Abstract
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.
