Ceftiofur Hydrochloride is an antibiotic drug used to treat certain infections in animals such as horses, cows, goats, sheep and pigs. It is indicated for the treatment of infections like shipping fever, pneumonia, urinary tract infections, and bovine interdigital necrobacillosis.
Ceftiofur sodium (Naxcel or Excenel sterile powder, Pharmacia & Upjohn Animal Health) is approved worldwide for the treatment of respiratory disease in beef cattle, dairy cattle, swine and horses. Ceftiofur Hydrochloride Injection is a ready-to-use formulation that has been approved for the treatment of swine and bovine respiratory disease (BRD). Dose recovery, drug distribution in tissues, residual concentrations, and metabolites are similar regardless of which ceftiofur salt is used.
Experience with BRD treatment suggests that ceftiofur is very safe in cattle, including lactating dairy cows, but should not be given to animals previously found to be allergic to the compound. This experience also provides an opportunity to monitor the emergence of resistance in respiratory pathogens. Since the drug was first marketed in 1988, many studies have shown no resistance to ceftiofur in the target pathogens (Mycoplasma haemolyticum, Pasteurella multocida, and Haemophilus sleepyticus).
To determine the efficacy and optimal dosage of ceftiofur in the treatment of hoof rot, seven well-controlled studies were conducted prior to obtaining approval for the use of ceftiofur in the treatment of hoof rot. These seven studies consisted of two dose titration studies to firstly assess the suitability of the model to test the treatment regimen and to determine the duration of treatment after provocation, and secondly to assess the two dose levels of ceftiofur at which treatment was initiated immediately after the onset of clinical signs of disease.
After determining that 1.0 mg CE/kg was effective for the treatment of hoof rot in these initial trials, this dose was subsequently compared with placebo and a positive control (hygromycin) for the treatment of induced and naturally occurring hoof rot in dairy and beef cattle under a variety of management conditions at multiple sites in the United Kingdom, United States, Canada, and France.
Ceftiofur Hydrochloride was used in one study; Ceftiofur sodium was used in all other studies. Ceftiofur was given by intramuscular injection in all but one (dose titration) study, and in one of these studies the product was given by subcutaneous injection.Both routes of injection have been determined to be interchangeable with regard to efficacy and target animal and human safety.