OBJECTIVE: To measure the amount of pantoprazole in human milk following its oral administration to a breast-feeding mother and to estimate human exposure. STUDY DESIGN: One woman was studied over a 24-hour interval after oral administration of 40-mg pantoprazole. Serial plasma and milk samples were collected over 24 hours, and pantoprazole concentrations were measured by high-performance liquid chromatography. A milk/plasma ratio of 0.022 was observed at tmax, 2 hours after dose administration. Infant exposure was measured as maximum concentration in milk multiplied by an estimated maximum consumption of 200 mL at this time. RESULTS: The relative infant dose was estimated to be 7.3 microg of pantoprazole, which is equivalent to 0.14% of the weight-normalized dose received by the mother. Because pantoprazole is unstable in acidic pH, the systemic dose received by the infant is expected to be lower if the ingested pantoprazole is exposed to acid in the infant's stomach. The mother detected no adverse events in the infant. CONCLUSION: These limited data show that pantoprazole is minimally excreted into breast milk. While it is not known if pantoprazole affects breast milk production, women who are breast-feeding do not have to stop breastfeeding when taking pantoprazole chronically.
OBJECTIVE: To measure the amount of pantoprazole in human milk following its oral administration to a breast-feeding mother and to estimate human exposure. STUDY DESIGN: One woman was studied over a 24-hour interval after oral administration of 40-mg pantoprazole. Serial plasma and milk samples were collected over 24 hours, and pantoprazole concentrations were measured by high-performance liquid chromatography. A milk/plasma ratio of 0.022 was observed at tmax, 2 hours after dose administration. Infant exposure was measured as maximum concentration in milk multiplied by an estimated maximum consumption of 200 mL at this time. RESULTS: The relative infant dose was estimated to be 7.3 microg of pantoprazole, which is equivalent to 0.14% of the weight-normalized dose received by the mother. Because pantoprazole is unstable in acidic pH, the systemic dose received by the infant is expected to be lower if the ingested pantoprazole is exposed to acid in the infant's stomach. The mother detected no adverse events in the infant. CONCLUSION: These limited data show that pantoprazole is minimally excreted into breast milk. While it is not known if pantoprazole affects breast milk production, women who are breast-feeding do not have to stop breastfeeding when taking pantoprazole chronically.