Classes
DEA Class; Rx
Common Brand Names; Vitamin K, Mephyton, AquaMephyton
- Hemostatics;
- Vitamins, Fat-Soluble
Description
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.
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.
Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.
Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.
Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.
Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.
Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously.
Dependent on indication, but upper limits of single doses are 2 mg/day PO and 1 mg/day IV/IM/subcutaneously.
How supplied
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