임신부및수유부의다빈도노출약물 1. 건조수산화알류미늄겔 (Dried aluminum hydroxide gel) 약물의분류 : 제산제 임신부약물등급 (US FDA): B 임신부안전및기형발생정보 (Micromedex/Reprotox ): 검색안됨 모유수유부약물등급 (Medi

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1 임신부및수유부의다빈도노출약물 1. 건조수산화알류미늄겔 (Dried aluminum hydroxide gel) 약물의분류 : 제산제 임신부약물등급 (US FDA): B 임신부안전및기형발생정보 (Micromedex/Reprotox ): 검색안됨 검색안됨 수산화알류미늄되어추적된임신부는총 206 례이었으며초기노출후자연유산율은 5.3%(11/206) 이었다. 임신 37 주이전의조산률은 4.4%(8/183), 2,500 g 미만의저체중증은 3.9%(7/179) 이었다. 주요기형발생 1.1%(2/183): both fetal ankle deformity(1), right kidney segmental cystic dysplasia(1) 가있었다. 수유부와수유아 4 쌍중부작용없었다. 2. 겐타마이신 (Gentamicin) 약물의분류 : 항생제 임신부약물등급 (US FDA): D An increase in malformations was not seen in one epidemiology study of gentamicin. Ototoxicity and nephrotoxicity in the fetus are theoretical possibilities of gentamicin use during pregnancy but these adverse effects have not been documented clinically. 모유수유부약물등급 (Medication and Mother s MilK): L2 Gentamicin use during lactation results in inconsequential neonatal exposure.

2 겐타마이신에노출된후추적된임신부는총 123 례이었으며초기노출후자연유산율은 5.3%(9/123) 이었다. 임신 37 주이전의조산률은 3.6%(4/111), 2,500 g 미만의저체중증은 1.8%(2/111) 이었다. 주요기형발생은 2.7%(3/111): CCAM(1), ASD(1), complex anomaly(1) 가있었다. 수유부와수유아 14 쌍중젖양감소 1 례있었지만부작용사례는없었다. 3. 구아이페네신 (Guaifenesin) 약물의분류 : 진해거담제 Guaifenesin exposure during pregnancy was associated with inguinal hernia in one report, but no increase in congenital anomalies was identified in other studies. 모유수유부약물등급 (Medication and Mother s MilK): L3 정보없음 구아이페네신에노출된후추적된임신부는총 489 례이었으며초기노출후자연유산율은 6.3%(31/489) 이었다. 임신 37 주이전의조산률은 3.3%(15/449), 2,500 g 미만의저체중증은 2.7%(12/449) 이었다. 주요기형발생 1.8%(8/449): DHC 로 2 개월후사망 (1), PDA(1), ASD with PDA(1), braincyst(1), hydronephrosis(1), right fetal liver mass(1), left dysplastic kidney with megaureter(1) 가있었다. 수유부 - 수유아 57 쌍중 12 례의젖양감소가있었지만부작용은없었다. 4. 나프록센 (Naproxen) 약물의분류 : 해열, 진통, 소염제 임신부약물등급 (US FDA): C Naproxen use during pregnancy has been suggested to increase miscarriage risk. Some, but not all, epidemiology studies have associated pregnancy use of NSAIDs, including naproxen, with an increase in heart defect risk. Use of this medication in late pregnancy is avoided due to concerns about premature closure of the ductus arteriosus.

3 모유수유부약물등급 (Medication and Mother s MilK): L3 Naproxen therapy is compatible with breast feeding. 나프록센노출된후추적된임신부는총 93 례이었으며초기노출후자연유산율은 4.3%(4/93) 이었다. 임신 37 주이전의조산률은 1.2%(1/86), 2,500 g 미만의저체중증은 5.8%(5/86) 이었다. 주 요기형발생은 2.3%(2/86): necrotizing enterocolitis(1), PDA(1) 가있었다. 수유부와수유아 27 쌍중젖양감소 2 례있었지만부작용사례는없었다. 5. 덱사메타손 (Dexamethasone) 약물의분류 : 부신호르몬제 임신부약물등급 (US FDA): C Dexamethasone is a glucocorticoid. Glucocorticoid use during pregnancy has been associated with an increased risk of cleft palate and impaired fetal growth. 모유수유부약물등급 (Medication and Mother s MilK): L3 When administered to lactating women, small amounts of corticosteroids entered human milk (62-64). Although data on the use of dexamethasone during lactation were not located, the American Academy of Pediatrics classified the corticosteroids prednisone #1169 and prednisolone #1359 as compatible with breastfeeding. With prednisolone, some clinicians recommended that mothers wait at least 4 hours before nursing if they are taking unusually high doses of this corticosteroid. Dexamethasone administered subcutaneously to female rats during lactation at a dose level of 100 mcg/kg/day resulted in reduced serum testosterone, FSH, and LH in nursing male pups. There was a delay in sexual maturation and decreases in sperm counts in the offspring. 덱사메타손에노출된후추적된임신부는총 72 례이었으며초기노출후자연유산율은 2.8%(2/72) 이었다. 임신 37 주이전의조산률은 5.7%(4/69), 2,500 g 미만의저체중증은 2.9%(2/69) 이었다. 기형발생은소기형 (minor anomaly) 만 5.8%(4/69): club foot(1), nevus(2), single umbilical artery(1) 만있었다.

4 수유부 - 수유아 45 쌍중젖양감소 2 례이었지만부작용사례는없었다. 6. 덱스트로메토르판 (Dextromethorphan HBr) 약물의분류 : 모르피난 (morphinan) 계약물 임신부약물등급 (US FDA): C Epidemiology studies involving, in aggregate, about 600 dextromethorphan-exposed pregnancies have not identified an increase in congenital anomalies. 모유수유부약물등급 (Medication and Mother s MilK): L3 We have not located studies on possible lactation effects of this agent. 덱스트로메토르판에노출된후추적된임신부는총 233 례이었으며초기노출후자연유산율은 5.6%(13/233) 이었다. 임신 37 주이전의조산률은 3.7%(8/214), 2,500 g 미만의저체중증은 3.2%(7/214) 이었다. 주요기형발생은 1.4%(3/216): PDA(1), left dysplastic kidney(1), ASD(1) 가있었다. 수유부 - 수유아 9 쌍중부작용사례는없었다. 7. 덱시부프로펜 (Dexibuprofen((s)-ibuprofen)) 약물의분류 : 비스테로이드항염증제 (NSAIDs, nonsteroidal anti-inflammatory drug) 임신부약물등급 (US FDA): C An increased risk of miscarriage was associated with use of ibuprofen or naproxen #1152, particularly near the time of conception, but a reanalysis of the data weakened the association. Some, though not all, epidemiology studies have suggested that use of NSAIDs, including ibuprofen, during pregnancy might increase the risk of cardiac defects and gastroschisis. Use during late pregnancy is avoided due to concerns about premature ductal closure. 모유수유부약물등급 (Medication and Mother s MilK): L1

