Baytril® 100 (enrofloxacin) Injectable is FDA

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 group1
• 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.
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.”
A
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 MIC90 in blood plasma
in less than an hour,4 and achieves CMAX (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
Q
1.2
0.8
0.4
MPC 90 * 2
MIC 90 * 4
0
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
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.
Q
A
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.
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.
2
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