Baytril® 100 (enrofloxacin) Injectable
Your first-line therapy
for treating BRD and
reducing the bacteria
load upfront.
Make single-dose Baytril® 100 (enrofloxacin) Injectable
your first-line therapy for BRD.
FDA-approved for both treatment of BRD and control (metaphylaxis) of BRD in high-risk cattle.
Whether controlling or treating bovine respiratory disease (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.
• Baytril 100 is effective with a single dose
for control and treatment usage.
• Baytril 100 outsells every antibiotic in its class.1
• Baytril 100 is bactericidal, and kills all four of
the major BRD-causing pathogens:
– Mannheimia haemolytica
– Pasteurella multocida
– Histophilus somni
– Mycoplasma bovis
• In vitro*, Baytril 100 kills 97% of key
BRD-causing bacteria in 1–2 hours.2,3
• Baytril 100 delivers therapeutic drug
concentrations to the site of infection in
the lungs in 1–2 hours.4
*The clinical significance of in vitro data
has not been demonstrated.
Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
Baytril® 100 (enrofloxacin) Injectable demonstrated statistically
significant control of BRD in high-risk cattle in a 14-day study.5
Baytril 100 was put to the test in a 14-day study at six different locations. At each of the study
sites, high-risk cattle injected with Baytril 100 were constantly exposed to BRD-causing bacteria
from other cattle to increase BRD pressure.
At the end of the study, findings from the
Baytril 100 cattle showed:
• Baytril 100 achieved a 33.7% reduction
in BRD versus the non-Baytril 100 group5
• This result was statistically significant
(P = 0.0012)5
Plus, clinical signs of depression and respiratory
distress from BRD were comparatively reduced
in the cattle that received Baytril 100.
A different dose for BRD control
and treatment.
Although the 3.4–5.7 mL/cwt (7.5–12.5 mg/kg)
dose is approved for treatment, the 5–5.5 mL/cwt
has settled out to be the most recommended
treatment dose by veterinarians. However, the approved dose for control of BRD in high-risk calves is
3.4 mL/cwt (7.5 mg/kg) and has been demonstrated as effective in reducing morbidity when used for
metaphylaxis in a 14-day study.5
Once bacteria are dead, they’re dead.
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 eradicate the bacteria that cause BRD.
Ask your veterinarian about using Baytril 100 as your go-to drug
for control of BRD in high-risk cattle or treatment of BRD.
Extra-label use in food-producing animals is prohibited.
Stressors, viruses and infectious bacteria can result in BRD.
Watch for the signs of sickness.
Stressors such as weaning, shipping, processing, ration change, overcrowding, commingling
and adverse weather compromise a calf’s immune system. A variety of viruses (IBR, BVD,
BRSV and PI3) can invade and damage the calf’s respiratory tract, which compromises its
natural defense mechanisms, including the ability to expel bacteria and dust from the lungs.
This damage, along with a suppressed immune system, permits the invasion of BRD-causing
bacteria such as Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and
Mycoplasma bovis.
When a calf develops BRD, it typically occurs within a few days following exposure. Sick calves
usually demonstrate some or all of the following clinical signs:
• Depression
• Drooping ears
• Extended head and bowed back
• Isolation from other cattle
• Lack of appetite
• Dull, sunken eyes
• Nasal/ocular discharge
• Loose feces
• Rapid breathing and coughing
• Elevated temperature (≥104°F)
Are your cattle at risk?
Consult with your veterinarian to see if conditions exist that may indicate your calves being at
high risk of contracting BRD. Some conditions may include:
• Transportation with animals from two or more farm origins
• An extended transport time with few to no rest stops
• An environmental temperature change of ≥30°F during transportation
• A ≥30°F range in temperature fluctuation within a 24-hour period
• Exposure to wet or cold weather conditions
• Excessive shrink (more than would be expected with a normal load of cattle)
• Stressful arrival processing procedures (e.g., castration or dehorning)
• Exposure within the prior 72 hours to animals showing clinical signs of BRD
Cattle intended for human consumption must not be slaughtered within 28
days from the last treatment. Do not use in calves to be processed for veal.
The sooner cattle feel better, the faster they get back to work eating.
Baytril® 100 (enrofloxacin) Injectable is backed by a history of success.
The first FDA-approved fluoroquinolone for the treatment of BRD, Baytril 100 has
been proven through 16 years of use and repeated field-testing. Today, single-dose Baytril 100
remains a leading antibiotic.1
• More than 45 million doses sold1 — and counting.
• Field studies indicate efficacy against the four major BRD pathogens.
• No suppression of appetite has been associated with Baytril 100 when used
according to the label.
• Approved for treatment of non-lactating dairy replacement heifers less than
20 months of age.
Plus, Baytril 100 is approved for the single-dose treatment of Mycoplasma bovis.
That means Baytril 100 can be used to treat all four major BRD pathogens with
a single dose.
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. Do not use in
calves to be processed for veal.
Both in vitro
vitro* and in vivo data
demonstrate the bacteria-killing qualities
of Baytril® 100 (enrofloxacin) Injectable.
