• 1.

    Antimicrobial stewardship definition and core principles. AVMA. Accessed May 15, 2021. https://www.avma.org/resources-tools/avma-policies/antimicrobial-stewardship-definition-and-core-principles

    • Search Google Scholar
    • Export Citation
  • 2.

    Li M, Gehring R, Riviere JE, Lin Z. Development and application of a population physiologically based pharmacokinetic model for penicillin G in swine and cattle for food safety assessment. Food Chem Toxicol. 2017;107(pt A):7487.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3.

    CLSI. Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals. 5th ed. Clinical and Laboratory Standards Institute; 2020.

    • Search Google Scholar
    • Export Citation
  • 4.

    Riviere J, Papich MG. Veterinary Pharmacology and Therapeutics. 10th ed. Wiley-Blackwell; 2018:867877.

  • 5.

    Martinez MN, Papich MG, Drusano GL. Dosing regimen matters: the importance of early intervention and rapid attainment of pharmacokinetic/pharmacodynamic target. Antimicrob Agents Chemother. 2012;56(6):27952805.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 6.

    Yáñez JA, Remsberg CM, Sayre CL, Forrest ML, Davies NM. Flip-flop pharmacokinetics – delivering a reversal of disposition: challenges and opportunities during drug development. Ther Deliv. 2011;2(5):643672.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 7.

    Riviere JE. Comparative Pharmacokinetics: Principles, Techniques and Applications. 2nd ed. Wiley; 2011.

  • 8.

    DeDonder KD, Gehring R, Baynes RE, et al. Effects of new sampling protocols on procaine penicillin G withdrawal intervals for cattle. J Am Vet Med Assoc. 2013;243(10):14081412.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 9.

    VetGRAM. FARAD. Accessed June 3, 2021. www.farad.org/vetgram/search.asp

  • 10.

    Ambrose PG. Monte Carlo simulation in the evaluation of susceptibility breakpoints: predicting the future: insights from the society of infectious diseases pharmacists. Pharmacotherapy. 2006;26(1):129134.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11.

    Trang M, Dudley MN, Bhavnani SM. Use of Monte Carlo simulation and considerations for PK-PD targets to support antibacterial dose selection. Curr Opin Pharmacol. 2017;36:107113.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 12.

    Bateman KG, Martin SW, Shewen PE, Menzies PI. An evaluation of antimicrobial therapy for undifferentiated bovine respiratory disease. Can Vet J. 1990;31(10):689696.

    • Search Google Scholar
    • Export Citation
  • 13.

    Mechor GD, Jim GK, Janzen ED. Comparison of penicillin, oxytetracycline, and trimethoprim-sulfadoxine in the treatment of acute undifferentiated bovine respiratory disease. Can Vet J. 1988;29(5):438443.

    • Search Google Scholar
    • Export Citation
  • 14.

    English PB. The therapeutic use of penicillin: the relationship between dose rate and plasma concentration after parenteral administration of benzylpenicillin (penicillin G). Vet Rec. 1965;77:810814.

    • Search Google Scholar
    • Export Citation
  • 15.

    Turnidge JD. The pharmacodynamics of β-lactams. Clin Infect Dis. 1998;27(1):1022.

  • 16.

    Teske RH, Rollins LD, Carter GG. Penicillin and dihydrostreptomycin serum concentrations after administration in single and repeated doses to feeder steers. J Am Vet Med Assoc. 1972;160(6):873878.

    • Search Google Scholar
    • Export Citation
  • 17.

    Hjerpe CA, Routen TA. Practical and theoretical considerations concerning treatment of bacterial pneumonia in feedlot cattle, with special reference to antimicrobic therapy. In: Proceedings of the 9th Annual Convention of AABP. American Association of Bovine Practitioners; 1976:97140.

    • Search Google Scholar
    • Export Citation
  • 18.

    Papich MG, Korsrud GO, Boison JO, et al. A study of the disposition of procaine penicillin G in feedlot steers following intramuscular and subcutaneous injection. J Vet Pharmacol Ther. 1993;16(3):317327.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 19.