5 Ibuprofen therapy is compatible with breast feeding. 덱시이부프로펜에노출된후추적된임신부는총 176 례이었으며초기노출후자연유산율은 7.4%(13/176) 이었다. 임신 37 주이전의조산률은 4.4%(7/154), 2,500 g 미만의저체중증은 1.9%(3/154) 이었다. 주요기형발생은 3.8%(6/158): hydronephrosis(2), VSD(2), ASD(1), PDA(1) 가있 었다. 수유부 - 수유아 67 쌍중젖양감소 11 례있었지만부작용사례는없었다. 8. 독시사이클린 (Doxycycline) 약물의분류 : 항생제 임신부약물등급 (US FDA): D L3 Based on experimental animal studies and human reports, doxycycline is not anticipated to increase the risk of congenital anomalies. Doxycycline is avoided during pregnancy because other tetracyclines have been associated with transient suppression of bone growth and with staining of developing teeth. 모유수유부약물등급 (Medication and Mother s MilK): Among women taking 100 or 200 mg doxycycline orally, average milk doxycycline concentrations were ~0.8 mg/l at 2 and 3 hours and ~0.4 mg/l at 4, 6, and 24 hours. One study reported that peak doxycycline milk concentrations (0.96 mg/l) occurred between 2 and 4 hours after a 100-mg dose with a concentration of 1.8 mg/l after a 200-mg dose. A different study reported that peak milk concentrations likely occurred 5-7 hours after a dose; concentrations were 0.6 mg/l after a 100-mg dose and 1.1 mg/l after a 200-mg dose. It was estimated that an exclusively nursing infant would be exposed to approximately 6% of the maternal weight-adjusted dose of doxycycline. It is not known if these doses of doxycycline in milk would be large enough to cause dental staining or inhibition of bone growth, but such effects are theoretically possible. The WHO Working Group on Drugs and Human Lactation concluded that the use of this drug for a short (one week) period during breastfeeding is probably safe. Unlike other tetracyclines, however, the oral absorption of doxycycline is not substantially inhibited by food or milk. 독시사이클린에노출된후추적된임신부는총 71 례이었으며초기노출후자연유산율은 8.5%(6/71) 이었다. 임신 37 주이전의조산률은 3.0%(2/62), 2,500 g 미만의저체중증은 1.5%(1/66) 이었다. 주요기형발생은 3.0%(2/66): abdominal cyst(1), ASD(1) 가있었다.

6 수유부 - 수유아 3 쌍중부작용사례는없었다. 9. 돔페리돈 (Domperidone maleate) 약물의분류 : 구토방지제, 위장관운동촉진제, 젖분비촉진제 임신부약물등급 (US FDA): Not classified Domperidone caused abnormal embryo development at 200 mg/kg/day in rats. A study of 120 human pregnancy exposures did not suggest an increase in adverse outcome. The FDA has issued a warning against the use of this drug as a galactogogue. 모유수유부약물등급 (Medication and Mother s MilK): L1 Domperidone has been used to augment lactation in puerperal women who failed to establish an adequate milk supply. In June, 2009, the Food and Drug Administration issued a warning noting that the use of domperidone by lactating women is not an approved indication for the drug, and data on the intravenous use of domperidone indicate it has been associated with cardiac arrhythmias, cardiac arrest, and sudden death. At that time, FDA pursued compounding pharmacies in the US that were supplying the drug, but their efforts were not successful. When used as a galactagogue, a dose of 30 mg/day has been recommended. Available estimates indicate that blood concentrations of domperidone after oral use are much lower than those associated with intravenous intoxication. However, in some studies oral dosing was associated with abnormal QT intervals in mothers and infants, and the use of this agent is not recommended in lactating women with known cardiac disease. A 2010 report by Canadian physicians on 46 mothers of premature infants found this agent increased milk production by over 250% and was not associated with detectable adverse effects in mothers or infants. French investigators reported that the incidence of oral domperidoneinduced QTc prolongation in infants was most closely correlated with elevated serum potassium. They recommended the measurement of the QT interval before and after oral domperidone therapy. In rats, the drug enters milk in small amounts, with 0.2% of the maternal dose reaching the rat pups. Human milk samples contained 0.28 and 2.6 ng/ml when the drug was administered at a dose of 30 mg/day and 0.49 ng/ml after a dose of 60 mg/day, suggesting that the dose to a nursing infant would be well under 0.1% of the dose to the mother. In 2001, the American Academy of Pediatrics classified domperidone among drugs that are usually compatible with breastfeeding. 돔페리돈에노출된후추적된임신부는총 227 례이었으며초기노출후자연유산율은 5.5%(17/227) 이었다. 임신 37 주이전의조산률은 3.9%(8/206), 2,500 g 미만의저체중증은 3.4%(7/206) 이었다. 주요기형발생은 1.5%(3/206): ASD(1), fetal hydrops(1), left ear anomaly(1) 가있 었다.

7 수유부 - 수유아 33 쌍중젖양감소 2 례있었다. 하지만 1 례의수유부에서젖양은늘어났으며부 작용사례는없었다. 10. 디아제팜 (Diazepam) 약물의분류 : 벤조디아제핀 (Benzodiazepine) 계약물 임신부약물등급 (US FDA): D Diazepam increases the incidence of cleft palate in mice. Most human studies do not show an increase in cleft palate or other defects in babies exposed during pregnancy. A neonatal withdrawal syndrome has been described. It might be preferable to use benzodiazepines that are less likely to accumulate in the fetus and infant such as lorazepam (#1233) or clonazepam (#1384). 모유수유부약물등급 (Medication and Mother s MilK): L3 Diazepam and its major metabolite n-desmethyldiazepam enter human milk. The reported milk:plasma ratios ranged from 0.2 to 2.7. Three neonates exposed to diazepam at a maternal dose of 30 mg/day during breastfeeding showed no evidence of sedation despite mean infant serum diazepam concentrations of 172 ng/ml (day 4) and 74 ng/ml (day 6) and mean serum desmethyldiazepam concentrations of 243 ng/ml (day 4) and 31 ng/ml (day 6). A full-term healthy male infant who had been exposed to diazepam in utero and during lactation (maternal dose 6-10 mg/day) had a serum diazepam concentration of 0.7 ng/ml and a serum desmethyldiazepam concentration of 46 ng/ml at 1 month of age. The mother noted that the infant was sedated only if nursed within 8 hours after her dose, but development was reportedly normal at 3 months of age. A study of 9 mothers at least 1 month postpartum who were administered diazepam as part of general anesthesia for tubal sterilization concluded that the maximum infant exposure would be 3% of the maternal dose and that there was no need to suspend breastfeeding after this exposure. The repeated use of diazepam by nursing mothers is not recommended by some authors because this drug might accumulate in exposed infants, causing poor suckling or somnolence. According to Lactmed, a Brazilian study on the duration of breastfeeding among mothers taking a variety of medications found that some mothers taking diazepam discontinued breastfeeding because of drowsiness in their infants. By contrast, 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 no reports of infant sedation among the approximately 10 mothers who took diazepam during lactation. Many of the women in the study were also taking other medications.the WHO Working Group on Drugs and Human Lactation concluded that mothers receiving occasional small doses of diazepam can safely breastfeed. 디아제팜에노출된후추적된임신부는총 204 례이었으며초기노출후자연유산율은 6.9%(14/204) 이었다. 임신 37 주이전의조산률은 5.9%(11/186), 2,500 g 미만의저체중증은 3.2%(6/186) 이었다. 주요기형발생은 2.7%(5/186): ASD(1), ASD with PDA(1), Ileal agenesis(1),

