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DOSAGE
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Ocular Infection: Instill 1/2" ribbon TID-QID into conjunctival sac
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Blepharitis: Apply to eyelashes BID to TID for 7 days
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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 ointment 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.
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Used off-label for Blepharitis
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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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Category C Corticosteroids have been found to be teratogenic in animal studies.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 ointment) 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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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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