▪ 약물의 분류: 진정제
▪ 임신부 약물등급(US FDA): D
▪ 임신부 안전 및 기형발생정보 :
Experimental animal studies did not show an increase in birth defects except with very high dose level exposure. Human studies have given mixed results. Withdrawal symptoms may occur after pregnancy or lactation exposure to benzodiazepines.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L3
▪ 모유수유 안전 및 유해성정보 :
Alprazolam is transferred to human milk A milk:plasma ratio of about 0.4 was calculated for this agent from data collected from four lactating women. Infants exposed to alprazolam in utero and through human milk may experience transient withdrawal symptoms of irritability and restlessness when exposure to this sedative is terminated. In a retrospective survey of 124 mothers who might have taken a benzodiazepine in pregnancy, all of whom took a benzodiazepine while nursing, there were several women whose infants were exposed to alprazolam during lactation. One mother reported sedation in the infant after she took alprazolam 0.25 mg/day twice while also taking sertraline 50 mg/day and zopiclone 2.5 mg every 3 days. The American Academy of Pediatrics classifies alprazolam as a drug for which the effects on the nursing infant are not known but might be of concern.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
알프라졸람에 노출된 후 추적된 임신부는 총 85례이었으며 초기 노출 후 자연유산율은 14.1%(12/85)이었다. 임신 37주 이전의 조산률은 4.3%(3/69), 2,500 g 미만의 저체중증은 6.0%(4/67)이었다. 주요기형발생은 6.0%(4/67): polydactyly of left foot(1), both leg stiffness(1), cyst of palate(1), PDA(1)가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 1쌍 중 부작용 사례는 없었다.