News

News

February 14, 2018

February 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. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 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. If you received this message from a colleague, subscribe now.
 

FEBRUARY 2018

New Drug Approvals

  • Biktarvy* (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history, or to replace the current regimen in a patient virologically suppressed on a stable regimen for at least three months with no history of treatment failure or known substitutions associated with resistance to bictegravir, emtricitabine, or TAF. Recommended dosage: one tablet once daily, with or without food.
  • Symfi Lo* (efavirenz, lamivudine, tenofovir disoproxil fumarate) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. Recommended dosage: one tablet once daily on an empty stomach, preferably at bedtime to improve tolerability of CNS side effects.
  • Firvanq (vancomycin oral solution), indicated for the treatment of C. difficile* associated diarrhea in adults and pediatric patients <18 years of age, and also for the treatment of enterocolitis caused by Staph. aureus (including MRSA) in adults and pediatric patients <18 years of age. Product availability: kits containing vancomycin powder (3.75, 7.5, 10.5, or 15 gm) and grape-flavored diluent that provide final drug concentrations of 25 mg/mL and 50 mg/mL after reconstitution. Expected product launch: early April, 2018.

New FDA-approved Indications

  • Ceftazidime-avibactam* is now indicated for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia caused by Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older. The drug was previously approved for complicated intra-abdominal infection (in combination with metronidazole) and complicated UTI, including pyelonephritis.

From the Centers for Disease Control and Prevention

  • February 9 CDC update on widespread influenza activity, including an audio recording. Click here.
  • Weekly US Influenza Surveillance Report. Click here.
  • The 2018 recommended immunization schedule for children and adolescents aged 18 years or younger. Click here.
  • The 2018 recommended immunization schedule for adults aged 19 or older. Click here.
  • Updated recommendations from the Advisory Committee on Immunization Practices (ACIP) and CDC regarding prevention of hepatitis B infection in the US (MMWR Recomm Rep 67:1, 2018). Available for download here.

Newly Released Treatment Guidelines

  • Clinical guidelines for the diagnosis and treatment of catheter-related bloodstream infection from the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and the Spanish Society of Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC) (Med Intensiva 42:5, 2018). The last Spanish catheter-related infections guidelines were published in 2004. The new guidelines are available for download on the SEIMC and SEMICYUC websites.
  • 2017 update of the German clinical guideline on epidemiology, diagnostics, therapy, prevention, and management of uncomplicated urinary tract infections in adult patients (Urol Int 2018 Jan 17 [Epub ahead of print]). This is an update of the 2010 version and is available for download on the Karger website.
  • 2017 update of the guideline for epidemiology, diagnosis, and treatment of adult patients with nosocomial pneumonia from the German Society for Anaesthesiology and Intensive Care Medicine, the German Society for Infectious Diseases, the German Society for Hygiene and Microbiology, the German Respiratory Society and the Paul-Ehrlich-Society for Chemotherapy, the German Radiological Society and the Society for Virology (Pneumologie 72:15, 2018). This is an update of the 2012 version.
  • Guidelines for the diagnosis and treatment of community-acquired pneumonia in adults who present to the hospital from the Dutch Working Party on Antibiotic Policy in collaboration with the Dutch Association of Chest Physicians, the Dutch Society for Intensive Care, and the Dutch College of General Practitioners (Neth J Med 76:4, 2018). These guidelines update the 2011 version and are available for download on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Azithromycin injection, Oseltamivir oral suspension
    • [Shortage recently resolved]: Penicillin G benzathine
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin oral suspension, Moxifloxacin injection, Ofloxacin 0.3% ophthalmic solution
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Clindamycin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: 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 detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
January 10, 2018

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. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

JANUARY 2018

New Drug Approvals

  • XEPI (ozenoxacin 1% cream) is indicated for the topical treatment of impetigo due to S. aureus or S. pyogenes in patients 2 months of age and older. Ozenoxacin is a member of a new generation of non-fluorinated quinolones. Recommended dosage: apply a thin layer to the affected area twice daily x5 days. Product availability: 10-, 30-, and 45-gram tubes.

