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