Baytril 100 (enrofloxacin) Injectable is FDA-approved for BRD control (metaphylaxis) in high-risk cattle. Whether controlling or treating BRD, it s important to kill bacteria to let the calf s immune system get back to work. Use Baytril 100 first to reduce the bacteria load in high-risk cattle right off the truck. 14 days. Six study sites. One major conclusion Baytril 100 demonstrated statistically significant control of BRD in high-risk cattle in a 14-day control study. 1 These studies were no cakewalk, either. At each of the study locations, cattle injected with Baytril 100 were constantly exposed to BRD-causing bacteria from other cattle to increase BRD pressure. At the end of the studies, findings from the Baytril 100 cattle showed: Baytril 100 achieved a 33.7% reduction in BRD versus the non-baytril 100 group 1 This result was statistically significant (P = 0.0012) 1 Quick on the draw to attack BRD. When it comes to BRD, time is of the essence. It s not about how long a drug stays on board the cattle s system, but how effectively the drug works to kill the bacteria that cause BRD. In vitro* studies show that Baytril 100 kills 97% of the key BRD-causing bacteria in 1 2 hours. 2,3 And once bacteria are dead, they re dead. Ask your veterinarian about using Baytril 100 as your go-to drug for control of BRD in high-risk cattle or treatment of BRD. *The clinical significance of in vitro data has not been demonstrated. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
Baytril 100 (enrofloxacin) Injectable FAQ Here are some answers to commonly asked questions about Baytril 100. Q A I thought it was illegal to use a fluoroquinolone for metaphylaxis. What changed? Baytril 100 can be used for metaphylaxis of BRD because the FDA has approved it for control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis. The FDA approved this indication after reviewing efficacy and safety data about Baytril 100, and agreeing with the findings regarding its effectiveness. In the late 1990s when Baytril 100 was first approved for treatment of BRD in cattle, there was a large amount of discussion about the use of fluoroquinolones in food animals. The FDA understands the importance of fluoroquinolones for both human and veterinary medicine. After 16 years on the market, there has been no significant shift in the susceptibility of BRD pathogens with the use of enrofloxacin. Since being introduced, Baytril 100 has been approved for many new uses, including use in dairy replacement heifers less than 20 months of age, for treatment and control of SRD in swine, and for treatment of M. bovis in cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Q A How can Baytril 100 (enrofloxacin) Injectable function as a metaphylaxis drug? Doesn t a drug concentration need to last for several days to be an effective control drug? That depends on the drug s mode of action. Bacteriostatic drugs work by inhibiting bacterial growth, so they need to stay above the MIC (minimum inhibitory concentration) in the animal for several days. Q A Bactericidal drugs like enrofloxacin kill bacteria, so extended duration of the effective concentration is not necessary. In the laboratory, Baytril 100 kills BRD pathogens in one to two hours, reducing the population.* 2,3 This in vitro* work helps us understand how products may work in animal infections. When selecting Baytril 100 for antibiotic therapy, it is important to kill the bugs on board instead of being concerned about drug on board. Baytril 100 is not a long-lasting drug. How can it be effective in a large group of animals with varying levels of disease? Bacterial killing studies done in the laboratory have demonstrated that Baytril 100 kills bacteria and reduces the bacterial population in the first 24 hours.* 2,3 In vitro,* Baytril 100 reaches MIC 90 in blood plasma in less than an hour, 4 and achieves C MAX (the highest drug concentration) in less than 6 hours. 2,3 Baytril 100 has a classic concentration-dependent profile 1.6 Pharmacokinetics:7.5 mg/kg μg/ml 1.2 0.8 0.4 0 MPC90* 2 MIC90* 4 0 4 8 12 16 20 24 28 32 36 40 44 48 Time (hr) * The clinical significance of in vitro data has not been demonstrated. Do not use in calves to be processed for veal.
Additional study information shows that Baytril 100 reaches high concentrations of active, unbound drug at the site of BRD infection. 5 Q A Since bacteria are commonly prevalent at some level in many high-risk animals, a reduction of the overall bacterial pathogen load should assist the animal s immune system to allow it to help the animal recover and return to positive health. We ve successfully used the single-day 5.7 ml/cwt (12.5 mg/kg) dose of Baytril 100 for years. Why is the control label single-day dose 3.4 ml/cwt (7.5 mg/kg)? Although the 5.7 ml/cwt (12.5 mg/kg) dose is the most common dosage for individual animal therapy, the 3.4 ml/cwt (7.5 mg/kg) dose has been demonstrated as effective in reducing morbidity when used for metaphylaxis in a 14-day control study. 1 Animals pulled with visual clinical symptoms of BRD are likely to have a more advanced case of respiratory disease than those animals not showing visual clinical symptoms. These infections demonstrate more severe symptoms and the higher dose has proven to be the most common dose to treat advanced cases of BRD. Meanwhile, the incidence of disease and the severity of disease in high-risk animals on arrival is usually less, and effective clinical results are therefore possible with Baytril 100 administered at the 3.4 ml/cwt (7.5 mg/kg) dose. Both dosages establish effective concentrations and duration above MIC, including effective MPC (mutant prevention concentrations). 2,3 Extra-label use in food-producing animals is prohibited.
Q A What is the label recommendation for treatment if I use Baytril 100 (enrofloxacin) Injectable for metaphylaxis? Following the use of Baytril 100 for control of BRD in high-risk calves, you should not have to make any change to the way you pull and treat. When you need to make a pull, you can still treat with a single-day 5.7 ml/cwt (12.5 mg/kg) dose of Baytril 100. Treatment studies have shown that Baytril 100 following Baytril 100 is still effective. The question is whether you prefer to use a bactericidal drug that kills bacteria, or a bacteriostatic drug that inhibits bacteria growth. Consult with your veterinarian to determine the best treatment regimen with Baytril 100 on your operation. Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment.
1 Data on file. 2 Blondeau JM, Borsos S, Blondeau LD, Blondeau BJ, Hesje C. (2005). The killing of clinical isolates of Mannheimia haemolytica (MH) by enrofloxacin (ENR) using minimum inhibitory and mutant prevention drug concentrations and over a range of bacterial inocula. In: ASM Conference on Pasteurellaceae; 23-26 October 2005; Kohala Coast, Big Island, Hawaii: American Society of Microbiology; Abstract B12. 3 Blondeau JM, Borsos SD, Hesje CH, Blondeau LD, Blondeau BJ. (2007). Comparative killing of bovine isolates of Mannheimia haemolytica (MH) by enrofloxacin, florfenicol, tilmicosin and tulathromycin using the measured minimum inhibitory concentration (MIC) and mutant prevention concentration (MPC) drug values. In: International Meeting of Emerging Diseases and Surveillance (IMED); Vienna, Austria; February 23-25, 2007; Figures 8-10. 4 Data on file. 5 Davis JL, Foster DM, Papich MG. (2007). Pharmacokinetics and tissue distribution of enrofloxacin and its active metabolite ciprofloxacin in calves. J Vet Pharmacol Ther. 30(6):564-571. 2015 Bayer HealthCare LLC, Animal Health, Shawnee Mission, Kansas 66201 Bayer, the Bayer Cross, Baytril and Right the first time are registered trademarks of Bayer. BL15176