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.
The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.
As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Bacterial resistance to POLY-PRED® (prednisolone,neomycin and polymyxin b) ophthalmic suspension may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medicatioin and consult a physician.
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
No studies have been conducted in animals or in humans to evaluate the potential of these effects due to prednisolone.
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.
No studies have been conducted with polymyxin B sulfate to evaluate carcinogenic or mutagenic potential. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.
Pregnany: Teratogenic Effects
Pregnancy Category C
Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice.
In mice, prednisolone has been shown to be teratogenic when given in doses 1
to 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 dosed with corticosteroids.
Animal reproduction studies have not been conducted with polymyxin B sulfate or neomycin sulfate. It is also not known whether polymyxin B sulfate or neomycin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
POLY-PRED® (prednisolone,neomycin and polymyxin b) ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
This drug is excreted in human milk. Caution should be exercised when POLY-PRED® (prednisolone,neomycin and polymyxin b) ophthalmic suspension is administered to a nursing woman.
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.