Phytonadione Pregnancy and Breastfeeding Warnings
Phytonadione Pregnancy Warnings
Use is not recommended unless clearly needed AU TGA pregnancy category: Not formally assigned to a pregnancy category. US FDA pregnancy category: C
Animal studies have not been conducted. Vitamin K1 does not readily cross the placenta. There are no controlled data in human pregnancy. AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Phytonadione Breastfeeding Warnings
The American Academy of Pediatrics classifies vitamin K1 as compatible with breastfeeding; they also caution that administration to the mother prenatally should not be substituted for newborn prophylaxis.
Caution is recommended; benefit to mother should outweigh risk to the infant Excreted into human milk: Yes Comments: Not recommended for nursing mothers as prophylaxis of newborn hemorrhagic disease.
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