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Updates

What's New in AusDI – April 2025

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

Drug Monographs

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 Isotretinoin (Systemic) monograph has been updated with information on sexual disorders based on changes to product information. Anhedonia, decreased libido, erectile dysfunction, gynaecomastia, and vulvovaginal dryness have been reported with isotretinoin. It is recommended that patients be asked about signs or symptoms of sexual dysfunction before starting isotretinoin treatment, and monitored during treatment for the development of new sexual disorders. Discontinuation of isotretinoin treatment may not alleviate symptoms and further specialist evaluation may be required.

Past Content Updates

March 2025

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2025 influenza season. The composition of the 2025 vaccine differs from the 2024 southern hemisphere and 2024/2025 northern hemisphere recommendations with the inclusion of one new strain for the influenza A(H3N2) subtype virus component.

February 2025

The Bupropion (Systemic) monograph has been updated with information on Brugada syndrome based on changes to product information. The use of bupropion may unmask Brugada syndrome, a rare genetic disease of the cardiac sodium channel characterised by electrocardiogram (ECG) changes, which may result in cardiac arrest and/or sudden death. Caution is recommended in patients with Brugada syndrome or risk factors such as a family history of cardiac arrest or sudden death.

January 2025

The Levetiracetam (Systemic) monograph has been updated with information on drug reaction with eosinophilia and systemic symptoms (DRESS) based on changes to product information. Rare cases of DRESS, also known as multiorgan hypersensitivity reactions, have been reported in patients taking levetiracetam. It is recommended that levetiracetam be discontinued if DRESS is suspected.

New Product Summary

Adenosine Baxter

Anagrelide ARX

ARX-Metoprolol

Blooms the Chemist Paracetamol Pain Relief

Chemists' Own Paracetamol Extra

Cyclizine Juno

Fabhalta

Fingolimod Dr.Reddy's

Fintepla

Flucloxacillin Baxter

Fulvestrant SXP

GA explore5

Metvant

Metvant fatty

MMA/PA explore5

Pharmacor Sacubitril/Valsartan

PKU Easy Microtabs Plus

Pombiliti

Prilotekal

Rivaroxaban Lupin

Rystiggo

Tolvaptan Lupin Composite Pack

Tranexamic Acid Waymade

Valtresto

Xobet

New Product Information

Apohealth Dexchlorpheniramine Allergy Relief

Apohealth Paracetamol Pain Relief

Chemists' Own Paracetamol Extra

Dapsomed

Ezetimibe/Rosuvastatin Sandoz

Fabhalta

Fintepla

Maraviroc Waymade

Pombiliti

Relfydess

Rystiggo

Tranexamic Acid Waymade

Product information with an update to safety includes Amitriptyline Viatris, Apo-Atorvastatin, Apo-Ezetimibe, Apo-Fentanyl, Apo-Sertraline, Apo-Topiramate, Canesoral, Canesoral Duo, Cephazolin Viatris, Clarithromycin Sandoz, DBL Methotrexate, Denpax, Dexamethasone Juno, Diaformin Alphapharm XR, Diamox, Donepezil Sandoz, Dymista Allergy, Epiramax, Esomeprazole Sandoz Hp7, Fentanyl Sandoz, Flagyl, Flagyl S, Fluconazole Sandoz Capsules, Gadovist, Genox, Glaumox, Jemperli, Levetiracetam GH Oral Solution, Levetiracetam SZ, Lucrin Depot and Lucrin Depot Paediatric, MersynoNight Night Time Pain Relief, Mesasal, Methoblastin (Bottle), Metronidazole Medsurge, Modafinil Sandoz, Mytolac, NorLevo-1, Noxicid Caps, Ocaliva, Oxycodone Sandoz, Palexia IR, Palexia SR, Polivy, Puri-Nethol, Rinvoq, Riximyo, Sandrena, Sigmaxin, Skyrizi, Sutent, Tamate, Tobra-day, Topiramate Sandoz, Tramal, Trulicity, Tygacil, Vyepti, Xeljanz and Xeljanz XR, Yervoy, Yonsa Pred, and Zetlam.

Product information with an update to indications includes Dupixent, Empaveli, Enlafax XR, Imfinzi, Kalydeco, Keytruda, Metrol, Opdivo, Padcev, Rybrevant, and Xtandi.

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