Results
INDICATIONS
- Vitamin K deficiency bleeding (VKDB); Prophylaxis for early and late bleeding: (hemorrhagic disease of the newborn): The preferred route is intramuscular. The oral route should be used only in circumstances when there are shortages of the parenteral form or the injection is refused by the parents. Observational studies in other countries of exclusively breast-fed infants on oral regimens identified the lowest prevalence of late VKDB with durations of vitamin K for at least 3 months
- Vitamin K deficiency bleeding: Bleeding resolves within a few hours after IV administration of vitamin K1.
FDA APPROVED INDICATION
Prophylaxis and treatment of vitamin K deficiency bleeding in neonates
CONTRAINDICATIONS/PRECAUTIONS
- Dermatologic: Cutaneous reactions, including eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions, have been reported with onset ranging from 1 day to a year after therapy; discontinue use if skin reactions occur.
- Immunologic: Hypersensitivity reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea and have occurred despite dilution and upon first dose.
- Dermatologic:
- Special Populations: Serious adverse reactions including “gasping syndrome” have been reported in neonates and infants due to benzyl alcohol content. Consider the combined daily metabolic load of benzyl alcohol from all sources. The minimum amount of benzyl alcohol at which serious adverse reactions can occur is unknown.
ADMINISTRATION
Intravenous:
- Administer at concentrations of 1, 2, or 10 mg/mL slowly not to exceed 1 mg/minute.
- Whenever possible, administer benzyl alcohol-free formulations.
ADVERSE EFFECTS
Severe reactions, including death, have been reported with IV administration in adults. These reactions are extremely rare, and have resembled anaphylaxis and included shock and cardiac/respiratory arrest. With IV administration, give very slowly, not exceeding 1 mg per minute, with physician present. Pain and swelling may occur at IM injection site. Efficacy of treatment with vitamin K1 is decreased in patients with liver disease. The risk of childhood cancer is not increased by IM administration of vitamin K1.
BLACK BOX WARNING
Warning – Hypersensitivity Reactions with Intravenous and Intramuscular use.
- Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of phytonadione. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.
MONITORING
Check prothrombin time when treating clotting abnormalities. A minimum of 2 to 4 hours is needed for measurable improvement.