WARNINGS
No infromation provided.
PRECAUTIONS
Genetic-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 HPA axis suppression by using 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 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 below).
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.
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 was prescribed.
- The treated skin area should not be bandaged or otherwise
covered or wrapped in order to be occlusive unless the
patient is directed to do so 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 patient
being treated in the diaper area, because these garments
may constitute occlusive dressings.
Laboratory Tests
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
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 results.
Usage in Pregnancy
Pregnancy Category C-Corticosteroids
are generally teratogenic in laboratory animals when administered
systemically at relativey 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 for pregnant patients or 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.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility
to topical-corticosteroid-induced HPA axis suppression
and Cushing’s syndrome than do 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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