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🏅 FDA Orphan Designation

PHYTONADIONE PHYTONADIONE

PHYTONADIONE

Manufacturer: Dr.Reddy's Laboratories Inc

Indicated for:
NON RARE IN EUROPE: Ulcerative colitisLemierre syndromeLymphoepithelial cyst of the pancreasHemolytic disease due to fetomaternal alloimmunizationMyopathic intestinal pseudoobstructionCongenital factor II deficiencyHypermethioninemia due to glycine N-methyltransferase deficiencyAcquired prothrombin deficiency
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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.

View full prescribing information on DailyMed (NLM) ↗

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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PHYTONADIONE PHYTONADIONE
Dr.Reddy's Laboratories Inc
PHYTONADIONE PHYTONADIONE
Dr.Reddy's Laboratories Inc

Where shown, WAC (Wholesale Acquisition Cost) is an estimate only — your actual cost depends on your insurance plan. Always verify pricing with your pharmacy or insurer.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.