florone- diflorasone diacetate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmacia and Upjohn Division of Pfizer

INN (International Name):

diflorasone diacetate

Pharmaceutical form:

CREAM

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.

Product summary:

FLORONE Cream is available in 30 gram and 60 gram collapsible tubes Store at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].

Summary of Product characteristics

FLORONE- DIFLORASONE DIACETATE CREAM
PHARMACIA AND UPJOHN DIVISION OF PFIZER
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FLORONE
(DIFLORASONE DIACETATE CREAM, USP)
0.05%
NOT FOR OPHTHALMIC USE
DESCRIPTION
Each gram of FLORONE Cream contains 0.5 mg diflorasone diacetate in a
cream base.
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:
FLORONE Cream contains diflorasone diacetate in an emulsified and
hydrophilic cream base of
propylene glycol, stearic acid, polysorbate 60, sorbitan monostearate
and monooleate, sorbic acid,
citric acid and water. The corticosteroid is formulated as a solution
in the vehicle using 15 percent
propylene glycol to optimize drug delivery.
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.
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
a