First-Time Generic Approvals (US)

  • Capreomycin injection, 1 gram per vial. Mylan Laboratories Ltd., approved November 27, 2017.
  • Praziquantel tablets, 600 mg. Par Pharmaceutical Inc., approved November 27, 2017.
  • Note: newly approved generic drugs are not always available on or after the approval date shown. Contact the listed manufacturer for further availability information.

New FDA Website for Breakpoint Updates

  • The 21st Century Cures Act, signed into law on December 13, 2016, requires the FDA to post information online about FDA’s recognition of antimicrobial susceptibility test interpretive criteria (breakpoints) established by a standards development organization (SDO), and online lists of exceptions or additions to the recognized breakpoints established by the SDO. This online approach will allow the FDA to more quickly communicate updated breakpoints than by updating and re-updating product labeling. Click here for antibacterials and here for antifungals.

Newly Released Treatment Guidelines

  • Clinical guidelines for the treatment of community-acquired skin and soft tissue infection from The Korean Society of Infectious Diseases and Korean Society for Chemotherapy, with support from the Korea Centers for Disease Control and Prevention (Infect Chemother 49:301, 2017). Available for download on the journal website.
  • Clinical guidelines for the use of antibiotics in adults with acute upper respiratory tract infection, developed as part of the 2016 Policy Research Servicing Project by the Korea Centers for Disease Control and Prevention (Infect Chemother 49:326, 2017). Available for download on the journal website.
  • Clinical practice guidelines for the diagnosis, management and treatment of hepatitis B virus infection from the Turkish Association for the Study of the Liver and Viral Hepatitis Society (Turk J Gastroenterol 28(suppl 2):73, 2017). Available for download on the journal website.
  • Recommendations for the screening, diagnosis and management of hepatitis C virus infection from the Turkish Association for the Study of the Liver and Viral Hepatitis Society (Turk J Gastroenterol 28(suppl 2): 90, 2017). Available for download on the journal website.
  • Clinical practice guidelines for the diagnosis, management and treatment of hepatitis delta virus infection from the Turkish Association for the Study of the Liver and Viral Hepatitis Society (Turk J Gastroenterol 28(suppl 2):84, 2017). Available for download on the journal website.

Antimicrobial agent-induced kidney stones

  • Drug-induced kidney stones represent 1-2% of all kidney stones. Sulfonamides were the first drugs implicated. The two main mechanisms involved in the formation of drug-induced stones are (1) crystallization of a poorly soluble compound (± metabolites) that has high urinary excretion and is often used in high doses, and (2) induction of stone formation by a drug through its metabolic action, such as changing urinary pH or interfering with the excretion of calcium, phosphate, oxalate, or other substances. Antimicrobial agent-induced kidney stones are generally caused by the first mechanism. Here is a list of known or reasonably likely offenders.
    • Antibacterials
      • Amoxicillin, ampicillin (mainly crystals; stones rare)
      • Ceftriaxone (crystals or stones; mainly in kids)
      • Ciprofloxacin (mainly crystals; stones rare)
      • Sulfadiazine (stones or crystals)
      • Sulfamethoxazole (mainly crystals)
    • Antivirals
      • Acyclovir (crystals, not stones)
      • Atazanavir (if ritonavir-boosted)
      • Foscarnet (crystals, not stones)
      • Indinavir
      • Possible or unlikely offenders (mainly a single case report implicates the drug): darunavir, efavirenz, lopinavir, nelfinavir, raltegravir, saquinavir, tenofovir
    • Reference: Drugs 2017 Dec 20 [Epub ahead of print]).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: None
    • [Shortage recently resolved]: Penicillin G benzathine
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin oral suspension, Moxifloxacin injection, Ofloxacin 0.3% ophthalmic solution
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine 900,000 units/Penicillin G procaine 300,000 units (Bicillin C-R 900/300), Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Clindamycin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: None
    • Recent discontinuations: 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 detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
December 14, 2017

