DIFLORASONE DIACETATE
OINTMENT USP, 0.05%

Rx only

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base.

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 and a molecular weight of 494.54. The structural formula is represented below:

Each gram of diflorasone diacetate ointment, for topical administration, contains 0.5 mg diflor-asone diacetate in an ointment base consisting of propylene glycol, glyceryl monostearate and white petrolatum.

Topical corticosteroids share anti-inflammatory, anti-pruritic 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.

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are uled in an approximate decreasing order of occurrence:

• Burning
• Itching
• Irritation
• Dryness
• Folliculitis
• Hypertrichosis
• Acneiform eruptions
• Hypopigmentation
• Perioral dermatitis
• Allergic contact dermatitis
• Maceration of the skin
• Secondary infections
• Skin atrophy
• Striae
• Miliaria

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Diflorasone diacetate ointment should be applied to the affected area as a thin film from one to three times daily depending on the severity or resistant nature of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Diflorasone Diacetate Ointment USP, 0.05% is available in the following size tubes:

Store at controlled room temperature 15° to 30°C (59° to 86°F). Keep tightly closed.

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

I243
#188
R10/98