[Experimental and clinical studies of an ampicillin suppository (KS-R1) in pediatrics]

Area of Science:

• Pharmacology
• Pediatric Medicine
• Infectious Diseases

Background:

• Ampicillin (ABPC) is a crucial antibiotic for treating bacterial infections in children.
• Rectal drug administration offers an alternative route for pediatric patients, especially those with swallowing difficulties or gastrointestinal issues.
• Assessing the pharmacokinetic profile and clinical efficacy of novel drug formulations is essential for pediatric care.

Observation:

• Blood ampicillin levels were measured in pediatric patients with heart disease following rectal administration of KS-R1 (125 mg and 250 mg).
• Pharmacokinetic data revealed specific ABPC concentrations and half-lives in different age groups (1-4 years and 7-10 years).
• Clinical observations noted an 87% effective rate (excellent and good) in 55 pediatric patients with infections.

Findings:

• Rectal KS-R1 achieved average blood ampicillin levels ranging from 6.8 to 0.1 mcg/ml within 4 hours in younger children and 5.2 to 0.1 mcg/ml in older children.
• The half-life of ampicillin was approximately 0.64-0.65 hours, indicating rapid absorption and elimination.
• Bacteriological analysis showed eradication of 74% of isolated strains, with diarrhea as the most common side effect (3 cases).

Implications:

• Rectal KS-R1 provides a potentially effective and safe method for delivering ampicillin in pediatric patients, particularly those with heart conditions.
• The study supports the use of rectal formulations for improving antibiotic adherence and therapeutic outcomes in pediatric populations.
• Further research could explore optimal dosing and long-term efficacy of rectal KS-R1 in diverse pediatric groups.