INDICATIONS AND USAGE:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.

CONTRAINDICATIONS:

Maxitrol is contraindicated in patients with epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral infections of the cornea and conjunctiva, mycobacterial infections of the eye, fungal diseases of ocular structures, as well as hypersensitivity to any component of the medication.

WARNINGS:

Maxitrol should not be injected or intraocularly administered.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye. Prolonged use may result in 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 infection.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.

Neomycin sulfate may cause cutaneous sensitization. Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. If hypersensitivity develops, treatment should be discontinued. Cross hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.

PRECAUTIONS:

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should discontinue use and consult a physician. Patients should be advised that their vision may be temporarily blurred following dosing with Maxitrol.

ADVERSE REACTIONS:

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.