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[Clinical and pharmacokinetic studies on intravenous administration of sulbactam/ampicillin in pediatrics].

Intravenous administration of sulbactam/ampicillin (SBT/ABPC) was evaluated in pediatric patients. The serum half-lives of both ABPC and SBT were approximately 1 hour following the intravenous injection or intravenous drip infusion of 20-35 mg/kg, and 30-50% of ABPC and 30-70% of SBT were recovered in the urine 6 hours. Cerebrospinal fluid concentrations of ABPC and SBT were 0.76 and 0.68 micrograms/ml, respectively, at 1 hour after intravenous drip infusion of the 58 mg/kg, and concentration ratios of the drugs in cerebrospinal fluid/serum were 6.39 and 5.71%, respectively. Thirty-four pediatric patients were treated with intravenous drip infusion of SBT/ABPC in doses ranging from 54 to 150 mg/kg divided into 3 times a day. The rate of clinical efficacy was 93.5% and the bacterial elimination rate was 92.3%. The synergistic activity of sulbactam with ampicillin was demonstrated against beta-lactamase-producing Staphylococcus aureus and Haemophilus influenzae isolated from patients in the present study. The side effects of SBT/ABPC were observed in 6 patients (5 diarrheas; 1 diarrhea with vomiting) out of 34 patients administered. Eosinophilia (2 patients) and a slight elevation of GOT (1 patient), GPT and LDH (1 patient) were observed. The tolerance to the therapy, however, was good.