No information provided.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency
after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia,
and glucosuria can also be produced in some patients by systemic absorption
of topical corticosteroids while on treatment. Patients applying a topical steroid
to a large surface area or to areas under occlusion should be evaluated periodically
for evidence of HPA axis suppression. This may be done by using the ACTH stimulation,
A.M. plasma cortisol, and urinary free cortisol tests. If HPA axis suppression
is noted, an attempt should be made to withdraw the drug, to reduce the frequency
of application, or to substitute a less potent corticosteroid. Infrequently,
signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental
systemic corticosteroids. For information on systemic supplementation, see prescribing
information for those products. Children may be more susceptible to systemic
toxicity from equivalent doses due to their larger skin surface to body mass
ratios. (See PRECAUTIONS - Pediatric use)
Allergic contact dermatitis to any component of topical corticosteroids is
usually diagnosed by a failure to heal rather than noting a clinical
exacerbation, which may occur with most topical products not containing corticosteroids.
Such an observation should be corroborated with appropriate diagnostic testing.
One peanut sensitive child experienced a flare of his atopic dermatitis after
5 days of twice daily treatment with Derma-Smoothe/FS® (see Clinical
If wheal and flare type reactions (which may be limited to pruritus) or other
manifestations of hypersensitivity develop, Derma-Smoothe/FS® should be
discontinued immediately and appropriate therapy instituted.
If concomitant skin infections are present or develop, an appropriate antifungal
or antibacterial agent should be used. If a favorable response does not occur
promptly, use of Derma-Smoothe/ FS® should be discontinued until the infection
has been adequately controlled.
Derma-Smoothe/FS® 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 (ppm).
Physicians should use caution in prescribing Derma-Smoothe/FS® for peanut
The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation test
A.M. plasma cortisol test Urinary free cortisol test
Carcinogenesis, mutagenesis, and 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®. 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
Teratogenic effects - 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®. Therefore, Derma-Smoothe/FS® 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® is administered to a nursing woman.
Derma-Smoothe/FS® may be used twice daily for up to 4 weeks in pediatric
patients 2 years and older with moderate to severe atopic dermatitis. Derma-Smoothe/FS®
should not be applied to the diaper area.
Application to intertriginous areas should be avoided due to the increased possibility of local adverse events such as striae, atrophy, and telangiectasia, which may be irreversible. The smallest amount of drug needed to cover the affected areas should be applied. Long term safety in the pediatric population has not been established.
Derma-Smoothe/FSR is not recommended for use on the face (see ADVERSE REACTIONS
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.
Derma-Smoothe/FS® 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 (ppm).
Physicians should use caution in prescribing Derma-Smoothe/FS® for peanut sensitive individuals.