8 polydactly, left foot(1), left preaxial polydactly(1) 가있었다. 수유부 - 수유아 1 쌍중부작용사례는없었다. 11. 디클로페낙 (Diclofenac) 약물의분류 : 비스테로이드항염증제 (NSAIDs) 임신부약물등급 (US FDA): C Based on experimental animal studies, inadvertent early pregnancy exposure to diclofenac is not expected to increase the risk of adverse pregnancy outcome. Human studies have produced inconsistent findings. Use during the third trimester might be associated with premature constriction of the ductus arteriosus. 모유수유부약물등급 (Medication and Mother s MilK): L2 Diclofenac therapy is compatible with breastfeeding. 디클로페낙에노출된후추적된임신부는총 122 례이었으며초기노출후자연유산율은 4.1%(5/122) 이었다. 임신 37 주이전의조산률은 3.5%(4/113), 2,500 g 미만의저체중증은 2.7%(3/113) 이었다. 주요기형발생은 2.7%(3/113): neck mass(1), PDA(1), right radial nerve palsy(1) 가 있었다. 수유부 - 수유아 4 쌍중젖양감소 1 례가있었다. 12. 라니티딘 (Ranitidine) 약물의분류 : 위산억제제 임신부약물등급 (US FDA): B Based on experimental animal studies and human reports, ranitidine is not expected to increase the risk of congenital anomalies. 모유수유부약물등급 (Medication and Mother s MilK): L2

9 Ranitidine is excreted in human milk. Rat studies suggested that that ranitidine is actively transported across mammary epithelial cells into rat milk. The available human data suggest that ranitidine might accumulate in human milk, with estimates of its milk:plasma ratio ranging from 0.6 to 24. The maximum dose ingested by the suckling infant might range from 6 to 12% of the maternal daily dose. The WHO Working Group on Human Lactation did not recommend the use of ranitidine during lactation without additional data characterize the extent of its accumulation in milk. 라니티딘에노출된후추적된임신부는총 257 례이었으며초기노출후자연유산율은 8.63%(22/257) 이었다. 임신 37 주이전의조산률은 2.6%(6/229), 2,500 g 미만의저체중증은 1.7%(4/229) 이었다. 주요기형발생은 1.7%(4/229): fetal dysmorphism(1), microtia(1), bilateral lacrimal duct cysts(1), undefined major anomaly(1) 가있었다. 수유부 - 수유아 18 쌍중젖양감소 2 례있었다. 13. 락토바실루스아시도필루스 (Lactobacillus acidophilus) 약물의분류 : 정장제 Use of Lactobacillus acidophilis in 127 human pregnancies was not associated with an increase in congenital anomalies. There is some evidence for increased risk of atopic sensitization in infants. 정보없음 락토바실러스에노출된후추적된임신부는총 38 례이었으며초기노출후자연유산율은 10.5%(4/38) 이었다. 임신 37 주이전의조산률은 6.5%(2/31), 2,500 g 미만의저체중증은 0.0% 이었 다. 주요기형발생은 6.5%(2/31): brain anomaly with seizure(1), left ear anomaly(1) 가있었다. 수유부 - 수유아 7 쌍중부작용사례는없었다. 14. 레바미피드 (Rebamipide)

10 약물의분류 : 소화성궤양용제 ( 위점막보호제, 궤양치료제, 위염치료제 ) 정보없음 정보없음 레바미피드에노출된후추적된임신부는총 152 례이었으며초기노출후자연유산율은 6.6%(10/152) 이었다. 임신 37 주이전의조산률은 5.8%(8/139), 2,500 g 미만의저체중증은 3.7%(5/134) 이었다. 주요기형발생은 3.0%(4/134): polydactly(1), unilateral cleft lip(1), small ASD with small PDA(1), left ear anomaly(1) 가있었다. 수유부 - 수유아 14 쌍중젖양감소 1 례있었다. 15. 레보노르게스트렐 (Levonorgestrel) 약물의분류 : 피임제 임신부약물등급 (US FDA): X Based on limited human experience with norgestrel and larger experience with oral contraceptives #1162, pregnancy exposure to norgestrel is considered unlikely to increase the risk of non-genital malformations. (*Special note: Dr. Anthony Scialli, Director of the Reproductive Toxicology Center, has testified in levonorgestrel-related litigation.) Norgestrel is excreted in human milk in small amounts. Based on available reports, the WHO Working Group on Drugs and Human Lactation estimated that a nursing infant would ingest a daily dose of 1.3% to 2.6% of the weight-adjusted daily dose of norgestrel. An estimated maximum figure for nursing exposure to maternal norgestrel was placed at 9%. In addition, newborns might not absorb norgestrel efficiently. Adverse effects on growth or development have not been reported. The use of this agent as a contraceptive during lactation was classified as safe, and it has not been associated with a reduction in milk production. A study that looked at a single 1.5 mg dose of levonorgestrel in 12 nursing women found peak drug concentrations in plasma at 1 to 4 hours and in milk at 2 to 4 hours. The authors stated that nursing could be resumed after 8 hours, but we do not know of a reason to delay nursing at all. A 2013 study

11 by Israeli investigators followed 71 women who used emergency contraception during lactation. They did not find adverse effects on milk production or nursing infants. Most women resumed breastfeeding less than 8 hours after drug administration. Two small 2011 studies reported on the possible effect of the postpartum placement of a levonorgestrel intrauterine device on breast-feeding. One found that early insertion did not adversely affect breastfeeding, and the other found that immediate IUD insertion markedly reduced the breastfeeding rate at 6 months postpartum. A six-year comparison of health problems in 220 children who breastfed while their mothers had either Norplant or a copper containing IUD #2107 in place found that, in the first year, breastfed infants in the Norplant group had higher incidence rates of mild episodes of respiratory infections (adjusted RR 1.17, CI ), skin conditions (adjusted RR 1.46, CI ), and eye infections (unadjusted RR 1.49, CI ). A basis for the possible relationship between these health effects and this form of steroidal contraception awaits further investigation. A 2012 study compared bone loss in 28 breastfeeding postpartum women on progestin-only contraception with that in 54 women using non-hormonal methods and reported that bone loss was reduced in the group using progestins. 레보노르게스트렐에노출된후추적된임신부는총 95 례이었으며초기노출후자연유산율은 9.5%(9/95) 이었다. 임신 37 주이전의조산률은 3.7%(3/81), 2,500 g 미만의저체중증은 3.7%(3/81) 이었다. 주요기형발생은 1.2%(1/81): difference of testis size(1) 가있었다. 수유부 - 수유아 5 쌍중부작용사례는없었다. 16. 레보설피리드 (Levosulpiride) 약물의분류 : 신경이완제, 위장운동촉진제 No data on use in human pregnancy were located. In 2011, the FDA updated the pregnancy section of the labeling for all antipsychotic drugs to highlight the risk of neonatal complications following exposure in the third trimester. These complications included extrapyramidal signs (abnormal involuntary muscle movements) that might result from dopamine blockade and sedation, breathing and feeding difficulties, agitation, tremor, and abnormally increased or decreased muscle tone. The FDA identified the latter group as "withdrawal symptoms," but they might also indicate side effects (toxicity) from residual drug exposure. These complications can resolve spontaneously or might require additional hospital care. 모유수유부약물등급 (Medication and Mother s MilK): L3 In lactating rats, sulpiride stimulated milk production. In some countries, sulpiride has been used as a galactogogue because of its ability to cause hyperprolactinemia. One group of investigators reported treatment of 36 women with inadequate lactation with sulpiride or placebo with the finding that sulpiride appeared to increase milk production with a resultant decrease in the need for supplementation to

