{"adverse_reactions":["ADVERSE REACTIONS The most frequent adverse reactions to tobramycin ophthalmic solution are hypersensitivity and localized ocular toxicity,including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treatedwith tobramycin ophthalmic solution. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.Other adverse reactions have not been reported from tobramycin ophthalmic solution therapy; however, if topical oculartobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the totalserum concentration."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY In Vitro Data: In vitro studies have demonstrated 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. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant togentamicin retain susceptibility to tobramycin."],"contraindications":["CONTRAINDICATIONS Tobramycin ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components."],"description":["DESCRIPTION Tobramycin Ophthalmic Solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapyof external ophthalmic infections. Each mL of Tobramycin Ophthalmic Solution contains: Active: Tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01%. Inactives: Boric acid, sodium chloride, sodium sulfate anhydrous, sodium hydroxide and/or sulfuric acid (to adjust pH), tyloxapol and water for injection. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positiveophthalmic pathogens. The structural formula of tobramycin is: C18H37N5O9 MW = 467.52 Chemical name: 0-{3-amino-3-deoxy-a-D-gluco-pyranosyl-(1®4)}-0-{2,6-diamino-2,3,6-trideoxy-a-D-ribohexo-pyranosyl-(1®6)}-2-deoxystreptamine."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill twodrops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation."],"effective_time":"20121020","general_precautions":["General As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, includingfungi. If superinfection occurs, appropriate therapy should be initiated."],"how_supplied":["HOW SUPPLIED 5 mL sterile solution in a plastic dispenser bottle (NDC 60505-0558-0), containing tobramycin 0.3% (3 mg/mL). Storage: Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat. Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326 237517 September 2005"],"how_supplied_table":["<table width=\"30%\"> <tbody> <tr> <td>Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9</td> <td>Manufactured for: Apotex Corp. Weston, FL 33326  </td> </tr> </tbody> </table>"],"id":"cbfa58dc-8243-a66d-8abb-f25af7565343","indications_and_usage":["INDICATIONS AND USAGE Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexacaused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children."],"information_for_patients":["Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution."],"nursing_mothers":["Nursing Mothers Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution, adecision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importanceof the drug to the mother."],"openfda":{},"overdosage":["OVERDOSAGE Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution (punctate keratitis, erythema,increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Tobramycin Ophthalmic Solution USP 0.3% label APOTEX CORP. NDC 60505-0558-0 Tobramycin Ophthalmic Solution USP 0.3% 3mg/mL Rx Only 5mL plastic dispenser bottle","PRINCIPAL DISPLAY PANEL - Tobramycin Ophthalmic Solution USP 0.3% carton APOTEX CORP. NDC 60505-0558-0 Tobramycin Ophthalmic Solution USP 0.3% 3mg/mL Rx Only 5mL plastic dispenser bottle"],"precautions":["PRECAUTIONS General As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, includingfungi. If superinfection occurs, appropriate therapy should be initiated. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. Pregnancy: Category B. Reproduction studies in three types of animals at doses up to thirty-three times the normal humansystemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, noadequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of humanresponse, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution, adecision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importanceof the drug to the mother."],"pregnancy":["Pregnancy: Category B. Reproduction studies in three types of animals at doses up to thirty-three times the normal humansystemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, noadequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of humanresponse, this drug should be used during pregnancy only if clearly needed."],"set_id":"4e661ca6-2998-0370-3875-576adbac64b4","spl_product_data_elements":["Tobramycin Tobramycin TOBRAMYCIN TOBRAMYCIN BENZALKONIUM CHLORIDE BORIC ACID SODIUM CHLORIDE SODIUM SULFATE ANHYDROUS SODIUM HYDROXIDE SULFURIC ACID TYLOXAPOL WATER image label carton"],"version":"1","warnings":["WARNINGS NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivityreaction to tobramycin ophthalmic solution occurs, discontinue use."]}