Phytomenadione (vitamin K)

Generic name
Phytomenadione (vitamin K)
Brand name
ATC Code
B02BA01
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Phytomenadione (vitamin K)

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Effect: 4-6 hours after oral administration; immediately after intravenous administration.
Stöckel et al. (1996) calculated a terminal t 1/2 of 26-193 h (median: 76 h) in newborns after p.o. and i.m. application (n = 25).

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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Prophylaxisfor vitamin K dependent hemorrhage after birth (DUTCH DOSE RECOMMENDATIONS)
  • Oral
    • weight at birth ≥ 1500 g
      • Directly post-partum: 1 mg/dose, once only.

      • If risk factors are present (if the oral route cannot be used or when certain medicines were used by the mother during pregnancy and lactation, such as phenobarbital, phenytoin, rifampicin, isoniazid, phenylbutazone and vitamin K antagonists): Intramuscular or intravenous administration.

    • ≥ 8 days
      • In breastfeeding (with or without Breast Milk Fortifier):
        Premature and full-term neonates:
         150         microg./day in 1 dose
      • Duration of treatment:

        Premature neonates: birth up to 35 weeks postmenstrual age + 12 weeks or until more than 500 ml of the daily diet consists of bottle feed.
        Full-term neonates of > 35 weeks: up to 12 weeks after birth or until more than 500 ml of the daily diet consists of bottle feed.

    • weight at birth < 1500 g

      • Intravenous prophylaxis: see IV administration. 

  • Intramuscular
    • weight at birth < 1500 g
      • Directly post-partum: 0.5 mg/dose, once only.
      • Duration of treatment:

        No further prophylaxis needed.

      • Only if the oral route cannot be used or when certain medicines were used by the mother during pregnancy and lactation, such as phenobarbital, phenytoin, rifampicin, isoniazid, phenylbutazone and vitamin K antagonists.

    • weight at birth ≥ 1500 g
      • Directly post-partum: 1 mg/dose, once only.
      • Duration of treatment:

        No further prophylaxis needed.

      • Only if the oral route cannot be used or when certain medicines were used by the mother during pregnancy and lactation, such as phenobarbital, phenytoin, rifampicin, isoniazid, phenylbutazone and vitamin K antagonists.

  • Intravenous
    • weight at birth < 1500 g
      • Directly post-partum: 0.5 mg/dose, once only.
      • Duration of treatment:

        In breastfeeding (with or without Breast Milk Fortifier): Oral prophylaxis from Day 8 onwards

    • weight at birth ≥ 1500 g
      • Directly post-partum: 1 mg/dose, once only.
      • Duration of treatment:

        In breastfeeding (with or without Breast Milk Fortifier): Oral prophylaxis from Day 8 onwards
Bile duct atresia
  • Oral
    • 1 month up to 18 years
      • 1 mg/day in 1 dose
Overdose of vitamin K antagonists
  • Intravenous
    • 1 month up to 18 years
      • 1 - 10 mg/dose in 20 minutes. Titrate the dose depending on the prothrombin time..
Gastrointestinal bleeding
  • Intravenous
    • 1 year up to 18 years
      • 0.2 mg/kg/day in 1 dose Max single dose: 10 mg/dose.
Supplements in cystic fibrosis
  • Oral
    • 1 month up to 2 years
      • 0.3 - 1 mg/day in 1 dose

      • Only if there are hepatic function disorders

    • 2 years up to 18 years
      • 1 - 10 mg/day in 1 dose

      • Only if there are hepatic function disorders.
Correction deficiency
  • Oral
    • 1 up to 5 kg
      • 1 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

    • 5 up to 10 kg
      • 2 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

    • 10 up to 20 kg
      • 4 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

    • 20 up to 30 kg
      • 5 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

  • Intramuscular
    • 1 up to 5 kg
      • 1 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

    • 5 up to 10 kg
      • 2 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

    • 10 up to 20 kg
      • 4 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency

    • 20 up to 30 kg
      • 5 mg/dose, once only.

      • Determine the frequency of administration after determining the cause of the deficiency
Prophylaxis of vitamin K dependent hemorrhage after birth (AUSTRIAN DOSE RECOMMENDATIONS)
  • Oral
    • Term neonate
      • 2 mg/dose First dose at day of birth; second dose after 4-6 days and third dose after 4-6 weeks.

