WARNINGS
No information provided.
PRECAUTIONS
General
Systemic absorption of topical corticosteroids has
produced reversible hypothalamicpituitary- 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.
If HPA axis suppression is noted (by using the urinary
free cortisol and ACTH stimulation tests) an attempt should be made to withdraw
the drug or to reduce the frequency of application.
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.
Pediatric patients 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. 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.
Laboratory Tests
The urinary free cortisol test and the ACTH stimulation
test may be helpful in evaluating the HPA axis suppression.
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 topical corticosteriods.
Studies to determine mutagenicity with hydrocortisone have revealed negative results.
Pregnancy Category C
Corticosteroids 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 Mothers
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.
Use In Pediatric Patients
PEDIATRIC 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.