General: The initial prescription and renewal of the medication order beyond 8 grams 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. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term 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 when appropriate.
If this product is used for 10 days or longer, intraocular pressure should
be monitored (see WARNINGS).
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 concentrations (80 Âµg/mL) tested; however, the effects of neomycin
on carcinogenesis and mutagenesis in humans are unknown.
Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.
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. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.
Pregnancy: Teratogenic Effects: Pregnancy Category C. Corticosteroids
have been found to be teratogenic in rabbits when applied topically at concentrations
of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a
concentration of 15% on days 10 to 13 of gestation. There are no adequate and
well-controlled studies in pregnant women. CORTISPORIN Ophthalmic Ointment (neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone ophthalmic ) should
be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Nursing Mothers: 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 other untoward effects. Because of the potential for serious adverse
reactions in nursing infants from CORTISPORIN Ophthalmic Ointment (neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone ophthalmic ) , a decision
should be made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in children have not been established.
Geriatric Use: No overall differences in safety or effectiveness have
been observed in between elderly and younger patients.