Vitamin K1 (phytonadione) (Rx) - Medscape Reference

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Tools & Referencevitamin K1 (phytonadione) (Rx)Brand and Other Names:Vitamin K, Mephyton, more...AquaMephyton

• Classes: Hemostatics;
• Vitamins, Fat-Soluble

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Sections

• Sections vitamin K1 (phytonadione)
• Dosing & Uses
• Interactions
• Adverse Effects
• Warnings
• Pregnancy
• Pharmacology
• Administration
• Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

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

Hypoprothrombinemia Due To Drugs or Factors Limiting Absorption or Synthesis

2.5-10 mg PO/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

Avoid IM route; increases risk of hematoma formation

Oral route more effective than SC route in nonbleeding patients in warfarin associated coagulopathy

IV rate not to exceed 1 mg/min

May use IV route in selected nonbleeding patients; use IV route in patients with major bleeding due to warfarin associated coagulopathy

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

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

Enter a drug name to check for any interactions. and vitamin K1 (phytonadione)

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No Interactions Found Interactions Found

Contraindicated

Serious

Significant - Monitor Closely

Minor

All Interactions Sort By: SeverityName

Contraindicated (0)

Serious (0)

Monitor Closely (40)

• aspirin rectal

  aspirin rectal increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

• aspirin/citric acid/sodium bicarbonate

  aspirin/citric acid/sodium bicarbonate increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• choline magnesium trisalicylate

  choline magnesium trisalicylate increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

• erythromycin base

  erythromycin base will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• erythromycin ethylsuccinate

  erythromycin ethylsuccinate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• erythromycin lactobionate

  erythromycin lactobionate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• erythromycin stearate

  erythromycin stearate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• fennel

  fennel increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• feverfew

  feverfew increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• flurbiprofen

  flurbiprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• forskolin

  forskolin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• garlic

  garlic increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ginger

  ginger increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ginkgo biloba

  ginkgo biloba increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• horse chestnut seed

  horse chestnut seed increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ibuprofen

  ibuprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ibuprofen IV

  ibuprofen IV increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• indomethacin

  indomethacin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ketoprofen

  ketoprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ketorolac

  ketorolac increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ketorolac intranasal

  ketorolac intranasal increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

• mefenamic acid

  mefenamic acid increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• meloxicam

  meloxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• mistletoe

  mistletoe and vitamin K1 (phytonadione) both decrease anticoagulation. Use Caution/Monitor.

• nabumetone

  nabumetone increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• naproxen

  naproxen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• nettle

  nettle and vitamin K1 (phytonadione) both decrease anticoagulation. Use Caution/Monitor.

• oxaprozin

  oxaprozin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• panax ginseng

  panax ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• pau d'arco

  pau d'arco increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• phytoestrogens

  phytoestrogens increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• piroxicam

  piroxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• reishi

  reishi increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• salicylates (non-asa)

  salicylates (non-asa) increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• salsalate

  salsalate increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• Siberian ginseng

  Siberian ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• sulfasalazine

  sulfasalazine increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• sulindac

  sulindac increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• tolmetin

  tolmetin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• warfarin

  vitamin K1 (phytonadione), warfarin. Either decreases effects of the other by anticoagulation. Use Caution/Monitor. Monitor INR with corresponding increases or decreases in vitamin K intake significantly affecting vitamin k blood levels.

Minor (8)

• chlorhexidine oral

  chlorhexidine oral will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

• cholestyramine

  cholestyramine decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

• ciprofloxacin

  ciprofloxacin will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

• colesevelam

  colesevelam decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

• colestipol

  colestipol decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

• meropenem/vaborbactam

  meropenem/vaborbactam will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

• mineral oil

  mineral oil decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

• orlistat

  orlistat decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Separate by 2 hours.

• aspirin rectal

  Monitor Closely (1)aspirin rectal increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

• aspirin/citric acid/sodium bicarbonate

  Monitor Closely (1)aspirin/citric acid/sodium bicarbonate increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• chlorhexidine oral

  Minor (1)chlorhexidine oral will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

• cholestyramine

  Minor (1)cholestyramine decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

• choline magnesium trisalicylate

  Monitor Closely (1)choline magnesium trisalicylate increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

• ciprofloxacin

  Minor (1)ciprofloxacin will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

• colesevelam

  Minor (1)colesevelam decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

• colestipol

  Minor (1)colestipol decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

• erythromycin base

  Monitor Closely (1)erythromycin base will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• erythromycin ethylsuccinate

