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Drug dosage identifier

Phytomenadione

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Dose and administration

Prophylaxis

Term infant

  1. Intramuscular injection 0.5-1mg IM at birth (preferred route)
  2. Oral administration:
    2mg oral soon after birth, then
    2mg oral at 3-7 days, then
    2mg oral at 6 weeks

Note: If the oral dose is vomited or regurgitated within one hour, a repeat dose should be given. When this preparation is prescribed orally the second and third doses may need to be administered after the baby has been discharged from hospital. It is the responsibility of the LMC and parents to ensure that subsequent doses are administered.

See the Vitamin K guideline for information on the risks of Vitamin K Deficiency Bleeding (VKDB).

Preterm infant <1.5kg

0.5mg IM at birth

Treatment of Vitamin K Deficiency Bleeding1

Intravenous 1 mg, repeated 8 hourly if necessary. Administer slowly.

Indications

  1. Prophylaxis of Vitamin K Deficiency Bleeding (VKDB).
  2. Treatment of VKDB or neonatal hypoprothrombinaemia.

Contraindications

Lack of parental consent (see Vitamin K guideline).

Precautions

  1. Delay IM administration in infants at risk of HIV and haemophilia as per guidelines.
  2. Severe hepatic dysfunction.
  3. Bleeding disorders that are not vitamin K dependent.
  4. Parenteral administration may increase risk of kernicterus.2

Drug interactions

Gentamicin: possible decrease in efficacy of IV vitamin K.

Clinical pharmacology

Phytomenadione (synthetic Vitamin K1), part of the hepatic carboxylase system, is essential for the formation of clotting factors II (prothrombin), VII, IX, and X, plus the clotting inhibitor proteins C and S. Lack of vitamin K results in an increased potential for haemorrhage. This can be reversed by the administration of vitamin K.

In Konakion MM paediatric ampoules, the vitamin K is contained in a physiological system of bile acid-lecithin micelles which result in a improved local and systemic tolerance than previous injection solutions.

Given orally, the vitamin K is absorbed mainly from the middle of the small intestine. Absorption is enhanced by the presence of bile and pancreatic juice; absorption is impaired by short bowel syndrome, biliary atresia, pancreatic insufficiency, and malabsorption syndromes. Systemic availability is approximately 50%, with wide inter-patient variability.

Vitamin K is eliminated by metabolic glucuronidation and sulphation. The half life is 1.5 to 3 hours (adults).

Possible adverse effects

  1. Anaphylactoid reaction.
  2. Local irritation possible, but is rare.

Special considerations

  1. Konakion MM® Paediatric is licensed for oral and parenteral administration.
  2. Intravenous administration should be reserved for potentially fatal haemorrhage.
  3. Prothrombin synthesis takes up to 2 hours to occur following parenteral administration of vitamin K.
  4. Efficacy of treatment with vitamin K is decreased with liver disease.

Management of Phytomenadione administration

Description

  • Konakion MM paediatric ampoules contain phytomenadione 2 mg in 0.2 ml with additives glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid and Water for Injection. The solution is a clear, slightly opalescent liquid.
  • If solution appears turbid or the ingredients have separated, do not use.

Prescription

  1. At birth, Vitamin K dose to be recorded on the Blue Neonatal Record.
  2. Subsequent doses are charted, as mg/dose, on the Stat side of the drug chart.

Administration

IM Injection

  1. Do NOT dilute further.2
  2. Administer by deep injection into the middle third of anterolateral aspect of the thigh (vastus lateralis muscle).

Slow IV Injection

  1. Do NOT dilute further.
  2. Administer slowly.
  3. Do NOT administer with other drugs, IV solutions, blood or blood products.

Observation and documentation

  1. Ensure informed consent has been obtained from parents.
  2. Use extreme caution during IV administration. Monitor vital signs.
  3. Ensure resuscitation equipment is available.

Storage

Unopened: Store at room temperature <25°C. Protect from light. Do not freeze.
Opened: Discard any remaining ampoule contents immediately after use.

Selected references

  1. Paediatric Formulary Committee. BNF for children 2005. London: BMJ Publishing Group,2005.
  2. Konakion MM® paediatric data sheet. Auckland: Roche Products (New Zealand) Ltd., 2005.
  3. Baxter K. Stockley's Drug Interactions. London: Pharmaceutical Press, 2006.

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Document Control

  • Date last published: 26 February 2019
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years