No information provided.
Systemic absorption of topical corticosteroids has
produced reversible hypothaÂlamic-pituitary-adrenal (HPA) axis suppression,
manifestations of Cushing's synÂdrome, hyperglycemia, and glucosuria in some
Conditions which augment systemic absorption include the
application of the more potent steroids, use over large surface areas,
prolonged use, and the addiÂtion 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 periodiÂcally 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 substiÂtute a less potent steroid.
Recovery of HPA axis function is generally prompt and
complete upon discontinuÂation of the drug. Infrequently, signs and symptoms of
steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
kChildren may absorb proportionally larger amounts of
topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS—Pediatric
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
onintertriginous or flexor areas, or on the face, this may occur even with
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 adÂequately controlled.
The following tests may be
helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
and Impairment of Fertility
Long-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
Pregnancy Category C
Corticosteroids are generally
teratogenic in laboratory animals when adminisÂtered 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 teratoÂgenic effects
from topically applied corticosteroids. Therefore, topical corticosteÂroids
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.
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 quantiÂties 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 corticosteroidÂinduced
hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome
than mature patients because of a larger skin surface area to body weight
(HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have
been reported in children receiving topical corticoÂsteroids. 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.
Administration of topical
corticosteroids to children should be limited to the least amount compatible
with an effective therapeutic regimen. Chronic corticosteroid therapy may
interfere with the growth and development of children.