12 achieve adequate nourishment of the infant. Another group, however, reported that this enhancement of lactation was confined to the early puerperal period and that by 90 days postpartum there was no enhancement of lactation with sulpiride in spite of continued hyperprolactinemia. A study of 6 nonpregnant, menstruating women found a combination of sulpiride and breast pumping ineffective in producing a milk supply compatible with nursing. Use of sulpiride as a galactogogue has been discouraged based on its theoretical effect on the developing neonatal nervous system. The American Academy of Breastfeeding Medicine did not recommend the use of galactogogues because of the paucity of research and the potential for serious adverse effects. Sulpiride has been detected in human milk. No reports of infant serum concentrations have been located. In studies of 38 breastfed infants, there were no reports of infant side effects. 레보설피리드에노출된후추적된임신부는총 251 례이었으며초기노출후자연유산율은 7.6%(19/251) 이었다. 임신 37 주이전의조산률은 3.6%(8/224), 2,500 g 미만의저체중증은 3.6%(8/225) 이었다. 주요기형발생은 1.8%(4/225): PDA(1), right hip mass(1), hydronephrosis(1), congenital heart defect(1) 가있었다. 수유부 - 수유아 24 쌍중젖양변화 2 례있었다. 17. 로라타딘 (Loratadine) 약물의분류 : 알레르기용제 임신부약물등급 (US FDA): B Based on experimental animal studies and human reports, loratadine is not believed to increase the risk of adverse pregnancy outcome. 모유수유부약물등급 (Medication and Mother s MilK): L1 In spite of theoretical concerns, use during lactation appears unlikely to cause harm. 로라타딘에노출된후추적된임신부는총 86 례이었으며초기노출후자연유산율은 4.7%(4/86) 이었다. 임신 37 주이전의조산률은 3.7%(3/82), 2,500 g 미만의저체중증은 3.7%(3/82) 이었다. 주요기형발생은 2.4%(2/82): dysplastic kidney left with megaureter(1), preaxial polydactyly, left hand(1) 가있었다.

13 수유부 - 수유아 4 쌍중젖양감소 2 례있었다. 18. 록소프로펜 (Loxoprofen sodium) 약물의분류 : 비스테로이드항염증제 (NSAIDs) 정보없음 정보없음 록소프로펜에노출된후추적된임신부는총 251례이었으며초기노출후자연유산율은 6.8%(17/251) 이었다. 임신 37주이전의조산률은 4.0%(7/227), 2,500 g 미만의저체중증은 3.1%(7/224) 이었다. 주요기형발생은 3.1%(7/227): right microtia with invisible external orifice(1), ASD with small PDA(1), persistent fetal circulation/unspecified seizure/right cleft palate/preaxial polydactyly/ptosis of eyelid&left eye(1), VSD(1), PDA(1), hydronephrosis of both kidney(1) 가있었다. 수유부 - 수유아 16 쌍중아기에게서졸음증상 1 례, 젖양감소 1 례가있었다. 19. 록시스로마이신 (Roxithromycin) 약물의분류 : 항생제 Limited human experience did not suggest an increase in adverse pregnancy outcome after exposure to roxithromycin. Roxithromycin is excreted in human milk in very small amounts. Less than 0.05% of an administered dose appears in milk (2). According to product labeling, no effect on fertility was observed in rats treated orally at dose levels up to 180 mg/kg/day.

14 록시스로마이신에노출된후추적된임신부는총 81례이었으며초기노출후자연유산율은 12.5%(10/81) 이었다. 임신 37주이전의조산률은 7.2%(5/69), 2,500 g 미만의저체중증은 5.9%(4/68) 이었다. 주요기형발생은 11.6%(8/69): postaxial polydactyly of left foot(1), dysplastic kidney left with megaureter(1), renal mass(1), imperforate anus(1), hydronephrosis(1), bilateral club foot(equinovarus) with knee rigidity(1), ASD with small PDA(1), congential heart anomaly(1) 가있었다. 수유부 - 수유아 2 쌍중부작용사례는없었다. 20. 리도카인 (Lidocaine) 약물의분류 : 국소마취제 임신부약물등급 (US FDA): B Based on experimental animal studies and human experience, lidocaine is not expected to increase the risk of congenital anomalies. 모유수유부약물등급 (Medication and Mother s MilK): L2 The excretion of lidocaine in human milk was demonstrated in a small number of women. The reported studies involved a dental procedure, tumescent liposuction, epidural analgesia, and the control of a ventricular dysrhythmia. When used for epidural analgesia in 27 women, a milk-plasma ratio of 1.07 was reported. Except for the possible induction of an allergic response, the small amount of this anesthetic and its metabolites that would be ingested orally by a nursing infant is unlikely to cause adverse effects. In 2001, the American Academy of Pediatrics listed lidocaine among drugs that are usually compatible with breastfeeding. 리도카인에노출된후추적된임신부는총 147례이었으며초기노출후자연유산율은 9.5%(14/147) 이었다. 임신 37주이전의조산률은 5.5%(7/128), 2,500 g 미만의저체중증은 2.4%(3/124) 이었다. 주요기형발생은 5.7%(7/124): fecial dysmorphism(1), right hip mass(1), bilateral inguinal hernia(1), right renal cyst(1), renal mass(1), ASD(1), VSD with PS(1) 가있었다. 수유부 - 수유아 9 쌍중부작용사례는없었다. 21. 리보스타마이신 (Ribostamycin)

15 약물의분류 : 항생제 Ribostamycin did not appear to increase malformations in a group of 85 exposed human pregnancies. We did not locate information on possible fertility or lactation effects of this agent 리보스타마이신에노출된후추적된임신부는총 120례이었으며초기노출후자연유산율은 6.7%(8/120) 이었다. 임신 37주이전의조산률은 6.5%(7/107), 2,500 g 미만의저체중증은 3.7%(4/107) 이었다. 주요기형발생은 3.7%(4/107): right ureteropelvic junction stenosis with right scrotal hydrocele(1), renal mass(1), unspecified seizure/right paramedian cleft palate/preaxial polydactyly of hand(1), congenital heart defect(1) 가있었다. 수유부 - 수유아 1 쌍중부작용사례는없었다. 22. 리소짐 (Lysozyme) 약물의분류 : 효소제제 We have not located studies on adverse reproductive or lactation effects of exposure to exogenous lysozyme. We have not located studies on adverse reproductive or lactation effects of exposure to exogenous lysozyme. 리소짐에노출된후추적된임신부는총 146 례이었으며초기노출후자연유산율은

16 5.5%(8/146) 이었다. 임신 37 주이전의조산률은 5.9%(8/135), 2,500 g 미만의저체중증은 2.2%(3/135) 이었다. 주요기형발생은 2.2%(3/135): dysplastic kidney left with megaureter(1), ASD(1), facial dysmorphism(1) 가있었다 수유부 - 수유아 1 쌍중부작용사례는없었다. 23. 린코마이신 (Lincomycin) 약물의분류 : 항생제 임신부약물등급 (US FDA): C Based on experimental animal studies, lincomycin therapy during pregnancy is not expected to increase the risk of congenital malformations. Lincomycin appears in human milk in concentrations similar to those in maternal plasma, and the amount of lincomycin exposure encountered by a nursing infant would be small. We have not located reports on adverse outcomes associated with exposure to lincomycin in milk; however, the infant might theoretically experience alterations in intestinal flora secondary to such exposure. Citing the availability of better studied antibiotics and a case report on bloody stools in an infant who was exposed to the related antibiotic clindamycin #1706, the WHO Working Group on breastfeeding did not recommend the use of lincomycin while nursing. 린코마이신에노출된후추적된임신부는총 95 례이었으며초기노출후자연유산율은 3.2%(3/95) 이었다. 임신 37 주이전의조산률은 4.4%(4/91), 2,500 g 미만의저체중증은 2.2%(2/90) 이었다. 주요기형발생은 4.4%(4/90): PDA(2), right liver mass(1), ileal agenesis(1) 가있었다. 수유부 - 수유아 22 쌍중부작용사례는없었다. 24. 마그네슘카보네이트 (Magnesium carbonate) 약물의분류 : 제산제 정보없음

