Application Nr Approved Date Route Status External Links
NDA050789 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Tobramycin For Injection, Usp Is Indicated For The Treatment Of Serious Bacterial Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Diseases Listed Below: Septicemia In The Pediatric Patient And Adult Caused By P. Aeruginosa , E. Coli , And Klebsiella Spp. Lower Respiratory Tract Infections Caused By P. Aeruginos A, Klebsiella Spp, Enterobacter Spp, Serratia Spp, E. Coli , And S. Aureus (Penicillinase- And Non-Penicillinase-Producing Strains). Serious Central-Nervous-System Infections (Meningitis) Caused By Susceptible Organisms. Intra-Abdominal Infections, Including Peritonitis, Caused By E. Coli , Klebsiella Spp, And Enterobacter Spp. Skin, Bone, And Skin Structure Infections Caused By P. Aeruginosa , Proteus Spp, E. Coli , Klebsiella Spp, Enterobacter Spp, And S. Aureus. Complicated And Recurrent Urinary Tract Infections Caused By P. Aeruginosa , Proteus Spp, (Indole-Positive And Indole-Negative), E. Coli , Klebsiella Spp, Enterobacter Spp, Serratia Spp, S. Aureus , Providencia Spp, And Citrobacter Spp. Aminoglycosides, Including Tobramycin Sulfate Injection, Usp Are Not Indicated In Uncomplicated Initial Episodes Of Urinary Tract Infections Unless The Causative Organisms Are Not Susceptible To Antibiotics Having Less Potential Toxicity. Tobramycin For Injection, Usp May Be Considered In Serious Staphylococcal Infections When Penicillin Or Other Potentially Less Toxic Drugs Are Contraindicated And When Bacterial Susceptibility Testing And Clinical Judgment Indicate Its Use. Bacterial Cultures Should Be Obtained Prior To And During Treatment To Isolate And Identify Etiologic Organisms And To Test Their Susceptibility To Tobramycin. If Susceptibility Tests Show That The Causative Organisms Are Resistant To Tobramycin, Other Appropriate Therapy Should Be Instituted. In Patients In Whom A Serious Life-Threatening Gram-Negative Infection Is Suspected, Including Those In Whom Concurrent Therapy With A Penicillin Or Cephalosporin And An Aminoglycoside May Be Indicated, Treatment With Tobramycin May Be Initiated Before The Results Of Susceptibility Studies Are Obtained. The Decision To Continue Therapy With Tobramycin Should Be Based On The Results Of Susceptibility Studies, The Severity Of The Infection, And The Important Additional Concepts Discussed In The Warnings Box Above.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tobramycin Sulfate TOBRAMYCIN SULFATE ZINC8214692

Comments