Efficacy, pharmacology, and safety of amdinocillin in treatment of neonates.
One hundred and nine neonates with complications conducive to lethal infections were investigated to determine the efficacy, pharmacokinetics, and safety of amdinocillin. Of these 109 neonates, 70 were participants in the clinical study and 39 in the pharmacokinetic study. Amdinocillin (40 mg/kg per day) and penicillin (60,000 units/kg per day) were administered separately in divided doses by intramuscular injection at six-hourly intervals for five days. Amdinocillin/penicillin proved to be a safe and effective alternative to gentamicin/penicillin; no adverse reactions were noted nor did the regimen adversely affect renal or hepatic function. Throughout the treatment period, amdinocillin maintained high therapeutic serum levels. Resistance to amdinocillin did not develop during treatment.