phytonadione

FDA Drug Profile — PHYTONADIONE

Drug Details

Generic Name
phytonadione
Brand Names
PHYTONADIONE
Application Number
ANDA207719
Sponsor
Henry Schein, Inc.
NDC Codes
2
Dosage Forms
INJECTION, EMULSION
Routes
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, PARENTERAL
Active Ingredients
PHYTONADIONE

Indications and Usage

1 INDICATIONS AND USAGE Phytonadione is indicated for the treatment of adults with 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 is indicated for the treatment of adults with 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 hypoprothrombinemia caused by coumarin or indanedione derivatives; • hypoprothrombinemia secondary to antibacterial therapy; • hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, 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. Phytonadione is a vitamin K replacement indicated for the treatment of adults with 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; ( 1 ) • Hypoprothrombinemia secondary to antibacterial therapy; ( 1 ) • 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; ( 1 ) • Other drug-induced hypoprothrombinemia where it is definitively shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. ( 1 )