Product Description.:
VRX 405, MEPHYTON
tablet , yellow , scored , round round
* 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 absorbed1
MEPHYTON? acts just like naturally occurring vitamin K, requires bile salts for absorption from the gastrointestinal tract, and generally exerts its effect within 6 to 10 hours
Important Safety Information1
Mephyton is contraindicated in patients with hypersensitivity to any component of this medication. An immediate coagulation effect should not be expected after administration. Mephyton will not counteract the anticoagulant action of heparin. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be keep as low as possible, and prothrombin time should be checked regularly. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
ADVERSE REACTIONS
Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration. The majority of these reported events occurred following intravenous 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.
