FLUOCINOLONE ACETONIDE oil

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

AvKARE, Inc.

INN (Jina la Kimataifa):

FLUOCINOLONE ACETONIDE

Tungo:

FLUOCINOLONE ACETONIDE 0.11 mg in 118.28 mL

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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).

Bidhaa muhtasari:

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 42291-284-04). 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]. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Caution: Rx only Manufactured for: AvKARE, Inc.                      Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals                                                Branchburg, NJ 08876 Mfg. Rev. 08-2015-00 AV Rev. 01/16

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
AVKARE, INC.
----------
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.
24
30
2
6
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
p