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. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

DECEMBER 2017

New Drug Approvals

  • Juluca*, an INSTI/NNRTI combination formulation of dolutegravir + rilpivirine, is a complete two-drug regimen for treatment of HIV-1 infection in adult patients who 1) are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months, 2) have no baseline pre-therapy resistance mutations, and 3) have no history of virologic treatment failure. Standard HIV-1 treatment consists of three or more drugs.
  •  

  • Shingrix (zoster vaccine recombinant, adjuvanted) is a new vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older. The recommended administration schedule is two 0.5 mL IM doses, given first at month zero and then anytime between 2-6 months later. In late October the Advisory Committee on Immunizations Practices (ACIP) voted that this new vaccine is 1) recommended for healthy adults of age ≥50 to prevent shingles and related complications, 2) recommended for adults who previously received the current vaccine (Zostavax), and 3) the preferred vaccine for preventing shingles and related complications. These recommendations will be published in MMWR and become official policy once they are approved by the CDC director.

First-Time Generic Approvals (US)

  • Darunavir ethanolate tablets, 600 mg (Teva), approved November 28.
  •  

  • Caspofungin injection, 50 mg and 70 mg vials (Mylan, Gland Pharma), approved September 29.

Newly Released Treatment Guidelines

  • New guidelines for the prevention, diagnosis and treatment of BK polyomavirus-associated hemorrhagic cystitis in hematopoietic stem cell transplant recipients from the ECIL-6 (6th European Conference on Infections in Leukemia) have been published (J Antimicrob Chemother 2017 Sept 8 [Epub ahead of print]).
  •  

  • Updated guidelines for the diagnosis and management of gastrointestinal complications in adult cancer patients from the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) have been published (Ann Hematol 2017 Nov 24 [Epub ahead of print]). These guidelines update the 2013 release and are available for download on the journal website.

  •  

  • New European guidelines for the management of pelvic inflammatory disease have been published (Int J STD AIDS 2017 Jan 1 [Epub ahead of print]). The guidelines are available for download on the International Union against Sexually Transmitted Infections (IUSTI) website.

  •  

  • Updated guidelines for primary prophylaxis of invasive fungal infections in patients with hematological malignancies from the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) have been published (Ann Hematol 2017 Dec 7 [Epub ahead of print]). These guidelines update the 2014 release and are available for download on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: None
    • [Shortage recently resolved]: Cefpodoxime oral suspension, Gentamicin injection
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin oral suspension, Moxifloxacin injection, Ofloxacin 0.3% ophthalmic solution
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine, Penicillin G benzathine 900,000 units/Penicillin G procaine 300,000 units (Bicillin C-R 900/300), Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Clindamycin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: None
    • Recent discontinuations: 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 detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
November 29, 2017

Press Release – VigiLanz Integration Available

Sanford Guide Content Integrated into VigiLanz
 
MINNEAPOLIS, MN and SPERRYVILLE, VA. – (November 29, 2017) – VigiLanz, a digital healthcare intelligence firm, announced today that users of its market-leading clinical intelligence platform now have direct access to The Sanford Guide, the industry’s top digital infectious disease content. Integrating content from The Sanford Guide lets clinicians and pharmacists take the critical next step in the antimicrobial de-escalation process by leveraging peer-reviewed recommendations on the latest treatments—without having to exit the VigiLanz workflow.
 
Through its exclusive partnership with Sanford Guide, VigiLanz clients can access the full suite of digital infectious disease content and associate it with specific rules. Users can then search comprehensive coverage of the latest clinician-designed treatment options for infectious diseases, syndromes, and pathogens from within the VigiLanz system, driving improved patient outcomes. “The value of this partnership to our clients extends beyond their VigiLanz users to include any clinician or pharmacist in need of the actionable treatment recommendations, tailored for use in clinical scenarios, from anywhere across the enterprise,” said VigiLanz Chairman and CEO Dr. David Goldsteen, MD, MBA.
 