17 정보없음 마그네슘카보네이트에노출된후추적된임신부는총 211례있었으며초기노출후자연유산율은 3.3%(7/211) 이었다. 임신 37주이전의조산률은 2.6%(5/191), 2,500 g 미만의저체중증은 2.7%(5/187) 이었다. 주요기형발생은 2.1%(4/187): right hip mass(1), right ureteropelvic junction stenosis with right scrotal hydrocele(1), VSD(1) 가있었다. 수유부 - 수유아 22 쌍중부작용사례는없었다. 25. 메칠에페드린 (Methylephedrine) 약물의분류 : 기관지확장제 No adverse outcomes were associated with methylephedrine use in 282 human pregnancies. 모유수유부약물등급 (Medication and Mother s MilK): L4 We have not located references on possible reproductive or lactation effects of this agent. 메칠에페드린에노출된후추적된임신부는총 721 례이었으며초기노출후자연유산율은 6.1%(44/721) 이었다. 임신 37 주이전의조산률은 3.5%(23/657), 2,500 g 미만의저체중증은 2.4%(16/655) 이었다. 주요기형발생은 2.7%(18/655): PDA(2), bilateral inguinal hernia(1), cyst in caudothalamic groove(1), dysplastic kidney left with megaureter(1), lacrimal duct obstruction with ptosis(2), hydronephrosis(2), upper gingival cyst(1), multicystic dysplastic kidney(1), right liver mass(1), ASD with small PDA(1), right ventricular hypertrophy of heart(1), facial dysmorphism(1), right inguinal hernia(1), cleft palate(1), right hydronephrosis(1) 가있었다. 수유부 - 수유아 14 쌍중부작용사례는없었다.

18 26. 메칠프레드니솔론 (Methylprednisolone) 약물의분류 : 부신피질호르몬제 임신부약물등급 (US FDA): C Methylprednisolone is a glucocorticoid. Glucocorticoid medication use during pregnancy has been associated with an increased risk of cleft palate and impaired fetal growth. 모유수유부약물등급 (Medication and Mother s MilK): L2 A case study read in abstract describes a six-weeks postpartum, breastfeeding patient who received 24 mg methylprednisolone acetate with 15 mg lidocaine for tenosynovitis. Lactation was suppressed at approximately 30 hours after the injection; milk production resumed 36 hours later. The author of the study suggested that dose level combined with injection into a high activity level joint may have facilitated absorption and led to the lactation suppression. When administered to lactating women, small amounts of methylprednisolone and other glucocorticoids enter human milk. The WHO Working Group on Drugs and Human Lactation did not consider available data adequate to make a recommendation on methylprednisolone. For maternal doses of prednisolone larger than 20 mg/day, some clinicians recommend that mothers wait at least 4 hours before nursing. Even at 80 mg/day, however, the amount secreted in milk would be equivalent to less than 10% of a nursing infant`s endogenous cortisol production, and it is unlikely that such a dose could produce clinically significant effects. In the breast-feeding infants of 2 women treated with 1 g/day at 3 and 5 months postpartum, exposures were less than a therapeutic dose would have been for the infant. Avoidance of nursing for 2-8 hours after a 1-g dose was suggested. A small number of case reports suggest that immunosuppressive doses of methylprednisolone do not suppress the IgA immunoglobin content of milk and do not alter the blood chemistry or infection rate of nursing infants. 메칠프레드니솔론에노출된후추적된임신부는총 181 례이었으며초기노출후자연유산율 은 8.8%(16/181) 이었다. 임신 37 주이전의조산률은 8.6%(14/163), 2,500 g 미만의저체중증은 6.2%(10/162) 이었다. 주요기형발생은 4.3%(7/162): right toe overlapping(2, 4th) with right club foot(1), left CCAM(1), scalp mass with left ear skin tag with anal dimpling(1), imperforate anus(1), ASD with small PDA(1), small anterio fontanelle with nevus(buttock) and coccyx dimple(1), right microtia with invisible external ear orifice(1) 가있었다. 수유부 - 수유아 19 쌍중젖양감소 3 례있었다. 27. 메퀴타진 (Mequitazine) 약물의분류 : 알레르기용제

19 정보없음 정보없음 메퀴타진에노출된후추적된임신부는총 105 례이었으며초기노출후자연유산율은 7.6%(8/105) 이었다. 임신 37 주이전의조산률은 3.3%(3/92), 2,500 g 미만의저체중증은 3.3%(3/91) 이었다. 주요기형발생은 2.2%(2/91): anal dimpling/skin fold at right chest(1), both hand polydactyly(1) 가있었다. 수유부 - 수유아 8 쌍중무른변 1 례있었다. 28. 메토클로프라미드 (Metoclopramide) 약물의분류 : 구토방지제 임신부약물등급 (US FDA): B Based on experimental animal studies and human experiences, metoclopramide therapy during pregnancy is not anticipated to increase the risk of congenital anomalies. 모유수유부약물등급 (Medication and Mother s MilK): L2 Metoclopramide administration can increase milk production, but the drug was present in human milk and produced detectable drug concentrations in the serum of nursing infants. The milk:plasma ratio for metoclopramide was approximately 2.0. Depression and mood swings have been reported in mothers using this agent. Metoclopramide has been used to induce lactation in adoptive mothers who wish to nurse. One report suggested that this method of lactation induction might be most effective in nulliparous women. The use of 10 mg metoclopramide 3 times a day for 17 days did not significantly improve milk production in a placebo-controlled study of women who delivered preterm. The reported adverse effects associated with neonatal exposure to metoclopramide included mild intestinal discomfort in two cases. Although the neonatal dose is relatively small (<45 mcg/kg/day), one clinical investigation suggested that the exposure might be capable of elevating infant prolactin concentrations. We did not locate studies on the long-term effects of exposure to this agent during infancy.

20 메토클로프라미드에노출된후추적된임신부는총 161 례이었으며초기노출후자연유산 율은 5.0%(8/161) 이었다. 임신 37 주이전의조산률은 3.4%(5/145), 2,500 g 미만의저체중증은 1.4%(2/141) 이었다. 주요기형발생은 0.7%(1/141): renal mass(1) 가있었다. 수유부 - 수유아 4 쌍중부작용사례는없었다. 29. 메트로니다졸 (Metronidazole) 약물의분류 : 항생제 임신부약물등급 (US FDA): B Metronidazole use during pregnancy has not been shown to increase the risk of adverse pregnancy outcome. 모유수유부약물등급 (Medication and Mother s MilK): L2 Metronidazole is excreted into human milk. The mean milk:plasma ratio was 0.9 for metronidazole and 0.76 for hydroxymetronidazole, a major metabolite. The mean milk concentration (around Cmax) was 15.5 mcg/ml for metronidazole and 5.7 mcg/ml for hydroxymetronidazole. Infant plasma metronidazole concentrations ranged from 1.27 to 2.41 mcg/ml, and the corresponding hydroxymetronidazole concentrations ranged from 1.1 to 2.4 mcg/ml. No significant adverse effects were observed in infants exposed to metronidazole. Because of the relatively large quantities of this drug excreted in milk, the WHO Working Group on drugs and human lactation suggested that breastfeeding be discontinued by mothers using repeated doses of metronidazole especially if the infant is premature. If metronidazole is needed for the treatment of trichomoniasis during lactation, it has been observed that exposure of the infant can be avoided if a single 2-g oral dose is given and breastfeeding discontinued for h to allow excretion of the drug. It is not clear, however, that avoidance of exposure to a single dose is important for infant health. Metronidazole is used in infants. The recommended dose for infants in the first week of life is 7.5 mg/kg/day. Although neither topical nor vaginal application of metronidazole have been studied during lactation, exposure of the infant is likely to be less than described with oral maternal use. 메트로니다졸에노출된후추적된임신부는총 81 례이었으며초기노출후자연유산율은 4.9%(4/81) 이었다. 임신 37 주이전의조산률은 5.5%(4/73), 2,500 g 미만의저체중증은 1.4%(1/72) 이었다. 주요기형발생은 1.4%(1/72): two skin tags(5x1 mm on right ear)/left ear derormity(1) 가있었다. 수유부 - 수유아 10 쌍중설사 1 례가있었다.

