Aztreonam-Avibactam approved in Europe
- Aztreonam-avibactam is a new monobactam / β-lactamase inhibitor combination. It was approved by the European Commission on 22 April 2024 for these indications in adults:
- Complicated intraabdominal infection (± metronidazole)
- HAP/VAP
- Complicated UTI including pyelonephritis
- Infections caused by aerobic gram-negative organisms in patients with limited treatment options
- Aztreonam is a monobactam β-lactam that is active against many Enterobacterales, P. aeruginosa, and other gram-negative organisms. It has no useful activity vs anaerobes or gram-positive organisms. It is generally stable to hydrolysis by Ambler class B enzymes (metallo-β-lactamases).
- Avibactam is a non-β-lactam, β-lactamase inhibitor. It inhibits Ambler class A and class C β-lactamases and some class D enzymes, including ESBLs, KPC and OXA-48 carbapenemases, and AmpC. Avibactam does not inhibit class B enzymes, and it is not able to inhibit many class D enzymes.
- The recommended dosage in normal renal function is 2 gm/0.67 gm (aztreonam-avibactam) IV load, then 1.5 gm/0.5 gm IV q6h. Doses are to be infused over three hours. The recommended duration of treatment is 5-14 days depending on the indication.
CDC COVID-19 Vaccine Recommendations, 2024-2025
- US CDC vaccine recommendations for COVID-19 are summarized in the Sanford Guide:
- CDC report (MMWR 2024;73:819-824) available in PDF form here.
Emergency Use Instructions for Oseltamivir
- On 19 July 2024, CDC issued Emergency Use Instructions (EUI) for oseltamivir for treatment or post-exposure prophylaxis (PEP) of pandemic influenza A viruses and novel influenza A viruses with pandemic potential. EUI provide information about emergency use of FDA-approved medical products that differ from or go beyond what is in the FDA-approved product labeling. Information on the following is provided in this EUI:
- Initiation of oseltamivir treatment after 48 hours from symptom onset.
- Treatment of severely ill hospitalized patients, including longer courses of treatment (e.g., 10 days), based on clinical judgment.
- Higher total daily dose and flexible duration for PEP. The EUI-recommended dosing regimen in most cases is twice daily for 5 or 10 days in asymptomatic close contacts of a confirmed or probable novel influenza A case or asymptomatic persons exposed to animals infected with highly pathogenic avian influenza A(H5N1) virus or other novel influenza A viruses.
- Treatment of term neonates under 2 weeks of age.
- PEP in neonates and infants less than 1 year of age.
- Treatment and PEP dosing regimens for preterm neonates and infants.
- Useful links:
Fexinidazole and HAT
- New 2024 WHO Guidelines for human African trypanosomiasis (HAT) establish oral treatment with fexinidazole (available in the US from Sanofi) as first-line against both East African and West African strains, no matter the disease stage. US CDC is in the process of updating their online materials to correspond.
Antimicrobial Shortages (US)
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New shortages:
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Resolved shortages:
- Isoniazid injection 100 mg/mL (15 Aug 2024)
- Valganciclovir powder for oral solution (12 Sep 2024)
- Valganciclovir 450 mg tablets (12 Sep 2024)
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Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 6 October 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
- Antibacterial drugs:
- Aminoglycosides:
- Gentamicin injection (22 Feb 2021)
- Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
- Cephalosporins:
- Cefazolin injection (4 Jun 2018)
- Cefdinir 300 mg capsules (29 Jun 2023)
- Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
- Cefotaxime injection (10 Jun 2015)
- FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details.
- Chloramphenicol injection (9 Oct 2023)
- Clindamycin phosphate injection (25 Jun 2015)
- Fluoroquinolones:
- Ciprofloxacin injection (13 Jan 2023)
- Levofloxacin injection in D5W (29 May 2024)
- Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
- Moxifloxacin 400 mg tablets (6 Dec 2023)
- Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
- Glycopeptides, glycolipopeptides, lipopeptides:
- Vancomycin injection (1 Jun 2015)
- Metronidazole injection (20 Oct 2021)
- Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
- Nitrofurantoin oral suspension (5 Jun 2018)
- Penicillins:
- Amoxicillin, all oral formulations (18 Oct 2022)
- Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
- Ampicillin injection (19 Oct 2023)
- Dicloxacillin 250 mg, 500 mg capsules (18 Aug 2021)
- Nafcillin injection (20 Mar 2024)
- Penicillin G benzathine injection (1 Feb 2023) Availability update here
- Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
- Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
- Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
- Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
- Rifaximin 200 mg tablets (11 Apr 2024)
- Antifungal drugs:
- Amphotericin B Lipid Complex (5 Aug 2022)
- Fluconazole injection (9 Aug 2024)
- Nystatin oral suspension (21 June 2024)
- Antimycobacterial drugs:
- Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
- Antiparasitic drugs:
- Mefloquine 250 mg tablets (14 May 2024)
- Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
- Antiviral drugs:
- Acyclovir injection (21 Feb 2024)
- Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
- Oseltamivir powder for oral suspension (1 Nov 2022)
- Ribavirin for inhalation solution (23 May 2023)
- Antimicrobial drugs recently discontinued:
- Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
- Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
- Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
- Ritonavir oral solution 80 mg/mL (Jan 2023)