Major Antibacterials: Modes of Action
Cell:
Penicillins
Cephalosporins
DNA:
Fluoroquinolones
Baytril 100
Advocin®
Excede®
Naxcel®
Baytril 100 is bactericidal. Its unique mode of action
kills the control center of BRD-causing bacteria.
Bacterial Cell
Ribosomes:
Macrolides
Tetracyclines
Bio-Mycin® 200
Fenicols
Nuflor®
Nuflor Gold®
Resflor Gold®
DNA controls all bacterial cell activities, including
metabolism, protein synthesis, cell maintenance and
energy production. Enrofloxacin, the active ingredient in
Baytril 100, penetrates the bacteria cell, inhibits the DNA
gyrase and kills BRD-causing bacteria.
Concentration-Dependent
(Concept Illustration)
Drug Level
Bacterial Population
• Baytril 100 kills bacteria in both its resting and
growth phases of bacterial development.6,7
Drug Level
Number of Bacteria
• Baytril 100 is broad-spectrum, killing the four major
BRD-causing bacteria.
• Baytril 100 has an active metabolite with equal or
higher in vitro* potency than the parent molecule.8
MIC90
0
24
Baytril 100 is concentration-dependent.*
Number of Bacteria
Drug Level
MIC90
Studies completed in the laboratory evaluate how
Baytril 100 kills bacteria.
0
24
Time (hours)
48
72
Baytril 100 has a classic concentration-dependent profile.
2.0
Drug Plasma Concentration (µg/mL)
*The clinical significance of in vitro data has not been demonstrated.
72
Drug Level
Bacterial Population
Baytril 100 concentrations minimize the
selection for bacteria resistance.
• Baytril 100 blood levels remain above MPC to kill
susceptible and mutant Mannheimia haemolytica
bacteria for 18 hours.*2,4
48
Time (hours)
Time-Dependent
(Concept Illustration)
Bactericidal killing studies were performed in the
laboratory to evaluate how Baytril 100 kills bacteria. These
in vitro* studies indicated that the higher the concentration
of Baytril 100, the faster it kills.2,3,9
• Baytril 100 reaches MPC (mutant prevention
concentrations) to Mannheimia haemolytica in blood
plasma in 40 minutes and in pleural interstitial fluid in
just over 6 hours.*2,4
Micotil® 300
Draxxin®
Zactran®
Zuprevo®
Pharmacokinetics: 12.5 mg/kg
1.8
enrofloxacin with active metabolite10
1.6
1.4
1.2
1.0
0.8
0.6
0.4
MIC90 = 0.125 µg/mL*
0.2
MPC 90*3
M. haemolytica
10
0
A withdrawal period has not been established
for this product in pre-ruminating calves.
0
2
4
6
8
10
12
14
Hours Post-SubQ Injection
16
18
20
22
24
Baytril 100 (enrofloxacin) Injectable
is field-proven in millions of cattle.1
Product Mode of Action Chart
®
ConcentrationDependent
Bactericidal
Baytril 100 (enrofloxacin)
Advocin™ (danofloxacin mesylate)
Baytril 100 reaches therapeutic levels at the site of
infection in the lungs within 1–2 hours.*4
• High bio-availability maximizes enrofloxacin’s ability
to get to the site of infection.
**Nuflor has been reported to show bactericidal claims against certain bacterial strains (see Nuflor label for additional information).
Time-Kill-Kinetics in M. haemolytica*9
10
• Highly lipophilic, enrofloxacin leaves the blood
and penetrates tissue.
Baytril 100 helps cattle feel better
and get back to the bunk.
(MIC = 0.06 µg/mL)
107
106
105
104
control
enrofloxacin 0.125 µg/mL
103
102
100
0
4
8
12
16
20
24
Time (hours)
• In vitro*, Baytril 100 kills 97 percent of BRD-causing
bacteria in 1–2 hours.2,3
Concentration in Lung Tissue (7.5 mg/kg)11
Lung healthy (Lh)
Lung diseased (Ld)
µg/mL or gm
2.0
1.6
1.2
0.8
0.4
8
24
Hours Post-Administration
Temperature Reduction
107.0
107.0
106.0
106.0
Temperature (°F)(F)
Temperature
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.
Mannheimia haemolytica
101
The sooner bacteria are killed, the faster a calf will feel
better and get back to work eating.
• In field trials, significant improvements in temperature
and attitude scores were noted within 24 hours
of treatment.12
9
108
Number of Bacteria (CFU/ mL)
• Baytril 100 has been shown to reach similar
drug levels in both diseased and healthy lungs.11
Draxxin® (tulathromycin)
Micotil® (tilmicosin)
Zactran® (gamithromycin)
Zuprevo® (tildipirosin)
Nuflor (florfenicol)**
Bio-Mycin® 200 (oxytetracycline)
Liquamycin® LA-200® (oxytetracycline)
Nuflor® and Nuflor Gold® (florfenicol)**
Resflor Gold® (florfenicol and flunixin meglumine)
Excede® (ceftiofur crystalline-free acid)
Excenel® RTU (ceftiofur hydrochloride)
Naxcel® (ceftiofur sodium)
Penicillin
Time-Dependent
• Baytril 100 reaches peak killing concentration
in less than 5 hours in the lungs.*4
Bacteriostatic
Baytril
100100
Baytril
Control
Control
105.0
105.0
104.0
104.0
103.0
103.0
102.0
102.0
101.0
101.0
10
1 22 33 44 55 66 7 7 8 8 99 10
Day
Day
Study Report 74653-Appendix 212
Single-dose Baytril® 100 (enrofloxacin) Injectable delivers reliable
and cost-effective antibacterial control of BRD
in high-risk cattle and treatment of BRD.
