Skip to content

Vitamin K1 (Phytonadione)

    DEA Class; Rx

    Common Brand Names; Vitamin K, Mephyton, AquaMephyton

    • Hemostatics; 
    • Vitamins, Fat-Soluble

    Synthetic compound; chemically indistinguishable from naturally occurring vitamin K
    For the treatment or prevention of hypoprothrombinemia due to vitamin K deficiency and oral anticoagulant-induced hypoprothrombinemia
    Avoid IM and IV administration when possible due to risk of serious hypersensitivity and anaphylactoid reactions

    Indicated for nutritional supplementation to prevent vitamin K deficiency and/or hypoprothrombinemia.

    For treatment of hemorrhagic disease of the newborn (HDN).
    For hemorrhagic disease of the newborn (HDN) prophylaxis.
    For the treatment of vitamin K antagonist-induced prothrombin deficiency (i.e., vitamin K antagonist reversal).
    For the treatment of familial hypocholesterolemia (eg., abetalipoproteinemia, hypobetalipoproteinemia, and chylomicron retention disease, CRD).

    Hypersensitivity

    Anaphylaxis with too-rapid IV administration (has resulted in death)

    Dyspnea

    Cyanosis

    Erythematous skin eruptions

    Pruritus

    Scleroderma-like lesions

    Flushing

    Hyperbilirubinemia (in premature neonates)

    Hypotension

    Injection site reactions

    Taste alterations

    Cardiac disorders: Tachycardia

    Neurologic: Dysgeusia, dizziness

    Skin and subcutaneous tissue disorders: Erythema, pruritic plaques

    Rapid IV administration may cause potentially fatal anaphylaxis

    Protect from light; agent is rapidly degraded

    Avoid IM route if patients is bleeding or in 3rd trimester of pregnancy

    Administer phtonadione to quickly lower INR into safe range in patients receiving vitamin K antagonists

    Other forms of vitamin K (eg, menadione) are not effective in these settings; only vitamin K1 (ie, phytonadione) should be used

    Time of onset depends on rate of synthesis of clotting factors

    Potential for overcorrection

    If initial doses do not reverse coagulopathy, higher doses are not likely to have any effect; inefective in hereditary hypoprothrombinemia

    Longer treatment durations (up to months) and much higher doses required in patients exposed to long-acting anticoagulant rodenticide

    Hemolysis, hyperbilirubinemia, and jaundice reported in newborns treated with larger than recommended doses; use caution

    Parenteral administration may cause cutaneous reactions; reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions; time of onset ranged from 1 day to a year after parenteral administration; discontinue therapy for skin reactions and institute medical management

    Serious adverse reactions including fatal reactions and “gasping syndrome” reported in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative; preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol; preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol; use benzyl alcohol-free formulations in neonates and infants, if available

    The drug formulation contains benzyl alcohol, which has been associated with gasping syndrome in neonates; the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants

    The drug formulation contains benzyl alcohol; if available, a Preservative-Free formulation is recommended when therapy is needed during lactation; phytonadione is present in breastmilk

    Upper tolerable intake levels in healthy, non-vitamin deficient individuals of all ages are not determinable due to a lack of data.

    Adults

    Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.

    Geriatric

    Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.

    Adolescents

    Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.

    Children

    Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.

    Infants

    Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.

    Neonates

    Dependent on indication, but upper limits of single doses are 2 mg/day PO and 1 mg/day IV/IM/subcutaneously.

    Vitamin K1 (phytonadione)

    tablet

    • 100mcg
    • 5mg

    injection emulsion

    • 2mg/mL
    • 10mg/mL
     

    Nutritional Supplementation

    Recommended daily intake (RDA)

    Males: 120 mcg/day PO

    Females: 90 mcg/day PO