▪ 약물의 분류: 항생제, 퀴놀론계항균약제
▪ 임신부 약물등급(US FDA): C
▪ 임신부 안전 및 기형발생정보 :
Ofloxacin and other quinolones are avoided during pregnancy because of concerns about cartilage toxicity. We did not locate human data reporting such toxicity.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L2
▪ 모유수유 안전 및 유해성정보 :
Ofloxacin was found in human milk at concentrations about equal to those in maternal serum. In one woman who took a 500-mg dose of this agent for 5 days, the peak levofloxacin concentration in milk was 8.2 mcg/mL 5 hours after dosing. The exposure predicted by this concentration was estimated to be below that used clinically in pediatric patients. Although categorized as “usually compatible with breast feeding” in 2001 by the American Academy of Pediatrics, the administration of ofloxacin is not universally recommended in nursing women, primarily because of concerns about cartilage toxicity.
However, in a rat study, reported in abstract, cartilage damage was not detected in animals exposed to ofloxacin only through milk. The authors suggest that the calcium and magnesium content of milk might bind to the drug and inhibit its absorption. Other commentators have pointed out that the calcium and magnesium content of rat milk can be as much as eight times higher than that found in human milk, suggesting that similar protection might not occur if this agent is used during human lactation.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
오플록사신에 노출된 후 추적된 임신부는 총 130례이었으며 초기 노출 후 자연유산율은 6.9%(9/130)이었다. 임신 37주 이전의 조산률은 6.8%(8/117), 2,500 g 미만의 저체중증은
1.8%(2/114)이었다. 주요기형발생은 2.6%(3/114): right renal cysts(1), ileal agenesis(1), ASD with small PDA(1)가 있었다. 그리고 사산 1례가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 12쌍 중 부작용 사례는 없었다.