What's in the Vitamin K supplement?
If your baby is given Vitamin K in the UK, they are likely to be given Konakion. You can access the Patient Information Leaflet here.
If they are given Vitamin K orally, they will be given either Konakion or Neokay. You can access the Neokay Patient Information Leaflet here.
Konakion ingredients
The active substance in Konakion MM Paediatric is Vitamin K1 (phytomenadione). Each 0.2 ml of liquid medicine contains 2 mg Vitamin K1.
Other ingredients are glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid and water for injections.
Informing Consent asked our medical and pharmacological advisers for more information about each ingredient:
- phytomenadione
- glycocholic acid
- lecithin
- sodium hydroxide
- hydrochloric acid
- water
Phytomenadione (active ingredient)
Our advisers say:
‘Phytomenadione is a synthetic form of Vitamin K1. It is the most direct way to increase Vitamin K levels in babies and can be given by injection or by mouth. Allergic reactions are rarely reported but are very unlikely in the newborn.’
Glycocholic acid
Our advisers say:
‘It is a naturally occurring bile acid conjugate that allows Vitamin K to be dispersed into mixed micelles, improving absorption and permitting intravenous administration.
Potential issues with glycocholic aid: Can cause local irritation if injected outside the vein. Bile acid-containing formulations have occasionally been associated with histamine release and hypersensitivity-type reactions.
The SmPC reports rare anaphylactoid reactions following intravenous (IV) administration, although it is difficult to determine whether these are caused by Vitamin K itself or the micellar excipients.
Intra-muscular (IM) is the usual route for administration, but it’s possible that intravenous (IV) dosing can happen unintentionally when performing IM injection, depending on the protocol used.’
Lecithin
Our advisers say:
‘Lecithin is a naturally occurring phospholipid widely used in intravenous lipid emulsions, vaccines and parenteral nutrition products.
Potential issues with lecithin: Rare allergic reactions. Theoretical concern in patients with severe soy allergy if soy-derived lecithin is used. Very occasionally implicated in infusion reactions in lipid-containing injectable products.
However, the quantity in this formulation is extremely small compared with nutritional lipid emulsions.’
Glycocholic acid + lecithin
Our advisers say:
‘Mixed micelle system.
Historically, injectable Vitamin K products used polyethoxylated castor oil (Cremophor EL), which was associated with a higher rate of severe hypersensitivity reactions. The mixed micelle formulation replaced that system and is generally considered safer.
Nevertheless, rare anaphylactoid reactions remain listed in the SmPC. The likely mechanisms include: Complement activation, non-IgE-mediated mast-cell activation, direct reactions to the micellar carrier. These events are very uncommon but can be serious when they occur.’
Sodium hydroxide and hydrochloric acid
Our advisers say:
‘These are simply pH-adjusting agents. After neutralisation they largely exist as trace amounts of sodium and chloride ions, so there is no evidence or expectation of these excipients causing issues.’
Water
Our advisers say:
‘Not a contentious ingredient; pharmacologically inert at administered doses.’
Neokay ingredients
The active substance in Neokay is Vitamin K1 (phytomenadione). Each capsule contains 1 mg Vitamin K1. The other ingredient is fractionated coconut oil.
Informing Consent asked our medical and pharmacological advisers for more information about each ingredient:
- phytomenadione
- coconut oil
Phytomenadione (active ingredient)
Our advisers say:
‘Phytomenadione is a synthetic form of Vitamin K1. It is the most direct way to increase Vitamin K levels in babies and can be given by injection or by mouth. Allergic reactions are rarely reported but are very unlikely in the newborn.’
Coconut oil
Our advisers say:
‘Fractionated coconut oil is a widely used, pharmacologically inert vehicle for fat-soluble medicines. It has an excellent safety record.
Allergic reactions are extremely uncommon, as the refining process removes the proteins responsible for coconut allergy. At the trace quantities present in Neokay and given administration is oral, toxicological risk is very low.’