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®
Pregnancy Category C
Dexamethasone has been shown to be teratogenic in mice
and rabbits following topical ophthalmic application in multiples of the
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.
There are no adequate or well-controlled studies in pregnant
women. MAXIDEX Ointment should be used during pregnancy only if the potential
benefit to the mother justifies the potential risk to the embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids
during pregnancy should be observed carefully for signs of hypoadrenalism.
Topically applied steroids are absorbed systemically.
Therefore, because of the potential for serious adverse reactions in nursing
infants from dexamethasone sodium phosphate, a decision should be made whether
to discontinue nursing or discontinue the drug, taking into account the
importance of the drug to the mother.
Safety and effectiveness in children have not been