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[Experimental and clinical evaluation of an ampicillin suppository (KS-R1)]
Abstract:
The basic and clinical studies of ampicillin suppository (KS-R1) in pediatric infections were carried out, and the following results were obtained: For study of absorption and excretion of KS-R1, a single dose of 250 mg of KS-R1 was administered to 3 cases. The mean serum levels were obtained 4.10 +/- 1.55 micrograms/ml at 30 minutes, and 1.52 +/- 0.25 micrograms/ml, 0.38 +/- 0.04 micrograms/ml at 1 and 2 hours after rectal administration, respectively. The serum levels were not detectable after 4 hours in all cases. The half lives were 0.39, 0.54 hour and 0.44 hour, respectively. The mean urinary excretion rate to 6 hours was 14.8%. Clinical efficacy was evaluated in 17 cases with tonsillitis (15 cases), bronchitis (1 case) and scarlet fever (1 case). Good responses were obtained in 15 of 17 cases (88.2%). Bacteriological response in the form of eradication was noted in 4 of 5 cases. Side effects were examined with all of the 19 cases, and eosinophilia was observed in 1 case.
Insights
Ampicillin suppositories (KS-R1) show promising absorption and excretion profiles in pediatric patients. Clinical trials indicate high efficacy in treating common pediatric infections like tonsillitis.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacokinetics
- Clinical Pharmacology
Background:
- Ampicillin is a widely used antibiotic for bacterial infections.
- Rectal administration offers an alternative route for pediatric drug delivery.
- Evaluating novel drug formulations like suppositories is crucial for improving patient compliance and therapeutic outcomes.
Purpose of the Study:
- To assess the pharmacokinetic profile (absorption and excretion) of ampicillin suppository (KS-R1).
- To evaluate the clinical efficacy and safety of KS-R1 in treating pediatric infections.
- To determine the suitability of KS-R1 as a therapeutic option for children.
Main Methods:
- Pharmacokinetic study involving rectal administration of 250 mg KS-R1 to 3 pediatric cases.
- Measurement of serum ampicillin levels at various time points post-administration.
- Clinical evaluation of KS-R1 efficacy in 17 pediatric patients with tonsillitis, bronchitis, and scarlet fever.
- Monitoring for adverse effects in 19 cases.
Main Results:
- Mean peak serum ampicillin levels reached 4.10 µg/ml at 30 minutes, with detectable levels up to 4 hours.
- Mean urinary excretion rate within 6 hours was 14.8%.
- Clinical efficacy demonstrated a good response in 15 out of 17 cases (88.2%), with bacterial eradication in 4 out of 5 cases. Eosinophilia was noted in one case.
Conclusions:
- Ampicillin suppository (KS-R1) exhibits favorable absorption and excretion characteristics in pediatric patients.
- KS-R1 demonstrates high clinical efficacy and a generally good safety profile for treating common pediatric infections.
- Ampicillin suppositories represent a viable and effective treatment option for pediatric infections.