Severe reactions, including fatalities, [have been] reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest.
Vitamin K1 Injection… contains… benzyl alcohol 9 mg added as preservative.
Little is known about the metabolic fate of vitamin K.
[T]he pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors.
Benzyl alcohol as a preservative… has been associated with toxicity in newborns.
An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement in the prothrombin time.
Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of Vitamin K1 Injection.
ADVERSE REACTIONS
– Deaths have occurred after intravenous and intramuscular administration.
– 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.
– Hyperbilirubinemia has been observed in the newborn following administration of phytonadione.
Prophylaxis of Hemorrhagic Disease of the Newborn
The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of Vitamin K1 Injection 0.5 to 1 mg within one hour of birth is recommended.
1 mg/0.5 mL Neonatal Concentration
Contains no more than 100 mcg/L of aluminum [per Liter, not per dose].* [See Comments below.]