Florfenicol and flunixin

Indications

nixiFLOR™ is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis , and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

Dosage and Administration

nixiFLOR™ should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated. For the 500 mL vial, do not puncture the stopper more than 20 times. * Do not administer more than 10 mL at each site. nixiFLOR™ Dosage Guide

Contraindications

Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.

Warnings

WARNINGS: NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains material that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, contact Parnell at 1-800-887-2763. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Precautions

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully monitored. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that have not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of florfenicol and flunixin meglumine with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored. Flunixin is a cyclo-oxygenase inhibitory NSAID, and as with others in this class, adverse effects may occur with its use. The most frequently reported adverse effects have been gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported for other drugs in this class. Not for use in animals intended for breeding purposes. The effects of florfenicol and flunixin meglumine on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. NSAIDs are known to have potential effects on both parturition and the estrous cycle. There may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of the estrous cycle. Studies have associated the use of flunixin in cattle with a delay in parturition and prolonged labor (which may increase the risk of stillbirth), and interference with involution and expulsion of fetal membranes (which may increase the risk for placental retention and metritis). Florfenicol and flunixin meglumine, when administered as directed, may induce a transient reaction at the site of injection and underlying tissues that may result in trim loss of edible tissue at slaughter. Residual Warning Image

Adverse Reactions

Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle. In cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use of flunixin meglumine.

Description

nixiFLOR™ is an injectable solution of the synthetic antibiotic florfenicol and the non-steroidal anti-inflammatory drug (NSAID) flunixin. Each milliliter of sterile nixiFLOR™ contains 300 mg florfenicol, 16.5 mg flunixin as flunixin meglumine, 300 mg 2-pyrrolidone, 35 mg malic acid, and triacetin qs.

Storage

Do not store above 30°C (86°F). Use within 28 days of first puncture and puncture a maximum of 20 times. Consider using automatic injection equipment or a repeater syringe. When using a needle or draw-off spike larger than 16 gauge, discard any remaining product immediately after use.

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 florfenicol and flunixin 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.