Toxicity and reproduction studies of ceftizoxime sodium.

Sodium (6R,7R)-7-[(Z)-2-(2-amino-4-thiazoyl)-methoxyiminoacetamido]-8-oxo-5-thia-1-azabicyclo[4,2,0] oct-2-ene-2-carboxylate (ceftizoxime sodium), a new semisynthetic cephalosporin derivative, was tested for acute toxicity in various laboratory animal species, nephrotoxicity in rabbits, subacute and chronic toxicity in rats and dogs, and effect on fertility and teratogenicity in rats and rabbits. The i.v. LD50 values of ceftizoxime sodium in mice and rats were around 6000 mg/kg, and no deaths occurred in dogs after the largest dose of 3200 mg/kg. There was no evidence of nephrotoxicity of ceftizoxime sodium in rabbits after an i.v. dose of 1000 mg/kg. Clear-cut changes in subacute and chronic toxicity studies of ceftizoxime sodium were local damage at the injection site and its secondary reactions, although reversible peripheral anemia was observed in one female dog given 1000 mg/kg i.v. In the reproduction studies, ceftizoxime sodium had no adverse effects on fertility or fetal development in rats or rabbits.