phytonadione

Contraindicated in:

Hypersensitivity;
Hypersensitivity or intolerance to benzyl alcohol (injection only).

Use Cautiously in:

Hepatic impairment;
Pedi: Use of injection formulations containing benzyl alcohol may lead to gasping syndrome in neonates and infants.

Exercise Extreme Caution in:

Severe life-threatening reactions have occurred following IV administration; use other routes unless risk is justified.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: eczematous reactions, flushing, kernicterus, rash, scleroderma-like lesions, urticaria

GI: gastric upset, hyperbilirubinemia (large doses in very premature infants), unusual taste

Hemat: hemolytic anemia

Local: erythema, pain at injection site, swelling

Misc: HYPERSENSITIVITY REACTIONS

Interactions ⬆ ⬇

Drug-drug:

Large doses will counteract the effect of warfarin.
Large doses of salicylates or broad-spectrum anti-infectives may ↑ vitamin K requirements.
Bile acid sequestrants, mineral oil, and sucralfate may ↓ vitamin K absorption from the GI tract.

Availability ⬆ ⬇

(Generic available)

Tablets: 5 mg
Solution for injection: 1 mg/0.5 mL; 10 mg/mL

Route/Dosage ⬆ ⬇

IV use of phytonadione should be reserved for patients with serious or life-threatening bleeding and elevated INR. Oral route is preferred in patients with elevated INRs and no serious or life-threatening bleeding. IM route should generally be avoided because of risk of hematoma formation.

Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency (From Factors Other Than Warfarin)

SC IV (Adults ): 10 mg as single dose.
PO (Adults ): 2.5–25 mg/day.
SC IV (Children >1 mo): 1–2 mg as single dose.
PO (Children >1 mo): 2.5–5 mg/day.

Vitamin K Deficiency (Supratherapeutic INR) Secondary to Warfarin

PO (Adults ): INR ≥5 and <9 (no significant bleeding): Hold warfarin and give 1–2.5 mg vitamin K; if more rapid reversal required, give ≤5 mg vitamin K; INR >9 (no significant bleeding): Hold warfarin and give 2.5–5 mg vitamin K.
IV (Adults ): Elevated INR with serious or life-threatening bleeding: 10 mg slow infusion.

Prevention of Hypoprothrombinemia During Total Parenteral Nutrition

IV (Adults ): 5–10 mg once weekly.
IV (Children ): 2–5 mg once weekly.

Prevention of Vitamin K–Deficiency Bleeding in Neonates

IM (Neonates ): 0.5–1 mg within 1 hr of birth; may repeat in 6–8 hr if needed. May be repeated in 2–3 wk if mother received previous anticonvulsant/anticoagulant/anti-infective/antitubercular therapy. 1–5 mg may be given IM to mother 12–24 hr before delivery.

Treatment of Vitamin K–Deficiency Bleeding in Neonates

IM SC (Neonates ): 1–2 mg/day.

Action ⬆ ⬇

Acts as a vitamin K replacement. Required for hepatic synthesis of blood coagulation factors II (prothrombin), VII, IX, and X.

Therapeutic effects:

Prevention of bleeding due to hypoprothrombinemia.

Classifications ⬆ ⬇

Therapeutic Classification: antidotes, vitamins

Pharmacologic Classification: fat soluble vitamins

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral or SUBQ administration. Oral absorption requires presence of bile salts. Some vitamin K is produced by bacteria in the GI tract.

Distribution: Unknown.

Metabolism/Excretion: Rapidly metabolized by the liver.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK‡	DURATION‡
PO	6–12 hr	unknown	unknown
SUBQ	1–2 hr	3–6 hr	12–14 hr
IV	1–2 hr	3–6 hr	12 hr

‡Control of hemorrhage.

‡Normal PT achieved.

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of phytonadione. Instruct to take as directed. Take missed doses as soon as remembered unless almost time for next dose. Notify health care provider of missed doses. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
Tell patient to report and seek treatment for signs and symptoms of bleeding (weakness; fast heartbeat; trouble breathing; dizziness; pale skin; tiredness; obvious bleeding in urine, stool, mouth, or nose; excessive menstrual flow).
Cooking does not destroy substantial amounts of vitamin K. Patient should not drastically alter diet while taking vitamin K. See Food Sources for Specific Nutrients for foods high in vitamin K.
Caution patient to avoid IM injections and activities leading to injury. Use a soft toothbrush, do not floss, and shave with an electric razor until coagulation defect is corrected.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications and alcohol.
Advise patient to inform health care provider of medication regimen prior to treatment or surgery.
Advise patient to carry identification at all times describing disease process.
Emphasize the importance of frequent lab tests to monitor coagulation factors.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