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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VITAMIN K1 INJECTION safely and effectively. See full prescribing information for VITAMIN K1 INJECTION.

VITAMIN K1 INJECTION (Phytonadione Injectable Emulsion, USP), 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 Vitamin K1 Injection. 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)

INDICATIONS AND USAGE

Vitamin K1 Injection is a vitamin K replacement 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.

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Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. (1.1)
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Hypoprothrombinemia due to antibacterial therapy. (1.1)
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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. (1.1)
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Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. (1.1)

Vitamin K1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. (1.2)

DOSAGE AND ADMINISTRATION

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Administer Vitamin K1 Injection by the subcutaneous route, whenever possible. (2.1)
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When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute. (2.1)

DOSAGE FORMS AND STRENGTHS

Injection: 1 mg/0.5 mL and 10 mg/mL single-dose ampuls. (3)

CONTRAINDICATIONS

Hypersensitivity to any component of this medication. (4)

WARNINGS AND PRECAUTIONS

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Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Use benzyl alcohol-free phytonadione formulations in neonates and infants, if available. (5.2)
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Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. (5.3)

ADVERSE REACTIONS

Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants. (7)

USE IN SPECIFIC POPULATIONS

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Pregnancy: If available, use a preservative-free phytonadione formulation in pregnant women. (8.1)
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Lactation: If available, use a preservative-free phytonadione formulation in lactating women. (8.2)
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Pediatric Use: The safety and effectiveness of Vitamin K1 Injection in pediatric patients from 6 months to 17 years have not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2025

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