Vitamin K

Vitamin K1

Approved 25 Jul 1983InjectionInjectable

The FDA lists this product in 3 strengths and forms.

Indications

Vitamin K 1 Injection is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.

Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. ( 1.1 )
Hypoprothrombinemia due to antibacterial therapy. ( 1.1 )
Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis. ( 1.1 )
Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. ( 1.1 ) Vitamin K 1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. ( 1.2 )

1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Vitamin K 1

Injection is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity:

anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;
hypoprothrombinemia due to antibacterial therapy;
hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;
other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

1.2Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Vitamin K 1

Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

Indications

Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. ( 1.1 )
Hypoprothrombinemia due to antibacterial therapy. ( 1.1 )
Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis. ( 1.1 )
Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. ( 1.1 ) Vitamin K 1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. ( 1.2 )

1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Vitamin K 1

anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;
hypoprothrombinemia due to antibacterial therapy;
hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;
other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

1.2Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Vitamin K 1

Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

Warnings and precautions

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Use benzyl alcohol-free phytonadione formulations in neonates and infants, if available. ( 5.2 )
Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. ( 5.3 )

5.1Hypersensitivity Reactions Fatal

and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea. Administer Vitamin K 1 Injection subcutaneously whenever feasible.

Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Dosage and Administration (2.1) ] .

5.2 Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative Use benzyl alcohol-free phytonadione formulations in neonates and infants, if available. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol‑preserved drugs, including Vitamin K 1 Injection. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

When prescribing Vitamin K 1 Injection in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including Vitamin K 1 Injection (contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Use in Specific Populations (8.1 , 8.2 and 8.4) ] .

5.3Cutaneous Reactions

Parenteral administration of vitamin K replacements (including Vitamin K 1 Injection) may cause cutaneous reactions. Reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions. Time of onset ranged from 1 day to a year after parenteral administration. Discontinue Vitamin K 1 Injection for skin reactions and institute medical management.

5.4Aluminum Toxicity 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.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Vitamin K 1

Injection contains benzyl alcohol, which has been associated with gasping syndrome in neonates. The preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants . If Vitamin K 1 Injection is needed during pregnancy, consider using a benzyl alcohol-free phytonadione formulation [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . Published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see Data ].

There are maternal and fetal risks associated with vitamin K deficiency during pregnancy [see Clinical Considerations ] . Animal reproduction studies have not been conducted with phytonadione. The estimated background risk for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma.

Administration of vitamin K 1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding.

Animal Data In pregnant rats receiving vitamin K 1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer.

Vitamin K1

Indications

1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Vitamin K 1

1.2Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Vitamin K 1

Two medicines in one question?

Vitamin K1

Indications

1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Vitamin K 1

1.2Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Vitamin K 1

Two medicines in one question?

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions Fatal

5.3Cutaneous Reactions

5.4Aluminum Toxicity WARNING:

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Vitamin K 1

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance