Drug utilization review of arbekacin sulfate injection in children

Abstract

As a part of post-marketing surveillance, a prospective drug use investigation was conducted. Although application children is not included in the indications, administration of arbekacin (ABK) to 720 evaluable cases was found in children. Among them, 596 children were suffering from septicemia or pneumonia caused by MRSA, the indicated illnesses. Drug utilization in these cases was analyzed. Underlying diseases were examined as background factors in patients: 66.6% of patients with septicemia and 70.9% of those with pneumonia had underlying diseases. Details of the underlying diseases were examined in 191 patients with septicemia and 219 patients with pneumonia. These patients were found to have multiple serious underlying diseases represented. by ventricular septal defect, hypoxic encephalopathy, respiratory distress syndrome, necrotic enteritis, and low birth weight. All of the 596 patients were examined for MRSA, and MRSA was isolated from 83.3% of the septicemia cases and 80.3% of the pneumonia cases. Mixed infection of MRSA and Pseudomonas aeruginosa or other organisms was found in 13.8% of the septicemia cases and 23.0% of the pneumonia cases. Concomitant use of ABK with other antibiotics was found in 90.9% of the septicemia cases and 90.0% of the pneumonia cases. Concomitantly used antibiotics were cephems, imipenem and penicillins in most cases. The efficacy was 73.5% for septicemia and 71.2% for pneumonia. Regarding safety, the prevalence and the types of adverse reactions were similar to those observed in adults and the elderly. No child-specific symptoms were found. The results suggested the importance of appropriate dose adjustment for newborns and infants whose renal function is not well developed, as a problem common to all aminoglycosides.