Pediatric Formulary

Phytomenadione (vitamin K)

Generic name

Phytomenadione (vitamin K)

Brand name

ATC Code

B02BA01

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Dosages

Side effects in children

Warnings & precautions in children

Contra-indications in children

Interactions

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 ≥ 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. 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 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 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.

Prophylaxisfor vitamin K dependent hemorrhage after birth (DUTCH DOSE RECOMMENDATIONS)

Oral
- ≥ 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.
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
- 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
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.

Gastrointestinal bleeding
Intravenous 1 year up to 18 years 0.2 mg/kg/day in 1 dose Max single dose: 10 mg/dose. 1 year up to 18 years ^[2] 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
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 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

Correction 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
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

Prophylaxis of vitamin K deficiency bleeding after birth (GERMAN RECOMMENDATION)
Intravenous Ill preterm neonates and Term neonate ^[10] Immediately after birth: 0.2 mg/kg/dose, once only. Max: 1 mg/dose. Continue with oral regimen if possible.. 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.. 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.. 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..

Prophylaxis of vitamin K deficiency bleeding after birth (GERMAN RECOMMENDATION)

Intravenous
- Ill preterm neonates and Term neonate
  ^[10]
  - Immediately after birth: 0.2 mg/kg/dose, once only. Max: 1 mg/dose. Continue with oral regimen if possible..
- 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..
- 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..
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..

Bile duct atresia
Oral 1 month up to 18 years 1 mg/day in 1 dose

Prophylaxis of vitamin K dependent hemorrhage after birth (AUSTRIAN DOSE RECOMMENDATIONS)
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 dependent hemorrhage after birth (AUSTRIAN DOSE RECOMMENDATIONS)

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.

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
	Fibrinogen Related Medicines Menu">	B02BB01

Local hemostatics
	Fibrinogen/trombine (Fibrin glue) Related Medicines Menu">	B02BC30

Blood coagulation factors
	Eptacog alfa Related Medicines Menu">	B02BD08
	Factor IX Related Medicines Menu">	B02BD04
	Factor VIII Related Medicines Menu">	B02BD02
	Protrombinecomplex Related Medicines Menu">	B02BD01

Other systemic hemostatics
	Eltrombopag Related Medicines Menu">	B02BX05
	Emicizumab Related Medicines Menu">	B02BX06
	Romiplostim Related Medicines Menu">	B02BX04

Blood coagulation factors
	Eptacog alfa Related Medicines Menu">	B02BD08
	Factor IX Related Medicines Menu">	B02BD04
	Factor VIII Related Medicines Menu">	B02BD02
	Protrombinecomplex Related Medicines Menu">	B02BD01

References

Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
C.F.M. Gijsbers, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2014, 3e druk
Franssen MJAM et al, Werkboek Kinderhematologie, VU Uitgeverij, 2001, 2e druk
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
Lafeber HN et al, Werkboek Enterale en Parenterale voeding van de pasgeborene. Derde druk, 2012
Gezondheidsraad, Brief advies over Vitamine K-suppletie bij zuigelingen, www.gezondheidsraad.nl, 29 juni 2010
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
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
CHEPLAPHARM Arzneimittel GmbH, SmPC Konakion MM 2 mg/ml ( RVG 03809) 22-10-2020, www.geneesmiddeleninformatiebank.nl
AWMF, S2k-Leitlinie" Prophylaxe von Vitamin-K-Mangel-Blutungen (VKMB) bei Neugeborenen", Stand: 03/2016

Phytomenadione (vitamin K)

Phytomenadione (vitamin K)

Phytomenadione (vitamin K)

Pharmacokinetics in children

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

Available formulations

Dosages

Renal impaiment in children > 3 months

Side effects in children

Contra-indications

Warnings & precautions in children

Interactions

VITAMIN K AND OTHER HEMOSTATICS

References

Changes

Therapeutic Drug Monitoring

Overdose