This dosage information may not include all the information needed to use Phytonadione safely and effectively. See additional information for Phytonadione.
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Usual Adult Dose for:
- Hypoprothrombinemia - Anticoagulant Induced
- Hypoprothrombinemia - Not Associated with Anticoagulant Therapy
- Hypoprothrombinemia - Prophylaxis
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Hypoprothrombinemia - Anticoagulant Induced
INR Bleed Reversal Therapy & Follow-Up Comment
<6 No No Omit 1 to 4 anticoagulant doses and
reduce dosage when resume therapy.
<10 No Yes Prior to surgical or dental procedures
give 0.5 to 1 mg IM, subcutaneously,
or IV. Check INR in 8 hours. May
repeat 0.5 mg in 24 hours if needed.
6-10 No No Omit 1 to 4 anticoagulant doses. May
consider phytonadione 0.5 to 2 mg orally,
IM, subcutaneously, or IV. Check INR
in 8 hours (12 to 48 hours if given orally).
May repeat 0.5 mg in 24 to 48 hours if
10-20 No No Phytonadione 3 to 5 mg orally, IM,
subcutaneously, or IV. Check INR in
8 hours (12 to 48 hours if given orally).
May repeat 0.5 mg in 24 hours if needed.
> 20 or Yes -- Phytonadione 10 mg IM, subcutaneously,
or IV. Check INR every 6 hours and
repeat dose every 12 hours as needed.
In acute situations, give fresh frozen
plasma or factor concentrates and
phytonadione 10 mg, to be repeated
Usual Adult Dose for Hypoprothrombinemia - Not Associated with Anticoagulant Therapy
2.5 to 25 mg orally, IM, subcutaneously, or IV.
The dosage, frequency, and route of administration should be determined by the severity of the condition.
If there is no bleeding and INR < 20: 2.5 to 5 mg (up to 10 mg) may be given orally, IM, subcutaneously, or IV.
For active bleeding: 10 to 25 mg IM, subcutaneously, or IV.
When given by injection, the effects may not be apparent for up to 8 hours. Therefore, a transfusion with fresh frozen plasma or factor concentrates is recommended in serious or life-threatening situations. The INR may be checked in 8 to 12 hours following parenteral therapy or 12 to 48 hours following oral therapy, and dosage repeated if necessary.
Usual Adult Dose for Hypoprothrombinemia - Prophylaxis
2.5 to 10 mg orally or 1 to 10 mg IM, depending on the patient's condition. Malabsorption syndromes: 10 mg IM monthly.
Surgical correction of biliary obstruction: 5 mg IM once a day for 3 days prior to surgery.
Prolonged antibiotics in at risk patients: 10 mg orally, IM, or subcutaneously prior to or concurrent with the first antibiotic dose.
Malnourished, debilitated, or TPN patients: 1 mg IM once a week.
Usual Pediatric Dose for Hypoprothrombinemia - Anticoagulant Induced
Infants and children:
No bleeding, rapid reversal needed, anticoagulation to continue: 0.5 to 2 mg, intravenously or subcutaneously.
No bleeding, rapid reversal needed, patient NOT continuing anticoagulation: 2 to 5 mg, intravenously or subcutaneously.
Significant bleeding, not life-threatening: 0.5 to 2 mg intravenously or subcutaneously.
Significant bleeding and life-threatening: 5 mg intravenously.
Adolescents: 2.5 to 10 mg/dose, subcutaneously or intravenously; may repeat in 6 to 8 hours if given by subcutaneous or intravenous route; may repeat 12 to 48 hours after oral route.
Usual Pediatric Dose for Vitamin K Deficiency
Infants and children:
2.5 to 5 mg orally once every 24 hours. Alternatively, 1 to 2 mg IV, IM or subcutaneously may be administered.
2.5 to 25 mg orally once every 24 hours. Alternatively, 10 mg IV, IM or subcutaneously may be administered.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
The administration of high dosages of phytonadione in patients with severe liver disease has resulted in further depression of liver function. Routine liver function tests should be performed if regular or prolonged therapy with phytonadione is necessary.
In patients with liver disease, repeated administrations of large dosages of phytonadione should be avoided if a favorable response is not obtained after the initial dose. Failure to respond may indicate a metabolic inability to utilize vitamin K or a coagulation defect unrelated to vitamin K deficiency.
Patients with severe hepatocellular damage will generally not respond to phytonadione.
Since control of hypoprothrombinemia may restore the risk for intravascular clotting, the dose should be kept as low as possible. Heparin should be available if needed to counteract a potential hypercoagulability. The administration of high dosages of phytonadione in patients with severe liver disease may result in further depression of liver function. Therefore, appropriate consideration should be GI
In cases where the hypoprothrombinemia is secondary to a malabsorption syndrome (e.g. sprue, regional enteritis, celiac disease, ulcerative colitis, bowel resection), phytonadione should be administered parenterally. Where there is obstructive jaundice or biliary obstruction (e.g. gallstones, stricture, fistulas), oral phytonadione may be given with bile salts to aid in absorption.
Fatalities and other severe reactions (hypersensitivity, anaphylaxis, shock, cardiac and/or respiratory arrest) have occurred during or immediately following the parenteral administration of phytonadione. The majority of these reactions have occurred with intravenous administration. The manufacturers of phytonadione, as well as some experts, recommend restricting the intravenous route of administration to those situations in which another route is not feasible and the benefits outweigh the increase in risk. The chance of a severe or fatal reaction with intravenous administration may be, but not necessarily, diminished by diluting phytonadione in a suitable fluid and infusing at a rate not to exceed 1 mg per minute.
Data not available
In patients given large doses of phytonadione (e.g. 10 mg or more), there may be a temporary resistance to prothrombin-depressing agents for up to a week. Upon reinstitution of anticoagulation therapy, the use of an agent with a different mechanism of action (e.g. heparin) may be necessary until the effects of the phytonadione are cleared.
Phytonadione should not be expected to produce coagulating effects immediately following administration. A minimum of 1 to 2 hours is required before improvements are generally seen. In otherwise healthy individuals with no malabsorption syndromes, response to oral phytonadione is only slightly slower than response to the intravenous form.