"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
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 Stopical 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.
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).
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.
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/19/2009
Additional Poly-Pred Information
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