General
Systemic absorption of topical corticosteroids has produced
reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations
of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the
more potent steroids, use over large surface areas, prolonged use, and the
addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid
applied to a large surface area or under an occlusive dressing should be
evaluated periodically for evidence of HPA axis suppression by using the urinary
free cortisol and ACTH stimulation 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 steroid.
Recovery of HPA axis function is generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid
withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity. (See PRECAUTIONS - Pediatric Use). If irritation develops, topical
corticosteroids should be discontinued and appropriate therapy instituted.
As with any topical corticosteroid product, prolonged use may produce atrophy
of the skin and subcutaneous tissues. When used on intertriginous or flexor
areas, or on the face, this may occur even with short-term use.
In the presence of dermatological infections, the use of an appropriate
antifungal or antibacterial agent should be instituted. If a favorable response
does not occur promptly, the corticosteroid should be discontinued until the
infection has been adequately controlled.
Information for Patients
Patients using topical corticosteroids should receive the
following information and instructions:
- This medication is to be used as directed by the physician. It is for
external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other
than that for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped
as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under
occlusive dressing.
- Parents of pediatric patients should be advised not to use tight-fitting
diapers or plastic pants on a child being treated in the diaper area, as these
garments may constitute occlusive dressings.
Laboratory TestsThe following tests may be helpful in evaluating the HPA axis
suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, Impairment of
FertilityLong-term animal studies have not been performed to evaluate the
carcinogenic potential or the effect on fertility of topical
corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have
revealed negative results.
PregnancyTeratogenic EffectsPregnancy Category CCorticosteroids are generally teratogenic in laboratory animals
when administered systemically at relatively low dosage levels. The more potent
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 topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Drugs of this class
should not be used extensively on pregnant patients, in large amounts, or for
prolonged periods of time.
Nursing MothersIt is not known whether topical administration of corticosteroids
could result in sufficient systemic absorption to produce detectable quantities
in breast milk. Systemically administered corticosteroids are secreted into
breast milk in quantities not likely to have a
deleterious effect on the infant. Nevertheless, caution should be exercised when
topical corticosteroids are administered to a nursing woman.
Pediatric UsePediatric patients may demonstrate greater
susceptibility to topical corticosteroid-induced HPA axis suppression and
Cushing's syndrome than mature patients because of a larger skin surface area to
body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome,
and intracranial hypertension 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 absence of response to ACTH stimulation. Manifestations of
intracranial hypertension include bulging fontanelles, headaches, and bilateral
papilledema.
Administration of topical corticosteroids to pediatric patients should be
limited to the least amount compatible with an effective therapeutic regimen.
Chronic corticosteroid therapy may interfere with the growth and development of
pediatric patients.
