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GENTAMICIN NORIDEM (Interpharma Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
gentamicin sulfate
Registration type
New generic medicine

For the treatment of infections due to one or more susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics).

Gentamicin sulfate may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. Aminoglycosides, including gentamicin sulfate are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics.

In suspected or documented Gram-negative sepsis, gentamicin sulfate should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk of toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin sulfate regimen should be considered.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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