      • Be aware the presence of risk factors: if mother uses certain medications during pregnancy and lactation, such as phenobarbital, phenytoin, rifampicin, isoniazid, phenylbutazone, and vitamin K antagonists) : 
        Breast-fed neonates/infants of mothers taking Vitamin K Antagonists: 1 mg/dose oral per week, until the neonate/infant either receives formula or complementary food (vegetables) regularly.

  • Intravenous
    • Preterm neonates and Term neonate
      • 0.3 mg/kg/dose, once only. After initial IV dose: switch to oral regimen..

      • IV administration only in sick preterm and term neonates. Be aware of risk factors for vitamin K deficiency: maternal use of certain medications during pregnancy and lactation, such as phenobarbital, phenytoin, rifampicin, isoniazid, phenylbutazone, and vitamin K antagonists; breastfeeding.
Prophylaxis of vitamin K deficiency bleeding after birth (GERMAN RECOMMENDATION)
  • Oral
    • Preterm neonates and Term neonate
      • 2 mg/dose A total of 3 doses: 1st: immediately after birth; 2nd: between the 3rd and 10th day of life; 3rd: 4-6 weeks after birth..
  • Intramuscular
    • Healthy preterm neonates and Term neonate
      • Immediately after birth:  1 mg/dose, once only.

      • In sick preterm infants, preterm infants at risk of bleeding, neonates <1500 g birth weight: 0.2 mg/kg/dose, max 1 mg/dose, immediately after birth. If initial dose <1 mg: administer additional doses depending on coagulation parameters (approximately 1 mg/week enteral or 8-10 microg/kg/day parenteral). After 4-6 weeks third dose: 2 mg/dose once orally

  • Intravenous
    • Ill preterm neonates and Term neonate
      • Immediately after birth:  0.2 mg/kg/dose, once only. Max: 1 mg/dose. Continue with oral regimen if possible..

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Local irritation at the injection site, very rarely anaphylactoid reactions after parenteral use.

There is a greater risk of kernicterus in parenteral administration in premature infants with a bodyweight of < 2.5 kg.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In the event of life-threatening bleeding or if rapid action is desired, administer (OR) prothrombin complex (PPSB).

I.v. administration can displace bilirubine bound to albumine. Therefore preterm and term neonates are at risk for kernicterus. Special caution is needed in neonates suffering from severe infections or acidosis, neonates with respiratory disfunctions and neonates who receive other bilirubin-replacing drugs (e.g. sulfonamides). I.m. or oral administration is preferred.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

VITAMIN K AND OTHER HEMOSTATICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Fibrinogen
B02BB01
Local hemostatics
B02BC30
Blood coagulation factors
B02BD08
B02BD04
B02BD02
B02BD01
Other systemic hemostatics
B02BX05
B02BX06
B02BX04
Blood coagulation factors
B02BD08
B02BD04
B02BD02
B02BD01

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. C.F.M. Gijsbers, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2014, 3e druk
  3. Franssen MJAM et al, Werkboek Kinderhematologie, VU Uitgeverij, 2001, 2e druk
  4. Gezondheidsraad, Vitamine K bij zuigelingen, www.gezondheidsraad.nl, 11 april 2017, https://www.gezondheidsraad.nl/sites/default/files/grpublication/201704_vitamine_k_bij_zuigelingen.pdf
  5. Lafeber HN et al, Werkboek Enterale en Parenterale voeding van de pasgeborene. Derde druk, 2012
  6. Gezondheidsraad, Brief advies over Vitamine K-suppletie bij zuigelingen, www.gezondheidsraad.nl, 29 juni 2010
  7. Turck D, et al, ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis., Clin Nutr, 2016, Jun;35(3), 557-77
  8. Stoeckel, K, et al, Elimination half-life of vitamin K: in neonates is longer than is generally assumed: implications for the prophylaxis of haemorrhaghic disease of the newborn, Eur J Clin Pharmacol, 1996, 49, 421-423
  9. CHEPLAPHARM Arzneimittel GmbH, SmPC Konakion MM 2 mg/ml ( RVG 03809) 22-10-2020, www.geneesmiddeleninformatiebank.nl
  10. AWMF, S2k-Leitlinie" Prophylaxe von Vitamin-K-Mangel-Blutungen (VKMB) bei Neugeborenen", Stand: 03/2016

Changes

Therapeutic Drug Monitoring


Overdose