PHYTONADIONE PHYTONADIONE
PHYTONADIONE
Manufacturer: Dr.Reddy's Laboratories Inc
Black Box Warning (Boxed Warning)
A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.
FDA-Approved Indications (8)
hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., ulcerative colitis
Population: all ages
hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., intestinal resection
Population: all ages
hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., cystic fibrosis of the pancreas
Population: all ages
prophylaxis and therapy of hemorrhagic disease of the newborn
Population: newborn
hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., obstructive jaundice
Population: all ages
hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., biliary fistula
Population: all ages
hypoprothrombinemia due to antibacterial therapy
Population: all ages
anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives
Population: all ages
Indications & Usage
INDICATIONS AND USAGE Phytonadione injectable emulsion, USP 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 injectable emulsion 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 phytonadione injectable emulsion metabolism, e.g., salicylates.
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