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.
GENERIC AVAILABLE: Yes
- Oral tablets: 5 mg, 100 mcg
- Solution for injection: 10 mg/ml, 1 mg/0.5 ml
STORAGE: 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.
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.
DRUG INTERACTIONS: 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.
PREGNANCY: Adequate and well-controlled studies of vitamin K use in pregnancy have not been conducted. As the dietary requirements of vitamin K are not different in pregnant women, supplementation of vitamin K during pregnancy is not required. Due to the lack of conclusive safety data, vitamin K should only be used during pregnancy if the potential benefits of treatment outweigh the potential risk to the mother or the fetus. Phytonadione is classified as FDA pregnancy risk category C (Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks).
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