Ceftiofur

Indications

Cattle NAXCEL Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. NAXCEL Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . Swine NAXCEL Sterile Powder is indicated for treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis . Sheep NAXCEL Sterile Powder is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida . Goats NAXCEL Sterile Powder is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. Horses NAXCEL Sterile Powder is indicated for treatment of respiratory infections in horses associated with Streptococcus zooepidemicus. Dogs NAXCEL Sterile Powder is indicated for the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis. Day-Old Chicks NAXCEL Sterile Powder is indicated for the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks. Day-Old Turkey Poults NAXCEL Sterile Powder is indicated for the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.

Dosage and Administration

Cattle Administer to cattle by intramuscular or subcutaneous injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner's judgement of severity of disease (i.e., for respiratory disease, extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite; and for foot rot, extent of swelling, lesion and severity of lameness). Swine Administer to swine by intramuscular injection at the dosage of 1.36 to 2.27 mg ceftiofur per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Sheep Administer to sheep by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner's judgement of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite). Goats Administer to goats by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24‑hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner's judgement of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite). Pharmacokinetic data indicate that elimination of the drug is more rapid in lactating does. For lactating does, the high end of the dose range is recommended. Horses Administer to horses by intramuscular injection at the dosage of 1.0 to 2.0 mg ceftiofur per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lbs body weight). A maximum of 10 mL may be administered per injection site. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days. Dogs Administer to dogs by subcutaneous injection at the dosage of 1.0 mg ceftiofur per pound (2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24-hour intervals for 5-14 days. Reconstituted NAXCEL Sterile Powder is to be administered to dogs by subcutaneous injection. No vial closure should be entered more than 20 times. Therefore, only the 1 gram vial is approved for use in dogs. Day-Old Chicks Administer by subcutaneous injection in the neck region of day-old chicks at the dosage of 0.08 to 0.20 mg ceftiofur/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks. Reconstituted NAXCEL Sterile Powder is to be administered by subcutaneous injection only. A sterile 26 gauge needle and syringe or properly cleaned automatic injection machine should be used. Day-Old Turkey Poults Administer by subcutaneous injection in the neck region of day-old turkey poults at the dosage of 0.17 to 0.5 mg ceftiofur/poult. One mL of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults. Reconstituted NAXCEL Sterile Powder is to be administered by subcutaneous injection only.

Contraindications

As with all drugs, the use of NAXCEL Sterile Powder is contraindicated in animals previously found to be hypersensitive to the drug.

Warnings

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth, and clothing. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product. 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. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.

Precautions

The effects of ceftiofur on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined. Cattle Following subcutaneous administration of ceftiofur sodium in the neck, small areas of discoloration at the site may persist beyond five days, potentially resulting in trim loss of edible tissues at slaughter. As with any parenteral injection, localized post-injection bacterial infections may result in abscess formation. Attention to hygienic procedures can minimize their occurrence. Swine The safety of ceftiofur has not been determined for swine intended for breeding. Horses The safety of ceftiofur has not been determined for horses intended for breeding. The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhea that could be fatal. If acute diarrhea is observed, discontinue use of this antimicrobial and initiate appropriate therapy. Dogs The safety of ceftiofur has not been determined for dogs intended for breeding, or pregnant dogs.

