FLUOCINOLONE ACETONIDE oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fluocinolone Acetonide (UNII: 0CD5FD6S2M) (Fluocinolone Acetonide - UNII:0CD5FD6S2M)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluocinolone acetonide 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).

Product summary:

Fluocinolone acetonide topical oil is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC #51672-1357-8). Scalp Oil is supplied with 2 shower caps. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
TARO PHARMACEUTICALS U.S.A., INC.
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FLUOCINOLONE ACETONIDE
TOPICAL OIL, 0.01%
(SCALP OIL)
RX ONLY
NDC 51672-1357-8
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. This formulation is
also marketed as Fluocinolone Acetonide Topical Oil, 0.01% 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 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 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.
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
24
30
2
6
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A2
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent