Phytonadione

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 fib …

• Whenever possible, phytonadione injectable emulsion, should be given by the subcutaneous route. (See Box Warning .) When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute
• Protect from light at all times
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
• Directions for Dilution Phytonadione injectable emulsion may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection
• Benzyl alcohol as a preservative has been associated with toxicity in newborns
• Therefore, all of the above diluents should be preservative-free (see WARNINGS )
• Other diluents should not be used
• When dilutions are indicated, administration should be startedimmediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampule
• Prophylaxis of Hemorrhagic Diseas e of the Newborn The American Academy of Pediatrics recommends that phytonadione be given to the newborn
• A single intramuscular dose of phytonadione injectable emulsion 0.5 to 1 mg within one hour of birth is recommended
• Treatment of Hemorrhagic Diseas e of the Newborn Empiric administration of phytonadione should not replace proper laboratory evaluation of the coagulation mechanism. …

• Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of phytonadione injectable emulsion
• Therefore, the recommended dose should not be exceeded (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION )

Hypersensitivity to any component of this medication.

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.

Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. There is no evidence to suggest that the small amount of benzyl alcohol contained in phytonadione injectable emulsion, USP, when used as recommended, is associated with toxicity. An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement in the prothrombin time. Whole blood or component therapy may also be necessary if bleeding is severe. …

Deaths have occurred after intravenous and intramuscular administration. (See Box Warning .) Transient “flushing sensations” and “peculiar” sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis. Pain, swelling, and tenderness at the injection site may occur. The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind. Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. …

Pregnancy Category C: Animal reproduction studies have not been conducted with phytonadione injectable emulsion It is also not known whether phytonadione injectable emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phytonadione injectable emulsion should be given to a pregnant woman only if clearly needed.

The intravenous LD 50 of phytonadione injectable emulsion in the mouse is 41.5 and 52 mL/kg for the 0.2% and 1% concentrations, respectively

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