CORTISPORIN Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology).
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus , streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseria species, and Pseudomonas aeruginosa.The product does not provide adequate coverage against Serratia marcescens.
CORTISPORIN Ophthalmic Ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.CORTISPORIN Ophthalmic Ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components.Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
NOT FOR INJECTION INTO THE EYE.
CORTISPORIN Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.
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 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 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 the 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.Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).