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What's New in AusDI – January, 2022

Browse the latest AusDI drug updates and medicines information – created and curated by trusted Australian editorial pharmacists, monthly.

New Product Summaries



Content Updates to Monographs

As part of our rigorous editorial updating process, the AusDI editorial team monitors safety information issued by the Australian Therapeutic Goods Administration (TGA), the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). FDA-approved indications and dosing information in adults and children are also reviewed by our editorial team and included in selected monographs.

The Clindamycin (Systemic) monograph has been updated with information about potential nephrotoxicity based on updates to some Product Information for clindamycin. There have been reports of acute kidney injury, including acute renal failure, associated with clindamycin use. Renal function monitoring should be considered during therapy in patients with pre-existing renal function impairment or taking concurrent nephrotoxic medications. Renal function monitoring should be performed during prolonged therapy.

New Consumer Medicine Information (CMI)





New Product Information (PI)

Product information with an update to safety includes 3TC, Alprolix, Arimidex, Biktarvy, Braltus, Cabenuva, Celapram, Combivir, Darunavir Juno, DBL Ciprofloxacin, DBL Sulfamethoxazole and Trimethoprim Concentrate, Dizole, EllaOne, Eloctate, Eylea, Fentanyl (AstraZeneca), Ganfort, Ganfort PF, Genvoya, Imbruvica, Infanrix Hexa, Keytruda, Lumigan, Lumigan PF, Meloxicam Sandoz Tablets, Montelukast Sandoz, Naltrexone GH, Noxafil Injection, Noxafil Tablets and Oral Suspension, Nubeqa, Odefsey, Olmesartan Sandoz, Olmetec Plus, Omnipaque, Patent Blue V, Precedex, Prezista, Retrovir, Setrona, Sevikar HCT, Symtuza, Tamoxifen Sandoz, Terlipressin Ever Pharma, Trazimera, Triumeq, Vancomycin Juno, Veklury Powder for Injection, Vfend, and Xevudy.

Product information with an update to indications includes Bridion, Kozenis, and Zejula.

Past Content Updates

December 2021

The Octreotide (Systemic) monograph has been updated with information about atrioventricular (AV) block based on a recent TGA Medicines Safety Update. AV blocks, including complete AV block, have been reported in Europe in patients receiving high doses of octreotide continuous intravenous infusion (100 micrograms per hour) and in patients receiving bolus octreotide intravenously (50 micrograms bolus followed by 50 micrograms per hour continuous infusion). In Australia, the TGA-approved indications for octreotide do not involve intravenous administration. However, some off-label uses do involve intravenous administration.

November 2021

The Ivermectin (Systemic) monograph has been updated to specify that it is not indicated for the prevention or treatment of coronavirus disease 2019 (COVID-19) based on a recent TGA media release & statement. Significant public health risks may occur due to individuals using ivermectin for the prevention of COVID-19 instead of getting vaccinated. Ivermectin doses suggested for use against COVID-19 have come from unreliable sources and are significantly higher than the approved doses for scabies or parasite treatment; these higher doses may be associated with serious side/adverse effects, including dizziness, neurological effects such as coma and seizures, severe nausea, and vomiting.

October 2021

The Metronidazole (Systemic) monograph has been updated with information about suicidal ideation based on updates to several metronidazole Product Information. Cases of suicidal ideation, with or without mental depression, have been reported during metronidazole treatment. It is recommended that patients be advised to discontinue metronidazole treatment and contact their healthcare professional immediately if psychiatric symptoms occur during treatment.

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