Fluocinolone Acetonide

Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is indicated for the topical treatment of:

• atopic dermatitis in adults
• moderate to severe atopic dermatitis in pediatric patients 3 months of age and older

Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces.

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

• Endocrine System Adverse Reactions
  [see

  5.1       Endocrine
  System Adverse Reactions

  Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can result from systemic absorption of topical corticosteroids.

  HPA axis suppression and Cushing’s syndrome have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios

  [see Use in Specific Populations (8.4)].

  Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

  If HPA axis suppression is documented, reduce the frequency of application or discontinue fluocinolone acetonide 0.01% topical oil, or substitute with a less potent corticosteroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

  
  
  

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  8.4 Pediatric Use

  The safety and effectiveness of fluocinolone acetonide 0.01% topical oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks.

  Safety and effectiveness of fluocinolone acetonide 0.01% topical oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established.

  Systemic Adverse Reactions in Pediatric Patients

  HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

  Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids

  [see Warnings and Precautions (5.1)]

  .

  Evaluation in Peanut-Sensitive Pediatric Patients

  A clinical trial was conducted to assess the safety of fluocinolone acetonide 0.01% topical oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric 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 trial evaluated the subjects’ responses to both prick test and patch test utilizing refined peanut oil NF, fluocinolone acetonide 0.01% topical oil and histamine/saline controls. 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 0.01% topical 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% topical oil.

  Evaluation in Pediatric Patients 2 to 6 years old

  
  
  Use of fluocinolone acetonide 0.01% topical oil in pediatric patients 2 to 6 years old is supported by open-label safety trials conducted in 33 pediatric subjects (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Subjects were treated with fluocinolone acetonide 0.01% topical oil twice daily for 4 weeks. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels 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 mcg/dL; normal: cortisol > 7 mcg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 mcg/dL)

  [see Clinical Pharmacology (12.2)]

  .

  Evaluation in Pediatric Patients 3 months to 2 years old

  Use of fluocinolone acetonide 0.01% topical oil in pediatric patients 3 months to 2 years old is supported by an open-label safety trial conducted in 29 pediatric subjects (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide 0.01% topical oil twice daily for 4 weeks

  [see Adverse Reactions (6.1)]

  . Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 mcg/dL)

  [see Clinical Pharmacology (12.2)]

  .

  
  
  

  ]
• Local Adverse Reactions
  [see

  5.2       Local Adverse Reactions

  Local adverse reactions may occur with use of topical corticosteroids, including fluocinolone acetonide 0.01% topical oil, and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria

  [see Adverse Reactions (6.1)]

  .

  
  
  

  ]
• Ophthalmic Adverse Reactions
  [see

  5.3       Ophthalmic
  Adverse Reactions

  Use of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of fluocinolone acetonide 0.01% topical oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

  
  
  

  ]

Fluocinolone Acetonide 0.01% Topical Oil (Body 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 dermatologic use. This formulation is also marketed as Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults and as fluocinolone acetonide oil, 0.01% for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C₂₄ H₃₀ F₂ O₆. 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 270°C 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.

Fluocinolone Acetonide 0.01% Topical Oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide 0.01% Topical Oil for peanut-sensitive individuals.

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.