Adverse Reactions

The use of ceftiofur may result in some signs of immediate and transient local pain to the animal. CLINICAL MICROBIOLOGY Summaries of MIC data are presented in Tables 1 and 2. Testing followed Clinical and Laboratory Standards Institute (CLSI) Guidelines. Table 1. Ceftiofur MIC Values of Bacterial Isolates from Clinical Field Studies in the USA Animal Organism Number Tested Date Tested MIC 90 Minimum inhibitory concentration (MIC) for 90% of the isolates. (μg/mL) MIC Range (μg/mL) Bovine Mannheimia haemolytica 461 1988-1992 0.06 ≤ 0.03-0.13 Mannheimia haemolytica 42 1993 0.015 ≤ 0.003-0.03 Pasteurella multocida 318 1988-1992 0.06 ≤ 0.03-0.25 Pasteurella multocida 48 1993 ≤ 0.003 ≤ 0.003-0.015 Histophilus somni 109 1988-1992 0.06 ≤ 0.03-0.13 Histophilus somni 59 1993 ≤ 0.0019 no range Fusobacterium necrophorum 17 1994 ≤ 0.06 no range Swine Actinobacillus pleuropn. 83 1993 ≤ 0.03 ≤ 0.03-0.06 Pasteurella multocida 74 1993 ≤ 0.03 ≤ 0.03-0.06 Streptococcus suis 94 1993 0.25 ≤ 0.03-1.0 Salmonella choleraesuis 50 1993 1.0 1.0-2.0 beta-hemolytic Streptococcus spp. 24 1993 ≤ 0.03 ≤ 0.03-0.06 Actinobacillus suis 77 1998 0.0078 0.0019-0.0078 Haemophilus parasuis 76 1998 0.06 0.0039-0.25 Sheep Mannheimia haemolytica 39 1992 0.13 ≤ 0.03-0.13 Pasteurella multocida 23 1992 ≤ 0.03 no range Canine Escherichia coli 44 1992 4.0 0.06-64.0 Escherichia coli 18 1990 0.25 0.13-0.5 Proteus mirabilis 17 1990 ≤ 0.06 ≤ 0.06-0.5 Proteus mirabilis 23 1992 1.0 ≤ 0.06-4.0 Turkey Escherichia coli 1204 1995 1.0 0.13->32.0 Table 2. Ceftiofur MIC Values of Bacterial Isolates from Diagnostic Laboratories in the USA and Canada The following in vitro data are available but their clinical significance is unknown. Animal Organism Number Tested Date Tested MIC 90 Minimum inhibitory concentration (MIC) for 90% of the isolates. (μg/mL) MIC Range (μg/mL) Bovine Mannheimia haemolytica 110 1997-1998 0.06 ≤ 0.03-0.25 Mannheimia haemolytica 139 1998-1999 ≤ 0.03 ≤ 0.03-0.5 Mannheimia haemolytica 209 1999-2000 ≤ 0.03 ≤ 0.03-0.12 Mannheimia haemolytica 189 2000-2001 ≤ 0.03 ≤ 0.03-0.12 Pasteurella multocida 107 1997-1998 ≤ 0.03 ≤ 0.03-0.25 Pasteurella multocida 181 1998-1999 ≤ 0.03 ≤ 0.03-0.5 Pasteurella multocida 208 1999-2000 ≤ 0.03 ≤ 0.03-0.12 Pasteurella multocida 259 2000-2001 ≤ 0.03 ≤ 0.03-0.12 Histophilus somni 48 1997-1998 ≤ 0.03 ≤ 0.03-0.25 Histophilus somni 87 1998-1999 ≤ 0.03 ≤ 0.03-0.125 Histophilus somni 77 1999-2000 ≤ 0.03 ≤ 0.03-0.06 Histophilus somni 129 2000-2001 ≤ 0.03 ≤ 0.03-0.12 Bacteroides fragilis group 29 1994 16.0 ≤ 0.06->16.0 Bacteroides spp., non- fragilis group 12 1994 16.0 0.13->16.0 Peptostreptococcus anaerobius 12 1994 2.0 0.13-2.0 Swine Actinobacillus pleuropn. 97 1997-1998 ≤ 0.03 no range Actinobacillus pleuropn. 111 1998-1999 ≤ 0.03 ≤ 0.03-0.25 Actinobacillus pleuropn. 126 1999-2000 ≤ 0.03 ≤ 0.03-0.06 Actinobacillus pleuropn. 89 2000-2001 ≤ 0.03 ≤ 0.03-0.06 Pasteurella multocida 114 1997-1998 ≤ 0.03 ≤ 0.03-1.0 Pasteurella multocida 147 1998-1999 ≤ 0.03 ≤ 0.03-0.5 Pasteurella multocida 173 1999-2000 ≤ 0.03 ≤ 0.03-0.06 Pasteurella multocida 186 2000-2001 ≤ 0.03 ≤ 0.03-0.12 Streptococcus suis 106 1997-1998 0.5 ≤ 0.03-4.0 Streptococcus suis 142 1998-1999 0.25 ≤ 0.03-1.0 Streptococcus suis 146 1999-2000 0.06 ≤ 0.03-4.0 Streptococcus suis 167 2000-2001 0.06 ≤ 0.03-4.0 Salmonella choleraesuis 96 1999-2000 1.0 0.03->4.0 Salmonella choleraesuis 101 2000-2001 1.0 0.5-2.0 Equine Streptococcus equi subsp. equi 12 1994 ≤ 0.0019 no range Streptococcus equi subsp. equi 29 2002 ≤ 0.03 ≤ 0.03-0.05 Streptococcus zooepidemicus 48 1994 ≤ 0.0019 no range Streptococcus zooepidemicus 59 2002 ≤ 0.03 ≤ 0.03-0.25 Rhodococcus equi 66 1998 4.0 ≤ 0.03-16.0 Rhodococcus equi 42 2002 8.0 ≤ 0.03->32.0 Bacteroides fragilis group 32 1995 >16.0 0.13->16.0 Bacteroides spp., non- fragilis