vitamin K-1, phytonadione

Phytonadione is a synthetic form of vitamin K that is chemically identically to the naturally occurring vitamin K. Vitamin K is found in many foods from both plant and animal sources. Common sources of vitamin K include green leafy vegetables such as

• broccoli,
• Brussels sprouts,
• collard greens,
• lettuce, and
• spinach.

Vitamin K plays a crucial role in blood coagulation and the formation of blood clots. Vitamin K is necessary for the production of clotting factors in the liver including active prothrombin (factory II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). The FDA approved phytonadione 1940.

Mephyton

GENERIC AVAILABLE: Yes

No

Serious hypersensitivity reactions, including anaphylactoid reactions and death have been reported with use of injectable phytonadione. The majority of these cases were associated with use of intravenous phytonadione.

Other side effects reported with use of injectable phytonadione include:

• flushing,
• injection site pain or discomfort,
• taste disturbances,
• dizziness,
• rapid or weak pulse,
• profuse sweating,
• low blood pressure (hypotension),
• shortness of breath, and
• cyanosis.

Hyperbilirubinemia (high levels of bilirubin in the blood), a byproduct of red blood cell breakdown, has been reported in newborns following administration of injectable phytonadione.

Oral vitamin K in Adults

• For the treatment of anticoagulant-induced prothrombin deficiency: The initial recommended dose is 2.5 mg to 10 mg or up to 25 mg by mouth (rarely 50 mg).
• For the treatment of hypoprothrombinemia due to other causes: the initial recommended dose is 2.5 mg to 25 mg or more (rarely up to 50 mg).
• For the treatment of bleeding or bleeding prophylaxis in patients with warfarin toxicity: Adults with INR > 10 with no significant bleeding: administer 2.5-5 mg by mouth. Hold warfarin therapy.
• Adults with serious bleeding at any elevation of INR: administer 5-10 mg intravenously by slow infusion in combination with 4-factor prothrombin complex concentrate. Hold warfarin therapy.
• For the treatment of hemorrhagic disease of the newborn: administer 1 mg/dose/day intramuscularly (into the muscle) or subcutaneously (into the fatty tissue). Higher doses may be required if mother has been receiving treatment with oral anticoagulants.
• For the prevention of hemorrhagic disease of the newborn: administer 0.5-1 mg intramuscularly within 1 hour of birth.

Phytonadione antagonizes or blocks the therapeutic benefits of warfarin (Coumadin) treatment. Warfarin inhibits vitamin K reductase, the enzyme responsible for reducing vitamin K. The reduced form of vitamin K is used by the liver to make blood clotting factors. When phytonadione is given to treat or prevent warfarin induced bleeding, a temporary resistance to warfarin may develop. Risk of resistance is higher with use of large doses of phytonadione.

It is not known if phytonadione is excreted into human milk. Because many drugs can enter breast milk and cause harm to the nursing infant, phytonadione should be used cautiously in nursing mothers.

What preparations of vitamin k-injection are available?

• Oral tablets: 5 mg, 100 mcg
• Solution for injection: 10 mg/ml, 1 mg/0.5 ml

How should I keep vitamin k-injection stored?

Tablets should be stored at room temperature between 15 C and 30 C (59 F and 86 F). Injectable vitamin K should be stored in original container at controlled room temperature between 20 C and 25 C (68 F and 77 F), and should be protected from light.