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What's New in AusDI – May, 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 Hydroxychloroquine (Systemic) monograph, Azithromycin (Systemic) monograph, and monographs for other systemic macrolide antibiotics have been updated based on a UK MHRA Drug Safety Update. An observational retrospective study in patients with rheumatoid arthritis has shown that the concurrent use of hydroxychloroquine with azithromycin is associated with an increased risk of cardiovascular events (including angina and heart failure) and cardiovascular mortality. Similar risks may be associated with the concurrent use of hydroxychloroquine and other systemic macrolide antibiotics. It is recommended that risk-benefit be carefully considered before initiating systemic macrolide antibiotics in patients being treated with hydroxychloroquine.

New Consumer Medicine Information (CMI)



New Product Information (PI)

Product information with an update to safety includes Adynovate, Apo-Donepezil, Apo-Mycophenolate Capsules, Apo-Piroxicam, Apo-Tramadol, Apo-Venlafaxine XR, Arabloc, Arava, Arazil, Arianna 1, Betahistine Mylan, Bicillin L-A, Biktarvy, Brintellix, Calcium Resonium, Celestone Chronodose Injection, Ceptolate, Chemists' Own Anti-Inflammatory Pain Relief Soft Capsules, Chemists' Own Anti-Inflammatory Pain Relief Tablet, Codral Original Day & Night + Dry Cough Capsules, Codral Original Day & Night Tablets, Cosentyx, Coveram, Coversyl, Coversyl Plus, Dilantin, Dilatrend, Diprosone, Diprosone OV, Dizole One, Donepezil Sandoz, Eleuphrat, Eloctate, Enbrel, Enstilar, Entyvio, Flagyl, Ibudeine, Idaprex, Idaprex Combi, Inflectra, Jakavi, Kadcyla, Kisqali, Kozenis, Lercan, Lioresal Tablets, Luxturna, Maxor Heartburn Relief, Maxydol, Meloxicam Sandoz Tablets, Methylphenidate-Teva XR, Metronide, Myfortic, Natrilix, Natrilix SR, Norditropin, Nurofen Plus, Obizur, Onivyde, Palexia IR, Palexia SR, Perindo, Perindo Combi, Pharmacor Sumatriptan, Posaconazole Juno, Prexum, Prexum Combi, Pristiq, Prograf and Advagraf XL, Qtern, Reaptan, Reminyl, Repatha, Sandoz Venlafaxine XR, Serc, Shingrix, Sudafed Sinus + Allergy & Pain Relief Tablets, Sudafed Sinus + Pain Relief Day & Night, Sudafed Sinus + Pain Relief Tablets, Tazopip, Tecentriq, Temodal, Topamax, Torisel, Tramedo, Vaxzevria, Vocabria, Vytorin, Vyvanse, Zeklen, Zonegran, Zydol, Zydol SR, and Zykadia.

Product information with an update to indications includes Apo-Zopiclone, Kozenis, and Zeposia.

Past Content Updates

April 2022

The Donepezil (Systemic) monograph has been updated with precautions about the risk of cardiac problems based on a recent TGA safety alert and updates to Product Information. QT interval prolongation and torsades de pointes have been reported with donepezil. Caution is recommended in patients with pre-existing or family history of QT interval prolongation, certain cardiac disease (e.g., bradyarrhythmia, heart failure, or recent myocardial infarction), electrolyte disturbances (hypokalaemia or hypomagnesaemia), or taking other medications that prolong the QT interval. Clinical monitoring may be necessary.

March 2022

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2022 influenza season. The composition of the 2022 vaccine differs from last year's southern hemisphere vaccine and the 2021/2022 northern hemisphere recommendations with the inclusion of two new strains for the A (H3N2)-like and B Victoria lineage viruses.

February 2022

The Mycophenolate (Systemic) monograph has been updated with a precaution for coronavirus disease 2019 (COVID-19) based on the Cellcept Product Information. Mycophenolate may increase the severity of COVID-19 because of its cytostatic effect on B- and T-lymphocytes. It is recommended that a dose reduction or discontinuation of mycophenolate be considered in patients with clinically significant COVID-19.

January 2022

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.

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.

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