The pharmacokinetics, PK/PD ratios, and Monte Carlo modeling of enrofloxacin HCl-2H O (Enro-C) and its reference preparation (Enro-R) were determined in cows. Fifty-four Jersey cows were randomly assigned to six groups receiving a single IM dose of 10, 15, or 20 mg/kg of Enro-C (Enro-C , Enro-C , Enro-C ) or Enro-R. Serial serum samples were collected and enrofloxacin concentrations quantified. A composite set of minimum inhibitory concentrations (MIC) of Leptospira spp. was utilized to calculate PK/PD ratios: maximum serum concentration/MIC (C /MIC ) and area under the serum vs. time concentration of enrofloxacin/MIC (AUC /MIC ). Monte Carlo simulations targeted C /MIC = 10 and AUC /MIC = 125. Mean C obtained were 6.17 and 2.46 μg/ml; 8.75 and 3.54 μg/ml; and 13.89 and 4.25 μg/ml, respectively for Enro-C and Enro-R. C /MIC ratios were 6.17 and 2.46, 8.75 and 3.54, and 13.89 and 4.25 for Enro-C and Enro-R, respectively. Monte Carlo simulations based on C /MIC  = 10 indicate that only Enro-C and Enro-C may be useful to treat leptospirosis in cows, predicting a success rate ≥95% when MIC  = 0.5 μg/ml, and ≥80% when MIC  = 1.0 μg/ml. Although Enro-C and Enro-C may be useful to treat leptospirosis in cattle, clinical trials are necessary to confirm this proposal.

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