Ocular irritation and punctate keratitis have been associated with the use of PRED-G®
suspension. The initial prescription and renewal of the medication order beyond 20 milliliters
should be made by a physician only after examination of the patient’s intraocular pressure,
examination of the patient with the aid of magnification such as slit lamp biomicroscopy and,
where appropriate, fluorescein staining.
As fungal infections of the cornea are particularly prone to develop coincidentally with longterm
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
There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
There are no published mutagenicity or impairment of fertility studies on prednisolone. Prednisolone has been reported to be non-carcinogenic.
Gentamicin has been shown to depress body weight, kidney weight, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were 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. PRED-G® suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 untoward effects. Because of the potential for serious adverse reactions in nursing infants from PRED-G® suspension, a decision should be made whether to discontinue nursing while the drug is being administered or to discontinue the medication.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.