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[Laboratory and clinical studies of sultamicillin in pediatric field]
T Nishimura1, K Tabuki, S Aoki
1Department of Pediatrics, Osaka Medical College.
Insights
Sultamicillin (SBTPC) demonstrated favorable pharmacokinetics and high efficacy in pediatric bacterial infections. This antibiotic combination showed excellent or good results in 33 out of 34 cases with minimal side effects.
Area of Science:
- Pharmacology
- Microbiology
- Pediatrics
Context:
- Sultamicillin (SBTPC) is an oral antibiotic prodrug.
- Pediatric bacterial infections require effective and safe treatment options.
Purpose:
- To evaluate the pharmacokinetics of sultamicillin (SBTPC) following oral administration in children.
- To assess the clinical efficacy and safety of sultamicillin (SBTPC) in treating pediatric bacterial infections.
Summary:
- Laboratory and clinical studies were conducted on sultamicillin (SBTPC). Pharmacokinetic parameters including peak serum levels and half-lives of ampicillin (ABPC) and sulbactam (SBT) were determined at various oral doses (5-20 mg/kg).
- Urinary excretion rates of ABPC and SBT were also measured. Clinical efficacy was evaluated in 34 pediatric patients with diverse bacterial infections, including tonsillitis, pharyngitis, and urinary tract infections.
- Treatment outcomes were categorized as excellent, good, or poor, with a high overall success rate. No significant adverse effects were reported.
Impact:
- Provides essential pharmacokinetic data for sultamicillin (SBTPC) in pediatric populations.
- Demonstrates the clinical effectiveness and favorable safety profile of sultamicillin (SBTPC) for treating common pediatric bacterial infections.
- Supports the use of sultamicillin (SBTPC) as a viable therapeutic option in pediatric infectious disease management.
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 5 mg/kg and to 3 children in a single dose at 10 mg/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 +/- 1.06 micrograms/ml and 2.43 +/- 0.68 and 2.96 +/- 0.77 micrograms/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 15 mg/kg. After oral administration, the mean serum levels of ABPC and SBT at 30 minutes were 6.55 +/- 1.63 and 6.00 +/- 1.00 micrograms/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 20 mg/kg. The peak serum levels of ABPC and SBT were 11.3 and 8.64 micrograms/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 5 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/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.