21 30. 메페나믹산 (Mefenamic acid) 약물의분류 : 비스테로이드항염증제 (NSAIDs) 임신부약물등급 (US FDA): C Mefenamic acid did not increase congenital anomalies in most experimental animal teratology studies. Human studies have associated the use of NSAIDs with an increased risk of miscarriage. NSAIDs #1245 are avoided during late pregnancy because of concerns about premature closure of the ductus arteriosus. Mefenamic acid enters human milk in small amounts. In ten nursing women who used mefenamic acid for four days, an average milk:plasma ratio of 0.18 was reported. On the fourth day the nursing infants had low but measurable plasma concentrations of the drug. Although more extensive data were called for, the WHO Working Group concluded the use of this drug during breastfeeding is probably safe. The American Academy of Pediatrics also classified this drug as compatible with breastfeeding. 메페나믹산에노출된후추적된임신부는총 181 례이었으며초기노출후자연유산율은 9.9%(18/181) 이었다. 임신 37 주이전의조산률은 3.8%(6/160), 2,500 g 미만의저체중증은 3.8%(6/159) 이었다. 주요기형발생은 1.3%(2/159): congenital heart defect(1), hydronephrosis(1) 가있 었다. 수유부 - 수유아 7 쌍중무른변 1 례, 젖양감소 1 례가있었다. 31. 멘톨 (Menthol) 약물의분류 : nasal medication, 외피용제 Oral administration of menthol did not cause fetal abnormalities in rabbits. We did not locate human data. 모유수유부약물등급 (Medication and Mother s MilK): L3 Treatment of 18 lactating women with menthol 100 mg showed the presence of this agent in the

22 milk with a peak concentration at six hours post capsule ingestion; the average concentration in milk was 8 mcg/l. Menthol essence applied to the nipple and areola after breastfeeding produced improvement in nipple fissures in primiparous women. L- 멘톨에노출된후추적된임신부는총 161 례이었으며초기노출후자연유산율은 7.5%(12/161) 이었다. 임신 37 주이전의조산률은 3.4%(5/146), 2,500 g 미만의저체중증은 2.1%(3/145) 이었다. 주요기형발생은 4.1%(6/145): necrotizing enterocolitis(1), choledochal cyst(1), congenital heart defect(1) 가있었다. 수유부 - 수유아 2 쌍중부작용사례는없었다. 32. 멜릴로투스액기스 (Melilotus extract) 약물의분류 : 소염제 정보없음 정보없음 멜릴로투스액기스에노출된후추적된임신부는총 65 례이었으며초기노출후자연유산율은 7.8%(5/65) 이었다. 임신 37 주이전의조산률은 0.0%, 2,500 g 미만의저체중증은 5.1%(3/59) 이었 다. 주요기형발생은 3.4%(2/59): right ureteropelvic junction stenosis with right scrotal hydrocele(1), VSD(1) 가있었다. 수유부 - 수유아에노출된사례는없었다. 33. 모사프라이드 (Mosapride) 약물의분류 : 위장관운동촉진제 정보없음

23 정보없음 모사프라이드에노출된후추적된임신부는총 132 례이었으며초기노출후자연유산율은 6.1%(8/132) 이었다. 임신 37 주이전의조산률은 3.3%(4/120), 2,500 g 미만의저체중증은 2.5%(3/121) 이었다. 주요기형발생은 4.1%(5/121): pulmonary artery stenosis(1), imperforate anus(1), ASD with small PDA(1), VSD with aortic stenosis(1), nasolacrimal duct obstruction(1) 가있었다. 수유부 - 수유아에 19 쌍중아기에게서졸음증상 1 례가있었다. 34. 미다졸람 (Midazolam) 약물의분류 : 최면진정제 임신부약물등급 (US FDA): D Based on experimental animal studies, midazolam use during pregnancy is not expected to increase the risk of congenital anomalies. Use near delivery can result in neonatal respiratory depression. 모유수유부약물등급 (Medication and Mother s MilK): L2 Data from 18 lactating mothers indicated that midazolam is excreted in human milk in small amounts. There were no reports of sedation or other adverse events in the breastfed infants of nineteen mothers who took midazolam while nursing. The mothers were recruited prospectively when they contacted a teratology information service about benzodiazepine use during lactation and were surveyed retrospectively by telephone. No information was available regarding dose, duration, or route of administration of midazolam. An expert panel of American Society for Gastrointestinal Endoscopy suggested breastfeeding be delayed for at least 4 hours after administration of midazolam during endoscopy. In their 1988 report, the WHO Working Group on Drugs and Human Lactation concluded that the use of this drug for a short period while breastfeeding is probably safe. The American Academy of Pediatrics classified midazolam among "drugs for which the effect on nursing infants is unknown but may be of concern". 미다졸람에노출된후추적된임신부는총 103 례이었으며초기노출후자연유산율은 10.7%(11/103) 이었다. 임신 37 주이전의조산률은 4.6%(4/87), 2,500 g 미만의저체중증은

24 3.4%(3/87) 이었다. 주요기형발생은 3.4%(3/87): hirschsprung s disease(1), right hip mass(1), paraurethral cyst(1) 가있었다. 수유부 - 수유아에 33 쌍중젖양감소 1 례있었다. 35. 바실루스서브틸리스 (Bacilllus subtilis) 약물의분류 : 정장제 정보없음 정보없음 바실루스서브틸리스에노출된후추적된임신부는총 134 례이었으며초기노출후자연유 산율은 6.7%(9/134) 이었다. 임신 37 주이전의조산률은 5.9%(7/118), 2,500 g 미만의저체중증은 3.4%(4/116) 이었다. 주요기형발생은 1.7%(2/116): unilateral cleft lip with palate, bilateral clenched hands, ventricular septal defect(1), right microtia with invisible external orifice(1) 가있었다. 수유부 - 수유아 8 쌍중젖양변화 1 례있었다. 36. 베타메타손 (Betamethasone) 약물의분류 : 부신호르몬제 임신부약물등급 (US FDA): C Betamethasone is a glucocorticoid. Glucocorticoid medication use during pregnancy has been associated in some studies with an increased risk of cleft palate and impaired fetal growth. 모유수유부약물등급 (Medication and Mother s MilK): L3 Antenatal betamethasone treatment was associated with a transient premature stimulation of lactose secretion into milk while women were still pregnant. It was not clear that these findings had clinical significance. In a study involving 46 women treated with antenatal betamethasone, lactation was most

