Included as part of the PRECAUTIONS section.
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
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
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.
Concomitant Skin Infections
Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists unchanged, Derma-Smoothe/FS® (fluocinolone acetonide) should be discontinued until the infection has been adequately treated.
Use in Peanut-Sensitive Individuals
Physicians should use caution in prescribing Derma-Smoothe/FS (fluocinolone acetonide) for peanut-sensitive
individuals. [See DESCRIPTION]
Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, Derma-Smoothe/FS (fluocinolone acetonide) should be discontinued immediately and appropriate therapy instituted.
Carcinogenesis, mutagenesis, impairment of fertility:
Long-term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of Derma-Smoothe/FS (fluocinolone acetonide) . Studies have not been
performed to evaluate the mutagenic potential of fluocinolone acetonide, the
active ingredient in Derma- Smoothe/FS. Some corticosteroids have been found
to be genotoxic in various genotoxicity tests (i.e. the in vitro human
peripheral blood lymphocyte chromosome aberration assay with metabolic activation,
the in vivo mouse bone marrow micronucleus assay, the Chinese hamster
micronucleus test and the in vitro mouse lymphoma gene mutation assay).
Use In Specific Populations
Pregnancy Category C: 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 Derma-Smoothe/FS (fluocinolone acetonide) . Therefore, Derma-Smoothe/FS (fluocinolone acetonide) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 Derma-Smoothe/FS (fluocinolone acetonide) is administered to a nursing woman.
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]
Evaluation in Peanut-Sensitive Pediatric Subjects
A clinical study was conducted to assess the safety of Derma-Smoothe/FS (fluocinolone acetonide) , 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, Derma-Smoothe/FS (fluocinolone acetonide)
and histamine/saline controls. Subjects were also treated with Derma- Smoothe/FS
twice daily for 7 days. Prick test and patch test results for all 13 patients
were negative to Derma-Smoothe/FS (fluocinolone acetonide) and the refined peanut oil. One of the 9 peanut-sensitive
patients experienced an exacerbation of atopic dermatitis after 5 days of Derma-Smoothe/FS (fluocinolone acetonide) .
The bulk peanut oil NF, used in Derma-Smoothe/FS (fluocinolone acetonide) is heated at 475°F for
at least 15 minutes, which should provide for adequate decomposition of allergenic
proteins. [See DESCRIPTION]
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 Derma-Smoothe/FS (fluocinolone acetonide) 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 > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL).
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 Derma-Smoothe/FS (fluocinolone acetonide) 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).