  Monitor Closely (1)erythromycin ethylsuccinate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• erythromycin lactobionate

  Monitor Closely (1)erythromycin lactobionate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• erythromycin stearate

  Monitor Closely (1)erythromycin stearate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

• fennel

  Monitor Closely (1)fennel increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• feverfew

  Monitor Closely (1)feverfew increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• flurbiprofen

  Monitor Closely (1)flurbiprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• forskolin

  Monitor Closely (1)forskolin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• garlic

  Monitor Closely (1)garlic increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ginger

  Monitor Closely (1)ginger increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ginkgo biloba

  Monitor Closely (1)ginkgo biloba increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• horse chestnut seed

  Monitor Closely (1)horse chestnut seed increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ibuprofen

  Monitor Closely (1)ibuprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ibuprofen IV

  Monitor Closely (1)ibuprofen IV increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• indomethacin

  Monitor Closely (1)indomethacin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ketoprofen

  Monitor Closely (1)ketoprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ketorolac

  Monitor Closely (1)ketorolac increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• ketorolac intranasal

  Monitor Closely (1)ketorolac intranasal increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

• mefenamic acid

  Monitor Closely (1)mefenamic acid increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• meloxicam

  Monitor Closely (1)meloxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• meropenem/vaborbactam

  Minor (1)meropenem/vaborbactam will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

• mineral oil

  Minor (1)mineral oil decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

• mistletoe

  Monitor Closely (1)mistletoe and vitamin K1 (phytonadione) both decrease anticoagulation. Use Caution/Monitor.

• nabumetone

  Monitor Closely (1)nabumetone increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• naproxen

  Monitor Closely (1)naproxen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• nettle

  Monitor Closely (1)nettle and vitamin K1 (phytonadione) both decrease anticoagulation. Use Caution/Monitor.

• orlistat

  Minor (1)orlistat decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Separate by 2 hours.

• oxaprozin

  Monitor Closely (1)oxaprozin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• panax ginseng

  Monitor Closely (1)panax ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• pau d'arco

  Monitor Closely (1)pau d'arco increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• phytoestrogens

  Monitor Closely (1)phytoestrogens increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• piroxicam

  Monitor Closely (1)piroxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• reishi

  Monitor Closely (1)reishi increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• salicylates (non-asa)

  Monitor Closely (1)salicylates (non-asa) increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• salsalate

  Monitor Closely (1)salsalate increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• Siberian ginseng

  Monitor Closely (1)Siberian ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• sulfasalazine

  Monitor Closely (1)sulfasalazine increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• sulindac

  Monitor Closely (1)sulindac increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• tolmetin

  Monitor Closely (1)tolmetin increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

• warfarin

  Monitor Closely (1)vitamin K1 (phytonadione), warfarin. Either decreases effects of the other by anticoagulation. Use Caution/Monitor. Monitor INR with corresponding increases or decreases in vitamin K intake significantly affecting vitamin k blood levels.

PreviousNext:

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

General disorders and administration site conditions: Pain, swelling, and tenderness at injection site

Skin and subcutaneous disorders: Erythema perstans

Postmarketing Reports

Cardiac disorders: Tachycardia

Neurologic: Dysgeusia, dizziness

Skin and subcutaneous tissue disorders: Erythema, pruritic plaques

PreviousNext:

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 patient is bleeding or in 3rd trimester of pregnancy

Administer phytonadione 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; ineffective 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 effects

• 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
• Use benzyl alcohol-free formulations in neonates and infants, if available

Drug interaction overview

• Anticoagulants

  • Phytonadione may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses are used
  • If this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (ie, heparin sodium)
  • Phytonadione does not affect anticoagulant actions of heparin

PreviousNext:

Pregnancy & Lactation

Pregnancy

Phytonadione injectable emulsion contains benzyl alcohol, which has been associated with gasping syndrome in neonates

Preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants

If needed during pregnancy, consider using a benzyl alcohol-free formulation

Published studies with 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

Clinical considerations

• 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

Injectable emulsion contains benzyl alcoholIf available, preservative-free phytonadione injectable emulsion is recommended when used during lactation

Present in breastmilk

There are no data on the effects of phytonadione injectable emulsion on breastfed children or on milk production

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.

PreviousNext:

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

PreviousNext:

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

PreviousNext:

Formulary

FormularyPatient Discounts

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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.

View explanations for tiers and restrictions

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.
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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.

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