FLUOCINOLONE ACETONIDE ointment

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

Prieinama:

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

INN (Tarptautinis Pavadinimas):

fluocinolone acetonide

Sudėtis:

fluocinolone acetonide 0.25 mg in 1 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Fluocinolone Acetonide Ointment USP, 0.025% 15 gram tubes, NDC 0168-0064-15 60 gram tubes, NDC 0168-0064-60 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I26415G R11/12 #296

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OINTMENT
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION:
Fluocinolone Acetonide Ointment 0.025% is intended for topical
administration. The active component
is the corticosteroid Fluocinolone Acetonide USP
(Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-
dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It
has an empirical formula of
C
H F O and a molecular weight of 452.49 (CAS Registry Number 67-73-2).
Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a
base containing 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. 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
24
30
2
6
pharmacokinetic pathways similar to systemically administered
corticosteroids. Corticosteroids are
bound to plasma proteins in varying degrees.