These highlights do not include all the information needed to use PHYTONADIONE INJECTABLE EMULSION, USP safely and effectively. See full prescribing information for PHYTONADIONE INJECTABLE EMULSION, USP. PHYTONADIONE Injection, for intravenous, intramuscular, and subcutaneous use. Initial U.S. Approval: 1960 WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified (5.1)

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These highlights do not include all the information needed to use PHYTONADIONE INJECTABLE EMULSION, USP safely and effectively. See full prescribing information for PHYTONADIONE INJECTABLE EMULSION, USP. PHYTONADIONE Injection, for intravenous, intramuscular, and subcutaneous use. Initial U.S. Approval: 1960 WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified (5.1)

Medication label

Why this: Advisory · dailymed-prescription

1.1 Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Phytonadione Injectable Emulsion, USP is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity; anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. 1.2 Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Phytonadione Injectable Emulsion, USP is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

generic_name: phytonadione
product_names: phytonadione
ndc: 0404-9935, 76329-1240, 0404-9935-05
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en