Further to DrugAlert volume 951, HPS Pharmacies wish to advise that all suppliers are experiencing a supply interruption for gentamicin 80mg/2mL ampoules. This has also led to some supply issues for tobramycin vials.
Gentamicin
Normal supplies of Gentamicin Noridem are expected to resume in early March 2025. Pfizer Gentamicin ampoules are currently unavailable and not expected to return until June 2025.
Two internationally registered alternatives have been approved for supply under Section 19A of the Therapeutic Goods Act 1989. One of these products is registered in Germany and all labelling is in the German language. However, the active ingredient and strength are readily identifiable in English. A comparison of these products is shown in the table below.
| Pfizer Gentamicin | Gentamicin Noridem | Gentamicin Amdipharm | Gentamicin Hexal | |
| Country of registration | Australia | Australia | UK | Germany |
| Pack size | 10 or 50 ampoules | 50 ampoules | 10 ampoules | 5, 10, or 20 ampoules |
| Ampoule type | Plastic | Glass | Glass | Glass |
| Excipients |
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|
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| Storage | < 25°C. Protect from light. | < 25°C | Do not store above 25°C. Do not freeze. | This medicinal product does not require special storage conditions. |
| Product information | Download here | Download here | Download here | Download here |
Please review the excipients of each product carefully, particularly for patients with hypersensitivities or where alternative routes of administration are used. For example, the off-label administration of gentamicin via inhalation requires careful consideration of formulation as excipients may increase the risk of airway irritation.
If an alternative formulation of gentamicin injection is required, the possibility of supply via the Special Access Scheme (SAS) could be explored on a case-by-case basis. The lead time for accessing SAS stock is longer, and ongoing availability is not certain.
The National Centre for Antimicrobial Stewardship publishes fact sheets that provide general recommendations to manage the gentamicin shortage. Individual patient assessment is required when interpreting these recommendations.
Tobramycin
The shortage of gentamicin has led to an increased demand for tobramycin 80mg vials. Tobramycin Viatris 80mg/2mL is currently unavailable and expected to return in late February 2025. Other brands of tobramycin 80mg/2mL vials currently have limited availability in some warehouses.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA. Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.
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