When is vitamin K (Vitamin K1/phylloquinone) supplementation recommended?

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Vitamin K Supplementation: When and How to Administer

Universal Newborn Prophylaxis

All newborns should receive vitamin K prophylaxis at birth to prevent life-threatening vitamin K deficiency bleeding (VKDB), with intramuscular administration being the most effective and reliable route. 1, 2, 3

Recommended Dosing for Healthy Term Newborns

The American Academy of Pediatrics recommends 0.5-1.0 mg vitamin K1 (phylloquinone) intramuscularly within one hour of birth as the gold standard. 1, 3 This single IM dose reduces the risk of VKDB from 1 in 59 (without prophylaxis) to 1 in 100,000. 4

Alternative oral regimens (less effective than IM but acceptable if IM is refused):

  • 3 doses of 2 mg orally: at birth, at 4-6 days, and at 4-6 weeks 1, 5
  • 2 mg at birth followed by weekly 1 mg doses for 3 months 1, 2

Critical caveat: Oral prophylaxis is not appropriate for preterm infants, those with cholestasis, impaired intestinal absorption, infants too unwell to take oral medication, or those whose mothers took medications interfering with vitamin K metabolism. 5 If the infant vomits within 1 hour of oral administration, repeat the dose. 5

Preterm Infants on Parenteral Nutrition

Preterm infants require 10 μg/kg/day of vitamin K1 when receiving parenteral nutrition. 1, 2


High-Risk Populations Requiring Ongoing Supplementation

Exclusively Breastfed Infants

All exclusively breastfed infants require vitamin K supplementation because breast milk contains very low levels of vitamin K. 6, 2 After initial newborn prophylaxis, continue supplementation throughout the breastfeeding period. 2

Infants with Maternal Drug Exposure

Infants whose mothers took anticonvulsants, anticoagulants (warfarin), or antituberculosis drugs require:

  • Higher initial doses (may need more than the standard 1 mg) 3
  • Antenatal maternal prophylaxis: 10-20 mg/day orally for 15-30 days before delivery prevents early VKDB 7
  • Repeated neonatal doses based on clotting factor profiles 7

Cystic Fibrosis Patients

Vitamin K status is often suboptimal in all CF patients and deficient in all those with CF-related liver disease. 6 Deficiency can cause intracranial hemorrhage in infants and contributes to low bone mineral density. 6

Recommended dosing for CF patients:

  • Infants: 0.3-1.0 mg/day 6, 2
  • Older children and adults: 1-10 mg/day depending on age 6, 2
  • Higher doses for those with documented low levels, long-term antibiotic use, liver disease, or severe malabsorption 6

Daily administration is preferred due to vitamin K's low storage capacity. 6, 2

Adults on Parenteral Nutrition

Adults receiving parenteral nutrition require 200 μg/day of vitamin K1 (150 μg supplemental plus variable amounts in lipid emulsion). 2, 8 This dose maintains hemostasis but may be excessive for patients on warfarin, potentially jeopardizing anticoagulant control. 8

Other Malabsorption Conditions

Patients with celiac disease, short bowel syndrome, cholestasis, or alpha-1-antitrypsin deficiency require supplementation due to fat malabsorption. 6, 2


Treatment of Active Vitamin K Deficiency

Hemorrhagic Disease of the Newborn

For treatment (not prophylaxis): 1 mg vitamin K1 subcutaneously or intramuscularly. 3 A prompt response (shortening of prothrombin time within 2-4 hours) is diagnostic of VKDB; failure to respond indicates another coagulation disorder. 1, 3 Higher doses may be necessary with maternal anticoagulant use, and whole blood or component therapy may be needed for excessive bleeding. 3

Anticoagulant-Induced Prothrombin Deficiency in Adults

Initial dose: 2.5-10 mg or up to 25 mg (rarely 50 mg may be required). 3 If prothrombin time hasn't shortened satisfactorily within 6-8 hours, repeat the dose. 3 Maximum effect occurs within 6-12 hours for IV administration versus 24 hours for oral. 2

Other Causes of Hypoprothrombinemia

Dosing: 2.5-25 mg or more (rarely up to 50 mg), with amount and route depending on severity. 3 Consider discontinuing or reducing interfering drugs (salicylates, antibiotics) as an alternative to vitamin K administration. 3


Administration Routes and Safety

Vitamin K1 (phylloquinone) is the safest form and is preferred over menadione salts. 6, 2 Vitamin K3 (menadione) is toxic and should never be used. 6

Route considerations:

  • Subcutaneous is preferred when possible 3
  • Intramuscular is most reliable for newborns 1, 2
  • Intravenous should be given very slowly (not exceeding 1 mg per minute) due to rare anaphylactoid reactions with bronchospasm and cardiac arrest 2, 3
  • Oral takes longer to work and depends on compliance 2

Vitamin K1 toxicity is not a concern—there are no known adverse effects of phylloquinone supplementation. 6, 2 The formulations approved in the United States have not been associated with childhood leukemia or other health problems. 4


Monitoring Vitamin K Status

There is no single established biomarker for vitamin K status. 6 Available options include:

  • Plasma phylloquinone concentration <0.15 μg/L indicates depletion/deficiency 6
  • PIVKA-II (undercarboxylated prothrombin) is the most sensitive marker of subclinical hepatic deficiency and should be used for at-risk patients when locally available 6, 1, 2
  • Prothrombin time (PT) is insensitive, only becoming elevated in severe deficiency 6
  • Undercarboxylated osteocalcin reflects bone vitamin K status but lacks established cut-offs 6

For CF patients, monitor vitamin K status at least annually and 3-6 months after dosage changes. 6


Special Clinical Situations

Patients on Warfarin

Anticoagulant control may improve with regular vitamin K intake at recommended doses (150 μg), but higher doses can cause warfarin resistance. 6 Monitor coagulation parameters closely when administering vitamin K to anticoagulated patients. 2

Women Planning Pregnancy

All women planning pregnancy should receive 400 μg folic acid daily (not vitamin K) in the preconceptional period and first trimester. 6 Vitamin K supplementation during pregnancy is only indicated if the mother is on anticonvulsants or prolonged antibiotic therapy. 9

References

Guideline

Treatment of Vitamin K Deficiency in Newborns

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Vitamin K Administration Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Prevention of Vitamin K Deficiency Bleeding.

Journal of midwifery & women's health, 2016

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Vitamin K in parenteral nutrition.

Gastroenterology, 2009

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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