Tocofersolan oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solution containing d-alpha-tocopherol in the form of tocofersolan.
Drugs List
Therapeutic Indications
Uses
Vitamin E deficiency due to digestive malabsorption in chronic cholestasis
Dosage
The dose should be adjusted according to the plasma vitamin E level.
Children
Total daily dose: 17mg/kg (equivalent to 0.34ml/kg daily of d-alpha-tocopherol in the form of tocofersolan).
The dose (in ml) can be calculated by dividing the prescribed dose of d-alpha-tocopherol (in mg) by 50.
Contraindications
Adults aged 18 years and above
Premature infants
Precautions and Warnings
High predisposition to thrombosis
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Treatment to be initiated and supervised by a specialist
Contains hydroxybenzoate
Monitor plasma Vitamin E levels initially monthly then at regular intervals
Monitor hepatic function in patients with hepatic impairment
Monitor prothrombin time in vitamin K deficient patients
Monitor prothrombin times closely in patients on anticoagulant therapy
Monitor renal function in patients with renal impairment
Pregnancy and Lactation
Pregnancy
Tocofersolan should be used with caution in pregnancy.
No clinical data on exposed pregnancies are available for tocofersolan. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development.
The manufacturer advises caution should be used when prescribing to pregnant women.
Lactation
Tocofersolan should be used with caution in breastfeeding.
It is not known if tocofersolan is excreted in human breast milk or animal milk.
The manufacturer advises a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with tocofersolan should be made taking into account the benefit of breast-feeding to the child and the benefit of tocofersan therapy to the woman.
Side Effects
Abdominal pain
Abnormal serum sodium levels
Alopecia
Asthenia
Diarrhoea
Fluctuating serum potassium levels
Headache
Increase in serum transaminases
Increased bleeding tendency
Pruritus
Rash
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: April 2019.
Reference Sources
Summary of Product Characteristics: Vedrop 50mg/ml oral solution. Orphan Europe (UK) Limited. Revised October 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 1 April 2019
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.