WARNINGS
NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates
and Hydrocortisone Ophthalmic Suspension should never be directly introduced
into the anterior chamber of the eye.
Prolonged use of corticosteroids may result in ocular hypertension and/or
glaucoma, with damage to the optic nerve, defects in visual acuity and fields of
vision, and 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
corticosteroids. In acute purulent conditions of the eye, corticosteroids 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 uncooperative
patients. Corticosteroids should be used with caution in the presence of
glaucoma.
The use of corticosteroids after cataract surgery may delay healing and
increase the incidence of filtering blebs.
Use of ocular corticosteroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex).
Employment of corticosteroid medication in the treatment of herpes simplex
requires great caution.
Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous
sensitization. A precise incidence of hypersensitivity reactions (primarily skin
rash) due to topical antibiotics is not known. 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).
PRECAUTIONSGeneral
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.
