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[Clinical and pharmacokinetics evaluation of flomoxef in pediatrics]
H Higashino1, T Kobayashi, K Shuto
1Department of Pediatrics, Kansai Medical University.
Abstract:
Flomoxef (FMOX, 6315-S), a new parenteral oxacephem antibiotic was investigated for its clinical efficacy and pharmacokinetics. The results obtained are summarized below. 1. Twenty-eight patients were treated with 39-152 mg/kg per day of FMOX by intravenous administration. Diagnosis of patients were pneumonia in 15 patients, acute upper respiratory tract infection in 5, acute enterocolitis in 3, urinary tract infection in 2 and cholangitis, suppurative lymphadenitis and suspicious sepsis in 1 patient each. Clinical effect was excellent in 7 cases, good in 8, fair in 5, poor in 2 and 6 cases were excluded because therapy periods were too short and other antibiotics were used together. Efficacy rate was 68% and the rate of bacterial disappearance was 83%. 2. Rash was found in 5 cases and thrombocytosis was found in 1 out of 28 cases. However, no severe adverse reaction was encountered. 3. The peak serum level of FMOX was 51.0 micrograms/ml after 20 mg/kg of drip infusion for 30 minutes and the half-life was 17.2 minutes in alpha-phase and 58.2 minutes in beta-phase.
Insights
Flomoxef (FMOX), a novel oxacephem antibiotic, demonstrated a 68% efficacy rate in treating various infections, with an 83% bacterial disappearance rate. Mild adverse effects like rash were observed, but no severe reactions occurred.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Medicine
Context:
- Parenteral antibiotics are crucial for treating severe bacterial infections.
- Oxacephem antibiotics represent a class of beta-lactam antibiotics with potential for broad-spectrum activity.
- Evaluating new antibiotic agents is essential for combating antimicrobial resistance.
Purpose:
- To assess the clinical efficacy and pharmacokinetic profile of Flomoxef (FMOX), a new parenteral oxacephem antibiotic.
- To determine the effectiveness of FMOX in treating a range of bacterial infections.
- To evaluate the safety and tolerability of FMOX in a clinical setting.
Summary:
- Twenty-eight patients received intravenous FMOX (39-152 mg/kg/day) for infections including pneumonia, respiratory tract infections, and urinary tract infections.
- An overall clinical efficacy rate of 68% was observed, with a bacterial disappearance rate of 83%.
- Adverse events included rash (5 cases) and thrombocytosis (1 case), with no severe reactions reported. Peak serum levels reached 51.0 mcg/ml with a half-life of 17.2 minutes (alpha-phase) and 58.2 minutes (beta-phase).
Impact:
- Flomoxef shows promising clinical efficacy and favorable pharmacokinetic properties for treating bacterial infections.
- The safety profile suggests FMOX is generally well-tolerated, warranting further investigation.
- These findings contribute to the understanding of oxacephem antibiotics and their potential clinical applications.