Because of the concern of nephrotoxicity and ototoxicity associated with neomycin,
this combination should not be used over a wide area or for extended periods
General: As with any antibacterial preparation, prolonged use may result
in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures
should be taken if this occurs. Use of steroids on infected areas should be
supervised with care as anti- inflammatory steroids may encourage spread of
infection. If this occurs, steroid therapy should be stopped and appropriate
anti- bacterial drugs used. Generalized dermatological conditions may require
systemic corticosteroid therapy.
Signs and symptoms of exogenous hyperadrenocorticism can occur with the use
of topical corticosteroids, including adrenal suppression. Systemic absorption
of topically applied steroids will be increased if extensive body surface areas
are treated or if occlusive dressings are used. Under these circumstances, suitable
precautions should be taken when long-term use is anticipated.
Specifically, sufficient percutaneous absorption of hydrocortisone can occur
in pediatric patients during prolonged use to cause cessation of growth, as
well as other systemic signs and symptoms of hyperadrenocorticism.
Laboratory Tests: Systemic effects of excessive levels of hydrocortisone
may include a reduction in the number of circulating eosinophils and a decrease
in urinary excretion of 17-hydroxycorticosteroids.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long- term studies
in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable
to oral administration of corticosteroids.
Pregnancy: Teratogenic Effects: Pregnancy Category C. Corticosteroids
have been shown to be teratogenic in rabbits when applied topically at concentrations
of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a
concentration of 15% on days 10 to 13 of gestation. There are no adequate and
well-controlled studies in pregnant women. Corticosteroids should be used during
pregnancy only if the potential benefit justifies the potential risk to the
Nursing Mothers: Hydrocortisone acetate appears in human milk following
oral administration of the drug. Since systemic absorption of hydrocortisone
may occur when applied topically, caution should be exercised when CORTISPORIN
Cream is used by a nursing woman.
Geriatric Use: Clinical studies of Cortisporin Cream (hydrocortisone, neomycin, polymyxin b) did not include
sufficient numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy. Pediatric Use: Safety and effectiveness in pediatric
patients have not been established (see PRECAUTIONS: General).