Skip to main content


Product name
Date registered
Evaluation commenced
Decision date
Approval time
125 (255 working days)
Active ingredients
amikacin sulfate
Registration type
New generic medicine

Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria, (see section 5.1 Pharmacodynamic properties).

Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin.

The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of staphylococcus who have failed to respond or are allergic to other available antibiotics.

Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.

In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in-vitro mixing of the two drugs causes inactivation of amikacin.

Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra- abdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

Help us improve the Therapeutic Goods Administration site