The initial prescription and renewal of the medication order beyond 20 milliliters
should be made by a physician only after examination of the patient with the
aid of magnification, such as slit lamp biomicroscopy and, where appropriate,
fluorescein staining. If signs and symptoms fail to improve after two days,
the patient should be re-evaluated.
The possibility of fungal infections of the cornea should be considered after
prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should
be monitored (see WARNINGS).
There have been reports of bacterial keratitis associated with the use of multiple
dose containers of topical ophthalmic products. These containers had been inadvertently
contaminated by patients who, in most cases, had a concurrent corneal disease
or a disruption of the ocular epithelial surface. (See PRECAUTIONS: Information
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) . Treatment
of human lymphocytes in vitro with neomycin increased the frequency of
chromosome aberrations at the highest concentration (80 μg/mL) tested; however,
the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Pregnancy Category C
Corticosteroids have been found to be teratogenic in animal studies. Ocular
administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of
fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation
and increased mortality rates have been observed in rats with chronic dexamethasone
therapy. There are no adequate and well-controlled studies in pregnant women.
Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Infants born of
mothers who have received substantial doses of corticosteroids during pregnancy
should be observed carefully for signs of hypoadrenalism.
It is not known whether topical administration of corticosteroids could result
in sufficient systemic absorption to produce detectable quantities in human
milk. Systemically-administered corticosteroids appear in human milk and could
suppress growth, interfere with endogenous corticosteroid production, or cause
other untoward effects. Because of the potential for serious adverse reactions
in nursing infants from Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) , a decision should be
made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.