▪ 약물의 분류: 면역억제제
▪ 임신부 약물등급(US FDA): C
▪ 임신부 안전 및 기형발생정보 :
Prednisone can be associated with fetal growth impairment in humans. Some glucocorticoids increase oral clefting in experimental animals and might do so in humans as well.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L2
▪ 모유수유 안전 및 유해성정보 :
When administered to lactating women, small amounts of prednisone and its active metabolite prednisolone will enter milk. For maternal doses of prednisolone larger than 20 mg/day, some clinicians have recommended that mothers wait at least 4 hours before nursing. Even at 80 mg/day, however, the amount secreted in breast milk would be equivalent to less than 10% of a nursing infant`s endogenous cortisol production, and it is unlikely that such a dose would produce clinically significant effects. The American Academy of Pediatrics classified prednisone and prednisolone as compatible with breastfeeding. A 2013 report from The National Transplantation Pregnancy Registry included 124 women with transplants who safely breastfed 169 infants while taking prednisone for as long as 48months. The depot injection of high doses of other corticosteroids in joints for tenosynovitis has been reported to cause temporary reduction of milk supply.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
프레드니솔론에 노출된 후 추적된 임신부는 총 287례이었으며 초기 노출 후 자연유산율은 6.2%(18/287)이었다. 임신 37주 이전의 조산률은 3.8&(10/262), 2,500 g 미만의 저체중증은
2.3%(6/257)이었다. 주요기형발생은 4.3%(11/257): unilateral cleft lip and palate left side/bilateral clenched hands/ventricular septal defect(1), necrotizing enterocolitis with perforation(1), PDA(1), nevus(3×3 ㎝) on wrist(1), both hands polydactyly(1), hydrocele and left wrist drop(1), imperforate anus(1), hydronephrosis(1), PDA(2), PFO with VSD(1)가 있었다. 그리고 사산 1례가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 23쌍 중 졸음(1), 무른 변(1), 모유량 감소(1)가 있었다.