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

Diflorasone diacetate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

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 uled 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.

OVERDOSAGE

Topically applied diflorasone diacetate cream, can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Diflorasone Diacetate Cream USP, 0.05% should be applied to the affected area twice daily.

HOW SUPPLIED

Diflorasone Diacetate Cream USP, 0.05% is available as follows:

NDC 0168-0242-15  15 gram tube
NDC 0168-0242-30  30 gram tube
NDC 0168-0242-60  60 gram tube

Store at or below 25°C (77°F). Keep tightly closed.

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I242
#171
R2/98

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