FLUOCINOLONE ACETONIDE oil

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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).

Rezumat produs:

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 54868-6347-0). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store upright 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 BY: Amneal Pharmaceuticals Branchburg, NJ 08876 DISTRIBUTED BY: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 05-2011 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma         74146

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE OIL
PHYSICIANS TOTAL CARE, INC.
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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 polyethylene
material with rubber elastic.
CLINICAL PHARMACOLOGY
24
30
2
6
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 inflam