Phytonadione injectable emulsion (Hospira) is available as a 2-mg/mL aqueous dispersion in 0.5-mL ampuls and as a 10-mg/mL aqueous dispersion in 1-mL ampuls.29 Each mL also contains polyoxyethylated fatty acid 70 mg, dextrose 37.5 mg, and benzyl alcohol 0.9% in water for injection.29 Hydrochloric acid may be used for pH adjustment.29
Phytonadione injectable emulsion 2 mg/mL also is available in 0.5-mL single-dose, preservative-free syringe cartridges (International Medication Systems).30 Each 0.5 mL also contains also contains polysorbate 80 10 mg, propylene glycol 10.4 mg, sodium acetate anhydrous 0.17 mg, and glacial acetic acid 0.00002 mL.30 Additional glacial acetic acid and/or sodium acetate anhydrous may be used for pH adjustment.30 Aluminum also is present.29
pH
The USP cites the official pH range as 3.5 to 7.31 Phytonadione injectable emulsion (Hospira) has a pH of 5 to 7.29
Aluminum Content
Aluminum content may vary depending on the product; specific product labeling should be consulted.
Phytonadione injectable emulsion (Hospira) 2 or 10 mg/mL is stated to contain no more than 100 or 110 mcg, respectively, of aluminum per L.29
Osmolality
The osmolality of phytonadione 10 mg/mL was 325 mOsm/kg by freezing-point depression and 303 mOsm/kg by vapor pressure.1071
Trade Name(s)
Vitamin K1
Phytonadione injectable emulsion should be administered by subcutaneous injection whenever possible.29; 30 Severe or fatal hypersensitivity reactions have occurred following intravenous or intramuscular administration.29; 30 Intravenous or intramuscular injection should be avoided unless subcutaneous injection is not feasible.29; 30 If intravenous administration is unavoidable, phytonadione may be given by slow direct intravenous injection, at a rate not exceeding 1 mg/min, or by intravenous infusion following dilution in a compatible infusion solution.29; 30
Phytonadione injectable emulsion is a yellow aqueous dispersion.29; 30 Intact containers should be stored at controlled room temperature in the original carton or ampul tray and protected from light at all times.29; 30 When dilutions are indicated, administration should start immediately after mixing with the diluent; unused portions of the diluted solution, as well as unused contents of the ampul or cartridge, should be discarded.29; 30
Phytonadione is oxygen sensitive.29
Light Effects
A study of phytonadione in intravenous solutions showed 50% decomposition in 15 days under fluorescent light and 43 to 63% in three hours on exposure to sunlight.463 A 10 to 15% loss occurs over 24 hours on exposure to fluorescent light or sunlight.854 It has been recommended that infusion solutions containing phytonadione require wrapping the container with aluminum foil or other opaque material for light protection.4
The loss of phytonadione (Roche) 0.05 to 0.1 mg/mL from solutions in glass and polypropylene containers unprotected or packaged in light-protective overwraps when exposed to neon light and daylight was evaluated. Losses approached 80% in one day unprotected from light exposure. A brown polyethylene light protection bag provided the best protection, yielding no phytonadione loss during a seven-day exposure period. A white “light-tight” light-protective overwrap and a black plastic waste disposal bag failed to protect the phytonadione completely. In the black bag, phytonadione losses of over 30% occurred in seven days; the white light-protective overwrap was worse, allowing loss of nearly half of the phytonadione in one day. Substantial differences in light protection are afforded by the different materials and the efficacy of purported light-protection barriers for light-sensitive drugs should be validated prior to use.1923
Substantial loss of phytonadione from both TPN and TNA admixtures due to exposure to sunlight was reported. In three hours of exposure to sunlight, 50% loss of phytonadione had occurred. The presence or absence of lipids did not affect stability.2049
Filtration
The manufacturer states that phytonadione passes through an inline filter with negligible loss occurring.854
For a list of references cited in the text of this monograph, search the monograph titled References.