Regulatory product record
CEFTIOFUR SODIUM FOR INJECTION
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- CEFTIOFUR SODIUM FOR INJECTION
- DIN
- 02412284
- DPD drug code
- 89683
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- INTRAMUSCULAR, SUBCUTANEOUS
- Pharmaceutical form(s)
- POWDER FOR SOLUTION
- Ingredients
- CEFTIOFUR (CEFTIOFUR SODIUM) (50 MG)
- Species (DPD record)
- DOGS
- Company
- BIO AGRI MIX LP (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 89683
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications7
BRD, footrot, metritis (label); Excede single-dose depot
CattleOn-label (ON_LABEL)1 source record · View provenance
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: BRD, footrot, metritis (label); Excede single-dose depot — Authorized (label)
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Respiratory infections, susceptible gram-negatives; foal infections; intrauterine infusion (extra-label)
HorseOn-label (ON_LABEL)1 source record · View provenance
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Respiratory infections, susceptible gram-negatives; foal infections; intrauterine infusion (extra-label) — Authorized (respiratory label)
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Respiratory disease label dosing
SwineOn-label (ON_LABEL)1 source record · View provenance
- Swine · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Respiratory disease label dosing — Authorized
- Swine · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Susceptible infections (extra-label UTI/sepsis)
DogCatExtra-label (EXTRA_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Susceptible infections (extra-label UTI/sepsis) — Extra-label
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Susceptible infections (extra-label UTI/sepsis) — Extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Mannheimia haemolytica Pasteurella multocida, Histophilus somni EXCEDE Sterile Suspension is indicated for treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with,andin beef, non-lactating dairy, and lactating dairy cattle. M. haemolytica P. multocida, H. somni EXCEDE Sterile Suspension is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with,and. Fusobacterium necrophorum Porphyromonas levii EXCEDE Sterile Suspension is also indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated withandin beef, non-lactating dairy, and lactating dairy cattle. EXCEDE Sterile Suspension is also indicated for treatment of acute metritis (0-10 days post-partum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens12
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects208
Hypersensitivity (rash→anaphylaxis; 1–15% penicillin cross-reactivity, human estimate) — Class
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Acute diarrhea (potentially fatal under stress) — The equine class warning
HorseNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Injection-site reactions — IM/SC
CattleSwineNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Swine · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Granulocytopenia/thrombocytopenia (rare) — Label-possible
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
ANIMAL SAFETY Intra-arterial injection may occur during administration of EXCEDE Sterile Suspension via middle third of the ear injection or base of the ear injection directed towards the opposite eye. Intra-arterial injection of EXCEDE Sterile Suspension is likely to result in sudden death of the animal. During the conduct of clinical studies, there was a low incidence of acute death (see) confirmed to be the result of inadvertent intra-arterial injection. No other adverse systemic effects were noted for either the antibiotic or formulation during any of the clinical and target animal safety studies.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Vomiting23 reports
- Death17 reports
- Lethargy (see also Central nervous system depression in 'Neurological')14 reports
- Anaemia NOS13 reports
- Leucocytosis NOS12 reports
- Other abnormal test result NOS12 reports
- Anorexia11 reports
- Death by euthanasia10 reports
- Depression10 reports
- Elevated serum alkaline phosphatase (SAP)10 reports
- Diarrhoea9 reports
- Elevated blood urea nitrogen (BUN)9 reports
Cat
- Death10 reports
- Anaemia NOS9 reports
- Fever8 reports
- Diarrhoea7 reports
- Anorexia6 reports
- Lack of efficacy (bacteria) - NOS6 reports
- Vomiting6 reports
- Dehydration5 reports
- Dyspnoea4 reports
- Elevated alanine aminotransferase (ALT)4 reports
- Not drinking4 reports
- Respiratory distress4 reports
Monitoring1
Clinical response; GI signs in horses; injection sites; residue/withdrawal compliance in food animals
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications4
Cephalosporin hypersensitivity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
As with all drugs, the use of EXCEDE Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
EXCEDE Sterile Suspension is contraindicated in horses with known allergy to ceftiofur or to ß-lactam (penicillins and cephalosporins) group antimicrobials. Due to the extended exposure in horses, based on the drug's pharmacokinetic properties, adverse reactions may require prolonged care.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
As with all drugs, the use of EXCEDE FOR SWINE Sterile Suspension 100 mg/mL is contraindicated in animals previously found to be hypersensitive to the drug.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions11
Penicillin-allergic patients (cross-reactivity); FDA judicious-use pressure on cephalosporins in food animals — extra-label dairy use prohibited (class regulatory note)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
