Severe reactions, including fatalities, have occurred during and
immediately after INTRAVENOUS injection of phytonadione even when
precautions have been taken to dilute the vitamin and avoid rapid
infusion. Typically these severe reactions have resembled hypersensitivity
or anaphylaxis, including shock and cardiac and/ or respiratory
arrest. Some patients have exhibited these severe reactions on receiving
phytonadione for the first time. Therefore, the INTRAVENOUS route
should be restricted to those situations where other routes are
not feasible and the serious risk involved is considered justified.
Phytonadione is a vitamin, which is a clear, yellow to amber, viscous,
odorless or nearly odorless liquid. It is insoluble in water, soluble
in chloroform and slightly soluble in ethanol. It has a molecular weight
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical
formula is C31H46O2.
Vitamin K1 Injection (Phytonadione Injection, USP) is a yellow,
sterile, nonpyrogenic aqueous colloidal solution available for injection
by the intravenous, intramuscular and subcutaneous routes. Each milliliter
contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative
70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol
9 mg added as preservative. May contain hydrochloric acid for pH adjustment.
pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.