No information provided.
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 (see DOSAGE AND ADMINISTRATION).
Therefore, patients receiving a large dose of any potent
topical steroid applied to a large surface area should be evaluated
periodically for evidence of HPA axis suppression by using the urinary free cortisol
and ACTH stimulation tests, and for impairment of internal homeostasis. If HPA
axis suppression or elevation of the body temperature occurs, an attempt should
be made to withdraw the drug, to reduce the frequency of application, or
substitute a less potent steroid.
Recovery of HPA axis function and thermal homeostasis are
generally prompt and complete upon discontinuation of the drug. Infrequently,
signs and symptoms of steroid withdrawal may occur, requiring supplemental
Children may absorb proportionally larger amounts of topical
corticosteroids and thus be more susceptible to systemic toxicity (see
PRECAUTIONS, Pediatric Use).
If irritation or hypersensitivity develops with the
combination nystatin and triamcinolone acetonide, treatment should be
discontinued and appropriate therapy instituted.
If there is a lack of therapeutic response, appropriate
microbiological studies (e.g., KOH smears and/or cultures) should be repeated
to confirm the diagnosis and rule out other pathogens, before instituting another
course of therapy.
A urinary free cortisol test and ACTH stimulation test may
be helpful in evaluating hypothalamicpituitary- adrenal (HPA) axis suppression
due to corticosteroids.
Carcinogenesis, Mutagenesis, And Impairment Of Fertility
Long-term animal studies have not been performed to evaluate
the carcinogenic or mutagenic potential or possible impairment of fertility in
males or females.
Pregnancy Category C
There are no teratogenic studies with combined nystatin and
triamcinolone acetonide. 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. Therefore, any topical corticosteroid
preparation should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Topical preparations containing corticosteroids should not
be used extensively on pregnant patients, in large amounts, or for prolonged
periods of time.
It is not known whether any component of this preparation is
excreted in human milk. Because many drugs are excreted in human milk, caution
should be exercised during use of this preparation by a nursing woman.
In clinical studies of a limited number of pediatric
patients ranging in age from two months through 12 years, nystatin and
triamcinolone acetonide cream formulation cleared or significantly ameliorated
the disease state in most patients.
Pediatric patients may demonstrate greater susceptibility to
topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression
and Cushing's syndrome than mature patients because of a larger skin surface
area to body weight ratio.
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