Tissue residue depletion and estimation of extralabel meat withdrawal intervals for tulathromycin in calves after pneumatic dart administration.

Autor:	Lin Z; Institute of Computational Comparative Medicine (ICCM), Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS., He C; Institute of Computational Comparative Medicine (ICCM), Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS., Magstadt DR; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA.; Veterinary Diagnostic Laboratory (VDL), College of Veterinary Medicine, Iowa State University, Ames, IA., Cooper VL; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA., Kleinhenz MD; Institute of Computational Comparative Medicine (ICCM), Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS.; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA., Smith JS; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA., Gorden PJ; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA., Wulf LW; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA.; Veterinary Diagnostic Laboratory (VDL), College of Veterinary Medicine, Iowa State University, Ames, IA., Coetzee JF; Institute of Computational Comparative Medicine (ICCM), Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS.; Department of Veterinary Diagnostic and Production Animal Medicine (VDPAM), College of Veterinary Medicine, Iowa State University, Ames, IA.; Veterinary Diagnostic Laboratory (VDL), College of Veterinary Medicine, Iowa State University, Ames, IA.
Jazyk:	angličtina
Zdroj:	Journal of animal science [J Anim Sci] 2019 Sep 03; Vol. 97 (9), pp. 3714-3726.
DOI:	10.1093/jas/skz231
Abstrakt:	The objectives of this study were to evaluate the injection site pathology and determine tissue residue depletion of tulathromycin in calves following pneumatic dart administration and to calculate the associated extralabel withdrawal interval (WDI). Castrated male Holstein calves were injected with ~2.6 mg/kg tulathromycin via pneumatic dart administration. At 1 (n = 2), 6, 12, 18, and 24 d after drug injection (n = 3/time point), calves were euthanized, and muscle, liver, kidney, fat, and injection site samples were harvested and analyzed for tulathromycin concentrations using a LC-MS/MS method. Gross pathology and histopathology evaluations on the injection site samples were also performed. Pneumatic dart administration of tulathromycin caused severe localized lesions of hemorrhage and edema on days 1 and 6, as well as severe pathological reactions in the subcutaneous muscle on days 1, 6, and 12. Slight to moderate reactions were still observed in the majority of the skin or subcutaneous/muscle samples on day 24. Measured tulathromycin concentrations were converted to calculate the concentrations of the marker residue CP-60,300 by dividing a conversion factor of 1.4. The data were used to calculate extralabel WDIs based on the guidelines from U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The results showed that tulathromycin concentrations were the highest in the liver (4,877.84 ± 65.33 µg/kg), kidney (5,819.52 ± 1,087.00 µg/kg), muscle (1,717.04 ± 140.35 µg/kg), injection site (51,884.05 ± 7,529.34 µg/kg), and fat (161.69 ± 36.48 µg/kg) at 6, 1, 1, 1, and 1 d, respectively, after treatment. Tulathromycin concentrations remained above the limit of quantification of 5 µg/kg in all tissues at 24 d. The calculated WDIs based on kidney data were 26 d using EMA method, 36 d using FDA method based on CP-60,300 data, and 45 d using FDA method based on tulathromycin data. These results suggest that pneumatic dart administration of tulathromycin causes injection site reactions in calves and an extended WDI is needed. One limitation of this study was the small sample size of 3 that did not meet FDA guideline requirement. Therefore, the calculated WDIs should be considered as preliminary and additional studies that use a larger number of animals and directly measure the concentrations of the marker residue CP-60,300 are needed to make a more conclusive recommendation on the extralabel WDI. (© The Author(s) 2019. Published by Oxford University Press on behalf of the American Society of Animal Science. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Databáze:	MEDLINE
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