This information is not for clinical use. These highlights do not include all the information needed to use Mephyton safely and effectively. Before taking Mephyton please consult with your doctor. See full prescribing information for Mephyton.

Indications And Usage

Mephyton 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. Mephyton tablets are indicated in: -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.

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Dosage And Administration

Mephyton Summary of Dosage Guidelines (See circular text for details.)
Adults Initial Dosage
Anticoagulant-Induced Prothrombin Deficiency (caused by coumarin or indanedione 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)

Contraindications

Hypersensitivity to any component of this medication.

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. To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Drug Interactions Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant or to use one which acts on a different principle, such as heparin sodium.