Baytril
Bayer HealthCare LLC Animal Health Division
Baytril 100 (enrofloxacin)
FULL PRESCRIBING INFORMATION: CONTENTS*
- PRODUCT BAYTRIL DESCRIPTION:
- INDICATIONS:
- BAYTRIL DOSAGE AND ADMINISTRATION:
- HUMAN WARNINGS:
- PRECAUTIONS:
- BAYTRIL ADVERSE REACTIONS:
- MICROBIOLOGY:
- EFFECTIVENESS:
- TOXICOLOGY:
- ANIMAL SAFETY:
- STORAGE CONDITIONS:
- HOW SUPPLIED:
- REFERENCES:
- PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
100 mg/mL Antimicrobial
Injectable Solution
For Subcutaneous Use in Beef Cattle, Non-Lactating Dairy Cattle and Swine Only
Not For Use In Female Dairy Cattle 20 Months of Age or Older
Or In Calves To Be Processed For Veal
CAUTION:
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
Federal (U.S.A.) law prohibits the extra-label use of this drug in food-producing animals.
PRODUCT DESCRIPTION:
Baytril® 100 is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent.
Each mL of Baytril® 100 contains 100 mg of enrofloxacin. Excipients are L-arginine base 200 mg, n-butyl alcohol 30 mg, benzyl alcohol (as a preservative) 20 mg and water for injection q.s.
CHEMICAL NOMENCLATURE AND STRUCTURE:
1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid.
INDICATIONS:
Cattle - Single-Dose Therapy: Baytril® 100 is indicated for the treatment of bovine respiratory disease (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 cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.
Cattle - Multiple-Day Therapy: Baytril® 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.
Swine: Baytril® 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
DOSAGE AND ADMINISTRATION:
Baytril® 100 provides flexible dosages and durations of therapy.
Baytril® 100 may be administered as a single dose for one day for treatment and control of BRD (cattle) and SRD (swine), or for multiple days for BRD treatment (cattle). Selection of the appropriate dose and duration of therapy for BRD treatment in cattle should be based on an assessment of the severity of the disease, pathogen susceptibility and clinical response.
500 mL - Do not enter the vial with a needle more than 30 times or enter the vial with a dosage delivery device more than 4 times. Any product remaining after these maximum number of entries should be discarded.
Cattle:
Single-Dose Therapy (BRD Treatment): Administer once, a subcutaneous dose of 7.5 - 12.5 mg/kg of body weight (3.4 - 5.7 mL/100 lb).
Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5 - 5.0 mg/kg of body weight (1.1 - 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.
Single-Dose Therapy (BRD Control): Administer once, a subcutaneous dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Examples of conditions that may contribute to calves being at high risk of developing BRD include, but are not limited to, the following:
• 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 dehoming).
• Exposure within the prior 72 hours to animals showing clinical signs of BRD.
Administered dose volume should not exceed 20 mL per injection site.
| Weight (lb) |
Treatment | Control | |
| Single-Dose Therapy 7.5 - 12.5 mg/kg Dose Volume (mL) |
Multiple-Day Therapy 2.5 - 5.0 mg/kg Dose Volume (mL) |
Single-Dose Therapy 7.5 mg/kg Dose Volume (mL) |
|
| 100 | 3.5 - 5.5 | 1.5 - 2.0 | 3.5 |
| 200 | 7.0 - 11.0 | 2.5 - 4.5 | 7.0 |
| 300 | 10.5 - 17.0 | 3.5 - 6.5 | 10.5 |
| 400 | 14.0 - 22.5 | 4.5 - 9.0 | 14.0 |
| 500 | 17.0 - 28.5 | 5.5 - 11.5 | 17.0 |
| 600 | 20.5 - 34.0 | 7.0 - 13.5 | 20.5 |
| 700 | 24.0 - 39.5 | 8.0 - 16.0 | 24.0 |
| 800 | 27.5 - 45.5 | 9.0 - 18.0 | 27.5 |
| 900 | 31.0 - 51.0 | 10.0 - 20.5 | 31.0 |
| 1000 | 34.0 - 57.0 | 11.0 - 23.0 | 34.0 |
| 1100 | 37.5 - 62.5 | 12.5 - 25.0 | 37.5 |
Swine:
Administer once, behind the ear, a subcutaneous dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).
