Scientific Publications by FDA Staff

J Vet Pharmacol Ther 2016 Dec;39(6):602-11

Depletion of florfenicol in lactating dairy cows after intramammary and subcutaneous administration.

Kawalek JC, Howard KD, Jones Y, Scott ML, Myers MJ

Eighteen Holstein dairy cows ranging in body weight from 500-700 kg and with an average milk yield of 37 +/- 6 kg/day were used to investigate the depletion of florfenicol (FFL) in milk and plasma of dairy cows. Three groups of six were administered FFL: Group A, intramammary (IMM) infusion of ~2.5 mg FFL/kg BW at three consecutive milking intervals (total amount of ~7.5 mg/kg BW); Group B, one IMM infusion (20 mg/kg BW) into one quarter and Group C, one subcutaneous (SC) treatment (40 mg/kg BW). IMM infusions were into the right front quarter. Cows were milked daily at 06:00 and 18:00 h. The highest concentrations (Cmax ) and time to Cmax (Tmax ) were: 1.6 +/- 2.2 mug.FFL/mL milk at 22 h (Group A), 5.5 +/- 3.6 mug.FFL/mL milk at 12 h (Group B), and 1.7 +/- 0.4 mug.FFL/mL milk at 12 h (Group C). The half-lives (t1/2 ) were ~19, 5.5, and 60 h, for Groups A, B, and C, respectively. FFL was below the limit of detection (LOD) by 60 h in three Group B cows, but above the LOD at 72, 84, and 120 h in three cows. FFL was above the LOD in milk from Group C's cows for 432-588 h. Plasma values followed the same trends as milk. The results demonstrate that IMM-infused FFL is bioavailable and below the LOD within 72-120 h. The concentration of FFL was detectable in both plasma and milk over the course of 2-3 weeks after SC administration. The absence of residue depletion data presents problems in determining safe levels of FFL residues in milk and edible tissues. The data presented here must not be construed as approval for extra-label use in food animals.