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An oral prescription vitamin K

MEPHYTON® IS AN ORAL PRESCRIPTION VITAMIN K TABLET AVAILABLE IN THE UNITED STATES

MEPHYTON (phytonadione) is indicated in the following coagulation disorders that are caused by faulty formation of factors II, VII, IX, and X due to vitamin K deficiency or interference with vitamin K activity1:

  • anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives
  • hypoprothrombinemia secondary to antibacterial therapy
  • hypoprothrombinemia secondary to administration of salicylates
  • hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently; otherwise, the oral vitamin K will not be absorbed1

MEPHYTON acts like naturally occurring vitamin K, requires bile salts for absorption from the gastrointestinal tract, and generally exerts its effect within 6 to 10 hours1.

Adults Initial Dosage
Anticoagulant-induced prothrombin deficiency (caused by coumarin or indianedione derivatives) 2.5 mg-10 mg or up to 25 mg (rarely 50 mg)
Hypoprothrombinemia due to other causes (antibiotics; salicylates, or other drugs; factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg)
Product MEPHYTON® Tab
Strength 5 mg
Unit per Bottle/Pack 100 scored tablets

Indication

MEPHYTON (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:

  • anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
  • hypoprothrombinemia secondary to antibacterial therapy;
  • hypoprothrombinemia secondary to administration of salicylates;
  • hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.

Important Safety Information

  • MEPHYTON is contraindicated in individuals with hypersensitivity to any component of this medication.
  • An immediate coagulant effect should not be expected after administration of phytonadione.
  • 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 a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.
  • Vitamin K1 is fairly rapidly degraded by light; therefore, always protect MEPHYTON from light. Store MEPHYTON in closed original carton until contents have been used.
  • Safety and effectiveness in pediatric patients have not been established with MEPHYTON.
  • Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration. Transient "flushing sensations" and "peculiar" sensations of taste have been observed with parenteral phytonadione, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis. Hyperbilirubinemia has been observed in the newborn following administration of parenteral phytonadione. This has occurred rarely and primarily with doses above those recommended.

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