Abstract |
SY5555 is a new oral penem antibiotic. Pharmacokinetic and clinical studies using SY5555 dry syrup ( powder which is dissolved before use) were performed in pediatric patients. 1. Pharmacokinetic investigation Peak plasma concentrations of SY5555 after dose of 5 mg/kg, 10 mg/kg and 15 mg/kg were, respectively, 1.58 +/- 0.37 micrograms/ml, 2.78 +/- 0.54 micrograms/ml and 5.28 micrograms/ml at 1 hour. The average half-life with 5 mg/kg administration was 0.94 +/- 0.05 hours, that with 10 mg/kg was 1.46 +/- 0.31 hours and that with 15 mg/kg was 0.88 hours. 2. Clinical investigation Enrolled in the study were 15 patients including 5 with acute otitis media, 5 with urinary tract infections and 1 each with pharyngitis, tonsillitis, bronchitis, pneumonia and subcutaneous abscess. Responses were excellent in 4 patients, good in 8 patients, fair in 2 patients and poor in 1 patient. In the assessment of the bacteriological efficacy, 8 out of 10 strains of organism identified previous to treatment were eradicated and 2 strains were unchanged, hence the eradication rate was 80.0%. 3. No adverse reactions attributable to the drug were observed and good drug compliance were obtained. From the above results, it has been concluded that SY5555 is a highly effective and safe agent for mild to moderate respiratory and urinary tract infections in children.
|
Authors | Y Harada, T Matsumoto, Y Tsuji, I Gondou, N Kobayashi, K Hayashi, T Uchida, Y Uehara, T Kido, T Fukuda |
Journal | The Japanese journal of antibiotics
(Jpn J Antibiot)
Vol. 48
Issue 2
Pg. 261-70
(Feb 1995)
ISSN: 0368-2781 [Print] Japan |
PMID | 7745815
(Publication Type: Clinical Trial, English Abstract, Journal Article)
|
Chemical References |
|
Topics |
- Administration, Oral
- Bacterial Infections
(drug therapy, microbiology)
- Carbapenems
(administration & dosage, pharmacokinetics)
- Child
- Child, Preschool
- Female
- Humans
- Infant
- Male
|