FDA approves Baytril 100 for control of BRD in high-risk cattle

Cattle producers and veterinarians now have a new option for control of Bovine Respiratory Disease (BRD) in beef and non-lactating dairy cattle at high risk of developing BRD. Baytril 100 (enrofloxacin) Injectable, manufactured by Bayer HealthCare LLC, Animal Health Division, has been approved by the Food and Drug Administration (FDA) for control of all four major BRD pathogens.

With the latest approval from FDA, Baytril 100 is the first and only fluoroquinolone approved for treatment of BRD and control of BRD in high-risk cattle, providing flexibility in treatment protocols.

Cattle producers and veterinarians now can rely on Baytril 100 for the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non‑lactating dairy cattle; and, for the control of BRD in beef and non-lactating dairy heifers less than 20 months of age at high risk of developing BRD associated with M.haemolytica, P. multocida, H. somni and M. bovis. 

BRD has a significant health and economic impact on cattle operations across the country. Particularly susceptible are cattle at high risk of developing infections due to stress and exposure to other cattle.

High-risk factors for cattle can include:

• Transportation with animals from two or more farm origins
• Extended transport time with few to no rest stops
• Environmental temperature changes of ≥30°F between locations, within a
  24-hour period upon arrival
• Exposure to wet or cold weather conditions
• Excessive shrink (more than would be expected with normal load of cattle)
• Stressful arrival processing procedures, such as castration or dehorning
• Exposure within previous 72 hours to animals showing clinical signs of BRD

“BRD in dairy replacement heifers have long-term, devastating consequences for the future of the herd,” said Keith Sterner, D.V.M., practitioner in Ionia, Mich. “Early diagnosis and treatment of these pathogens are critical to help prevent irreparable damage to young and particularly susceptible animals.” 

In the lab, Baytril 100 kills 97 percent of the key BRD-causing bacteria in one to two hours^1,2 in vitro.* In a clinical field study, Baytril 100 demonstrated statistically significant control of BRD in high-risk cattle in a 14-day study³.

“In 2011, this antibiotic was approved for treatment of Mycoplasma bovis, which is a very challenging pathogen for dairy replacement heifer operations,” said Todd Firkins, Livestock Category Manager, Food Animal Products, Bayer HealthCare Animal Health division. “With the option of Baytril 100 as a control tool for BRD in high-risk heifers, producers and veterinarians now can treat their cattle more efficiently to kill BRD and help the calf’s immune system get back to work.”

Available in 100 mL, 250 mL and 500 mL bottles, Baytril 100 has been a choice for many bovine veterinarians and cattle producers since its introduction in 1998 and is the largest-selling, single-dose antibiotic in its class. The first FDA-approved fluoroquinolone antimicrobial for use against BRD, Baytril 100 is a proven and effective BRD antimicrobial.

For more information about Baytril 100, call Bayer Veterinary Services at
1-800-422-9874 or visit www.Baytril100.com.

 

*The clinical significance of in vitro data has not been demonstrated.

Footnotes:

1. Blondeau J.M., Borsos S., Blondeau L.D., Blondeau B.J., Hesje C. 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; 2005 October 23-26; Kohala Coast, Big Island, Hawaii: American Society of Microbiology; 2005. Abstract B12.

2. Blondeau J.M., Borsos S.D., Hesje C.H., Blondeau L.D., Blondeau B.J. Comparative Killing of Bovine Isolates of Mannheimia haemolytica 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.

3. Data on file.

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Extra-label use of this product in food-producing animals is prohibited. Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

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