If local infection should continue or become severe, or
in the presence of systemic infection, appropriate systemic antibacterial
therapy, based on susceptibility testing, should be considered.
Because of the concern of nephrotoxicity and ototoxicity
associated with neomycin, this combination product should not be used over a
wide area or for extended periods of time.
There are articles in the current medical literature that
indicate an increase in the prevalence of persons sensitive to neomycin.
It is recommended that NEO-SYNALAR® cream not be used
under occlusive dressings. 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,
Therefore, patients receiving a large dose of a 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. 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
The following tests may be helpful in evaluating the HPA
Urinary free cortisoltest
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
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 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 patients may demonstrate greater
susceptibility to topical corticosteroid-induced hypothalmicpituitary- adrenal
(HPA) axis suppression and Cushing's syndrome than mature patients because of a
larger skin surface area to body weight ratio.
Hypothalmic-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