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Phytonadione Pregnancy and Breastfeeding Warnings

Phytonadione is also known as: Aquamephyton, Konakion, Mephyton, Vitamin K, Vitamin K1

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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Mephyton (phytonadione)." Merck & Co, Inc, West Point, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Vitamin K Injection (phytonadione)." Abbott Pharmaceutical, Abbott Park, IL.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Mephyton (phytonadione)." Merck & Co, Inc, West Point, PA.
  2. "Product Information. Vitamin K Injection (phytonadione)." Abbott Pharmaceutical, Abbott Park, IL.
  3. Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 9th ed." Philadelphia, PA: Llippincott Williams & Wilkins (2011):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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