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Enrofloxacin

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This page reprints a manufacturer label. Everything below in quotation marks is copied from BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA Norbrook Laboratories Limited Norbrook Laboratories Limited Enrofloxacin 100 enrofloxacin enrofloxacin enrofloxacin arginine butyl alcohol benzyl alcohol water covetrus ® Approved by FDA under ANADA # 200-495 Enrofloxacin 100 Injection (enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution For Subcutaneous Use In Beef Cattle And Non-Lactating Dairy Cattle For Intramuscular Or Subcutaneous Use In Swine 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. To assure responsible antimicrobial drug use, enrofloxacin should only be used as a second-line drug for colibacillosis in swine following consideration of other therapeutic options. PRODUCT DESCRIPTION:, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA Norbrook Laboratories Limited Norbrook Laboratories Limited Enrofloxacin 100 enrofloxacin enrofloxacin enrofloxacin arginine butyl alcohol benzyl alcohol water covetrus ® Approved by FDA under ANADA # 200-495 Enrofloxacin 100 Injection (enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution For Subcutaneous Use In Beef Cattle And Non-Lactating Dairy Cattle For Intramuscular Or Subcutaneous Use In Swine 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. To assure responsible antimicrobial drug use, enrofloxacin should only be used as a second-line drug for colibacillosis in swine following consideration of other therapeutic options. PRODUCT DESCRIPTION: by BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA, a enrofloxacin product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 23 other stored labels carry the same active ingredient and are listed at the end.

The label

Product: BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA Norbrook Laboratories Limited Norbrook Laboratories Limited Enrofloxacin 100 enrofloxacin enrofloxacin enrofloxacin arginine butyl alcohol benzyl alcohol water covetrus ® Approved by FDA under ANADA # 200-495 Enrofloxacin 100 Injection (enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution For Subcutaneous Use In Beef Cattle And Non-Lactating Dairy Cattle For Intramuscular Or Subcutaneous Use In Swine 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. To assure responsible antimicrobial drug use, enrofloxacin should only be used as a second-line drug for colibacillosis in swine following consideration of other therapeutic options. PRODUCT DESCRIPTION:. Manufacturer: BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA. FDA Structured Product Label set id e130df06-e2ae-47cd-884a-fb38b93f2077. Label effective 2026-04-29. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

Cattle - Single-Dose Therapy: Enrofloxacin 100 Injection 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-DayTherapy: Enrofloxacin 100 Injection 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: Enrofloxacin 100 Injection 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. Enrofloxacin 100 injection is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage and Administration

Enrofloxacin 100 Injection provides flexible dosages and durations of therapy. Enrofloxacin 100 Injection may be administered as a single dose for one day for treatment and control of BRD (cattle), for treatment and control of SRD or for control of colibacillosis (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. Cattle: Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single 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 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, by subcutaneous injection, a single 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 for 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 dehorning). Exposure within the prior 72 hours to animals showing clinical signs of BRD. Administered dose volume should not exceed 20 mL per injection site. Table 1 - Enrofloxacin 100 Injection Dose and Treatment Schedule for Cattle* *Dose volumes have been rounded to the nearest 0.5 mL within the dose range. Treatment Control Weight (lb) 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, either by intramuscular or subcutaneous (behind the ear) injection, a single 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. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated. Table 2- Enrofloxacin 100 Injection Dose Schedule for Swine Weight (lb) Dose Volume (mL) 15 0.5 30 1.0 50 1.7 100 3.4 150 5.1 200 6.8 250 8.5 Dilution of Enrofloxacin 100 Injection: Enrofloxacin 100 Injection may be diluted with sterile water prior to injection. The diluted product should be used within 24 hours. Store diluted solution in amber glass bottles between 4-40°C (36-104°F). Table 3 - Dilution Schedule* *For 1 mL dose volume from diluted solution Swine weight mL of Enrofloxacin 100 Injection mL of sterile water Number of doses 10 lb 34 mL 66 mL 100 15 lb 51 mL 49 mL 100 20 lb 68 mL 32 mL 100 25 lb 85 mL 15 mL 100 100 mL vial: Use within 30 days of first puncture and puncture a maximum of 36 times. When using a needle or draw-off spike larger than 16 gauge, discard any remaining product immediately after use. 250 mL and 500 mL vials: Use within 30 days of first puncture. Puncture a maximum of 36 times with a needle or dosage delivery device 16 gauge or smaller, or 4 times with a draw-off spike 5 mm or smaller. When using a needle larger than 16 gauge, or a draw-off spike larger than 5 mm, discard any remaining product immediately after use. RESIDUE WARNINGS: Cattle: Animals 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. 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, to obtain a copy of the Safety Data Sheet (SDS) or to report adverse reactions, call Covetrus ® North America at (855) 724-3461.

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 in cattle or swine, or intramuscular injection in swine, can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter. Enrofloxacin 100 Injection contains different excipients than other enrofloxacin 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. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), call Covetrus ® North America at (855) 724-3461. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1 -888-FDA-VETS or online at www.fda.gov/reportanimalae. 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.

Storage

Protect from direct sunlight. Do not refrigerate or freeze. Store below 77°F(25°C). Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming enrofloxacin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 4,021 reports

Reactions most often coded in dogs, 4,021 reports
VeDDRA reaction termReports
Vomiting816
Lethargy (see also Central nervous system depression in 'Neurological')496
Anorexia427
Death by euthanasia397
Other abnormal test result NOS348
Death339
Diarrhoea318
Ataxia253
Elevated alanine aminotransferase (ALT)249
Seizure NOS248
Lack of efficacy - NOS239
Fever234
Leucocytosis NOS233
Decreased appetite193
Weight loss192

Outcome as recorded by the reporter: Outcome Unknown 923; Recovered/Normal 859; Ongoing 689; Died 398; Euthanized 369; Recovered with Sequela 51.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

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