ive against the following common bacterial eye pathogens: 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.

clera, perforations have been known to occur with the use of topical steroids. precautions: general: the possibility of fungal infections of the cornea should be considered after long-term steroid dosing. as with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. if superinfection occurs, appropriate therapy should be initiated. when multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. information for patients: do not touch dropper tip to any surface, as this may contaminate the contents. contact lenses should not be worn during the use of this product. carcinogenesis, mutagenesis, impairment of fertility: no studies have been conducted to evaluate the carcinogenic or mutagenic potential. no impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day. pregnancy: 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. 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. 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. nursing mothers: systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when tobramycin and dexamethasone ophthalmic suspension is administered to a nursing woman. pediatric use: safety and effectiveness in pediatric patients below the age of 2 years have not been established. geriatric use: no overall differences in safety or effectiveness have been observed between elderly and younger patients.

nvasion 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. postmarketing experience: additional adverse reactions identified from post-marketing use include anaphylactic reaction, erythema multiforme. the following additional adverse reactions have been reported with the individual components listed below: dexamethasone: cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with cyp3a4 inhibitors. aminoglycosides: neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or parkinson's disease, because of their potential effect on neuromuscular function. to report suspected adverse reactions, contact perrigo at 1-866-634-9120 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

proteus vulgaris strains, haemophilus influenzae and h. aegyptius, moraxella lacunata, acinetobacter calcoaceticus and some neisseria species. no data are available on the extent of systemic absorption from tobramycin and dexamethasone ophthalmic suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs.