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Gentamicin Injection USP 40 mg/mL (80 mg/2 mL) ampoules

Safety advisory - alternative product filling shortage may cause airway irritation if administered via inhalation

25 October 2019

Consumers and health professionals are advised that Gentamicin Injection USP 40 mg/mL (80 mg/2 mL) ampoules may cause irritation to the airways if used as an inhalation to treat certain infections in the lungs due to the presence of the preservatives methylparaben 0.9 mg and propylparaben 0.1 mg.

Gentamicin Injection USP 40 mg/mL (80 mg/2 mL) ampoules is an unregistered product (sourced from overseas) that has been approved for use as an alternative product during the current shortage of Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule. This product is not expected to be available again until 30 January 2020.

In the meantime, the TGA has granted approval under Section 19A of the Therapeutic Goods Act 1989 to Link Medical Products to supply the alternative product, Gentamicin Injection USP 40 mg/mL (80 mg/2 mL) ampoules, for the following indications:

  • 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, 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.

While Gentamicin Injection USP 40 mg/mL (80 mg/2 mL) ampoule is a suitable alternative in most situations, clinicians using this product for off-label use via inhalation may need to take the presence of preservatives into account and the possible effect they may have on a patient's airways.

Although Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule has not been approved for use via inhalation and its Product Information references only intramuscular or intravenous use, the TGA is aware that there is some off-label use via inhalation.

Information for consumers

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals

During the shortage, health professionals who would have used Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule via inhalation for a patient may need to consider other products for the patient's treatment.

If a preservative-free gentamicin product is required, health professionals may wish to request supply via the Special Access Scheme (SAS).

Link Medical Products can be contacted on 1800 181 060. Information about this Section 19A approval has been published in the TGA's online Section 19A database.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.