The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.
Fungal infections of the cornea are particularly prone to develop coincidentally with long term applications of steroids.
The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.Secondary bacterial ocular infection following suppression of host responses also occurs.
TOBRADEX Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular 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 superficial ocular 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:Staphylococci, including S.
epidermidis(coagulase-positive and coagulase-negative), including penicillin-resistant strains.Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii,most Proteus vulgaris strains, Haemophilus influenzae and H.aegyptius, Moraxella lacunata, Acinetobacter calcoaceticusand some Neisseria species.
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva.
Mycobacterial infection of the eye.
Fungal diseases of ocular structures.Hypersensitivity to a component of the medication.
NOT FOR INJECTION INTO THE EYE.
Sensitivity to topically applied aminoglycosides may occur in some patients.
If a sensitivity reaction 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.
Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients 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.