vitamin K1 (phytonadione) (Rx)

Brand and Other Names:Vitamin K, Mephyton, more...AquaMephyton
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mcg
  • 5mg

injection emulsion

  • 2mg/mL
  • 10mg/mL
more...

Nutritional Supplementation

Recommended daily intake (RDA)

Males: 120 mcg/day PO

Females: 90 mcg/day PO

Hypoprothrombinemia Due To Drugs or Factors Limiting Absorption or Synthesis

2.5-10 mg PO/IV/IM/SC; may be increased PRN to 25 mg or, rarely, to 50 mg; may be repeated in 12-48 hours

Reversal of Warfarin Effects

Omit 1-2 doses, or hold warfarin; monitor INR and adjust warfarin dose accordingly

INR 4.5-10, no bleeding: 2012 ACCP guidelines suggest against routine use; 2008 ACCP guidelines suggest considering vitamin K1 (phytonadione) 1-2.5 mg PO once

INR >10, no bleeding: 2012 ACCP guidelines recommend vitamin K1 PO (dose not specified); 2008 ACCP guidelines suggest 2.5-5 mg PO once; INR reduction observed within 24-48 hr, monitor INR and give additional vitamin K if needed

Minor bleeding, any elevated INR: Consider 2.5-5 mg PO once; may repeat if needed after 24 hr

Major bleeding, any elevated INR: 2012 ACCP guidelines recommend prothrombin complex concentrate, human (PCC, Kcentra) plus vitamin K1 5-10 mg IV (dilute in 50 mL IV fluid and infuse over 20 min)

NOTE: High vitamin K doses (ie, 10 mg or more) may cause warfarin resistance for a week or more; consider using heparin, LMWH, or direct thrombin inhibitors to provide adequate thrombosis prophylaxis in clinical conditions requiring chronic anticoagulation therapy (eg, atrial fibrillation)

Dosing Considerations

PO dose may be repeated in 12-48 hr and SC/IV/IM dose in 6-8 hr if necessary

IV rate not to exceed 1 mg/min

Use of high vitamin K doses (10-15 mg) may cause warfarin resistance for ≥1 week

Dosage Forms & Strengths

tablet

  • 100mcg
  • 5mg

injection emulsion

  • 2mg/mL
  • 10mg/mL
more...

Nutritional Supplementation

RDA

0-6 months: 2 mcg/day

6-12 months: 2.5 mcg/day

1-3 years: 30 mcg/day

4-8 years: 55 mcg/day

9-13 years: 60 mcg/day

14-18 years: 75 mcg/day

Hemorrhagic Disease of the Newborn

Prophylaxis: 0.5-1 mg IM within 1 hr of birth

Treatment: 1 mg/dose/day SC; my require higher doses if mother has been receiving oral anticoagulants

Next:

Interactions

Interaction Checker

and vitamin K1 (phytonadione)

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            Frequency Not Defined

            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

            Postmarketing Reports

            Cardiac disorders: Tachycardia

            Neurologic: Dysgeusia, dizziness

            Skin and subcutaneous tissue disorders: Erythema, pruritic plaques

            Previous
            Next:

            Warnings

            Black Box Warnings

            Severe reactions, including fatalities, have occurred during and immediately after IV administration, even when precautions have been taken with proper dilution and avoidance of rapid infusion

            Severe reactions also reported after IM administration; typically, these severe reactions involve hypersensitivity or anaphylaxis and include shock and cardiac or respiratory arrest

            IV/IM reactions may occur with first dose (no prior exposure to phytonadione)

            Restrict use of IV/IM routes to situations where SC administration is not feasible and serious risk involved is considered justified

            Contraindications

            Hypersensitivity

            Cautions

            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

            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

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            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; if therapy is needed during pregnancy, consider using a benzyl alcohol-free formulation; published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes; there are maternal and fetal risks associated with vitamin K deficiency during pregnancy; animal reproduction studies have not been conducted with phytonadione

            Pregnant women with vitamin K deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery; subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage

            Lactation

            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; there are no data on effects of therapy on the breastfed child or on milk production; the developmental and health benefits of breastfeeding should be considered along with the clinical need for therapy and any potential adverse effects on breastfed child from the drug or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Promotes hepatic synthesis of clotting factors II, VII, IX, X (exact mechanism is unknown)

            Pharmacokinetics

            Onset: 6-10 hr (PO); 1-2 hr (IV)

            Peak effect: 24-48 hr (PO); 12-14 hr (IV)

            Metabolism

            Metabolized in liver

            Elimination

            Excretion: Urine, feces

            Previous
            Next:

            Administration

            IV Administration

            Dilute in preservative-free NS, D5W, or D5NS and infuse slowly; infusion rate not to exceed 1 mg/min

            IV route should be used only if administration by another route is not feasible

            Storage

            Protect injection emulsion from light at all times

            May be autoclaved

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.