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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 0.05%
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INDICATIONS
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TOBRADEX® ST 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.
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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. Tobramycin is 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 (tobramycin) in the combination is included to provide action against susceptible bacteria. In vitro studies have demonstrated that tobramycin is active against susceptible isolates of the following bacteria: Staphylococcus aureus (includes penicillin-resistant isolates), Staphylococcus epidermidis (includes penicillin-resistant isolates), Streptococci, including some Group A other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Haemophilus aegypticus, Klebsiella pneumoniae, Moraxella lacunata, Morganella morganii, Neisseria perflava, Neisseria sicca, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa. In vitro bacterial studies demonstrate that in some cases bacteria resistant to gentamicin are susceptible to tobramycin.
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CONTRAINDICATIONS & WARNINGS
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TOBRADEX ST, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
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Hypersensitivity to a component 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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Category C. Corticosteroids have been shown 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 (equivalent to human doses of 16 and 32 mg/kg/day, respectively) and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TOBRADEX® ST ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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NOTE
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ST = "Suspension Technology". Addition of xanthan gum allows reduction of dexamethasone concentration to 0.05% without reducing efficacy.
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Glaucoma and cataract risk with extended use.
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