FOR TOPICAL OPHTHALMIC USE. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of MAXIDEX® (dexamethasone ophthalmic suspension).
Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.
MAXIDEX® (dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. There are no adequate or well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXIDEX® (dexamethasone ophthalmic suspension) is administered to a nursing woman.
The safety and effectiveness of MAXIDEX have been established in the pediatric patients. Use of MAXIDEX in all pediatric age groups is supported by evidence from adequate and well-controlled studies of MAXIDEX in adults with safety data from additional adequate and well controlled trials in pediatric patients.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.