group 12 1995 4.0 0.25-4.0 Fusobacterium necrophorum 16 1995 ≤ 0.06 no range Canine Escherichia coli 26 2000 32 0.25->32 Proteus mirabilis 14 2000 0.25 0.06-0.25 Turkey Escherichia coli 17 1998-1999 1.0 0.25-1.0 Escherichia coli 25 1999-2000 0.50 0.12-0.5 Escherichia coli 20 2000-2001 2.0 0.12-16.0 Citrobacter spp. 37 1995 32.0 0.5->32.0 Enterobacter spp. 51 1995 >32.0 0.13->32.0 Klebsiella spp. 100 1995 1.0 0.13-2.0 Proteus spp. 19 1995 1.0 0.06-32.0 Pseudomonas spp. MIC 50 is 32 μg/mL 31 1995 >32.0 0.06->32.0 Salmonella spp. 24 1995 1.0 0.5-1.0 Staphylococcus spp. (coagulase positive) 17 1995 2.0 1.0-2.0 Staphylococcus spp. (coagulase negative) 26 1995 8.0 0.13->32.0 Chicken Escherichia coli 62 1997-1998 0.50 0.25-2.0 Escherichia coli 53 1998-1999 4.0 0.25->4.0 Escherichia coli 67 1999-2000 0.50 0.12-16.0 Escherichia coli 90 2000-2001 1.0 ≤ 0.03-8.0 Based on the pharmacokinetic studies of ceftiofur in swine and cattle after a single intramuscular injection of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (swine) or 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (cattle) and the MIC and disk (30 μg) diffusion data, the following breakpoints are recommended by CLSI. Zone Diameter (mm) MIC (μg/mL) Interpretation ≥ 21 ≤ 2.0 (S) Susceptible 18-20 4.0 (I) Intermediate ≤ 17 ≥ 8.0 (R) Resistant A report of "Susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of "Intermediate" is a technical buffer zone and isolates falling into this category should be retested. Alternatively the organism may be successfully treated if the infection is in a body site where drug is physiologically concentrated. A report of "Resistant" indicates that the achievable drug concentrations are unlikely to be inhibitory and other therapy should be selected. Based on the pharmacokinetic studies of ceftiofur in horses after a single intramuscular injection of 1 mg ceftiofur equivalents/lb (2.2 mg/kg) BW, clinical effectiveness data and MIC data, the following breakpoint is recommended by CLSI. Zone Diameter (mm) MIC (μg/mL) Interpretation ≥ 22 ≤ 0.25 (S) Susceptible The susceptible only category is used for populations of organisms (usually one species) for which regression analysis (disk vs. MIC) cannot be performed. These breakpoints will permit detection of strains with decreased susceptibility as compared to the original population. Standardized procedures Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard – Second Edition. NCCLS document M31-A2. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, 2002. require the use of laboratory control organisms for both standardized diffusion techniques and standardized dilution techniques. The 30 μg ceftiofur sodium disk should give the following zone diameters and the ceftiofur sodium standard reference powder (or disk) should provide the following MIC values for the reference strain. Ceftiofur sodium disks or powder reference standard is appropriate for both ceftiofur salts. Table 3. Acceptable quality control ranges for ceftiofur against Clinical and Laboratory Standards Institute recommended American Type Culture Collection (ATCC) reference strains Organism Name (ATCC Number) Zone Diameter All testing performed using a 30μg disk. (mm) MIC Range (μg/mL) Escherichia coli (25922) 26–31 0.25–1.0 Staphylococcus aureus (29213) — 0.25–1.0 Staphylococcus aureus (25923) 27–31 — Pseudomonas aeruginosa (27853) 14–18 16.0–64.0 Actinobacillus pleuropneumoniae (27090) 34–42 Quality control ranges are applicable only to tests performed by disk diffusion test using a chocolate Mueller-Hinton agar, incubated in 5-7% CO 2 for 20-24 hours. 0.004–0.015 MIC quality control ranges are applicable only to tests performed by broth microdilution procedures using veterinary fastidious medium (VFM). Histophilus somni (700025) 36–46 0.0005–0.004