25 significantly impaired in subjects who received the corticosteroid 3 to 9 days before delivering. When administered to lactating women, small amounts of corticosteroids appeared in milk. Some clinicians recommended that mothers wait at least 4 hours before nursing if they were taking doses of prednisolone larger than 20 mg/day. Although data on the use of betamethasone during lactation were not located, the American Academy of Pediatrics classified the corticosteroids prednisone and prednisolone #1359 as compatible with breastfeeding. 베타메타손에노출된후추적된임신부는총 21 례이었으며초기노출후자연유산율은 9.5%(2/21) 이었다. 임신 37 주이전의조산률은 0.0%, 2,500 g 미만의저체중증은 5.3%(1/19) 이었 다. 주요기형발생은없었으나소기형이 nevus on right elbow(1), left club foot(1) 으로 2 례가있었다. 수유부 - 수유아 6 쌍중부작용사례는없었다. 37. 벤지다민 (Benzydamine) 약물의분류 : 비스테로이드항염증제 (NSAIDs) 정보없음 Based on experimental animal studies, benzydamine is not expected to increase the risk of congenital malformations after topical use. 모유수유부약물등급 (Medication and Mother s MilK): 정보없음 벤지다민에노출된후추적된임신부는총 65 례이었으며초기노출후자연유산율은 4.6%(3/65) 이었다. 임신 37 주이전의조산률은 1.6%(1/61), 2,500 g 미만의저체중증은 3.3%(2/61) 이었다. 주요기형발생은 1.6%(1/61): nasolacrimal duct obstruction with ptosis(1) 가있었다. 수유부 - 수유아에노출된사례는없었다. 38. 브로멜라인 (Bromelain) 약물의분류 : 효소제제

26 We did not locate information on bromelain use during human pregnancy. We have not located other references on possible reproductive or lactation effects of bromelain. 브로멜라인에노출된후자연유산율은 2.9% 이며, 인공유산은 8.6% 이었다. 한편, 37 주이전의 조산률은 10.0% 이며, 2,500 g 미만의저체중증은 1.7% 이었다. 기형아발생률은 0% 이었다. 수유부 - 수유아 11 쌍중설사 1 례, 젖양감소 1 례있었다. 39. 브롬페니라민 (Brompheniramine maleate) 약물의분류 : 항히스타민제 임신부약물등급 (US FDA): C Brompheniramine use during pregnancy was associated with increased malformation risk in one human study but not in a second human study. Another study found an increased risk for combined pheniramine derivatives. 모유수유부약물등급 (Medication and Mother s MilK): L3 A case report described a 3-month-old nursing infant who became irritable, cried excessively, and had difficulty sleeping shortly after the mother began ingesting a medication containing 6 mg of dexbrompheniramine and 120 mg of d-isoephedrine. The symptoms resolved spontaneously within 12 hours when breastfeeding was stopped. An investigation questioned women who used antihistamines for seasonal allergies or colds while lactating and 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 might, 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

27 reassuring reports that have been published and on the available reports indicating that low amounts of other antihistamines appear in milk. If anticholinergic effects of antihistamines result in a decrease in milk supply, such an effect might resolve on discontinuation of the medication, but 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. 브롬페니라민에노출후자연유산율은 8.3% 이며, 인공유산은 6.7% 이었다. 한편, 37 주이전의 조산률은 2.0% 이며, 2,500 g 미만의저체중증은 15.5% 이었다. 기형아발생률은 4.2%(1/48): PDA(1) 가있었다. 수유부 - 수유아에노출된사례는없었다. 40. 브롬헥신 (Bromhexine) 약물의분류 : 진해거담제 Based on experimental animal studies, pregnancy exposure to the bromhexine metabolite ambroxol appears unlikely to cause adverse outcome. We have not located studies on bromhexine itself. We have not located references on possible reproductive or lactation effects of bromhexine, the parent compound. 브롬헥신에노출된후추적된임신부는총 83 례이었으며초기노출후자연유산율은 6.0%(5/83) 이었다. 임신 37 주이전의조산률은 3.9%(3/77), 2,500 g 미만의저체중증은 1.3%(1/76) 이었다. 주요기형발생은 2.6%(2/76): ASD with PDA(1), PDA(1) 가있었다. 수유부 - 수유아 2 쌍중부작용사례는없었다. 41. 비사코딜 (Bisacodyl)

28 약물의분류 : 완하제 임신부약물등급 (US FDA): B Analysis of milk from 8 lactating women given bisacodyl 10 mg daily for 7 days did not find detectable concentrations of drug or metabolites. We have not located additional references on possible reproductive or lactation effects of this agent. 모유수유부약물등급 (Medication and Mother s MilK): L2 Analysis of milk from 8 lactating women given bisacodyl 10 mg daily for 7 days did not find detectable concentrations of drug or metabolites. We have not located additional references on possible reproductive or lactation effects of this agent. 비사코딜에노출된후추적된임신부는총 89 례이었으며초기노출후자연유산율은 6.7%(6/89) 이었다. 임신 37 주이전의조산률은 4.9%(4/81), 2,500 g 미만의저체중증은 2.5%(2/81) 이었다. 주요기형발생은 1.2%(1/81): micro penis with small right testis(1) 가있었다. 수유부 - 수유아 2 쌍중부작용사례는없었다. 42. 비오디아스타제 (Biodiastase, biotamylase) 약물의분류 : 건위소화제 정보없음 정보없음 비오디아스타제에노출된후추적된임신부는총 149 례이었으며초기노출후자연유산율은 10.1%(15/149) 이었다. 임신 37 주이전의조산률은 6.4%(8/125), 2,500 g 미만의저체중증은 4.8%(6/126) 이었다. 주요기형발생은 1.6%(2/126): mega cisterna magna(13.6 mm )(1), fetal hydrops(1)( 출생후에도있었는지확인이필요합니다 ) 가있었다. 그리고사산 2 례가있었다.

29 수유부 - 수유아 13 쌍중부작용사례는없었다. 43. 세라티오펩티다제 (Serratiopeptidase) 약물의분류 : 효소제제 Serratiopeptidase has not been studied for pregnancy, fertility, or lactation effects. 정보없음 세라티오펩티다제에노출된후추적된임신부는총 278 례이었으며초기노출후자연유산율 은 7.3%(16/218) 이었다. 임신 37 주이전의조산률은 0%, 2,500 g 미만의저체중증은 3.6%(7/197) 이었다. 주요기형발생은 1.0%(2/197): PDA(1), wrist drop left(1) 가있었다. 수유부 - 수유아 13 쌍중젖양감소 1 례있었다. 44. 세티리진 (Cetirizine) 약물의분류 : 항히스타민제 임신부약물등급 (US FDA): B Based on experimental animal studies and reported human experience, cetirizine and levocetirizine are not believed to increase the risk of adverse pregnancy outcome. 모유수유부약물등급 (Medication and Mother s MilK): L2 Preclinical studies reported in the product labeling found decreased weight gain in pups nursed by mice given 40 times the human dose level of cetirizine. About 3% of the maternal dose is detectable in the milk of dogs. The labeling states that human milk has also been shown to contain cetirizine; however, information on milk concentrations was not supplied. Although the labeling states that use in nursing mothers is not recommended, we have not located data that permits an estimate of human risk, if any, from such exposure of nursing infants. A case report described a mother who was taking sodium oxybate #3838 and cetirizine, among other agents, and successfully nursed for 6 months with normal

30 growth in the infant. 염산세티리진에노출된후추적된임신부는총 210례이었으며초기노출후자연유산율은 2.9%(6/210) 이었다. 임신 37주이전의조산률은 6.1%(12/196), 2,500 g 미만의저체중증은 3.1%(6/196) 이었다. 주요기형발생은 4.0%(8/196): PDA(2), right renal cysts(1), bilateral inguinal hernia(1), imperforate anus(1), liver mass(1), right radial nerve palsy with wrist and hand drop(1), knee rigidity(1) 가있었다. 그리고사산 1례가있었다. 수유부 - 수유아 7 쌍중부작용사례는없었다. 45. 세파드록실 (Cefadroxil) 약물의분류 : 항생제 Based on experimental animal studies, use of cefadroxil during pregnancy is not anticipated to increase the risk of congenital anomalies. 모유수유부약물등급 (Medication and Mother s MilK): L1 Small amounts of cefadroxil are excreted in human milk, although the drug is not detectable in the first hour after ingestion. A single 500-mg oral dose resulted in peak milk concentrations between 0.6 and 0.9 mg/l five to six hours later. Briggs et al. have suggested two potential problems cephalosporin intake might create for the nursing infant: modification of bowel flora and interference with the interpretation of culture results if a fever work-up is required. Cefadroxil use was judged compatible with breastfeeding by the American Academy of Pediatrics Committee on Drugs and the WHO Working Group on Drugs and Human Lactation. 세파드록실에노출된후추적된임신부는총 83 례이었으며초기노출후자연유산율은 4.8%(4/83) 이었다. 임신 37 주이전의조산률은 6.8%(5/73), 2,500 g 미만의저체중증은 4.1%(3/74) 이었다. 주요기형발생은 2.7%(2/74): PDA(1), right renal cysts(1) 가있었다. 수유부 - 수유아 3 쌍중부작용사례는없었다.