Administered dose volume should not exceed 5 mL per injection site.
| Weight (lb) | Dose Volume (mL) |
| 50 | 1.7 |
| 100 | 3.4 |
| 150 | 5.1 |
| 200 | 6.8 |
| 250 | 8.5 |
Cattle: Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This productis 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 preruminating calves. Do not use in calves to be processed for veal.
Swine: Animals intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose.
HUMAN WARNINGS:
Not for use in humans. Keep out of reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. For customer service or to obtain product information, including a Material Safety Data Sheet, call 1-800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.
PRECAUTIONS:
The effects of enrofloxacin on cattle or swine reproductive performance, pregnancy and lactation have not been adequately determined.
The long-term effects on articular joint cartilage have not been determined in pigs above market weight.
Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.
Baytril® 100 contains different excipients than other Baytril® products. The safety and efficacy of this formulation in species other than cattle and swine have not been determined.
Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures. Quinolone-class drugs have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. See Animal Safety section for additional information.
ADVERSE REACTIONS:
No adverse reactions were observed during clinical trials.
MICROBIOLOGY:
Enrofloxacin is bactericidal and exerts its antibacterial effect by inhibiting bacterial DNA gyrase (a type II topoisomerase) thereby preventing DNA supercoiling and replication which leads to cell death.1 Enrofloxacin is active against Gram-negative and Gram-positive bacteria.
EFFECTIVENESS:
Cattle: A total of 845 calves with naturally-occurring BRD were treated with Baytril® 100 in eight field trials located in five cattle-feeding states. Response to treatment was compared to non-treated controls. Single-dose and multiple-day therapy regimens were evaluated. BRD and mortality were significantly reduced in enrofloxacin-treated calves. No adverse reactions were reported in treated animals.
The effectiveness of Baytril® 100 for the control of respiratory disease in cattle at high risk of developing BRD was evaluated in a six-location study in the U.S. and Canada. A total of 1,150 crossbred beef calves at high risk of developing BRD were enrolled in the study. Baytril® 100 (7.5 mg/kg BW) or an equivalent volume of sterile saline was administered as a single subcutaneous injection within two days after arrival. Cattle were observed daily for clinical signs of BRD and were evaluated for success on Day 14 post-treatment. Treatment success in the Baytril® 100 group (497/573, 87.83%) was significantly higher (P = 0.0013) than success in the saline control group (455/571, 80.92%). In addition, there were more treatment successes (n = 13) than failures (n = 3) in the group of animals positive for M. bovis on Day 0 that were treated with Baytril® 100. No product-related adverse reactions were reported.
Swine: A total of 590 pigs were treated with Baytril®100 or saline in two separate natural infection SRD field trials. For the treatment of SRD, the success rate of enrofloxacin-treated pigs that were defined as “sick and febrile” (increased respiratory rate, labored or dyspneic breathing, depressed attitude and a rectal temperature ≥ 104°F) was statistically significantly greater than the success rate of saline-treated “sick and febrile” pigs. For the control of SRD, mean rectal temperature, mortality (one trial) and morbidity were statistically significantly lower for enrofloxacin-treated pigs in pens containing a percentage of “sick and febrile” pigs compared to saline-treated pigs.
The effectiveness of Baytril® 100 administered as a single SC dose of 7.5 mg/kg BW for the treatment and control of SRD associated with M. hyopneumoniae was demonstrated using an induced infection model study and three single-site natural infection field studies. In the model study, 72 healthy pigs were challenged with a representative M. hyopneumoniae isolate and treated with Baytril® 100 or saline. A statistically significant (P < 0.0001) decrease in the mean total lung lesion score was observed in the Baytril® 100-treated group (4%) compared with the saline-treated group (27%) at 10 days post-treatment. In two field studies evaluating effectiveness for treatment of SRD, a total of 300 pigs with clinical signs of SRD (moderate depression, moderately increased respiratory rate, and a rectal temperature of ≥ 104°F) were enrolled and treated with Baytril® 100 or saline. At 7 days post-treatment, the cure rate was statistically significantly higher at each site (P < 0.0001) in the Baytril® 100-treated groups (61.3% and 92%) compared with the saline-treated groups (26.7% and 33.3%). In one field study evaluating effectiveness for control of SRD, a group of 400 pigs in which > 15% had clinical signs of SRD (moderate depression score, moderately increased respiratory rate, and a rectal temperature of ≥ 104°F) was enrolled and treated with Baytril® 100 or saline. At 7 days post-treatment, the cure rate was statistically significantly higher (P < 0.0002) in the Baytril® 100-treated group (70.0%) compared with the saline-treated group (48.5%). In addition to M.hyopneumoniae, B.bronchiseptica was also isolated in sufficient numbers from these field studies to be included in the SRD treatment and control indications.
