Abstract
We performed laboratory and clinical evaluation of S-1108 granules, a new oral cephalosporin antibiotic, in the pediatric field.
1. Pharmacokinetics of S-1108 was examined with 6 patients, at a dose of 4mg/kg that was orally ingested 30 minutes after meal.
Mean plasma concentrations at 30 minutes, 1, 2, 4, 6 and 8 hours after dose were 0.35, 0.63, 0.86, 0.75, 0.37 and 0.09μg/ml, respectively, with a half life of 1.14 hours. The urinary recoverry rate in the first 8 hours was 25.5%.
2. The clinical efficacy of S-1108 was evaluated in 31 patients with various infectious diseases. S-1108 was administered at doses ranging 2 to 4.2mg/kg/dosage, 3 times a day for 1/3 to 10 days. Clinical effects were excellent in 19, good in 12, with an efficacy rate of 100%. Bacteriologically, all causative organisms except two of Staphylococcus aureus and Haemophilus influenzae were eradicated, with an eradication rate of 80%.
As an adverse reaction, mild diarrhea was noted in 2 patients. Slight elevations of GOT and/ or GPT were noted in 2 patients. Only 1 child had difficulty ingesting the antibiotic preparation.
From the above results, we have concluded that S-1108 is a highly effective and safe for patients with various infectious diseases in the pediatric fields.
