▪ 약물의 분류: 각성제
▪ 임신부 약물등급(US FDA): C

▪ 임신부 안전 및 기형발생정보 :
Caffeine intake in humans does not appear to increase the risk of congenital anomalies. There are conflicting data on whether caffeine is associated with an increased risk of miscarriage or a decrease in birth weight. The studies suggesting these adverse effects identify 200-300 mg/day (equivalent to about 2-3 cups of coffee or 4-6 cans of cola) as the dose above which toxicity might occur.

▪ 모유수유부 약물등급(Medication and Mother’s MilK): L2

▪ 모유수유 안전 및 유해성정보 :
Caffeine is excreted in human milk but milk caffeine concentrations are only about 1% of maternal plasma concentrations. The half-life of caffeine in the milk was 4 hours. Because newborn
biotransformation of caffeine is limited, even small regular doses of caffeine might produce clinically significant plasma concentrations. Although the American Academy of Pediatrics classified caffeine among drugs that are usually compatible with breastfeeding, the possibility of infant irritability or sleep disturbances was noted. A prospective cohort study examined 885 infants born to mothers with documented caffeine intake during pregnancy and the first 3 months of breastfeeding. Nearly 20% were considered to be heavy consumers (at least 300 mg/day) during pregnancy and 14.3% were heavy consumers 3 months postpartum. No association was seen with nighttime awakening in the infants at 3 months of age. The accidental exposure of a premature infant to a high dose of caffeine (300 mg/kg) was associated with irritability, tachycardia, tachypnea, diuresis, electrolyte abnormalities, hyperglycemia, and metabolic acidosis, but these symptoms resolved over a period of 96 hours with only supportive treatment. No long-term effect was noted.

▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):

1) 기형발생정보
카페인에 노출된 후 추적된 임신부는 총 510례이었으며 초기 노출 후 자연유산율은 7.7%(39/510)이었다. 임신 37주 이전의 조산률은 5.1%(23/450), 2,500 g 미만의 저체중증은 2.9%(13/450)이었다. 주요기형발생은 2.2%(10/450): two skin tags right ear with left ear abnormality(1), bilateral inguinal hernia(1), dysplastic kidney left with megaureter(1), nasolacrimal duct obstruction with
ptosis(1), upper gingival cyst(1), PDA(1), micro penis with small right testis(1), right hydronephrosis(1), cleft palate(1), choledochal cyst(1)가 있었다. 그리고 사산 3례가 있었다.

2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 6쌍 중 부작용 사례는 없었다.

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