DIFLORASONE DIACETATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

diflorasone diacetate (UNII: 7W2J09SCWX) (diflorasone - UNII:T2DHJ9645W)

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

diflorasone diacetate

Composition:

diflorasone diacetate 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for 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. Use of topical corticosteroids, including diflorasone diacetate ointment 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 diflorasone diacetate ointment with eyes. Advise patients to report any visual symptoms.

Product summary:

Diflorasone Diacetate Ointment USP, 0.05% is available in the following size tubes: NDC 0168-0243-15 NDC 0168-0243-30 NDC 0168-0243-60 15 gram tube 30 gram tube 60 gram tube Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed. 46228315A R07/18 #188

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE OINTMENT
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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DIFLORASONE DIACETATE
OINTMENT USP, 0.05%
FOR TOPICAL USE
NOT FOR OPHTHALMIC USE
DESCRIPTION
Chemically, diflorasone diacetate is
6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-
3,20-dione17,21-diacetate with the molecular formula C
H F O and a molecular weight of 494.54.
The structural formula is represented below:
Each gram of diflorasone diacetate ointment contains 0.5 mg
diflorasone diacetate in an ointment base of
propylene glycol, glyceryl monostearate and white petrolatum.
CLINICAL PHARMACOLOGY
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.
Each gram of diflorasone diacetate ointment contains 0.5 mg
diflorasone diacetate in an ointment
base.
26
32
2
7
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