CORTISPORIN Ophthalmic Suspension 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, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.

One or two drops in the affected eye every 3 or 4 hours, depending on the severity of the condition. The suspension may be used more frequently if necessary.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

Plastic DROP DOSE® dispenser bottle of 7.5 mL (NDC 61570-036-75).

Store at 15° to 25°C (59° to 77°F).

Prescribing Information as of July 2003. Distributed by: Monarch pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834. FDA Rev date: 11/25/2003

Last reviewed on RxList: 4/30/2008
This monograph has been modified to include the generic and brand name in many instances.