There is a possibility of fungal infections of the cornea after long term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of non-susceptible organisms, including fungi, if superinfection occurs, appropriate therapy should be initiated.

Patients requiring multiple prescriptions or whenever clinical judgment dictates the use of magnification such as lamp biomicroscopy or fluorescein staining where appropriate.

Cross-sensitivity to other aminoglycoside antibiotics may occur, if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Pregnancy: 

Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. OPIDEX (tobramycin and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

WARNING:  NOT FOR INJECTION INTO THE EYE.

Sensitivity to topically applied aminoglycosides may occur in some patient. If sensitivity does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation. Routine monitoring of intraocular pressure is needed even though it may be difficult in children and uncooperative patients.  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 steroids, in acute purulent conditions of the eye. Steroids may mask infection or enhance existing infection.