Abstract
Pharmacokinetic and clinical evaluation of an injectable cephem antibiotics, cefozopran (SCE-2787, CZOP), was conducted in newborn patients and the following results were obtained:
1. Clinical results
The clinical efficacy of CZOP was evaluated in one each patient with intrauterine infection and suspected septicemia. The efficacy was“excellent”in both patients. No clinically serious adverse drug reactions of signs and symptoms and abnormal alterations of the laboratory test values were recognized.
2. Pharmacokinetics
CZOP was intravenously given to newborn patients at doses of 25.0, 20.0 and 18.75 mg/kg. The blood CZOP concentrations were 44.7±7.0μg/ml (n=3), 48.3μg/ml and 48.2μg/ml at one hour after administration, respectively. The elimination half life (T 1/2) was 4.22±1.17 hours (n=3) in the patients given 25.0 mg/kg and 2.74 hours in the patient given 20.0 mg/kg.
The urinary drug excretion rate was 44.58.7% and 31.3±9.7% of dose within 8 hours after administration of 25.0 mg/kg and 20.0 mg/kg, respectively.
