FLUOCINOLONE ACETONIDE oil

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Amneal Pharmaceuticals LLC

INN (שם בינלאומי):

FLUOCINOLONE ACETONIDE

הרכב:

FLUOCINOLONE ACETONIDE 0.11 mg in 118.28 mL

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Fluocinolone Acetonide 0.01% Topical Oil is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil). Fluocinolone Acetonide 0.01% Topical Oil 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).

leaflet_short:

Fluocinolone Acetonide 0.01% Topical Oil is supplied in a 4 fluid ounce bottle with a net content of 118.28 mL.  It is labeled as Scalp Oil (NDC 65162-703-86). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store upright at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or www.amneal.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION: Rx only Distributed by: Amneal Pharmaceuticals Bridgewater, NJ  08807 Rev. 08-2015-00

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
AMNEAL PHARMACEUTICALS LLC
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FLUOCINOLONE ACETONIDE 0.01% TOPICAL OIL (SCALP OIL)
For Topical Use Only-
Not for Oral, Ophthalmic, or Intravaginal Use
DESCRIPTION
Fluocinolone Acetonide 0.01 % Topical 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
use dermatologic use. This formulation is also marketed as
Fluocinolone Acetonide
0.01% Topical 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% for chronic eczematous external otitis.
Chemically, fluocinolone
acetonide is C
H
F O . It has the following structural formula:
Fluocinolone acetonide in Fluocinolone Acetonide 0.01% Topical Oil has
a molecular
weight of 452.50. It is a white crystalline powder that is odorless,
stable in light, and
melts at 270ºC with decomposition; soluble in alcohol, acetone and
methanol; slightly
soluble in chloroform; insoluble in water.
Each gram of Fluocinolone Acetonide 0.01% Topical Oil 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
24
30 2
6
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 inflamma