Flac

Fluocinolone Acetonide Oil, 0.01% Ear Drops is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of Fluocinolone Acetonide Oil, 0.01% Ear Drops into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of Fluocinolone Acetonide Oil, 0.01% Ear Drops into the ear. Keep head tilted for about a minute to allow Fluocinolone Acetonide Oil, 0.01% Ear Drops to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%.

Fluocinolone Acetonide Oil, 0.01% Ear Drops contain 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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for the treatment of atopic dermatitis and Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:

Fluocinolone acetonide in Fluocinolone Acetonide Oil, 0.01% Ear Drops 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% Ear Drops 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.

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 A2 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 A2.

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 absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone Acetonide Oil, 0.01% Ear Drops is in the low to medium range of potency as compared with other topical corticosteroids.

Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of fluocinolone acetonide oil, 0.01% ear drops twice daily, after 7 days of treatment, showed fluocinolone acetonide oil, 0.01% ear drops to be superior to placebo in clearing the signs and symptoms of eczematous external otitis.

Clinical safety studies were conducted on the same formulation of fluocinolone acetonide oil 0.01%, marketed as fluocinolone acetonide topical oil, 0.01%. Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 μg/dL; normal: cortisol > 7μg/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 μg/dL).

A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls on the 13 individuals. These subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01%. Importantly, the bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated just below 450° F for at least 30 minutes, which should provide for adequate decomposition of allergenic proteins.

Fluocinolone Acetonide Oil, 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC 45802-009-10).

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]

CAUTION: Rx only

Manufactured By Padagis

Yeruham, Israel

Distributed By

PadagisTM

Allegan, MI 49010 • www.padagis.com

Rev 07-22

0N300 RC J3