Tobramycin / Dexamethasone Ophthalmic Suspension 0.3%/0.05%

TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05%) 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. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other 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 isolates, Haemophilus influenzae , H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Contact your doctor if the symptoms begin to get worse or if you do not see any improvement in the condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Do not use tobramycin and dexamethasone ophthalmic if you have a viral or fungal infection in the eye. It is used to treat infections caused by bacteria only.

It is not known whether tobramycin and dexamethasone ophthalmic will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is not known whether tobramycin and dexamethasone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available.

The most frequent adverse reactions to topical ocular tobramycin (TOBREX® ) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.

The reactions due to the steroid component are: increased intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.

Secondary Infection.

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.

Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure.

Read the entire FDA prescribing information for Tobradex ST (Tobramycin / Dexamethasone Ophthalmic Suspension 0.3%/0.05%)