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[Clinical evaluation of cefroxadine dry syrup in children (author's transl)]
Insights
Cefroxadine dry syrup, a new oral cephalosporin antibiotic, demonstrated high clinical efficacy in children with common infections, achieving a 91.4% success rate. This palatable antibiotic is recommended at 10 mg/kg, 3-4 times daily.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Antibiotic resistance necessitates novel therapeutic agents.
- Oral cephalosporins are widely used for pediatric infections.
- Cefroxadine is a new oral cephalosporin antibiotic.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of cefroxadine dry syrup in pediatric patients.
- To determine the pharmacokinetic profile of cefroxadine in children.
- To establish an appropriate dosage regimen for cefroxadine in pediatric use.
Main Methods:
- Pharmacokinetic study in 3 children receiving a single oral dose (10 mg/kg).
- Clinical efficacy evaluation in 36 pediatric patients with various infections (23.1–44.4 mg/kg/day in divided doses).
- Adverse reactions and palatability were also assessed.
Main Results:
- Cefroxadine achieved peak blood concentrations within 30-60 minutes (16.9–18.2 µg/ml), with levels decreasing by 4 hours.
- An overall efficacy rate of 91.4% was observed in 35 patients, with an 88.9% causative organism eradication rate.
- Adverse reactions were generally mild and transient, with good palatability reported.
Conclusions:
- Cefroxadine dry syrup is a potent and effective oral antibiotic for treating common pediatric infections.
- The recommended dosage for children is 10 mg/kg, administered 3 to 4 times daily.
- Cefroxadine offers a favorable safety profile and palatability for pediatric use.
Abstract:
Clinical efficacy of cefroxadine dry syrup, a new oral cephalosporin antibiotic, was evaluated in children, and the following results were obtained. 1. Three children were given a single oral dose of about 10 mg/kg of the drug when fasting, and its blood concentrations were determined. Blood concentrations were maximum at 30 approximately 60 minutes, i.e., 16.9 approximately 18.2 microgram/ml, and markedly low at 4 hours. 2. Thirty-six patients with the following diseases were tested with 23.1 approximately 44.4 mg/kg/day of the drug in 3 to 4 divided doses; 21 patients with lacunar tonsillitis, 2 with tonsillitis, 1 with scarlet fever, 4 with bronchitis and tonsillitis, 2 with cystitis, 4 with pyelonephritis, 1 with impetigo and 1 with probable Mycoplasma pneumonia. An overall efficacy rate in 35 patients excluding the last mentioned case was 91.4%, i.e., excellent in 20, good in 12 and poor in 3, and an eradication rate of the causative organisms was 88.9%. 3. Adverse reactions noted were diarrhea in 1 patient, eruption and diarrhea in 1 transient neutropenia in 1, eosinophilia in 3 and an elevation of GOT and GPT in 1. None were significant. 4. Taste and flavor of the drug was considered to be well palatable to children. 5. Taking into consideration of the results of fundamental evaluation of the drug, cefroxadine dry syrup is considered to be a potent new antibiotic in children, and the recommended dose will be 10 mg/kg 3 to 4 times a day.