phytonadione

fye-toe-na-DYE-one

Therapeutic Classification: antidotes, vitamins

Pharmacologic Classification: fat soluble vitamins

REMS

Prevention and treatment of hypoprothrombinemia, which may be associated with:
- Excessive doses of warfarin,
- Salicylates,
- Certain anti-infective agents,
- Nutritional deficiencies,
- Prolonged total parenteral nutrition.
Prevention and treatment of vitamin K-deficiency bleeding in neonates.

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.

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.

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.

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.

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

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

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.

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.
PO (Adults ): 2.5–25 mg/day.
SC IV (Children >1 mo): 1–2 mg 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.

(Generic available)

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

Monitor for frank and occult bleeding (guaiac stools, Hematest urine, and emesis). Monitor pulse and BP frequently; notify health care professional immediately if symptoms of internal bleeding or hypovolemic shock develop. Inform all personnel of patient’s bleeding tendency to prevent further trauma. Apply pressure to all venipuncture sites for at least 5 min; avoid unnecessary IM injections.
Pedi: Monitor for side effects and adverse reactions. Children may be especially sensitive to the effects and side effects of vitamin K. Neonates, especially premature neonates, may be more sensitive than older children.

Lab Test Considerations:

Monitor INR prior to and during vitamin K therapy to determine response to and need for further therapy.

The parenteral route is preferred for phytonadione therapy but, because of severe, potentially fatal hypersensitivity reactions, IV vitamin K is not recommended.
- Administration of whole blood or plasma may also be required in severe bleeding because of the delayed onset of this medication.
- Phytonadione is an antidote for warfarin overdose but does not counteract the anticoagulant activity of heparin.

IV Administration:

Intermittent Infusion: Diluent: Dilute in 0.9% NaCl, D5W, or D5/0.9% NaCl.
Rate: Administer over 30–60 min. Rate should not exceed 1 mg/min.

Instruct patient to take phytonadione as directed. Take missed doses as soon as remembered unless almost time for next dose. Notify health care professional of missed doses.
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 report any symptoms of unusual bleeding or bruising (bleeding gums; nosebleed; black, tarry stools; hematuria; excessive menstrual flow).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications and alcohol.
Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Advise patient to carry identification at all times describing disease process.
Emphasize the importance of frequent lab tests to monitor coagulation factors.

Prevention of spontaneous bleeding or cessation of bleeding in patients with hypoprothrombinemia secondary to impaired intestinal absorption or oral anticoagulant, salicylate, or anti-infective therapy.
Prevention of hemorrhagic disease in the newborn.

NDC Code

0187- Bausch Health US LLC
- 0187-1704- Mephyton
  - 0187-1704-05- 1 BOTTLE in 1 CARTON (0187-1704-05) > 100 TABLET in 1 BOTTLE

0409- Hospira, Inc.
- 0409-9157- Vitamin K1
  - 0409-9157-01- 5 TRAY in 1 CONTAINER (0409-9157-01) > 5 AMPULE in 1 TRAY (0409-9157-50) > .5 mL in 1 AMPULE (0409-9157-31)

0409- Hospira, Inc.
- 0409-9158- Vitamin K1
  - 0409-9158-01- 5 TRAY in 1 CONTAINER (0409-9158-01) > 5 AMPULE in 1 TRAY (0409-9158-50) > 1 mL in 1 AMPULE (0409-9158-31)

0409- Hospira, Inc.
- 0409-9158- Vitamin K1
  - 0409-9158-25- 5 TRAY in 1 CONTAINER (0409-9158-25) > 5 AMPULE in 1 TRAY > 1 mL in 1 AMPULE

0904- Major Pharmaceuticals
- 0904-6882- Phytonadione
  - 0904-6882-10- 20 BLISTER PACK in 1 CARTON (0904-6882-10) > 1 TABLET in 1 BLISTER PACK

