FLUOCINOLONE ACETONIDE OIL

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Disponible des:

Lyne Laboratories, Inc.

Designació comuna internacional (DCI):

FLUOCINOLONE ACETONIDE

Composición:

FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

FLUOCINOLONE ACETONIDE OIL- FLUOCINOLONE ACETONIDE OIL OIL
LYNE LABORATORIES, INC.
----------
FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL)
NDC 0374-5090-01
FOR TOPICAL USE ONLY - NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE
DESCRIPTION
Fluocinolone Acetonide Topical Oil, 0.01% contains fluocinolone
acetonide {(6α, 11β, 16α)-6,9-
difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione,
cyclic 16,
17 acetal with acetone}, a synthetic corticosteroid for topical
dermatologic use. Chemically,
fluocinolone acetonide is C
H
F
O
. It has the following structural formula:
Fluocinolone acetonide in fluocinolone acetonide topical oil, 0.01%
has a molecular weight of 452.50.
It is a white crystalline powder that is odorless, stable in light,
and melts at 270°C with decomposition;
soluble in alcohol, acetone and methanol; slightly soluble in
chloroform; insoluble in water.
Each gram of fluocinolone acetonide topical oil, 0.01% contains
approximately 0.11 mg of
fluocinolone acetonide in a blend of oils, which contains isopropyl
alcohol, isopropyl myristate, light
mineral oil, oleth-2 and refined peanut oil NF.
Each packaged product contains 2 shower caps. The shower cap is made
of low density polyethylene
material with rubber elastic.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, fluocinolone acetonide has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A
.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determ