CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any
of the components of the preparation.
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.
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 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 substitute a less potent steroid.
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.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more
susceptible to systemic toxicity. (See 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:
1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which
it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be
occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive
dressing.
5. 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 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.
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.
Pediatric Use
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 children receiving topical corticosteroids.
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.