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® ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus; Escherichia coli; Hemophilus influenzae; Klebsiella/ Enterobacter species; Neisseria species; and Pseudomonas aeruginosa.The product does not provide adequate coverage against: Serratia marcescens; Streptococci, including Streptococcus pneumoniae.
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva.
Mycobacterial infection of the eye.
Fungal diseases of the ocular structures.
Hypersensitivity to a component of the medication.(Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
NOT FOR INJECTION INTO THE EYE.Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.Employment of a steroid medication in the treatment of herpes simplex requires great caution.There exists a potential for neomycin sulfate to cause cutaneous sensitization.
The exact incidence of this reaction is unknown.
The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid.
A sensitization reaction may manifest simply as a failure to heal.
During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed.
Symptoms usually subside quickly on withdrawing the medication.Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).