LABORATORY AND CLINICAL STUDIES OF SULTAMICILLIN IN PEDIATRIC FIELD

We have carried out laboratory and clinical studies on sultamicillin (SBTPC). The results are summarized as follows. SBTPC was given by oral administration to 2 children in a single dose at 5mg/kg and to 3 children in a single dose at 10mg/kg. After the oral administration, mean peak serum levels of ampicillin (ABPC) and sulbactam (SBT) obtained for the 2 dose levels were 1.91±1.34 and 2.06±1.06μ and 2.43±0.68 and 2.96±0.77μg/ml at 1 hour, respectively, and mean half-lives were 0.80±0.10 and 0.98±0.46 hour and 1.57±0.57 and 2.01±0.70 hours, respectively. SBTPC was given to 2 children in a single dose at 15mg/kg. After oral administration, the mean serum levels of ABPC and SBT at 30 minutes were 6.55±1.63 and 6.00±1.00μg/ml, and the mean half-lives were 0.90±0.13 and 0.82±0.16 hour. SBTPC was given to 1 child at a single dose of 20mg/kg. The peak serum levels of ABPC and SBT were 11.3 and 8.64μg/ml, and the half-lives were 0.87 and 0.92 hour. Mean urinary excretion rates of ABPC and SBT were 38.4±2.7 and 34.6±4.7%, 43.0±3.6 and 41.6±5.8%, 47.7±5.2 and 51.6±3.5% in 6 hours and 66.1 and 59.2% in 8 hours after oral administration of 5mg/kg, 10mg/kg, 15mg/kg and 20mg/kg, respectively. Treatment with SBTPC was made in 34 cases of pediatric bacterial infections; 2 cases of pharyngitis, 19 cases of tonsillitis, 2 cases of bronchitis, 3 cases of impetigo, 2 cases of staphylococcal skalded skin syndrome, 4 cases of urinary tract infection and 1 case each of pneumonia and scarlet fever. Results obtained were excellent in 20 cases, good in 13 cases and poor in 1 case. No significant side effect due to the drug was observed in any cases.