Sodium feredetate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation of sodium feredetate.
Drugs List
Therapeutic Indications
Uses
Prophylaxis of iron deficiency anaemia
Treatment of iron deficiency anaemia
Dosage
Adults
Therapeutic dose
5ml (27.5mg of elemental iron) increasing gradually to 10ml three times daily.
Children
Therapeutic dose
3 to 6mg/kg (max 200mg) of elemental iron daily given in 2 to 3 divided doses.
Alternative sources suggest the following dosage:
Children aged 12 to 18 years:5ml three times daily, increased gradually to 10ml three times daily.
Children aged 5 to 12 years:5ml three times daily.
Children aged 1 to 5 years:2.5ml three times daily.
Children aged 1 month to 1 year:Up to 2.5ml twice daily.
Prophylactic dose
Children aged 12 to 18 years
60mg of elemental iron.
Children aged 6 to 12 years
30mg to 60mg of elemental iron.
Children aged 2 to 6 years
20mg to 30mg of elemental iron.
Children aged 6 to 24 months
12.5mg of elemental iron.
Alternative sources suggest the following dosage:
Children aged 1 month to 1 year: 1ml daily. Prophylactic iron supplementation may be required in babies of low birth-weight who are solely breast-fed. Supplementation is started 4 to 6 weeks after birth and continued until mixed feeding is established.
Neonates
Therapeutic dose
Alternative sources suggest the following:
Up to 2.5ml twice daily. Initially smaller doses are recommended.
Prophylactic dose
Babies of low birth weight who are solely breast-fed:
5mg daily of elemental iron is recommended. Higher doses up to 2mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4 to 6 weeks after birth and continued until mixed feeding is established.
Contraindications
Haemochromatosis
Haemosiderosis
Hereditary fructose intolerance
Repeated blood transfusions
Precautions and Warnings
Restricted sodium intake
Gastrointestinal disorder
Haemolytic anaemia
Sodium content of formulation may be significant
Exclude non-iron deficiency anaemia
Contains alcohol
Contains hydroxybenzoate
Contains ponceau 4R (E124) - may cause allergic reactions
Presentations with sorbitol unsuitable in hereditary fructose intolerance
May affect results of some laboratory tests
Children: Avoid prolonged or excessive use
Advise patient stools may be discoloured
Advise patient to take after food to reduce gastro-intestinal disturbances
Pregnancy and Lactation
Pregnancy
Sodium feredetate is considered safe for use during pregnancy.
Manufacturer advises that no adverse effects have been reported during use in pregnancy.
Lactation
Sodium feredetate is considered safe for use during breastfeeding.
Manufacturer advises that no adverse effects have been reported in breastfeeding.
Side Effects
Discolouration of stools
Hypersensitivity reactions
Mild diarrhoea
Nausea
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: March 2020
Reference Sources
Summary of Product Characteristics: Sytron 27.5mg iron per 5 ml Oral Solution. Kyowa Kirin Limited. Revised November 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 February 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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