    Korsrud GO, Boison JO, Papich MG, et al. Depletion of intramuscularly and subcutaneously injected procaine penicillin G from tissues and plasma of yearling beef steers. Can J Vet Res. 1993;57(4):223230.

    • Search Google Scholar
    • Export Citation
  • 20.

    Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). FDA. Accessed May 15, 2021. https://www.fda.gov/animal-veterinary/guidance-regulations/animal-medicinal-drug-use-clarification-act-1994-amduca

    • Search Google Scholar
    • Export Citation
  • 21.

    Sundlof SF. Drug and chemical residues in livestock. Vet Clin North Am Food Anim Pract. 1989;5(2):411449.

  • 22.

    Lindemayr H, Knobler R, Kraft D, Baumgartner W. Challenge of penicillin-allergic volunteers with penicillin-contaminated meat. Allergy. 1981;36(7):471478.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 23.

    Wicher K, Reisman RE, Arbesman CE. Allergic reaction to penicillin in milk. JAMA. 1969;208(1):143145.

  • 24.

    Craigmill AL. A physiologically based pharmacokinetic model for oxytetracycline residues in sheep. J Vet Pharmacol Ther. 2003;26(1):5563.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 25.

    Luthman J, Jacobsson SO. Distribution of penicillin G in serum and tissue cage fluid in cattle. Acta Vet Scand. 1986;27(3):313325.

  • 26.

    Riviere JE, Webb AI, Craigmill AL. Primer on estimating withdrawal times after extralabel drug use. J Am Vet Med Assoc. 1998;213(7):966968.

    • Search Google Scholar
    • Export Citation
  • 27.

    Li M, Gehring R, Riviere JE, Lin Z. Probabilistic physiologically based pharmacokinetic model for penicillin G in milk from dairy cows following intramammary or intramuscular administrations. Toxicol Sci. 2018;164(1):85100.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 28.

    Bengtsson B, Franklin A, Lutman J, Jacobsson SO. Concentrations of sulphadimidine, oxytetracycline and penicillin G in serum, synovial fluid and tissue cage fluid after parenteral administration to calves. J Vet Pharmacol Ther. 1989;12(1):3745.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 29.

    Beef Quality Assurance. Accessed April 21, 2021. https://www.bqa.org/

  • 30.

    Gehring R, Baynes RE, Craigmill AL, Riviere JE. Feasibility of using half-life multipliers to estimate extended withdrawal intervals following the extralabel use of drugs in food-producing animals. J Food Prot. 2004;67(3):555560.

    • Crossref
    • Search Google Scholar
    • Export Citation

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Update on withdrawal intervals following extralabel use of procaine penicillin G in cattle and swine

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  • 1 Food Animal Residue Avoidance and Depletion Program (FARAD), Department of Population Health and Pathobiology, College of Veterinary Medicine, North Carolina State University, Raleigh, NC
  • | 2 FARAD, Department of Biomedical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC
  • | 3 FARAD, Institute of Computational Comparative Medicine, Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS
  • | 4 FARAD, Department of Biomedical Sciences and Pathobiology, Virginia-Maryland College of Veterinary Medicine, Blacksburg, VA
  • | 5 FARAD, Department of Large Animal Clinical Sciences, College of Veterinary Medicine, University of Florida, Gainesville, FL
  • | 6 Department of Environmental and Global Health, College of Public Health and Health Professions, University of Florida, Gainesville, FL
Introduction

Extralabel drug use (ELDU) is defined as the use of an FDA-approved medication in a manner that differs from what is provided on the label of the medication. 1 Administration of the medication to a different species or at a different dose, volume, route, duration, indication, or frequency than indicated on the label is considered ELDU. Extralabel drug use also requires an extended withdrawal period to avoid violative residues, and practitioners can get advice on withdrawal intervals (WDIs) following ELDU from the Food Animal Residue Avoidance and Depletion Program (FARAD). Penicillin is one of the most commonly used

Contributor Notes

Corresponding author: Dr. Foster (dmfoster@ncsu.edu)