When is intramuscular vitamin K (phytonadione) indicated, and what are the recommended adult and newborn doses?

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Intramuscular Vitamin K (Phytonadione): Indications and Dosing

Intramuscular vitamin K is indicated primarily for newborn hemorrhagic disease prophylaxis (0.5-1 mg within one hour of birth) and for reversal of warfarin-induced coagulopathy in adults (2.5-25 mg, up to 50 mg in severe cases), though the subcutaneous route is preferred when feasible in adults due to safety concerns. 1, 2

Newborn Prophylaxis

The single most critical indication for IM vitamin K is prevention of vitamin K deficiency bleeding (VKDB) in all newborns:

  • Administer 0.5-1.0 mg IM within one hour of birth 1, 2, 3
  • This is the gold standard and most reliable method to prevent early, classic, and late VKDB 1
  • IM administration creates a depot effect, maintaining protective levels for at least 2 months, significantly longer than oral formulations which last only 3-4 weeks 4
  • The prolonged efficacy results from vitamin K forming a viscous mass in muscle tissue that is slowly absorbed over many weeks 4

For treatment of active hemorrhagic disease of the newborn:

  • Give 1 mg IM or subcutaneously 2
  • Higher doses may be necessary if the mother received oral anticoagulants 2
  • A prompt PT shortening within 2-4 hours confirms the diagnosis 1, 2

Special newborn populations requiring IM (not oral) administration: 3, 5

  • Preterm infants (who require 10 μg/kg/day on parenteral nutrition) 1, 6
  • Infants with cholestasis or impaired intestinal absorption 3
  • Infants too unwell to take oral vitamin K 3
  • Infants whose mothers took medications interfering with vitamin K metabolism 3

Adult Indications

For warfarin reversal with major or life-threatening bleeding:

  • Initial dose: 2.5-10 mg, up to 25 mg initially; rarely 50 mg may be required 2
  • Must be given with prothrombin complex concentrate (PCC) 25 IU/kg for rapid reversal 7
  • Vitamin K is essential because factor VII has a short half-life (6 hours); give 5-10 mg IV to maintain clotting factor levels after PCC wears off 7
  • PCC reverses warfarin within 10-30 minutes, while vitamin K takes 6-12 hours IV or 24 hours orally to reach maximum effect 7, 6
  • Check INR 30 minutes after PCC dosing; repeat dosing guided by clinical and laboratory assessment 7

For elevated INR without major bleeding:

  • 2.5-10 mg is the typical range 2
  • If PT not shortened satisfactorily in 6-8 hours, repeat the dose 2
  • Oral and IV routes show similar efficacy at 24 hours, though IV acts faster initially 8

For hypoprothrombinemia from other causes:

  • Dose range: 2.5-25 mg or more (rarely up to 50 mg) 2
  • Amount and route depend on severity and response 2

Route Selection and Safety

Critical safety consideration: Subcutaneous route is preferred over IM in adults when possible 2

  • When IV or IM administration is unavoidable, inject very slowly, not exceeding 1 mg per minute 2
  • The FDA label emphasizes avoiding IV/IM routes when possible due to risk of severe reactions 2

For emergency antidote stocking in hospitals:

  • Stock 50-100 mg total per facility 7
  • Initial dose should be IV (not exceeding 10 mg), with subsequent doses given orally 7
  • For patients with elevated INR and active bleeding, also administer prothrombin complex concentrate 7

Common Pitfalls

  • Do not give IV glucose to patients at risk of thiamine deficiency before administering thiamine, as this can precipitate Wernicke's encephalopathy 7
  • Large vitamin E doses can exacerbate vitamin K deficiency and affect coagulation 7
  • Benzyl alcohol preservatives are toxic to newborns; use preservative-free diluents 2
  • Oral vitamin K prophylaxis in newborns requires strict compliance with multi-dose protocols and is less reliable than IM 3, 4
  • Vitamin K administration may affect anticoagulant therapy response; monitor coagulation parameters 6

References

Guideline

Vitamin K Dosing Recommendations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Does intramuscular vitamin K1 act as an unintended depot preparation?

Journal of paediatrics and child health, 1996

Guideline

Vitamin K1 Dosing Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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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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