Fluocinolone Acetonide

Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the

• topical treatment of atopic dermatitis in adult patients (
  1.1 Adult Patients with Atopic Dermatitis

  Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients.
  )
  
  
• topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks (
  1.2 Pediatric Patients with Atopic Dermatitis

  Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.
  )
  
  

Limitations of Use:

• Apply the least amount to cover affected areas.
  
  Discontinue when disease is controlled. (
  1.3 Limitations of Use

  Apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.
  
  Fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions.

  [see Adverse Reactions (6)and Use in Specific Populations (8.4)]

  .
  )
  
  
• Do not use in the diaper area. (
  1.3 Limitations of Use

  Apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.
  
  Fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions.

  [see Adverse Reactions (6)and Use in Specific Populations (8.4)]

  .
  )
  
  
• Do not use on the face, axillae, or groin. (
  1.3 Limitations of Use

  Apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.
  
  Fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions.

  [see Adverse Reactions (6)and Use in Specific Populations (8.4)]

  .
  ,
  6.2 Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old

  An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. The following adverse reactions were reported in the study

  [See Use in Specific Populations (8.4)]:

  Adverse Reactions (%), N=30Includes one subject who withdrew at Week 2

  Adverse Reaction	# of subjects (%)
  Diarrhea	1 (3)
  Vomiting	1 (3)
  Pyrexia	3 (10)
  Abscess	1 (3)
  Molluscum	1 (3)
  Nasopharyngitis	2 (7)
  URI	1 (3)
  Otitis media	1 (3)
  Cough	6 (20)
  Rhinorrhea	4 (13)
  Atopic dermatitis	1 (3)
  Eczema	1 (3)
  Hyperpigmentation	1 (3)
  Hypopigmentation	2 (7)
  Rash	1 (3)
  ,
  8.4 Pediatric Use

  8.4.1 Systemic Adverse Reactions in Pediatric Patients

  HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children 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, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids.

  [See Warnings and Precautions (5.1)]

  8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects

  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 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 subjects’ responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% 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 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%. The bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated between 232˚C – 246˚C (450˚F – 475˚F) for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

  [See Description (11)]

  8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old

  Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Subjects were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. 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 µg/dL; normal: cortisol > 7 µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL).

  8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old

  An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. 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 µg/dL).
  )

Fluocinolone acetonide topical oil, 0.01% is not for oral, ophthalmic, or intravaginal use.

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide topical oil, 0.01%. Therefore, fluocinolone acetonide topical oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. (
  5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression

  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 also be produced by systemic absorption of topical corticosteroids.

  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, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

  Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

  Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

  Children 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)]
  )
• Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. (
  5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression

  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 also be produced by systemic absorption of topical corticosteroids.

  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, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

  Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

  Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

  Children 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)]
  )
• Modify use should HPA axis suppression develop. (
  5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression

  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 also be produced by systemic absorption of topical corticosteroids.

  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, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

  Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

  Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

  Children 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)]
  )
• Potent corticosteroids use on large areas, prolonged use or occlusive use may increase systemic absorption. (
  5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression

  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 also be produced by systemic absorption of topical corticosteroids.

  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, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

  Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

  Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

  Children 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)]
  )
• Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. (
  5.2 Local Adverse Reactions with Topical Corticosteroids

  Local adverse reactions may occur with use of topical corticosteroids 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)]
  ,
  5.3 Allergic Contact Dermatitis with Topical Corticosteroids

  Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a

  failure to heal

  rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
  ,
  6.1 Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects

  An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil, 0.01% when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:

  Incidence of Adverse Reactions (%), N=58

  Adverse Reaction (AR)The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction.	# of subjects (%)	Day 14	Day 28End of Treatment	Day 56Four Weeks Post Treatment
  Any AE	15 (26)	6 (10)	7 (12)	7 (12)
  Telangiectasia	5 (9)	3 (5)	4 (7)	2 (4)
  Erythema	3 (5)			3 (5)
  Itching	3 (5)			3 (5)
  Irritation	3 (5)			3 (5)
  Burning	3 (5)			3 (5)
  Hypopigmentation	2 (4)	2 (4)
  Shiny skin	1 (2)		1 (2)
  Secondary atopic dermatitis	1 (2)			1 (2)
  Papules and pustules	1 (2)			1 (2)
  Keratosis pilaris	1 (2)			1 (2)
  Folliculitis	1 (2)		1 (2)
  Facial herpes simplex	1 (2)	1 (2)
  Acneiform eruption	1 (2)		1 (2)
  Ear infection	1 (2)		1 (2)
  )
• Children may be more susceptible to systemic toxicity from equivalent doses. (
  5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression

  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 also be produced by systemic absorption of topical corticosteroids.

  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, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

  Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

  Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

  Children 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)]
  ,
  8.4 Pediatric Use

  8.4.1 Systemic Adverse Reactions in Pediatric Patients

  HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children 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, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids.

  [See Warnings and Precautions (5.1)]

  8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects

  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 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 subjects’ responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% 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 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%. The bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated between 232˚C – 246˚C (450˚F – 475˚F) for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

  [See Description (11)]

  8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old

  Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Subjects were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. 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 µg/dL; normal: cortisol > 7 µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL).

  8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old

  An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. 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 µg/dL).
  )