Noting that the company’s antimicrobial stewardship platform recently achieved the top overall satisfaction rating in the “Antimicrobial Stewardship 2017” performance report from KLAS Research, Goldsteen added that, “The Sanford Guide’s exceptional content and clinical guidance are the perfect complement to our nationally-recognized platform, advancing care quality and patient safety through industry-leading guidance on the treatment of infectious diseases.”
 
The VigiLanz clinical intelligence platform leverages real-time monitoring of thousands of patient care data elements to help improve medication safety, antimicrobial stewardship, infection prevention, quality and care management, and patient safety. Its state-of-the-art rules engine analyzes that data and pushes alerts to clinicians at the point of care when interventions and other actions are necessary, driving significant improvements in safety, efficiency, performance, and reimbursement.
 
Trusted by clinicians in over 100 countries, The Sanford Guide is optimized to minimize time-to-answer while providing comprehensive guidance at the point of care. With continually updated information based on the latest available evidence, focused anti-infective drug information, interactive dosing tables, and extensive links to references and related resources, The Sanford Guide provides actionable guidance that is accessible, concise, and reliable. “By integrating The Sanford Guide’s trusted clinical treatment recommendations with its top-rated clinical surveillance tools, VigiLanz is helping hospital and health systems take their approach to infectious disease and antimicrobial stewardship to the next level,” said Sanford Guide CEO and Managing Editor Jeb Sanford.
 
For more information on the integrated VigiLanz-Sanford Guide solution, visit Sanford Guide in booth #740 during the ASHP Midyear Clinical Meeting and Exhibition taking place Dec. 3-7 in Orlando.
 
About Sanford Guide
Since 1969, Sanford Guide has been a leader in point-of-care recommendations for the treatment of infectious diseases. Widely used by pharmacists, physicians, physician assistants, and nurses, Sanford Guide helps to improve patient care by providing carefully curated recommendations based on the latest evidence. With over 1 million users worldwide, Sanford Guide takes pride in responsiveness to customers, the development of innovative solutions, and providing content that is unparalleled in quality and clinical applicability.
 
About VigiLanz
Founded in 2001, VigiLanz Corporation (www.vigilanzcorp.com) is a privately held, rapidly growing provider of SaaS health care intelligence and predictive analytics. The firm is focused on aggregating disparate EHR transactional workflow and documentation data across health systems to identify real-time clinical issues that avoid or minimize harm, optimize clinical outcomes and support preventive care along the entire health system continuum. VigiLanz supports a large and growing community of hospital CMOs, CMIOs, CIOs, quality teams, infectious disease and control specialists, pharmacists, and other clinicians dedicated to real-time inpatient and outpatient care. VigiLanz is shaping the emerging era of real-time health care by delivering enterprise intelligence technology and services that improve clinical outcomes, patient care and operational effectiveness.
 
Download the press release.

November 14, 2017

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. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

NOVEMBER 2017

New Drug Approvals

  • Heplisav-B, a recombinant, adjuvanted two-dose hepatitis B vaccine, for prevention of infection caused by all known virus subtypes in adults ≥18 years of age. Regimen: two 0.5 mL doses IM, one month apart.
  • Letermovir* (Prevymis) for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic stem cell transplant. The recommended dosage is 480 mg IV or orally once daily, initiated between day 0 and day 28 post-transplant and continued through day 100. Product availability: tablets (240 mg, 480 mg), injection.

New Treatment Guidelines

  • New British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease have been published (Thorax 72 (Suppl 2):ii1, 2017). The guidelines are available for download on the journal website.
  • New clinical practice guidelines for the management of chronic pain in patients living with HIV from the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA) have been published (Clin Infect Dis 65:e1, 2017). The guidelines are available for download on the IDSA website.

