FLUOCINOLONE ACETONIDE OIL oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

INN (International Name):

FLUOCINOLONE ACETONIDE

Composition:

FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluocinolone acetonide 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).

Product summary:

Fluocinolone Acetonide Oil 0.01% (Ear Drops) is supplied in 1 fluid ounce bottles containing 20 mL (Dropper Included) (NDC # 64980-329-20). Keep tightly closed. Store at 20°-25°C (68°to 77°F); excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. Discard Fluocinolone Acetonide Oil 0.01%(Ear Drops) 2 months after initial use. CAUTION: Rx only Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301 Manufactured for: Rising Pharmaceuticals, Inc., Saddle Brook, NJ 07663 R1-04/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE OIL- FLUOCINOLONE ACETONIDE OIL OIL
RISING PHARMACEUTICALS, INC.
----------
FLUOCINOLONE ACETONIDE OIL 0.01%
(EAR DROPS)
NDC 64980-329-20
FOR OTIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Fluocinolone Acetonide Oil 0.01% (Ear Drops) 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. Chemically, fluocinolone acetonide is C
H
F O . It has the following
structural formula:
_Fluocinolone acetonide in fluocinolone acetonide 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 oil 0.01% 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.
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 prostaglandins and leukotrienes by
inhibiting the
release of their common precursor arachidonic acid. Arachidonic acid
is released from
membrane phospholipids by phospholipase A .
24
30 2
6
2
2
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids
is determined by many factors including the vehicle and the integrity
of the epidermal
barrier. Occlusion of topical corticosteroids can enhance penetration.
Topical
corticosteroids can be abs