FLUOCINONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN)

Available from:

Cosette Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluocinonide Cream USP, 0.05% (Emulsified Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluocinonide Cream, USP 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary- adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.  HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical cortic

Product summary:

Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0713-0664-15), 30 g (NDC 0713-0664-31) and 60 g (NDC 0713-0664-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Distributed by: Cosette Pharmaceuticals,Inc. South Plainfield, NJ 07080 VC7673 Rev. 09/2022 8-0664CPLNC3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINONIDE- FLUOCINONIDE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
FLUOCINONIDE CREAM, USP 0.05%
(EMULSIFIED BASE)
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Fluocinonide Cream, USP 0.05% (Emulsified Base) is intended for
topical administration.
The active component is the corticosteroid fluocinonide, which is the
21-acetate ester of
fluocinolone acetonide and has the chemical name
pregna-1,4-diene-3,20-dione,21-
(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,
(6α ,11β,16α
)-. It has the following chemical structure:
Mol. Formula: C
H
F
O
Mol. Wt: 494.53
Fluocinonide Cream, USP 0.05% (Emulsified Base) contains fluocinonide
0.5 mg/g in a
water-washable aqueous emollient base of cetyl alcohol, citric acid
(anhydrous), mineral
oil, polysorbate 60, propylene glycol, purified water, sorbitan
monostearate, stearyl
alcohol.
CLINICAL PHARMACOLOGY
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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.
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 cortico