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News

January 13, 2021

January ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To sign up for ID updates to your inbox, register here.
 
Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. If you received this message from a colleague, subscribe now.
 

January 2021

 

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • COVID-19 Vaccine (Emergency Use Authorization). See COVID-19 Prevention for summary of FDA Provider Fact Sheet / Emergency Prescribing Information for each.
    • Pfizer-BioNTech COVID-19 Vaccine on 11 Dec 2020 (US FDA).
    • Moderna COVID-19 Vaccine on 18 Dec 2020 (US FDA).
    • Oxford AstraZeneca COVID-19 Vaccine on 30 Dec 2020 (UK)
  • Vaccine development pipeline: see COVID-19, Prevention for summary of other vaccine development and clinical trials.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • A living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). Available on the BMJ website.

Voluntary Product Recall

  • Merck has initiated a global product recall of ceftolozane-tazobactam 1.5 gm vials. Due to a recent issue identified during routine testing (sterility test results of seven batches were out of specification), product manufacturing has been temporarily stopped. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. The seven batches were not released to the market. While all product distributed to the market has met the registered specifications for release, it was manufactured on the same equipment as the affected batches. As a result, the company has initiated a voluntary Class II (health care provider level) global recall of all ceftolozane-tazobactam within expiry.

New Product Approval

  • Ansuvimab-zykl (Ebanga), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. The recommended dosage is a single 50 mg/kg IV infusion. It is available in lyophilized form.

Update to CDC Treatment Guidelines for Gonococcal Infection

  • For treatment of uncomplicated urogenital, rectal, or pharyngeal gonorrhea, CDC now recommends a single 500 mg IM dose of ceftriaxone. For persons weighing ≥150 kg (300 lbs), a single 1 gm IM dose of ceftriaxone should be administered. If chlamydial infection has not been excluded, doxycycline 100 mg orally twice a day for 7 days (not azithromycin) is recommended (MMWR Morb Mortal Wkly Rep 2020;69:1911). The full update, which includes other changes such as ceftriaxone dosing for pharyngeal gonorrhea and cefixime dosing (alternative regimen), is available at PMC.

Other New or Updated Treatment Guidelines

  • Updated recommendations for the use of antiretroviral drugs in pregnant women with HIV infection and interventions to reduce perinatal HIV transmission in the US, from the HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission. The recommendations are available here.
  • Guidelines for diagnosis and management of intraabdominal infection, from the Chinese Society of Surgical Infection and Intensive Care and the Chinese College of Gastrointestinal Fistula Surgeons (Clin Infect Dis 2020;71(suppl 4):S337).
  • Updated guidelines for therapeutic drug monitoring of vancomycin, from the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society (Clin Infect Dis 2020;71(suppl 4):S363). The guidelines were last updated in 2015.
  • Southern African guidelines on the safe, easy, and effective use of pre-exposure prophylaxis to prevent HIV acquisition (South Afr J HIV Med 2020;21:1152). The guidelines were last updated in 2016 and are available at PMC.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 3, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since December 27, 2020: Posaconazole injection
    • Shortage recently resolved: Doxycycline injection, Metronidazole injection, Pentamidine isethionate
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Tobramycin injection, Tobramycin lyophilized powder for injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Cefoxitin injection, Ceftazidime injection, Ceftazidime/avibactam injection, Ceftolozane/tazobactam injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antimycobacterial drugs
      • Ethambutol tablets
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Amphotericin B injection, Clotrimazole 10 mg oral troches, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: 
    • Recent discontinuations: Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).
  • For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/
December 18, 2020

Therapeutic Vancomycin Monitoring Using AUC

During our 30 minute webinar on vancomycin monitoring, we received a number of questions from attendees. We answered most of these during the session, but still had a few left to cover. Sanford Guide editor Douglas Black PharmD prepared answers to these questions.

 

Q. Does the 400-600 µg x hr/mL target apply to all serious MRSA infections, or is a different target recommended for endocarditis, osteomyelitis, meningitis, etc.?

A. At present, the data allow us only to identify 400-600 µg x hr/mL as the appropriate AUC24 target for serious MRSA infection. There is no compelling evidence to support a different target for a specific MRSA infection. We are in need of more data supporting AUC monitoring for meningitis (since S. pneumoniae is the likely pathogen in adults, not S. aureus).