One ear injection = a week of drug (Excede): the CFA depot changed cattle BRD logistics — and made injection-site placement (posterior ear) a regulatory requirement, not a suggestion.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
The equine stress-diarrhea warning rides every systemic antimicrobial decision in horses — ceftiofur included despite its mild-fecal-flora study.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolite identity: you measure desfuroylceftiofur, not parent — susceptibility reports say "ceftiofur" meaning the metabolite complex.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Food-animal cephalosporin politics: FDA's judicious-use agenda makes extra-label dairy ceftiofur a legal landmine — label-only territory.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions2
Aminoglycosides — Synergy potential (class)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Bacteriostatics — Antagonism theoretical
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics6
Mechanism — 3rd-gen cephalosporin — active metabolite desfuroylceftiofur; gram-negative-strong spectrum
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
CFA depot — Crystalline free acid = sustained-release weeks-class depot from one ear injection
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Horse caution — Antimicrobials + equine stress → acute potentially-fatal diarrhea (class warning); one study: minimal fecal-flora effect at 4 mg/kg IM
HorseNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
® ® 90 Pasteurella multocida, Mannheimia haemolytica Histophilus somni Ceftiofur administered as either ceftiofur sodium (NAXCELSterile Powder), ceftiofur hydrochloride (EXCENELRTU Sterile Suspension), or ceftiofur crystalline free acid (EXCEDE Sterile Suspension) is metabolized rapidly to desfuroylceftiofur, the primary metabolite. Subcutaneous administration of ceftiofur crystalline free acid, either in the middle third of the posterior aspect of the ear (middle third of the ear, MOE) of beef and non-lactating dairy cattle, or in the posterior aspect of the ear where it attaches to the head (base of the ear, BOE) of beef, non-lactating dairy, and lactating dairy cattle, provides therapeutic concentrations of ceftiofur and desfuroylceftiofur-related metabolites in plasma above the lowest minimum inhibitory concentration to encompass 90% of the most susceptible isolates (MIC) for the labeled BRD pathogens,and, for generally not less than 150 hours after a single administration (See Figure 8).
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
® Ceftiofur is a beta-lactam antibiotic from the cephalosporin class. Beta lactams exert their inhibitory effect by interfering with bacterial cell wall synthesis. This interference is primarily due to its covalent binding to the penicillin-binding proteins, which are essential for synthesis of the bacterial wall. Ceftiofur administered as either ceftiofur sodium (NAXCELSterile Powder) or ceftiofur crystalline free acid (EXCEDE Sterile Suspension) is rapidly metabolized to desfuroylceftiofur, the primary metabolite with antimicrobial activity. Two intramuscular injections of EXCEDE Sterile Suspension at a dose of 6.6 mg/kg body weight in the horse provide concentrations of ceftiofur and desfuroylceftiofur related metabolites in plasma above the therapeutic target of 0.2 µg/mL for the entire 96 hour (4 day) dosing interval and for 6 days after the second injection (or a total of 10 days from the beginning of treatment) (see Figure 2 and Table 3). Figure 2. Average plasma concentration of ceftiofur and desfuroylceftiofur related metabolites in horses following the intramuscular administration of either EXCEDE Sterile Suspension at a dose of 3.0 mg/lb (6.6 mg/kg) administered twice at a 96 hour interval or NAXCEL Sterile Powder at a dose of 1.0 mg/lb (2.2 mg/kg BW) once daily for 10 consecutive days. Table 3. Pharmacokinetic parameters measured after either two intramuscular injections of EXCEDE Sterile Suspension at a dose of 3.0 mg/lb (6.6 mg/kg) BW at a 96 hour interval or NAXCEL Sterile Powder at a dose of 1.0 mg/lb (2.2 mg/kg) BW once daily for 10 consecutive days are summarized in the following table. PK Parameter CCFA-SS at 6.6 mg/kg BW administered twice 96 h apart (Mean ± SD; n=12) Ceftiofur sodium at 2.2 mg/kg BW once daily for 10 days (Mean ± SD; n=11) 0-∞ AUC(µg∙h/mL) 157 (19.1) 353 (44.9) >0.2 t(h) 262 (29.0) ND Dose 1 Dose 2 Dose 1 Dose 10 max T(h) 21.6 (5.8) 15.6 (6.3) 1 2.0 (3.3) max C(µg/mL) 0.78 (0.19) 1.0 (0.24) 4.31 ± 0.78 3.99 (1.23)
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Label statements per product; cephalosporin class generally low-risk.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 227–235 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references16
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Combined chitosan and baicalein promote mammary involution during early dry period in dairy cows.
Study summary not available in the imported record. Open the original citation to review the study.
- Dual population-level processes contribute to polyclonal ceftiofur heteroresistance in swine-derived Escherichia coli.
Study summary not available in the imported record. Open the original citation to review the study.
- Genomic Characterization of Multidrug-Resistant Escherichia coli from Bovine Mastitis and Therapeutic Evaluation of Thanatin Combined with Gallium Nitrate.
Study summary not available in the imported record. Open the original citation to review the study.
- Veterinary-specific breakpoints for ceftiofur applicable to canine Escherichia coli.
Study summary not available in the imported record. Open the original citation to review the study.
- Antimicrobial Resistance in Escherichia coli From Diagnostic Fecal and Uterine Samples of Swine in Northern Vietnam.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.