▪ 약물의 분류: 소화성궤양용제
▪ 임신부 약물등급(US FDA): B
▪ 임신부 안전 및 기형발생정보
Based on experimental animal studies, famotidine is not expected to increase the risk of congenital anomalies. Human experience has been reassuring.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L1
▪ 모유수유 안전 및 유해성정보
Famotidine appeared in rat milk and the product labeling reported that growth impairment occurred in nursing pups when maternally toxic dose levels were given to the dams. These dose levels were 600 times the human dose. The labeling also stated that famotidine appeared in human milk. Although the package labeling warned against use of famotidine in nursing women, we have not identified data supporting this warning. Human milk:plasma ratios after 40 mg famotidine averaged 1.78 at 6 hours, when milk concentration peaked at 72 ng/mL. This concentration was similar to the peak plasma concentration of the mother; however, the plasma peak was hours earlier. The high milk:plasma ratio at 6 hours was due to famotidine being eliminated from plasma sooner than from milk, rather than from concentration of the drug in milk. Feeding a 5-1/2 pound newborn infant an ounce of milk containing peak concentrations of famotidine every 2 hours would result in a dose of about 0.01 mg/kg/day. This dose is about 2% on a weight-adjusted basis of the recommended adult dose of about 0.6 to 0.7mg/kg/day. An abstract reported that average concentrations of famotidine in milk samples from 7women given famotidine 40 mg/day for 3 days at 12 to 16 weeks postpartum were 53 and 55 ng/mL at3 and 6 hours after a dose. Famotidine has been used in newborn infants at dose levels higher than are transmitted in human milk.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
파모티딘에 노출된 후 추적된 임신부는 총 98례이었으며 초기 노출 후 자연유산율은 5.1%(5/98)이었다. 임신 37주 이전의 조산률은 2.2%(2/89), 2,500 g 미만의 저체중증은 2.3%(2/87)
이었다. 주요기형발생은 2.3%(2/87): renal mass(1), PDA(1)가 있었다. 그리고 사산 1례가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 2쌍 중 젖양변화 1례가 있었다.