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DOSAGE
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Mild/Moderate Bacterial Infection: 1-2 gtts q4-6hrs
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Severe Bacterial Infection: For the first 24-48hrs, 1-2 gtts q2hr. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
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GENERIC
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tobramycin 0.3%, dexamethasone 0.1%
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INDICATIONS
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TOBRADEX® (tobramycin and dexamethasone 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 conjunctivitis 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.
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MECHANISM OF ACTION
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aminoglycoside corticosteroid: Aminoglycosides prevent bacterial protein synthesis. Corticosteroids inhibit arachidonic acid release.
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MICROBIOLOGY
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Dexamethasone is a potent corticoid. Active against a wide variety of gram-negative and gram-positive bacteria includings some penicillin-resistant and gentamicin-resistant strains
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The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and 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 calcoaceticus and some Neisseria species.
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CONTRAINDICATIONS & WARNINGS
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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.
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Hypersensitivity to this or other aminoglycosides, corticosteroids, or any components of the medication.
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PEDIATRIC USE
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Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
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PREGNANCY
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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 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus.
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There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
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NOTE
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Exercise caution with severe or unresponsive keratitis as steroids will exacerbate many nonbacterial infections.
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