16714- Northstar Rx LLC.
- 16714-973- Phytonadione
  - 16714-973-01- 1 BOTTLE in 1 CARTON (16714-973-01) > 100 TABLET in 1 BOTTLE

43598- Dr.Reddy's Laboratories Inc
- 43598-405- PHYTONADIONE PHYTONADIONE
  - 43598-405-16- 5 AMPULE in 1 CARTON (43598-405-16) > 1 mL in 1 AMPULE (43598-405-11)

50090- A-S Medication Solutions
- 50090-1753- Mephyton
  - 50090-1753-0- 5 TABLET in 1 BOTTLE (50090-1753-0)

50090- A-S Medication Solutions
- 50090-4521- Vitamin K1
  - 50090-4521-0- 1 mL in 1 AMPULE (50090-4521-0)

50090- A-S Medication Solutions
- 50090-4523- Vitamin K1
  - 50090-4523-0- .5 mL in 1 AMPULE (50090-4523-0)

52565- Teligent Pharma, Inc.
- 52565-142- Phytonadione
  - 52565-142-25- 25 AMPULE in 1 TRAY (52565-142-25) > .5 mL in 1 AMPULE

52565- Teligent Pharma, Inc.
- 52565-143- Phytonadione
  - 52565-143-25- 5 AMPULE in 1 TRAY (52565-143-25) > 1 mL in 1 AMPULE

52584- General Injectables and Vaccines, Inc
- 52584-046- PHYTONADIONE
  - 52584-046-01- 1 BOX in 1 BAG (52584-046-01) > 1 SYRINGE in 1 BOX > .5 mL in 1 SYRINGE

52584- General Injectables and Vaccines, Inc
- 52584-158- Vitamin K1
  - 52584-158-01- 1 AMPULE in 1 BAG (52584-158-01) > 1 mL in 1 AMPULE

52584- General Injectables and Vaccines, Inc.
- 52584-405- PHYTONADIONE
  - 52584-405-11- 1 AMPULE in 1 BAG (52584-405-11) > 1 mL in 1 AMPULE

60687- American Health Packaging
- 60687-381- Phytonadione
  - 60687-381-94- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-381-94) > 1 TABLET in 1 BLISTER PACK (60687-381-11)

68682- Oceanside Pharmaceuticals
- 68682-170- Phytonadione
  - 68682-170-30- 1 BOTTLE in 1 CARTON (68682-170-30) > 30 TABLET in 1 BOTTLE

69238- Amneal Pharmaceuticals NY LLC
- 69238-1051- Phytonadione
  - 69238-1051-1- 1 BOTTLE in 1 CARTON (69238-1051-1) > 100 TABLET in 1 BOTTLE

69238- Amneal Pharmaceuticals NY LLC
- 69238-1051- Phytonadione
  - 69238-1051-3- 1 BOTTLE in 1 CARTON (69238-1051-3) > 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1014- Phytonadione
  - 70710-1014-1- 1 BOTTLE in 1 CARTON (70710-1014-1) > 100 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1014- Phytonadione
  - 70710-1014-4- 10 BLISTER PACK in 1 CARTON (70710-1014-4) > 10 TABLET in 1 BLISTER PACK (70710-1014-2)

70771- Cadila Healthcare Limited
- 70771-1318- Phytonadione
  - 70771-1318-1- 1 BOTTLE in 1 CARTON (70771-1318-1) > 100 TABLET in 1 BOTTLE

70771- Cadila Healthcare Limited
- 70771-1318- Phytonadione
  - 70771-1318-4- 10 BLISTER PACK in 1 CARTON (70771-1318-4) > 10 TABLET in 1 BLISTER PACK (70771-1318-2)

76329- International Medication Systems, Limited
- 76329-1240- Phytonadione
  - 76329-1240-1- 1 SYRINGE in 1 CARTON (76329-1240-1) > .5 mL in 1 SYRINGE

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Pronunciation ⬇

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Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

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Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

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Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

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