The Newborn Vitamin K Shot Ingredients

What is in the newborn Vitamin K shot

There are so many decisions for new parents to make. One of the first is whether or not to give Vitamin K to their newborn baby.  If the answer is yes, the next decision is whether to give oral or injectable Vitamin K.  This article is a review of the ingredients in two of the brands of injectable Vitamin K for newborns.

Where to learn more about Vitamin K and Newborn Hemorrhagic Disease

To learn more about the reasons to give Vitamin K and the likelihood of a newborn baby developing Newborn Hemorrhagic Disease I recommend reading:

Vitamin K  Evidence Based Birth, Evidence on The Vitamin K Shot in Newborns, https://evidencebasedbirth.com/evidence-for-the-vitamin-k-shot-in-newborns/, 2019.

Two Brands of Vitamin K Shots

Two brands of Newborn Vitamin K injections that are readily available to homebirth midwives are Pfizer and International Medical Systems. (International Medical Systems is a U.S. company).  A list of ingredients for both of these is listed below.

Preservative-Free Vitamin K

The parents who choose to give a Vitamin K shot sometimes ask for a preservative-free Vitamin K shot.  The Vitamin K shot made by International Medical Systems does not contain alcohol or any other preservative.

A List of Ingredients for Two Brands of Vitamin K

Vitamin K  Phytoniadone Injection- Made by International Medication Systems (a U.S. company)

This one is also known as  “Preservative Free Vitamin K”

1 mg of Vitamin K1 (phytonadione), a fat-soluble vitamin derived from plants

  • 10 mg of Polysorbate 80, which is an emulsifier and helps Vitamin K1 (a fat-soluble Vitamin) dissolve in liquid for the injection. Polysorbate 80 is made from natural plant-based sugar, sorbitol, and plant-based oleic acid is used in a wide variety of foods, medicines, and vitamin supplements, and is included in the Handbook of Green Chemicals. The one-time vitamin K shot contains 10 mg of polysorbate 80 (about 3 mg/kg for a 7-pound baby), and there is no reason to believe that this amount is harmful to newborns
  • 10.4 mg of Propylene glycol, which helps absorb extra water and keep the vitamin K in solution. Propylene glycol has been recognized as safe by the FDA for use in food products. According to the World Health Organization, propylene glycol is safe to consume in amounts up to 25 mg/kg of body weight per day. The vitamin K shot includes 10.4 mg of propylene glycol or about 3.3 mg/kg for a 7-pound newborn Any cases of severe side effects from propylene glycol are from decades ago and were related to very high doses.
  • 0.17 mg of Sodium acetate anhydrous, a mixture of salt and bicarbonate, is used to adjust the pH of the injection.
  • 0.00002 mL of Glacial acetic acid, also known as vinegar, is used to adjust the pH of the injection

Vitamin K Phytoniadone Injection made by Pfizer

  • 1 mg of Vitamin K1 (phytonadione), a fat-soluble vitamin derived from plants
  • 35 mg Polyoxyethylated fatty acid derivative, solvent, and emulsifier made by reacting ethylene oxide with castor oil and used to dissolve the vitamin K into liquid form. Used in many drugs. Very rarely, this ingredient has caused an anaphylactic reaction in patients receiving large doses by intravenous infusion, but there are no reported cases of this effect in newborns receiving the intramuscular vitamin K shot with this ingredient.
  • 18.75 mg Hydrous dextrose, this is simply sugar. (Which is also used when a newborn has hypoglycemia-low blood sugar.) 
  • 4.5 mg Benzyl alcohol, preservative. A very small amount is used to prevent bacterial contamination in the shot. You would need to give approximately 100 times higher amounts of benzyl alcohol on a daily basis in order to cause any side effects
  • It May contain hydrochloric acid to adjust the pH.

 

More detail about the individual ingredients in Vitamin K Injectables

To read more about the individual ingredients in Newborn K look at this blog article,  The Science of Mom, Are the Ingredients in the Newborn Vitamin K Shot Safe? https://scienceofmom.com/2015/11/09/are-the-ingredients-in-the-newborn-vitamin-k-shot-safe/, 2015.

Talk to Your Midwife

Midwives are an excellent resource to discuss Newborn Vitamin K.  New parents can ask the midwife about the pros and cons of Vitamin K at their prenatal appointments.

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