No information provided.
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 that augment systemic absorption include 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 HP A axis suppression using urinary-free cortisol and ACTH stimulation tests. If HP A 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 HP A axis function is generally prompt and complete on discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.
Pediatric patients may absorb proportionately larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity (see Pediatric Use under
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, Cordran should be discontinued until the infection has been adequately controlled.
The following tests may be helpful in evaluating
the HPA axis suppression: Urinary-free cortisol test ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
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.
Usage in Pregnancy
Pregnancy Category C
Corticosteroids are generally
teratogenic in laboratory animals when administered systemically at relatively
low dosage levels. The more potent cortico-steroids 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 for pregnant patients or in large amounts or
for prolonged periods of time.
It 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 patients may demonstrate greater susceptibility
to topical corticosteroid-induced HPA axis suppression and Gushing's syndrome
than do mature patients because of a larger skin surface area to body weight
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.