(Approval lapsed) Gentamicin Injection USP 10mg/mL (20 mg/2mL) (Teligent OU)

Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella - Enterobacter - Serratia species, Staphylococcus species (coagulase positive and coagulase negative).

Gentamicin Injection should be considered for the treatment of the following conditions when caused by susceptible organisms:

• Septicaemia,
• Respiratory tract infections,
• Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis,
• Urinary tract infections (recurrent, complicated).Gentamicin Injection is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials.

Gentamicin Injection may be considered as initial therapy in suspected or confirmed gram negative infections and therapy may be instituted before obtained results of susceptibility testing. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regime.

The decision to continue therapy with gentamicin should be based on the results of susceptibility tests, the severity of the infection, and the important additional considerations outlined in the Product information for DBL GENTAMICIN 10mg/1mL (as sulfate) Injection - AUSTR 16339 in section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. If the causative organisms are resistant to gentamicin and the patient is not responding favourably, other appropriate therapy should be instituted.