Phytonadione

Phytonadione

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Questions & Answers

Side Effects & Adverse Reactions

An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement in the prothrombin time. Whole blood or component therapy may also be necessary if bleeding is severe.

Phytonadione will not counteract the anticoagulant action of heparin.

When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.

Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate that the condition being treated is inherently unresponsive to vitamin K.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Phytonadione is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.

Phytonadione injection is indicated in:

anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
prophylaxis and therapy of hemorrhagic disease of the newborn;
hypoprothrombinemia due to antibacterial therapy;
hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;
other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

History

There is currently no drug history available for this drug.

Other Information

Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.71.

Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H4602; and its structural formula is:

Chemical Structure

Phytonadione Injectable Emulsion, USP, is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 3.5 to 7.0. It is available for injection by the intravenous, intramuscular, and subcutaneous route.

Each 0.5 mL contains 1 mg phytonadione (Vitamin K1), 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation.

Phytonadione Manufacturers


  • Amphastar Pharmaceuticals, Inc.
    Phytonadione Injection, Emulsion [Amphastar Pharmaceuticals, Inc.]
  • General Injectables & Vaccine, Inc
    Phytonadione Injection, Solution [General Injectables & Vaccine, Inc]
  • General Injectables & Vaccines, Inc
    Phytonadione Injection, Emulsion [General Injectables & Vaccines, Inc]
  • Amphastar Pharmaceuticals, Inc.
    Phytonadione Injection, Emulsion [Amphastar Pharmaceuticals, Inc.]
  • International Medication Systems, Limited
    Phytonadione Injection, Emulsion [International Medication Systems, Limited ]
  • General Injectables & Vaccines, Inc
    Phytonadione Injection, Emulsion [General Injectables & Vaccines, Inc]
  • Cardinal Health
    Phytonadione Injection, Emulsion [Cardinal Health]
  • General Injectables & Vaccines, Inc
    Phytonadione Injection, Emulsion [General Injectables & Vaccines, Inc]

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