Vitamin K

Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.

Pharmaceutical Name

Trade (marketing or proprietary) name: AquaMEPHYTON

Generic (nonproprietary or active ingredient) name: Phytonadione injection

Indication and Usage

Reason the product has been approved for sale on the market.

The FDA has approved this injection 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
• 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 is it definitely shown
  that the result is due to interference with vitamin K metabolism, e.g., salicylates.

AquaMEPHYTON is indicated for prophylaxis (prevention) and treatment of vitamin K-deficiency bleeding in neonates

Manufacturer Insert

AquaMEPHYTON

Phytonadione Injectable Emulsion

Ingredients

Phytonadione, polyoxyethylated fatty acid derivative, dextrose, benzyl alcohol (preservative), water, glacial acetic acid

Ingredients in the “preservative-free” version, Phytonadione Injectable Emulsion, USP by Amphastar Pharmaceuticals: Phytonadione, polysorbate 80, propylene glycol, sodium acetate anhydrous, and glacial acetic acid.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Hypersensitivity to phytonadione or any other component of this medication.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Hypersensitivity Reactions with intravenous and intramuscular use.

Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of AquaMEPHYTON. 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 AquaMEPHYTON subcutaneously whenever feasible. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified

Side note for Treatment of Vitamin K Deficiency Bleeding in Neonates: The recommended dosage of AquaMEPHYTON is 1 mg given either subcutaneously or intramuscularly. Consider higher doses if the mother has been receiving oral anticoagulants.

Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative

Use benzyl alcohol-free 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 AquaMEPHYTON. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. When prescribing AquaMEPHYTON in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including AquaMEPHYTON (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

Cutaneous (Skin) Reactions

Parenteral administration of vitamin K replacements (including AquaMEPHYTON) 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 of substances outside of the gastrointestinal tract) administration. Discontinue AquaMEPHYTON for skin reactions and institute medical management.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Vitamin K Injection can cause: shock, cardiorespiratory arrest, flushing / weakness, diaphoresis (abnormal sweating), chest pain, tachycardia (fast heartbeat), cyanosis (blue skin), dyspnea (shortness of breath), gasping syndrome: central nervous system depression, metabolic acidosis, and gasping respirations, eczematous reactions, scleroderma-like patches/lesions, urticaria (hives), delayed reactions up to a year, Hyperbilirubinemia (jaundice), anaphylactic reactions, Dysgeusia (altered sense of taste), Fatal hypersensitivity reactions, dizziness, erythema (skin reddness), pruritic plaques, gradual neurological deterioration, hypotension, seizures, intracranial hemorrhage, hematologic (blood) abnormalities, skin breakdown, hepatic (liver) and renal failure, bradycardia (slow heart rate), cardiovascular collapse

Specific Populations

Fertility

Studies of carcinogenicity, genotoxicity or impairment of fertility have not been conducted with phytonadione.

Pediatric

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. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L).

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. When prescribing AquaMEPHYTON in infants consider the combined daily metabolic load of benzyl alcohol from all sources including AquaMEPHYTON (AquaMEPHYTON 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. Whenever possible, use preservative-free phytonadione formulations in neonates. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. Premature and low birth weight infants may be more likely to develop toxicity.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

AquaMEPHYTON aqueous colloidal solution of vitamin K1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post- translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. In normal animals and humans, phytonadione is virtually devoid of activity. However, in animals and humans deficient in vitamin K, the 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.

Analytical Deep Dives

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Alternatives

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Additional information to research

Per the NIH, breast milk contains all the nutrients an infant needs in the first 6 months of life [source].

Per the manufacturer, half of the synthetic vitamin K injection is stored in the baby’s liver for delayed release. However, vitamin K levels continue to increase in breastmilk as your baby grows. Incorporating vitamin K-rich foods into your diet may also increase the vitamin K content in your breast milk. Foods like leafy green vegetables (kale, spinach, and broccoli), brussels sprouts, and fermented foods like sauerkraut are high in vitamin K.

There is emerging research on the use of probiotics with the Lactobacillus rhamnosus GG strain that may help support vitamin K production in the gut for your baby.

Additionally, delayed cord clamping, or waiting till the cord stops pulsing, will also maximize the amount of vitamin K naturally available in a baby’s body after birth. The NIH also states this helps with iron levels.