Phytomenadione paediatric parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for oral or parenteral use containing 2mg phytomenadione per 0.2ml in a mixed micelles vehicle of glycocholic acid and lecithin.
Drugs List
Therapeutic Indications
Uses
Antidote to coumarin-type anticoagulant overdosage
Haemorrhagic disease of the newborn - prophylaxis and treatment
Unlicensed Uses
Neonatal biliary atresia and liver disease
Dosage
Children
Antidote therapy to anticoagulant drugs of the coumarin type
Specialist advice from a haematologist should be obtained before giving as an antidote to anticoagulant drugs of the coumarin type in infants and children.
Vitamin K administration is likely to interfere with anticoagulation with warfarin for 2 to 3 weeks. Consider the reason for the patient being on warfarin and whether or not anticoagulant therapy has to be continued.
Patients continuing to receive warfarin for the partial reversal of anticoagulation
30micrograms/kg administered by intravenous injection.
Patients requiring complete reversal of a warfarin overdose
250micrograms/kg to 300micrograms/kg administered by intravenous injection. Frequent monitoring of vitamin K dependent clotting factors is essential.
Neonates
Prophylaxis of vitamin k deficiency bleeding
Healthy neonates of 36 weeks gestation or more
1mg by intramuscular injection at birth or soon after birth
or
2mg orally at birth or soon after birth. This oral dose should be followed by a second oral dose of 2mg at 4 to 7 days.
In addition to the doses at birth and at 4 to 7 days, a further 2mg oral dose should be given 1 month after birth. In exclusively formula fed infants the third oral dose can be omitted.
Preterm neonates of less than 36 weeks gestation weighing 2.5kg or more, and term neonates at special risk
1mg by intramuscular or intravenous injection at birth or soon after birth.
The size and frequency of further doses should be determined based on coagulation status.
Preterm neonates of less than 36 weeks gestation weighing less than 2.5kg
400micrograms/kg by intramuscular or intravenous injection at birth or soon after birth. Doses should not be exceeded.
Frequency of further doses should be determined based on the coagulation status.
Therapy of early or late vitamin k deficiency bleeding
Initially 1mg intravenously and further doses as required, depending on clinical picture and coagulation status.
Therapy may need to be accompanied by a more immediate effective treatment, such as transfusion of whole blood or blood clotting factors to compensate for severe blood loss and delayed response to vitamin K1.
Neonatal biliary atresia and liver disease (unlicensed)
1mg daily orally.
Administration
For antidote therapy to anticoagulant drugs of the coumarin type administer by slow intravenous injection only.
For the treatment and prophylaxis of vitamin k deficiency bleeding in neonates and infants administer by intramuscular, intravenous injection or orally.
Contraindications
None known
Precautions and Warnings
Premature infants weighing less than 2.5kg
Cholestasis
Not all routes are licensed for all indications
Treatment to be initiated and supervised by a specialist
Do not administer orally if cholestatic disease present
Use only if the solution is clear
Monitor prothrombin times
Severe haemorrhage: consider transfusion of whole blood or clotting factors
May cause anaphylactic / anaphylactoid reactions
Parenteral administration to preterm infants <2.5kg - risk of kernicterus
Do not dilute or mix with other parenteral medications.
Particular care is required when calculating and measuring the dose in relation to the baby's weight.
Pregnancy and Lactation
Pregnancy
Not indicated in patients of child bearing age, relevant data is not available.
Lactation
Not indicated in patients of child bearing age, relevant data is not available.
Side Effects
Anaphylactoid reaction
Atrophy (localised)
Inflammation (injection site)
Local reaction at injection site
Necrosis (injection site)
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2021
Reference Sources
Summary of Product Characteristics: Phytomenadione 2mg/0.2ml solution for injection. Cheplapharm Arzneimittel GmbH. Revised May 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 October 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.