Clinical studies on sultamicillin fine granule in pediatric field

Pharmacokinetics, safety and effects on bacterial infection of sultamicillin (SBTPC) fine granule were evaluated in 17 children. The results obtained are summarized as follows. 1. Pharmacokinetics in 3 children receiving a single dose of 10 mg per kg body weight were evaluated. The half-life of ampicillin (ABPC) was 1.38 +/- 0.14 hours and that of sulbactam was 0.93 +/- 0.26 hour. 2. Fourteen cases, including 7 tonsillitis, 2 pharyngitis, 2 bronchitis, and 1 each of cystitis, scarlet fever and cellulitis were treated with SBTPC fine granule. The clinical efficacy rate was 100%. 3. Bacteriological efficacies classified by causative organisms were evaluated in 5 children. Staphylococcus aureus was responsible in 3 cases, Streptococcus pyogenes in 1 case, Escherichia coli and Proteus mirabilis in 1 case. Eradication rate was 100%. SBTPC was more active than ABPC against ABPC-resistant strains and almost equal to or more active than cephalexin or cefaclor. 4. The only abnormal laboratory test value observed was eosinophilia in 2 children. No side effects were recorded. From the above results it is concluded that SBTPC fine granule is one of first choices of effective, useful and safe antibiotics for the treatment of infections in pediatric field.