소아에서의 Ciprofloxacin 사용 현황 및 안전성 평가
Drug Use Evaluation of Ciprofloxacin focused on Adverse Drug Reactions
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Background : Ciprofloxacin is a second-generation of fluoroquinolone antibiotic. The most recent reported and considered adverse drug reactions (ADRs) for children were the musculoskeletal ADRs, thus, in 2009, Korea Food & Drug Administration (KFDA) designated the ciprofloxacin as age-limited drugs for those under 18 years old. On the other hand, FDA approved ciprofloxacin for treatments of complicated urinary tract infections and pyelonephritis in children. Despite the KFDA’s designation of age-limited drugs, the use of ciprofloxacin for children has not been decreased and is not frequently used. Objective : This study was conducted in order to evaluate the patterns of ciprofloxacin by focusing on ADRs and providing information for the safety of ciprofloxacin in Korea. Method : We conducted a retrospective study by involving children who were treated with ciprofloxacin between July 1, 2009 and June 30, 2011 at Seoul National University Hospital. Results : A total of 195 children with a median age of 11 years old were being studied, of whom 116 (60.0%) were males. The mean dose of ciprofloxacin was 20.5mg/kg/day which was within a recommendable range. The most common comorbidities were Crohn’s diseases and hematooncology diseases such as leukemia and blastoma. Indications were divided into two groups,“prophylactic”(110 children) and “therapeutic”(69 children). Most patients in the “prophylactic”group changed from ciprofloxacin to other antibiotics due to high fevers, and 40 out of 69patients in the“ therapeutic”group had clinical successes. 17 out of 195 patients took the diagnostic tests for etiologic organisms where Enterococcus species were mostly documented. ADRs were also evaluated, and 14 patients were reported with ADRs. Nausea and vomiting were the most common types of ADRs and one patient was reported with arthropathy. Conclusion : This study confirmed that ciprofloxacin has been used to a large extent even though the KFDA designated ciprofloxacin as age-limited drugs, and one patient in this study was reported with arthropathy. We thus recommend that drug monitoring of ciprofloxacin for pediatric patients should be intensively conducted by healthy professionals .
Abstract
Background : Ciprofloxacin is a second-generation of fluoroquinolone antibiotic. The most recent reported and considered adverse drug reactions (ADRs) for children were the musculoskeletal ADRs, thus, in 2009, Korea Food & Drug Administration (KFDA) designated the ciprofloxacin as age-limited drugs for those under 18 years old. On the other hand, FDA approved ciprofloxacin for treatments of complicated urinary tract infections and pyelonephritis in children. Despite the KFDA’s designation of age-limited drugs, the use of ciprofloxacin for children has not been decreased and is not frequently used. Objective : This study was conducted in order to evaluate the patterns of ciprofloxacin by focusing on ADRs and providing information for the safety of ciprofloxacin in Korea. Method : We conducted a retrospective study by involving children who were treated with ciprofloxacin between July 1, 2009 and June 30, 2011 at Seoul National University Hospital. Results : A total of 195 children with a median age of 11 years old were being studied, of whom 116 (60.0%) were males. The mean dose of ciprofloxacin was 20.5mg/kg/day which was within a recommendable range. The most common comorbidities were Crohn’s diseases and hematooncology diseases such as leukemia and blastoma. Indications were divided into two groups,“prophylactic”(110 children) and “therapeutic”(69 children). Most patients in the “prophylactic”group changed from ciprofloxacin to other antibiotics due to high fevers, and 40 out of 69patients in the“ therapeutic”group had clinical successes. 17 out of 195 patients took the diagnostic tests for etiologic organisms where Enterococcus species were mostly documented. ADRs were also evaluated, and 14 patients were reported with ADRs. Nausea and vomiting were the most common types of ADRs and one patient was reported with arthropathy. Conclusion : This study confirmed that ciprofloxacin has been used to a large extent even though the KFDA designated ciprofloxacin as age-limited drugs, and one patient in this study was reported with arthropathy. We thus recommend that drug monitoring of ciprofloxacin for pediatric patients should be intensively conducted by healthy professionals .
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