Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after… INTRAMUSCULAR injection of Phytonadione…
Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia.
Phytonadione Injectable Emulsion, USP is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.
The recommended dosage of Phytonadione… is 0.5 mg to 1 mg within one hour of birth for a single dose.
Avoid use of other diluents that may contain benzyl alcohol, which can cause serious toxicity in newborns or low birth weight infants…
Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with… intramuscular administration of Phytonadione… despite dilution… These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea.
Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative
– Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including Phytonadione. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.
The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known…
Clinical Trials and Post-Marketing Experience
– Tachycardia, hypotension.
– Generalized flushing; pain, swelling, and tenderness at injection site.
– Hyperbilirubinemia
– Fatal hypersensitivity reactions, anaphylactic reactions.
– Dysgeusia, dizziness.
– Dyspnea.
– Erythema, pruritic plaques, scleroderma-like lesions, erythema perstans.
– Cyanosis.
Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative.
Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low- birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.
Whenever possible, use preservative-free phytonadione formulations in neonates.
Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from Phytonadione Injectable…
Each 0.5 mL of Phytonadione Injectable… contains… polysorbate 80…propylene glycol…