Temocillin. Summary of safety studies

Temocillin is a novel injectable beta-lactam antibiotic designed for parenteral use. It is active against the majority of Gram-negative bacteria and is stable to a wide range of beta-lactamases. Disposition and metabolic studies on temocillin in animals and man demonstrate that the drug is well distributed throughout the body tissues and will cross the placenta. The major route of elimination is via the kidney (89%) where the drug is excreted unchanged as parent compound, mainly by the glomerular filtration of unbound temocillin. A full toxicological safety evaluation programme has been completed and includes acute, subacute and chronic toxicology in rat and dog, and reproductive and mutagenicity studies. Temocillin was well tolerated in animals at dosages of up to 1000 mg/kg and appears to be without any potential hazard for man in dosages which are well in excess of the proposed therapeutic dose.