Phytonadione Pregnancy and Breastfeeding Warnings
Phytonadione Pregnancy Warnings
Phytonadione has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Phytonadione is only recommended for use during pregnancy when benefit outweighs risk.
Placental transfer of physiological quantities of vitamin K is generally considered low. A maternal-cord concentration ratio of 30:1 has previously been reported, although cord concentrations of 37% to 110% those of maternal serum have been reported in mothers with high serum vitamin K levels. A considerable maternal-fetal concentration gradient is believed to be required for effective diffusion across the placenta. In one study, pharmacological doses of phytonadione given to the mothers (10 mg orally daily for an average of 1 month just prior to pregnancy) were able to enhance cord concentrations of vitamin K by 15 fold.
Phytonadione Breastfeeding Warnings
Although human milk tends to be low in vitamin K and there appears not to be a significant correlation between maternal dietary intake and milk concentration of the vitamin, pharmacological doses of vitamin K can increase milk concentrations substantially. A singe 20 mg oral dose of phytonadione produced a 70-fold increase in the milk concentration of vitamin K in one mother after 12 hours. Likewise, an average increase of greater than 100-fold was noted in the milk of 11 lactating mothers 12 hours following the ingestion of 20 mg of phytonadione and remained above baseline even after 7 days. Similar results have been observed in other studies.
Phytonadione is excreted into human milk when given in pharmacological doses. The effects on the nursing infant are unreported. The manufacturer recommends that caution be used when administering phytonadione to nursing women.
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