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Updates

What's New in AusDI – October 2024

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 Levonorgestrel (Intrauterine-Systemic) monograph has been updated with changes to the duration of use based on changes to product information. The Mirena brand of levonorgestrel intrauterine device has been shown to be effective for up to eight years when used for contraception. It can now be inserted and left in the uterine cavity for up to eight years for contraception (previously five years), then removed or replaced after eight years.

Past Content Updates

September 2024

The Anastrozole (Systemic) and Exemestane (Systemic) monographs have been updated to include information about tendon disorders based on changes to product information. The use of third generation aromatase inhibitors, including anastrozole, exemestane and letrozole, have been associated with tendinitis and tenosynovitis. Tendon rupture may also be a potential risk. It is recommended that patients be monitored for signs and symptoms of tendon disorders during treatment with these medications.

August 2024

The Azithromycin (Systemic) monograph has been updated to include information about cardiovascular death based on changes to product information for azithromycin. An approximately two-fold increased short-term potential rare risk of acute cardiovascular death in adults treated with azithromycin compared to other antibacterials, including amoxicillin, has been shown in some observational studies. However, there are insufficient data in these studies to establish or exclude a causal link. Risk of acute cardiovascular death was observed to be greater in the first five days of azithromycin treatment. It is recommended that electrocardiographic (ECG) screening be considered in patients at high risk of QT interval prolongation.

July 2024

The Montelukast (Systemic) monograph has been updated to include more information about neuropsychiatric events based on a Drug Safety Update from the MHRA. Neuropsychiatric events have been reported in children, adolescents, and adults. A range of neuropsychiatric events have been associated with montelukast including sleep disorders, hallucinations, anxiety, depression, and changes in behaviour and mood. It is recommended that patients and their caregivers be informed about neuropsychiatric events and advised to seek immediate medical attention if they occur. It is recommended that montelukast treatment be discontinued if new or worsening neuropsychiatric events occur.

New Product Summary

Apo-Fluconazole

ARX-Rivaroxaban

ARX-Ticagrelor

Avloire

Blooms Celecoxib

Chemists' Own Anti-Inflammatory Pain Relief Rapid

Cipla Daptomycin

Cipla Hydrocortisone

Diaformin Alphapharm XR

Dutatam

Emtricitabine and Tenofovir Disoproxil Fumarate [Laurus Labs]

Hepcludex

Imanib

Litfulo

Metronidamed

Montelukast-WGR

Omeprazole-WGR

Perindopril Arginine/Amlodipine-WGR

Rivaroxaban-Teva

Simvastatin-WGR

Timoptol-LA [Santen Oy]

Varenicline Viatris - Initiation Pack

Vazkepa

Vegzelma

Zilbrysq

New Product Information

Diaformin Viatris

Furosemide-AFT

Glyconeo

Hepcludex

Litfulo

Lyclear

Vazkepa

Zilbrysq

Product information with an update to safety includes Alphamox, Amlodipine/Valsartan Novartis, Amoxycillin Sandoz Capsules and Suspension, Amoxycillin Sandoz Tablet, Amphotericin Liposomal SUN, Apo-Anastrozole, Apo-Azithromycin, Arianna 1, Asmol CFC-Free Inhaler, Ausfam, Azith, Azithromycin Sandoz, Azithromycin Viatris Powder for Injection, Azithromycin Viatris Tablets, Brilinta, Caduet, Caelyx, Calquence, Cambia, Cardizem, Cardizem CD, Cefuroxime SXP, Clarithromycin Sandoz, Comfarol Forte, Comirnaty Omicron XBB.1.5, Cosopt, Cosopt Preservative Free, Cymbalta, DBL Gemcitabine Solution for Injection, DBL Vinblastine, Decapeptyl, Diltiazem Sandoz CD, Dotarem, Duloxetine Sandoz, Dymista, Dynastat, Etoposide Ebewe, Exforge, Flopen Viatris, Gopten, Hydromorphone Juno, Hydroxycarbamide Medsurge, Ibimicyn, Imrest, Keytruda, Lanvis, Lucentis, Maxamox Suspension, Maxamox Tablets, Mersyndol, Mersyndol Forte, Minirin/Octostim Injections, M-M-R II, Moviprep Orange, Nolvadex, Norvasc, Ofev, Orencia, Ozpan, Panamax Co, Pariet, Plenvu, Priorix, Priorix-Tetra, Prodeine, Prodeine Forte, Prodeinextra, ProQuad, Remifentanil Viatris, Rifadin, Shingrix, Spedra, Sunleca, Tavneos, Tenofovir GH, Tevimbra, Valtrex, Vasocardol, Vasocardol CD, Xtandi, Xylocard, Zelitrex, Zempreon CFC-Free Inhaler, and Zolpimist.

Product information with an update to indications includes Imatinib Sandoz and Paxlovid.

 

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