Vitamin K1 (Phytonadione) Uses/Indications Dosage Side effects-

Classes

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

Indications

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).

Contraindications

Hypersensitivity

Adverse Effects

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

Warnings

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

Pregnancy and Lactation

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

Maximum Dosage

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

Adults