TOXICOLOGY:
The oral LD50 for laboratory rats was greater than 5000 mg/kg of body weight. Ninety-day feeding studies in dogs and rats revealed no observable adverse effects at treatment rates of 3 and 40 mg/kg respectively. Chronic studies in rats and mice revealed no observable adverse effects at 5.3 and 323 mg/kg respectively. There was no evidence of carcinogenic effect in laboratory animal models. A two-generation rat reproduction study revealed no effect with 10 mg/kg treatments. No teratogenic effects were observed in rabbits at doses of 25 mg/kg or in rats at 50 mg/kg.
ANIMAL SAFETY:
Cattle: Safety studies were conducted in feeder calves using single doses of 5, 15 and 25 mg/kg for 15 consecutive days and 50 mg/kg for 5 consecutive days. No clinical signs of toxicity were observed when a dose of 5 mg/kg was administered for 15 days. Clinical signs of depression, incoordination and muscle fasciculation were observed in calves when doses of 15 or 25 mg/kg were administered for 10 to 15 days. Clinical signs of depression, inappetance and incoordination were observed when a dose of 50 mg/kg was administered for 3 days. No drug-related abnormalities in clinical pathology parameters were identified. No articular cartilage lesions were observed after examination of stifle joints from animals administered 25 mg/kg for 15 days.
A safety study was conducted in 23-day-old calves using doses of 5, 15 and 25 mg/kg for 15 consecutive days. No clinical signs of toxicity or changes in clinical pathology parameters were observed. No articular cartilage lesions were observed in the stifle joints at any dose level at 2 days and 9 days following 15 days of drug administration.
An injection site study conducted in feeder calves demonstrated that the formulation may induce a transient reaction in the subcutaneous tissue and underlying muscle. No painful responses to administration were observed.
Swine: A safety study was conducted in 32 pigs weighing approximately 57 kg (125 lb) using single doses of 5, 15, or 25 mg/kg daily for 15 consecutive days. Incidental lameness of short duration was observed in all groups, including the saline-treated controls. Musculoskeletal stiffness was observed following the 15 and 25 mg/kg treatments with clinical signs appearing during the second week of treatment. Clinical signs of lameness improved after treatment ceased and most animals were clinically normal at necropsy.
A second study was conducted in two pigs weighing approximately 23 kg (50 lb), treated with 50 mg/kg for 5 consecutive days. There were no clinical signs of toxicity or pathological changes.
An injection site study conducted in pigs demonstrated that the formulation may induce a transient reaction in the subcutaneous tissue. No painful responses to administration were observed.
STORAGE CONDITIONS:
Protect from direct sunlight. Do not refrigerate, freeze or store at or above 40°C (104°F). Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.
HOW SUPPLIED:
Baytril® 100:
Code: 08711170-023699 100 mg/mL 100 mL Bottle
Code: 08711278-032199 100 mg/mL 250 mL Bottle
Code: 80456115 100 mg/mL 500 mL Bottle
REFERENCES:
1.Hooper, D. C., Wolfson, J. S., Quinolone Antimicrobial Agents, 2nded, 59 - 75, 1993.
U.S. Patent No. 5,756,506
For customer service or to obtain product information, including a Material Safety Data Sheet, call 1-800-633-3796.
For medical emergencies or to report adverse reactions, call 1-800-422-9874.
November, 2012
80908653, R.3
©2011 Bayer HealthCare LLC
17656
Baytril® 100
Bayer, the Bayer Cross, and Baytril are registered trademarks of Bayer.
NADA 141-068, Approved by FDA
PRINCIPAL DISPLAY PANEL
Baytrilenrofloxacin INJECTION, SOLUTION
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