 

Q. What about the use of AUC monitoring for other infections?

A. The revised guidelines are based on improved efficacy and safety data for AUC24/MIC monitoring for serious MRSA infections. The guidelines exclude nonserious infections such as urinary tract infections and skin and soft tissue infections. In addition, they do not apply to other pathogens such as methicillin-susceptible S. aureus, coagulase-negative Staphylococcus, or streptococci (we need data on the appropriate AUC24 target for these). The guidelines also do not apply to MRSA infections for which the vancomycin MIC is known to be greater than 1 µg/mL by broth microdilution.

 

Q. When doing AUC monitoring, why is it recommended to assume a vancomycin MIC of 1 µg/mL?

A. Vancomycin MIC depends on the method used to measure it. For example, the vancomycin MIC determined by E-test methodology tends to be 1.5-2x higher than the MIC measured by broth microdilution (BMD). There is known disagreement between commercially available MIC automated testing methods, E-test, and BMD, complicated by ±1 doubling dilution variability in results. We also know that at most institutions, the vancomycin MIC by BMD is 1 µg/mL or less (and there hasn’t been much MIC creep). Therefore, for monitoring purposes the vancomycin MIC for MRSA should be assumed to be 1 µg/mL (unless it is known to be something different using BMD).

 

Q. Can we use AUC monitoring during AKI?

A. We believe the AUC target monitoring range (400-600 µg x hr/mL) also applies to patients with renal dysfunction, although outcome studies validating this target for patients receiving hemodialysis, a hybrid hemodialysis therapy such as SLED, or CRRT are not available. Patients with unstable renal function are certainly going to be a challenge. We need more published data to help us with AUC monitoring in renal dysfunction; for now, trough-based dosing or dosing by concentration in some patients might be more practical. For example, the guideline recommendation for patients on hemodialysis is to monitor by targeting a predialysis concentration of 15-20 µg/mL, which will serve as a reasonable proxy for an AUC of 400-600 µg x hr/mL.

December 14, 2020

December ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To sign up for ID updates to your inbox, register here.
 

December 2020

Sanford Guide Announcements

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • COVID-19 Vaccine
    • FDA authorizes emergency use of Pfizer-BioNTech COVID-19 Vaccine on 11 Dec 2020. See COVID-19 Prevention for summary of FDA Provider Fact Sheet / Emergency Prescribing Information.
    • Vaccine development pipeline: see COVID-19, Prevention for summary of other vaccine development and clinical trials.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • A living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). The first version of this living guidance focuses on corticosteroids. Available on the BMJ website.
  • Guidelines on COVID-19 management in cancer patients, from the Infectious Diseases Working Party of the German Society for Hematology and Medical Oncology (Eur J Cancer 2020;140:86). The guidelines are available at PMC.
  • Casirivimab + Imdevimab (administered together). FDA EUA (11/21/20) for treatment of mild to moderate COVID-19 in adults and children (age ≥12 years, wt ≥40 kg) who are at risk of progression to severe disease and/or hospitalization.

Baloxavir Updates

  • In addition to its indication for treatment of acute uncomplicated influenza, baloxavir marboxil is now indicated for post-exposure prophylaxis of influenza in persons 12 years of age and older following contact with an infected person. The dosing is the same as for treatment of acute infection.
  • Also new is a granule form for oral suspension, intended for patients who are unable to swallow tablets. One bottle contains 40 mg of baloxavir marboxil (after reconstitution with 20 mL of water) and must be used within 10 hours.

