General: As with other antibiotic preparations, prolonged use of NEOSPORIN
Ophthalmic Ointment may result in overgrowth of nonsusceptible organisms including
fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to NEOSPORIN Ophthalmic Ointment (neomycin, polymyxin and bacitracin zinc ophthalmic ointment) may also develop. If
purulent discharge, inflammation, or pain becomes aggravated, the patient should
discontinue use of the medication and consult a physician.
There have been reports of bacterial keratitis associated with the use of topical
ophthalmic products in multiple-dose containers which have been inadvertently
contaminated by patients, most of whom had a concurrent corneal disease or a
disruption of the ocular epithelial surface (see PRECAUTIONS: INFORMATION
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: Long-term studies
in animals to evaluate carcinogenic or mutagenic potential have not been conducted
with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes
in vitro with neomycin increased the frequency of chromosome aberrations at
the highest concentration (80 Âµg/mL) tested; however, the effects of neomycin
on carcinogenesis and mutagenesis in humans are unknown.
Polymyxin B has been reported to impair the motility of equine sperm, but its
effects on male or female fertility are unknown. No adverse effects on male
or female fertility, litter size or survival were observed in rabbits given
bacitracin zinc 100 gm/ton of diet.
Pregnancy: Teratogenic Effects: Pregnancy Category C.
Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin
B sulfate, or bacitracin. It is also not known whether NEOSPORIN Ophthalmic
Ointment can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. NEOSPORIN Ophthalmic Ointment (neomycin, polymyxin and bacitracin zinc ophthalmic ointment) should be given to a pregnant
woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be exercised
when NEOSPORIN Ophthalmic Ointment (neomycin, polymyxin and bacitracin zinc ophthalmic ointment) is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not
Geriatric Use: No overall differences in safety or effectiveness have
been observed between elderly and younger patients.