FLUOCINOLONE ACETONIDE oil

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Quagen Pharmaceuticals LLC

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).

Produktbesonderheiten:

Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied in bottles containing 4 fluid ounces. It is labeled as fluocinolone acetonide topical oil, 0.01% (scalp oil) (NDC # 70752-158-06) . Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied with 2 shower caps. Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature]. CAUTION: Rx Only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52026  Rev. 04/21

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
QUAGEN PHARMACEUTICALS LLC
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FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL)
For Topical Use Only-
Not for Oral, Ophthalmic, or Intravaginal Use
DESCRIPTION
Fluocinolone acetonide topical oil, 0.01% (scalp oil) 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. This formulation is also marketed as fluocinolone
acetonide topical oil,
0.01% (body oil) for use as body oil for atopic dermatitis in adults
and for moderate to
severe atopic dermatitis in pediatric patients 2 years and older, and
as fluocinolone
acetonide oil, 0.01% (ear drops) for chronic eczematous external
otitis. Chemically,
fluocinolone acetonide is C
H
F O . It has the following structural formula:
Fluocinolone acetonide 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% (scalp oil)
contains approximately
0.11 mg of fluocinolone acetonide in a blend of oils, which contain
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
24
30 2
6
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 inflamma