Tobramycin 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for a topical therapy of external infections.
Each mL of solution contains: Tobramycin 0.3% (3 mg/mL ); Inactives and Purified Water, and Benzalkonium Chloride 0.01% as a preservative
Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.
Pharmacology: Studies have demonstrated tobramycin is active against susceptible strains of the following micro-organisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-betahemolytic species, some non-hemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerugenes, Proteus mirabilis (indole-negative) and indole-positive Proteus species, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin. A significant bacterial population resistant to tobramycin has not yet emerged; however; bacterial resistance may develop upon prolonged use.
Tobramycin is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin. Clinical studies have shown tobramycin to be safe and effective for use in children.
As prescribed by physician.
Solution: In mild to moderate disease, instill one or two drops in the affected eye(s) every four hours until improvement, following which treatment should be reduced prior to discontinuation.
Clinically apparent signs and symptoms of an overdose of Tobramycin Solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reactions seen in some patients.
Tobramycin Solution is contraindicated in patients with known hypersensitivity to any of its components.
NOT FOR INJECTION INTO THE EYE.
Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to tobramycin occurs, discontinue use.
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Usage in Pregnancy: Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic doses have revealed no evidence of impaired infertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Because of the potential for adverse reactions in nursing infants Tobramycin, a decision should be made whether to discontinue nursing the infants or discontinue the drug, taking into account the importance of the drug to the mother.
Usage in Pregnancy: Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic doses have revealed no evidence of impaired infertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Because of the potential for adverse reactions in nursing infants Tobramycin, a decision should be made whether to discontinue nursing the infants or discontinue the drug, taking into account the importance of the drug to the mother.
The most frequent adverse reactions to Tobramycin Solution are localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with Tobramycin. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from Tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Store at temperature not exceeding 30°C. Keep container tightly dosed.
S01AA12 - tobramycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Celsus Tobramycin Eye Drops eye drops 0.3 %
5 mL x 1's (P185/container)
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