Vitamin K1 Injection
(phytonadione) Injectable Emulsion, USP
Aqueous Dispersion of Vitamin K1 Ampul
Protect from light. Keep ampuls in tray until time of use.
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. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is 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 of 450.70.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula
is C31H46O2 and its structural formula is:
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is
a yellow, sterile, nonpyrogenic aqueous dispersion 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.
Last reviewed on RxList: 11/7/2008
This monograph has been modified to include the generic and brand name in many instances.