31 46. 세파클러 (Cefaclor) 약물의분류 : 항생제 임신부약물등급 (US FDA): B Based on experimental animal studies, cefaclor is not expected to increase the risk of birth defects. 모유수유부약물등급 (Medication and Mother s MilK): L1 Cefaclor is transferred to human milk in small amounts. In a one study, 5 nursing mothers reported taking cefaclor (dosage unspecified). One mother reported diarrhea in her infant. The WHO Working Group on Drugs and Human Lactation concluded that the use of this drug during breastfeeding is safe. 세파클러에노출된후추적된임신부는총 270 례이었으며초기노출후자연유산율은 7.4%(20/270) 이었다. 임신 37 주이전의조산률은 4.6%(11/241), 2,500 g 미만의저체중증은 4.2%(10/238) 이었다. 주요기형발생은 4.9%: pulmonary artery stenosis(1), dimpling/dolicocephaly/minimal pneumothorax or skin fold at right chest(1), ASD with small PDA(1), ASD(1), right ureteropelvic junction stenosis with right scrotal hydrocele(1), persistent fetal circulation/pneumothorax/unspecified seizure/fight cleft palate unspecified/accessory thumb right/ ptosis of left eye(1), fetal hydrops(1), nasolacrimal duct obstruction(1) 가있었다. 수유부 - 수유아 23 쌍중젖양감소 2 례있었다. 47. 세프라딘 (Cephradine) 약물의분류 : 항생제 Based on experimental animal studies and a small number of human cases, cephradine is not expected to increase the risk of congenital anomalies. The milk:plasma ratio for cephradine was estimated to be about 0.2. We did not locate reports on adverse effects in nursing infants.

32 세프라딘에노출된후추적된임신부는총 110 례이었으며초기노출후자연유산율은 5.4%(6/110) 이었다. 임신 37 주이전의조산률은 5.0%(5/100), 2,500 g 미만의저체중증은 3.1%(3/98) 이었다. 주요기형발생은없었다. 수유부 - 수유아 10 쌍중부작용사례는없었다. 48. 소브레롤 (Sobrerol) 약물의분류 : 진해거담제 정보없음 정보없음 소브레롤에노출된후추적된임신부는총 80 례이었으며초기노출후자연유산율은 1.2%(1/80) 이었다. 임신 37 주이전의조산률은 4.0%(3/75), 2,500 g 미만의저체중증은 1.4%(1/74) 이었다. 주요기형발생은 1.3%(1/75): ASD with small PDA(1) 가있었다. 수유부 - 수유아에노출된사례는없었다. 49. 슈도에페드린 (Pseudoephedrine) 약물의분류 : 교감신경흥분제 임신부약물등급 (US FDA): C L3 Pseudoephedrine is avoided during pregnancy because of its possible vasoconstrictive activity and findings in some but not all studies of an increase in gastroschisis, hemifacial microsomia, and limb reduction defects. 모유수유부약물등급 (Medication and Mother s MilK):

33 Pseudoephedrine is excreted in human milk. The reported milk:plasma ratio for this agent is approximately 2.5. Calculations from the available data indicate that a nursing infant might ingest between 0.6% and 5.0% of the maternal dose. Among 19 infants exposed to pseudoephedrine through human milk (10 to pseudoephedrine alone), 2 were described by their mothers as irritable. In another report, agitation was described in 4 of 174 infants exposed while nursing. One placebo controlled study involving 8 lactating mothers who took a single 60 mg dose of pseudoephedrine found a 24% reduction in milk volume during the following 24 hours. Based on this effect, a treatment plan using pseudoephedrine was devised for women with hypergalactia. In 2001, the American Academy of Pediatrics categorized pseudoephedrine as compatible with breastfeeding, and the WHO Working Group on Human Lactation concluded that the occasional use of pseudoephedrine during lactation is probably safe. 슈도에페드린에노출된후추적된임신부는총 717 례이었으며초기노출후자연유산율은 6.4%(46/717) 이었다. 임신 37 주이전의조산률은 0.02%(1/648), 2,500 g 미만의저체중증은 3.4%(22/646) 이었다. 주요기형발생은 2.3%(15/648): PDa(1), anal dumpling/dolicocephaly/minimal pneumothorax or skin fold at right chest(1), CCAM(1), bilateral inguinal hernia(1), ASD(3), cyst in caudothalamic groove(1), PDA(1), nasolacrimal duct obstruction with ptosis(1), cryptorchidism with cystic dysplastic change of right kidney(1), imperforate anus(1), multicystic dysplastic kidney(1), liver mass(1), right hydronephrosis(1) 가있었다. 수유부 - 수유아 22 쌍중젖양감소 1 례가있었다. 50. 슈크랄페이트 (Sucralfate) 약물의분류 : 항궤양제 임신부약물등급 (US FDA): B Based on experimental animal studies, sucralfate therapy during pregnancy is not expected to increase the risk of congenital anomalies. 모유수유부약물등급 (Medication and Mother s MilK): L1 We did not locate information on the excretion of sucralfate in milk. Aluminum is secreted into human milk in small quantities. These small quantities of aluminum intake have not been associated with toxic effects in exposed newborns. Some studies suggest however, that an increased GI aluminum absorption occurs in newborns and that the renal excretion of this element may be reduced.

34 슈크랄페이트에노출된후추적된임신부는총 82 례이었으며초기노출후자연유산율은 13.4%(11/82) 이었다. 임신 37 주이전의조산률은 1.4%(1/69), 2,500 g 미만의저체중증은 1.5%(1/68) 이었다. 주요기형발생은없었다. 수유부 - 수유아 4 쌍중젖양변화 1 례있었다. 51. 스코폴라민 (Scopolamine) 약물의분류 : 항콜린제 임신부약물등급 (US FDA): C Human experience with scopolamine does not suggest an increased risk of congenital malformations. 모유수유부약물등급 (Medication and Mother s MilK): L3 The package labeling of the product Transderm Scop indicates that scopolamine is present in milk. We did not locate reports on adverse effects in neonates exposed to scopolamine in milk. The American Academy of Pediatrics classified scopolamine as compatible with breastfeeding. 스코폴라민에노출된후추적된임신부는총 11 례이었으며초기노출후자연유산율은 0% 이 었다. 임신 37 주이전의조산률은 0%, 2,500 g 미만의저체중증은 0% 이었다. 주요기형발생은없 었다. 수유부 - 수유아 1 쌍중부작용사례는없었다. 52. 스코폴리아엑기스 (Scopolia extract) 약물의분류 : 항콜린제 임신부약물등급 (US FDA): C 정보없음 Atropine use during pregnancy has not been associated with an increased risk of birth defects. 모유수유부약물등급 (Medication and Mother s MilK):