General
The initial prescription and renewal of the medication order
beyond 20 mL 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 2
days, the patient should be re-evaluated.
The possibility of fungal infections of the cornea should be considered after
prolonged corticosteroid dosing. 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 for Patients).
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.
Information for Patients
Patients should be instructed to avoid allowing the tip of the
dispensing container to contact the eye, eyelid, fingers, or any other surface.
The use of this product by more than one person may spread infection.
Patients should also be instructed that ocular products, if handled
improperly, can become contaminated by common bacteria known to cause ocular
infections. Serious damage to the eye and subsequent loss of vision may result
from using contaminated products (see PRECAUTIONS: General).
If the condition persists or gets worse, or if a rash or allergic reaction
develops, the patient should be advised to stop use and consult a physician. Do
not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children.
Carcinogenesis, Mutagenesis, Impairment of
Fertility
Long-term studies in animals to evaluate carcinogenic or
mutagenic potential have not been conducted with polymyxin B sulfate. Treatment
of cultured human lymphocytes in vitro with neomycin
increased the frequency of chromosome aberrations at the highest concentrations
(80 ug/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. Use of
corticosteroid medication in the treatment of herpes simplex requires great
caution. Polymyxin B has been reported to impair the motility of equine sperm,
but its effects on male or female fertility are unknown. 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 -18 of gestation and in
mice when applied topically at a concentration of 15% on days 10 -13 of
gestation. There are no adequate and well-controlled studies in pregnant women.
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension
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 Neomycin and Polymyxin B Sulfates and
Hydrocortisone Ophthalmic Suspension, 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 pediatric patients have not been
established.
Geriatric Use
No overall differences in safety or effectiveness have been
observed between elderly and younger patients.
