Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions
including anaphylactic symptoms and life-threatening or less severe asthmatic
episodes in certain susceptible people. The overall prevalence of sulfite sensitivity
in the general population is unknown and probably low. Sulfite sensitivity is
seen more frequently in asthmatic than in nonasthmatic people.
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 additions of
occlusive dressings. Therefore, patients receiving a large dose of potent topical
steroids 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 PRECAUTIONS-Pediatric Use.) 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 on intertriginous or flexor areas,
or on the face, this may occur even with short-term use. 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
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
animal studies have not been performed to evaluate the carcinogenic potential
or the affect 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.
It is not known whether topical 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 patients may demonstrate greater susceptibility
to a topical corticos-teroid-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.