▪ 약물의 분류: 진통제
▪ 임신부 약물등급(US FDA): C
▪ 임신부 안전 및 기형발생정보 :
Based on experimental animal studies, use of tramadol during pregnancy is not expected to increase the risk of congenital anomalies. There are case reports of withdrawal in a newborn after habitual maternal tramadol use during pregnancy.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L3
▪ 모유수유 안전 및 유해성정보 :
Tramadol and its active metabolite O-desmethyltramadol were excreted in human milk. Seventy-five mothers who were 2 to 4 days postpartum provided 3 milk samples from both breasts during the 6 hours following a dose of 100 mg of oral tramadol after taking at least 4 doses. The average milk concentration of tramadol was 748 mcg/L (range 681-815 mcg/L), and the average milk concentration of Odesmethyltramadol was 203 mcg/L (range 188-217 mcg/L). These values translated to an average infant dosage of 112 and 30 mcg/kg daily of the drug and metabolite, respectively. An exclusively breastfed infant would receive maternal weight-adjusted dosages of 2.24% of tramadol and 0.64% of its metabolite. This dose would represent roughly 3% of a typical intravenous newborn dosage. A subsequent study of this population evaluated drug transport/excretion in human milk and estimated infant exposure. The mean estimated relative infant doses in extensive and poor CYP2D6 metabolizers, respectively, were 2.16 and 2.60% for tramadol and 0.93 and 0.47% for the metabolite. In 2017, the FDA recommended against the use of tramadol during breastfeeding because of the theoretical risk of infant respiratory suppression.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
트라마돌에 노출된 후 추적된 임신부는 총 141례이었으며 초기 노출 후 자연유산율은 6.3%(9/141)이었다. 임신 37주 이전의 조산률은 2.3%(3/128), 2,500 g 미만의 저체중증은 1.6%(2/124)이었다. 주요기형발생은 0.8%(1/124): VSD with aortic stenosis(1)가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 4쌍 중 부작용 사례는 없었다.