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Brand name: Gentamicin (Pfizer (Perth)) TM

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Active ingredients: gentamicin

The Therapeutic Goods Administration (TGA) has a recall notice on this product.

Gentamicin Injection BP 80 mg in 2 mL Steriluer

Recall Action Commencement Date: 6 October 2017

Pack Size: 10 and 50 packs

Batches/Expiry Dates:

• A115 - 30.11.2017

• A115A - 30.11.2017

• A115B - 30.11.2017

• A129 - 31.12.2017

• A297 - 31.05.2018

• A316 - 31.08.2018

• A318 - 31.05.2018

• A342 - 31.07.2018

• A394 - 31.10.2018

• A448 - 31.12.2018

Reason: Pfizer advises that, following an internal investigation, some batches of Gentamicin Injection BP 80 mg in 2 mL Steriluer are being recalled as they may contain a higher than expected intrinsic constituent (histamine) in the finished product. Histamine administered intravenously or intramuscularly could potentially lead to signs and symptoms of hypersensitivity reactions including anaphylaxis.

Further information on this recall can be found at http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01281-1

What it is used for

Indications as at November 2000; 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 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 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 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 regimen should be considered.

How to take it

The way to take this medicine is: Intravenous. This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.

  • Store below 25 degrees Celsius
  • Protect from Light
  • Shelf lifetime is 2 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

Clear, pale yellow, sterile aqueous solution.

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on March 1, 2021. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient gentamicin

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Consumer Medicines Information (CMI)

For side effects, taking other medicines and more

Print the CMI.

Listen to the CMI.


Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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