The initial prescription and renewal of the medication
order beyond 20 milliliters of PRED MILD® 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 2 days, the patient should be re-evaluated.
As fungal infections of the cornea are particularly prone
to develop coincidentally with longterm local corticosteroid applications,
fungal invasion should be suspected in any persistent corneal ulceration where
a corticosteroid has been used or is in use. Fungal cultures should be taken
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No studies have been conducted in animals or in humans to
evaluate the potential of these effects.
Prednisolone has been shown to be teratogenic in mice
when given in doses 1-10 times the human dose. Dexamethasone, hydrocortisone,
and prednisolone were ocularly applied to both eyes of pregnant mice five times
per day on days 10 through 13 of gestation. A significant increase in the
incidence of cleft palate was observed in the fetuses of the treated mice.
There are no adequate well-controlled studies in pregnant women. Prednisolone
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
It is not known whether topical ophthalmic administration
of corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in breast 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 prednisolone, 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.
The safety and effectiveness in pediatric patients have
been established. Use in pediatric patients is supported by evidence from
adequate and well-controlled studies of prednisolone acetate ophthalmic
suspension in adults with additional data in pediatric patients.
No overall differences in safety or effectiveness have
been observed between elderly and younger patients.