General
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adre-nal (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 HPAaxis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.
If HPAaxis 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 Topical Oil® (see CLINICAL STUDIES section).
If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, DermOtic® Oil 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 DermOtic® Oil should be discontinued until the infection has been adequately controlled.
DermOtic® Oil 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 DermOtic® Oil for peanut-sensitive
individuals.
Laboratory Tests
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 Fluocinolone Acetonide Oil. Studies
have not been performed to evaluate the mutagenic potential of fluocinolone
acetonide, the active ingredient in DermOtic® Oil. 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).
Pregnancy
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 DermOtic® Oil. Therefore, DermOtic® Oil should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
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 DermOtic® Oil is administered to a nursing woman.
Pediatric Use
DermOtic® Oil may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis.
DermOtic® Oil is not recommended for use on the face (See ADVERSE
REACTIONS 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.
DermOtic® Oil 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 DermOtic® Oil for peanut sensitive individuals.
Last updated on RxList: 3/3/2009
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