New or Updated Treatment Guidelines

Practice Pearls from the Recent Literature

  • A pharmacokinetic drug interaction between hydromorphone and rifampin might be unexpected, given the minor role of the CYP450 system in hydromorphone metabolism. In a randomized crossover study of 12 subjects, rifampin reduced the AUC of oral and intravenous hydromorphone by 43% and 26%, respectively. This is similar to the magnitude of the interaction between morphine and rifampin, and may be due to induction of UGT (glucuronidation) enzymes by rifampin (Anesth Analg 2020 Nov 6 [Epub ahead of print]).
  • Appropriate dosing of linezolid in obesity is uncertain. In a prospective pharmacokinetic study in critically ill obese patients (median total body weight 140 kg) with severe skin and soft tissue infections, the probability of PK/PD target attainment with standard dosing  (600 mg q12h) failed to reach ≥90% for organisms with MICs ≥2 µg/mL. These data add to a growing body of evidence that standard dosing of linezolid in obesity may be inadequate (Antimicrob Agents Chemother 2020 Nov 30 [Epub ahead of print]).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of December 13, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since November 10: None
    • Shortage recently resolved: Metronidazole injection, Pentamidine isethionate
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Tobramycin injection, Tobramycin lyophilized powder for injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Cefoxitin injection, Ceftazidime injection, Ceftazidime/avibactam injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline injection
      • Topical (miscellaneous) antibacterials: Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antimycobacterial drugs
      • Ethambutol tablets
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Amphotericin B injection, Clotrimazole 10 mg oral troches, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: 
    • Recent discontinuations: Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).
November 12, 2020

November ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To sign up for ID updates to your inbox, register here.
 

November 2020

 

Sanford Guide Announcements

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • IgG1 monoclonal antibody. Bamlanivimab. FDA EUA (11/9/20) for outpatient use in mild to moderate COVID-19 in adolescents (age >12 yrs and wt > 40 kg) and adults who are at risk of progression to severe disease.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • A living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). The first version of this living guidance focuses on corticosteroids. Available on the BMJ website.
  • Vaccine development pipeline: see COVID-19, Prevention for summary of vaccine development and clinical trials.

New Drug Approvals

  • Inmazeb*, a combination of three monoclonal antibodies (atoltivimab, maftivimab, and odesivimab-ebgn in a 1:1:1 ratio), approved by the US FDA for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Recommended dosage: 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg IV as a single infusion. Product availability: single-dose vials, 241.7 mg of each antibody per 14.5 mL.

New or Updated Treatment Guidelines

Practice Pearls from the Recent Literature

  • No data on CSF penetration of ceftolozane-tazobactam have previously been available. In ten critically ill patients with an indwelling external ventricular drain, CSF penetration ratios of ceftolozane and tazobactam were both 0.2, and 3 gm IV q8h achieved a >90% probability of target attainment in the CSF only when MICs were ≤0.25 µg/mL. These data suggest inadequate CSF exposure for gram-negative infection using maximal dosing of ceftolozane-tazobactam unless pathogen MICs are very low (Antimicrob Agents Chemother 2020 Oct 19 [Epub ahead of print]).
  • Pharmacokinetic/pharmacodynamic data for minocycline are limited, given that the drug was approved about a half-century ago. In a PK study in 55 patients, IV minocycline (200 mg IV q12h) was predicted to result in a suboptimal PK/PD profile for Acinetobacter baumannii infection with MIC values ≥1 µg/mL (CLSI susceptibility breakpoint ≤4 µg/mL), emphasizing the importance of considering combination therapy when using minocycline for A. baumannii and raising questions about current interpretive breakpoints (Antimicrob Agents Chemother 2020 Nov 9 [Epub ahead of print]).
  • A patient with COVID-19 administered remdesivir (RDV) developed marked sinus bradycardia on day two of treatment (heart rate 38 bpm, baseline 60-70 bpm). No cardiotoxic drugs in her regimen were identified, and her bradycardia was attributed to COVID-19. After two days of persistent bradycardia with eventual QRS complex widening and other cardiac symptoms, RDV was discontinued and atropine administered. Her bradycardia, widened QRS, and other symptoms resolved rapidly, suggesting a possible rare RDV adverse effect (JACC Case Rep 2020 Oct 28 [Epub ahead of print]).
  • Pharmacokinetic changes commonly associated with extracorporeal membrane oxygenation (ECMO) include increased volume of distribution and alterations in drug clearance. Published data regarding caspofungin have been inconclusive, but two recent studies (in critically ill and lung transplant patients) suggest no significant effect of ECMO on caspofungin pharmacokinetics (Antimicrob Agents Chemother 2020;64:e00345-20; Antimicrob Agents Chemother 2020 Aug 17 [Epub ahead of print]).
  • Remdesivir (RDV) is not recommended in its EUA for patients with eGFR <30 mL/min in part because the drug vehicle, sulfobutylether-β-cyclodextrin (SBECD), may accumulate to toxic concentrations. However, each 100 mg of lyophilized powder and solution of RDV contain only 3 gm and 6 gm of SBECD, respectively, compared to the maximum recommended safety threshold of 250 mg/kg/day for SBECD. Although conclusive safety data in patients with eGFR <30 mL/min are lacking, the recommended 5-10 day RDV treatment duration and relatively low concentrations of SBECD suggest benefit may outweigh risk, particularly since SBECD is readily removed by hemodialysis and CRRT (J Am Soc Nephrol 2020;31:1384).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 10, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since October 13: None
    • Shortage recently resolved: Metronidazole injection
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Tobramycin injection, Tobramycin lyophilized powder for injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Cefoxitin injection, Ceftazidime injection, Ceftazidime/avibactam injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline injection
      • Topical (miscellaneous) antibacterials: Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antimycobacterial drugs
      • Ethambutol tablets
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Amphotericin B injection, Clotrimazole 10 mg oral troches, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets, Pentamidine isethionate
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: 
    • Recent discontinuations: Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).
October 15, 2020

October ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To receive these updates via email, subscribe now.
 

OCTOBER 2020

 

Announcements

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • A living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). The first version of this living guidance focuses on corticosteroids. Available on the BMJ website.
  • Updated guidance on the management of COVID-19 from a joint American Thoracic Society/European Respiratory Society Task Force (Eur Respir Rev 2020;29:200287). This release updates prior guidance from the Task Force on the pharmacological management of acute COVID-19, including remdesivir, HCQ, and dexamethasone. Available at PMC.
  • Vaccine development pipeline: see COVID-19, Prevention for summary of vaccine development and clinical trials.

New or Updated Treatment Guidelines

  • 2020 updated guidelines on diagnosis, management, and prevention of central venous catheter-related infections in hematology and oncology, by the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (Ann Hematol 2020 Sep 30 [Epub ahead of print]). These guidelines update the 2012 release and are available on the journal website.
  • 2020 recommendations from the International Antiviral Society-USA Panel regarding the use of antiretroviral drugs for the treatment and prevention of HIV infection in adults (JAMA 2020 Oct 14 [Epub ahead of print]). These recommendations update the 2018 release.

Practice Pearls from the Recent Literature

  • Population pharmacokinetic modeling suggests that in critically ill patients treated with caspofungin, the standard fixed-dose regimen may achieve inadequate drug exposure in all patients weighing ≥120 kg, over 80% of median-weight (78 kg) patients, and about 25% of lower-weight (≤50 kg) patients. A weight-based dosing regimen (2 mg/kg loading dose, then 1.25 mg/kg q24h) might be more appropriate (Antimicrob Agents Chemother 2020;64: e00905-20).

  • In a large, retrospective cohort study from the UK, macrolide use during the first trimester of pregnancy was associated with an increased risk of any major malformation, and specifically cardiovascular malformations, compared to penicillins. Macrolide prescribing in any trimester was associated with an increased risk of genital malformations (BMJ 2020;368:m331).

  • Penicillins, including piperacillin-tazobactam, delay the elimination of high-dose methotrexate by interfering with renal proximal tubular secretion of MTX. Severe toxicity (renal, neurologic, hepatic, hematologic, dermatologic, GI, pulmonary) may result from concomitant use (J Oncol Pharm Pract 2020 Sept 2 [Epub ahead of print]).

  • Hyponatremia is a known but probably underappreciated adverse effect of TMP-SMX. Natriuresis is thought to be the most likely explanation, although a recent report provides evidence more consistent with SIADH (Medicine 2020;99:e20746).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 13, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since September 13: Amphotericin B injection
    • Shortage recently resolved: Metronidazole injection
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Tobramycin injection, Tobramycin lyophilized powder for injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Cefoxitin injection, Ceftazidime injection, Ceftazidime/avibactam injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline injection
      • Topical (miscellaneous) antibacterials: Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antimycobacterial drugs
      • Ethambutol tablets
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Clotrimazole 10 mg oral troches, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets, Pentamidine isethionate
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: 
    • Recent discontinuations: Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).