PRECAUTIONS
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.
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.
Information for the Patient
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 has been
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 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.
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