Overview
DESCRIPTION Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorlessliquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone.
Mechanism of Action
CLINICAL PHARMACOLOGY Phytonadione injectable emulsion, 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.
Indications
- 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...
Common Doses
- 1 mg
- 10 mg
- 25 mg
- 50 mg
Dosage
DOSAGE AND ADMINISTRATION 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.
Black Box Warning
BOXED WARNING WARNING — INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest.
Contraindications
- CONTRAINDICATIONS Hypersensitivity to any component of this medication.
Side Effects
- ADVERSE REACTIONS 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.
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.