Description

NAXCEL Sterile Powder contains the sodium salt of ceftiofur which is a broad spectrum cephalosporin antibiotic active against gram-positive and gram-negative bacteria including β-lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal in vitro , resulting from inhibition of cell wall synthesis. Each mL of the reconstituted drug contains ceftiofur sodium equivalent to 50 mg ceftiofur. The pH was adjusted with sodium hydroxide and monobasic potassium phosphate. Chemical Structure of Ceftiofur Sodium Chemical Name of Ceftiofur Sodium 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)(methoxyimino)-acetyl]amino]-3-[[(2-furanylcarbonyl)thio] methyl]-8-oxo-, monosodium salt, [6R-[6α,7β(Z)]]- Chemical Structure RECONSTITUTION OF THE STERILE POWDER NAXCEL Sterile Powder should be reconstituted as follows: 1 gram vial— Reconstitute with 20 mL Sterile Water for Injection. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur. 4 gram vial— Reconstitute with 80 mL Sterile Water for Injection. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur. Shake thoroughly prior to use.

Storage

Store unreconstituted product at controlled room temperature 20° to 25° C (68° to 77° F). Store reconstituted product either in a refrigerator 2° to 8° C (36° to 46° F) for up to 7 days or at controlled room temperature 20° to 25° C (68° to 77° F) for up to 12 hours. Protect from light. Color of the cake may vary from off-white to a tan color. Color does not affect potency. ONE-TIME SALVAGE PROCEDURE FOR RECONSTITUTED PRODUCT At the end of the 7-day refrigeration or 12-hour room temperature storage period following reconstitution, any remaining reconstituted product may be frozen for up to 8 weeks without loss in potency or other chemical properties. This is a one-time only salvage procedure for the remaining product. To use this salvaged product at any time during the 8-week storage period, hold the vial under warm running water, gently swirling the container to accelerate thawing, or allow the frozen material to thaw at room temperature. Rapid freezing or thawing may result in vial breakage. Any product not used immediately upon thawing should be discarded.

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 ceftiofur 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.