• Control dose is 30–40% smaller in size and
cost than the most common treatment dose.
• Convenient, single-dose therapy reduces time
and labor costs.
• Single-dose therapy reduces animal handling,
which reduces stress on sick cattle.
• Baytril 100 is easy to syringe, even in
cold weather.13
MIC Susceptibility Values For Enrofloxacin
Pathogen
†
†
Number of
Isolates
MIC50
µg/mL
MIC90
µg/mL
Histophilus somni
104
0.015
0.03
Mycoplasma spp.
124
0.25
0.5
Mannheimia haemolytica
121
0.06
0.06
Pasteurella multocida
108
0.015
0.03
†The MIC for 50% and 90% of the isolates.
Baytril 100 Dose and Treatment Schedule‡
TREATMENT:
Single-Dose
Therapy
12.5 mg/kg
Dose Size (mL)
CONTROL:
Single-Dose
Therapy
7.5 mg/kg
Dose Size (mL)
100
5.5
3.5
200
11.0
7.0
300
17.0
10.5
400
22.5
14.0
500
28.5
17.0
600
34.0
20.5
700
39.5
24.0
800
45.5
27.5
900
51.0
31.0
1,000
57.0
34.0
1,100
62.5
37.5
Withdrawal
Time
28 Days
28 Days
Cattle
Weight (Ib)
Based on research conducted to date, we believe 12.5 mg/kg to be
the most appropriate dosing rate for treatment.
‡Dose volumes have been rounded to the nearest 0.5 mL
within the dose range.
Subcutaneous injection can cause a transient local tissue reaction that
may result in trim loss of edible tissue at slaughter.
In clinical studies, Baytril® 100 (enrofloxacin) Injectable
delivered fewer mortalities than
some other cattle antibiotics.14,15
• Bayer is committed to high industry standards
for injectable animal health products and the
production of quality meat and dairy products.
• Use Baytril 100 with confidence —
veterinarians have successfully used
enrofloxacin worldwide for more than 20 years.
• Baytril 100 has been shown to be safe in
beef cattle of all ages and in dairy heifers
less than 20 months of age.
Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
Comparison of Case Fatality in Field Trials
18%a
Competition
Baytril 100
11%b
11%c
Micotil
20
18
16
14
12
10
8
6
4
2
Nuflor
• Baytril 100 is backed by Bayer, a leading-edge
animal health company committed to the
veterinary and cattle industries.
CFR (%)
To help you understand and use our product better,
Bayer commits a sizeable investment of time and
money to field trial comparison studies. The trend
emerging from multiple studies demonstrates that
Baytril 100 results in fewer fatalities.
1%d
Study 151.678 (P= 0.02)14 Study 08–99 (P=0.013)15
Different superscripts represent statistically different values.
Data on file.
Blondeau JM, Borsos S, Blondeau LD, Blondeau, et al. (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, et al. 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:
International Society for Infectious Diseases. February 23-25, 2007. Figures 8-10.
4
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.
5
Data on file.
6
Claus GW. Microbial Nutrition, Metabolism, and Growth. In: Carter GR, Chengappa MM, Roberts AW, eds. (1995). Essentials of Veterinary Microbiology. 5th ed.
Philadelphia, PA; Williams & Wilkins; 39.
7
Wetzstein H-G, deJong A. (1996). In vitro bactericidal activity and PAE of fluoroquinolones used in veterinary medicine. In: Ford R, ed., Second International
Veterinary Symposium on Baytril® Proceedings. Compend Contin Educ Pract Vet. 18(2):22-29.
8
Grobbel M, Lübke-Becker A, Wieler LH, et al. (2007). Comparative quantification of the in vitro activity of veterinary
fluoroquinolones. Vet Microbiol. 124(1–2):73–81.
9
Concentration-dependent Killing Activity of Baytril® 100 (enrofloxacin). Bayer Study, BL04195 (Pirro et al., BCVA Autumn Meeting, Glasgow, October 2000).
10
Data on file.
11
Data on file.
12
Freedom of Information Summary for Baytril® 100 (enrofloxacin) Injectable, NADA: 141-068.
13
Data on file.
14
Data on file.
15
Data on file.
1
2
©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.
Bio-Mycin is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.
Advocin, Draxxin, Excede, Excenel, Liquamycin, LA-200 and Naxcel are registered trademarks of Zoetis.
Nuflor, Nuflor Gold, Resflor Gold and Zuprevo are registered trademarks of Intervet, Inc.
Micotil is a registered trademark of Eli Lilly and Company.
Zactran is a registered trademark of Merial Limited.
BL15173