Phytonadione

Phytonadione Injectable Emulsion is a vitamin K replacement indicated for the treatment of 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 deficiency caused by coumarin or indanedione derivatives,. • 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 vitamin K metabolism, e.g., salicylates.

Phytonadione Injectable Emulsion aqueous colloidal solution of vitamin K 1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post-translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. In normal animals and humans, phytonadione is virtually devoid of activity.

• Administer Phytonadione Injectable Emulsion by the subcutaneous route, whenever possible. • When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute.

Hypersensitivity to phytonadione or any other component of this medication. Hypersensitivity to any component of this medication.

Boxed warning (– hypersensitivity reactions with intravenous and intramuscular use): Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. • Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. Hypersensitivity Reactions Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea.

The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions • Cutaneous Reactions Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia.

Anticoagulants Phytonadione Injectable Emulsion may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Phytonadione Injectable Emulsion are used. Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (i.e., heparin sodium). Phytonadione Injectable Emulsion does not affect the anticoagulant action of heparin Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants.

Store at 20°C to 25°C (68°F to 77°F). Store container in closed original carton until contents have been used.