Fluocinolone Acetonide 0.01% Oil Ear Drops

For Otic Use Only        NDC13925-508-20
Not for Ophthalmic Use

Fluocinolone acetonide 0.01% Oil 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.

Chemically, fluocinolone acetonide is C₂₄ H₃₀ F₂ O₆. It has the following structural formula:

Fluocinolone acetonide 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 0.01% Oil 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, refined peanut oil NF, and fragrances.

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.

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 0.01% Oil Ear Drops twice daily, after 7 days of treatment, showed Fluocinolone acetonide 0.01% Oil 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%. 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 0.01% Oil 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 0.01% oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 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 0.01% oil and histamine/saline controls on the 13 individuals. These subjects were also treated with fluocinolone acetonide 0.01% oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide 0.01% oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide 0.01% oil use. Importantly, the bulk peanut oil used in fluocinolone acetonide 0.01% oil is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

Fluocinolone acetonide 0.01% Oil 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 and older.

Fluocinolone acetonide 0.01% Oil Ear Drops 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).

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluocinolone acetonide 0.01% Oil Ear Drops is administered to a nursing woman.

Pediatric Use: Fluocinolone acetonide 0.01% Oil Ear Drops may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis.

Fluocinolone acetonide 0.01% Oil Ear Drops is not recommended for use on the face (See ADVERSE REACTION section).

Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS).

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Fluocinolone acetonide 0.01% Oil Ear Drops is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million.

Physicians should use caution in prescribing Fluocinolone acetonide 0.01% Oil Ear Drops for peanut-sensitive individuals.

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 0.01% Oil.

Topically applied Fluocinolone acetonide 0.01% Oil Ear Drops can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of Fluocinolone acetonide 0.01% Oil 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 0.01% Oil into the ear. Keep head tilted for about a minute to allow Fluocinolone acetonide 0.01% Oil 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.

Fluocinolone acetonide 0.01% Oil Ear Drops is supplied in a 1 fluid ounce bottle containing 20 mL net weight (Dropper Included). (NDC # 13925-508-20).

MANUFACTURED BY:
Hill Dermaceuticals, Inc.
Sanford, Florida 32773

FOR:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401

Code: 171G244-1
Date: 01/2014

NDC 13925-508-20

Rx only

FLUOCINOLONE
ACETONIDE 0.01% OIL

EAR DROPS

EAR DROPS

For Otic Use Only
Not For Ophthalmic Use

Net contents: 20 mL

SETON
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 20 mL Label