▪ 약물의 분류: 항히스타민제
▪ 임신부 약물등급(US FDA): C
▪ 임신부 안전 및 기형발생정보(Micromedex):
Based on experimental animal studies and human reports, triprolidine is not expected to increase the risk of congenital malformations.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L1
▪ 모유수유 안전 및 유해성정보(Micromedex):
Triprolidine is excreted in human milk in small amounts. In the one available study, the peak milk concentration occurred 1 to 2 h after dosing and the milk:plasma ratios calculated for two mothers after a single dose were 0.50 and 0.56. It was estimated that a nursing infant would ingest less than 1% of the single maternal dose. No side effects were reported in this paper in three infants exposed to maternal doses of 2.5 mg triprolidine and 60 mg pseudoephedrine.
An investigation that questioned women who used antihistamines for seasonal allergies or colds while lactating found that mothers noted irritability, drowsiness, or decreased sleep in their neonates in 22.6% of the study population. No side effect was serious enough for a mother to seek medical attention for the infant. In another study by these same investigators, minor adverse reactions that did not require medical attention were reported by 9.4% of the mothers using antihistamines. The most commonly observed effect in 6 of 8 reports was irritability.
Because of their anticholinergic effects, antihistamines may, in theory, reduce milk production. In spite of this theoretical concern, advice to women on the use of these agents can be based on the generally reassuring reports that have been published and on the available reports indicating that low amounts of this and other antihistamines appear in milk. If anticholinergic effects of antihistamines result in a decrease in milk supply, we would assume that such an effect would resolve on discontinuation of the medication, but again we are not aware of data on this question. If jitteriness or poor feeding develop in a nursing infant with maternal use of antihistamines, it would be reasonable to stop the medication or to switch to formula feeding and look for resolution of the infant`s symptoms, but it seems unlikely that a causal relationship between these symptoms and lactational exposure to antihistamines will occur very often.
We have not located references on possible male reproductive effects of this agent.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
트리프로리딘에 노출된 후 추적된 임신부는 총 144례이었으며 초기 노출 후 자연유산율은 4.8%(7/144)이었다. 임신 37주 이전의 조산률은 3.1%(4/131), 2,500 g 미만의 저체중증은 1.5%(2/131)이었다. 주요기형발생은 3.1%(4/131): ASD(1), upper gingival cyst(1), right liver mass(1), knee rigidity(1)가 있었다. 그리고 사산 1례가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 5쌍 중 부작용 사례는 없었다.