Updated Treatment Guidelines

  • The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents has released an updated version of the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. The guidelines are available for download on the AIDSinfo website.
  • The Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States have also been updated and are available for download on the AIDSinfo website.

Practice Pearls

  • Tetracycline is generally avoided in young children younger than eight years of age in part because of the risk of teeth staining. However, there are important pharmacologic differences among the members of the tetracycline class so generalizations may be inaccurate. In a retrospective study of 39 children (mean age 0-7.9 years) who received empiric doxycycline therapy (10 mg/kg/day x2-3 days then 5 mg/kg/day, mean treatment duration 12.5 days), no tetracycline-like staining or enamel hypoplasia of developing teeth was detected. Two previous studies likewise found no evidence of teeth discoloration following doxycycline treatment (J Antimicrob Chemother 72:2887, 2017).

  • Ciprofloxacin and fluconazole are commonly used for prophylaxis and treatment of infections in patients with hematological malignancies. They are both known for prolonging the QTc interval, a risk factor for the development of potentially lethal ventricular tachyarrhythmias, but how perilous is the combination? In a prospective observational study of 170 patients treated with both drugs, the prevalence of QTc-prolongation (>450 ms in males, >470 ms in females) was low (4.7%, mean prolongation 10.7 ms) and in no patient did the QTc interval exceed 500 ms. No patients experienced complications related to QTc interval prolongation and there were no cases of Torsade de pointes. These data suggest that the QTc-prolonging effect of concomitant ciprofloxacin and fluconazole may not be clinically relevant, and routine ECG monitoring of such patients is probably not necessary (Br J Clin Pharmacol 2017 Oct 22 [Epub ahead of print]).
  • It is relatively unusual for a beta-lactam antibiotic to affect CYP450 enzymes. Nafcillin induces CYP2C9 and CYP3A4, presumably explaining its ability to decrease the hypoprothrombinemic effect of warfarin. Similarly, dicloxacillin has been reported to decrease INR in warfarin-treated patients but the mechanism is unestablished. In a study performed in 12 healthy volunteers using a 5-drug pharmacokinetic cocktail, dicloxacillin (1 gm three times daily x10 days) was found to induce CYP2C9, CYP2C19, and CYP3A4. Details of the mechanism were further investigated in vitro using cryopreserved human liver cells. It is reasonable to be cautious when prescribing dicloxacillin to patients receiving narrow therapeutic index drugs metabolized by these CYP enzymes (Br J Clin Pharmacol 2017 Nov 4 [Epub ahead of print]).
  • The pharmacokinetics of many drugs in patients with cystic fibrosis (CF) are altered relative to healthy persons. Commonly observed changes include enhanced renal clearance, enhanced hepatic clearance, and variation in volume of distribution. In a prospective study of ceftaroline in seven patients with CF (mean age 20.3 years), the mean half-life was 1.1 hours, considerably shorter than the expected half-life of ceftaroline in the non-CF population (2.7 hours). 15 mg/kg (maximum 600 mg) IV q8h resulted in a mean Cmax of 22.7 µg/mL, which was adequate to achieve >60% time above an MIC of 1 µg/mL (the typical MIC90 of ceftaroline vs. MRSA). In comparison, 600 mg IV q12h in the non-CF population results in a Cmax of 21.3 µg/mL. These data provide evidence of accelerated clearance of ceftaroline in CF patients and support an increased dosage regimen (J Cyst Fibros 2017 Nov 2 [Epub ahead of print]).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Doxycycline hyclate injection, Moxifloxacin injection
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin oral suspension, Ofloxacin 0.3% ophthalmic solution
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine, Penicillin G benzathine 900,000 units/Penicillin G procaine 300,000 units (Bicillin C-R 900/300), Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Clindamycin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
    • [Shortage recently resolved]: Cefpodoxime oral suspension
  • Antimicrobial drugs newly discontinued: None
    • Recent discontinuations: 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)