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

Interactions
PK
Renal impairment
References

Sucroferri-oxyhydroxide complex (Oral iron)

Generic name
Sucroferri-oxyhydroxide complex (Oral iron)
Brand name
ATC Code
B03AB02

Pharmacokinetics in children

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

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Available formulations

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Dosages

Iron deficiency anaemia
  • Oral
    • 1 month up to 18 years
      •  Initial dose elemental iron (Fe3+): 1 mg/kg/day in 1 dose. Max: 60 mg/day. If needed, titrate to 3 mg/kg/day based on the severity of anemia and clinical response.  .
      • Duration of treatment:

        Administration should be continued until the Hb level is normalized. After normalization, therapy should be continued. In principle, the total duration of therapy should not exceed three months.

        • 1 mg Fe = 2,17 mg ferri polysacharate complex 
        • Take the iron preparation between meals whenever possible, preferably with drinks or foods containing vitamin C and in any case not with dairy products.
        • The dosage has been reduced adjusted according to the guidelines of the Dutch Society for Hematology (1 mg/kg/day elemental iron). Based on the upregulation of hepcidin after iron supplementation, evidence in adults suggests that less frequent and lower doses provide better iron absorption in the gut and fewer side effects. Children's hepcidin regulation of iron absorption is completely intact, and most likely exhibits a similar pattern of upregulation to that of adults.
        • In children 12 years of age and older, intermittent administration of 200 mg/dose twice a week can be considered.
Iron supplementation after birth
  • Oral
    • Premature neonates weight at birth < 2000 g
      • From 2-6 weeks after birth.
        Elemental iron (Fe3+):         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        6-12 months

        • 1 mg Fe = 2,17 mg ferri polysacharate complex 
        • During admission with any type of feeding, after discharge only with breastfeeding or normal infant feeding, not with post-discharge feeding.
        • Optimal iron supplementation for premature and preterm neonates has not been established.
    • Premature neonates weight at birth 2000 up to 2500 g
      • From 2-6 weeks after birth exclusively when breastfed, until a corrected age of 6 months. 
        Elemental iron (Fe3+):         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        6-12 months

        • 1 mg Fe = 2,17 mg ferri polysacharate complex 
        • Optimal iron supplementation for premature and term infants has not been established.
    • Term and preterm neonates weight at birth ≥ 2500 g
      • In principle, no supplementation is necessary. If Hb < 6.0 mmol/l and ferritin < 20 μg/l supplementation of Fe on individual indication
        Elemental iron (Fe3+):         2 - 3         mg/kg/day in 1 - 3 doses.
      • Duration of treatment:

        Administration should be continued until the Hb level is normalized. After normalization, therapy should be continued. In principle, the total duration of therapy should not exceed three months.

        • 1 mg Fe = 2,17 mg ferri polysacharate complex 
        • Optimal iron supplementation for premature and term neonates has not been established.
Hyperphosphataemia
  • Oral
    • 2 years up to 6 years
      • Initial dose: 500 mg/day in 3 doses. Max: 1.250 mg/day. Increase or decrease initial dose by 125 mg-250 mg based on serumphosphate concentration..
    • 6 years up to 9 years
      • Initial dose: 750 mg/day in 3 doses. Max: 2.500 mg/day. Increase or decrease initial dose by 125 mg, 250 mg or 375 mg based on serumphosphate concentration..
    • 9 years up to 12 years
      • Initial dose: 1.000 mg/day in 3 doses. Max: 3.000 mg/day. Increase or decrease initial dose by 250 mg or 500 mg based on serumphosphate concentration..
    • ≥ 12 years
      • Initial dose: 1.500 mg/day in 3 doses. Max: 3.000 mg/day. Increase or decrease initial dose by 500 mg based on serumphosphate concentration..

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Gastrointestinal disorders such as nausea, vomiting, diarrhea, constipation, pain in the lower abdomen, decreased appetite and black staining of feces. Discoloration of teeth.

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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

  •  Young children are very sensitive to the toxic side effects of iron preparations. Caution should be exercised when combining with dietary or other iron salt supplements because of the risk of possible iron overdose.
  • It is advised that doses be taken divided throughout the day to reduce the risk of stomach upset. Taking should be done between meals if possible to obtain better absorption. Administration preferably 30 minutes before food. This is because food reduces the absorption of iron. The medication should not be combined with dairy products. Absorption is reduced by many substances: antacids, phosphates calcium salts, quinolones, tetracyclines and penicillamine. An interval of 2-3 hours should be maintained between intake of the iron preparation and these medications. Orange juice and vitamin C improve absorption.
  • Discoloration of teeth may occur during treatment with iron salts. According to the literature, this discoloration may disappear on its own after the end of treatment, or it should be removed by using an abrasive toothpaste, possibly removed by a dentist. To prevent discoloration of the teeth, the drops should be diluted well with water and swallowed through a straw.
  • The stool may be discolored black.
  • After normalization of hemoglobin, therapy is continued for two to three months to replenish iron stores.

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Interactions

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

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Iron bivalent, oral preparations
B03AA03
B03AA02
B03AA01
B03AA01
B03AA07
B03AA05
Iron trivalent, oral preparations
B03AB05
B03AB02
Iron, parenteral preparations
B03AC
B03AC
IRON, PARENTERAL PREPARATIONS
B03AC
B03AC

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References

  1. Stoffel NU, et al., Oral iron supplementation in iron-deficient women: How much and how often?, Mol Aspects Med, 2020, 75, 100865
  2. Moretti D, et al., Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women., Blood, 2015, 126(17), 1981-9
  3. Dors, N. et al. , Achtergrondinformatie per ziektebeeld: IJzergebreksanemie, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld/, Juli 2019
  4. Domellöf M, et al, Iron requirements of infants and toddlers, J Pediatr Gastroenterol Nutr., 2014, 58(1), 119-29
  5. Long H, et al., Benefits of iron supplementation for low birth weight infants: a systematic review, BMC Pediatr, 2012, Jul 16, 12:99
  6. Uyoga MA, et al., The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants., Am J Clin Nutr., 2020, 112(4), 1132-41
  7. von Siebenthal HK, et al., Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
  8. Teva Nederland BV, SmPC Ferrofumaraat (RVG 51411) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  9. Wegmüller R, et al., Hepcidin-guided screen-and-treat interventions for young children with iron-deficiency anaemia in The Gambia: an individually randomised, three-arm, double-blind, controlled, proof-of-concept, non-inferiority trial., Lancet Glob Health, 2023, 11(1), e105-e16
  10. Vifor Pharma., SmPC Ferrum Hausmann, Lösung 50 mg Eisen/ml., https://www.fachinfo.de/suche/fi/005720, 09-2022
  11. Rao R, et al, Iron therapy for preterm infants,, Clin Perinatol, 2009, Mar;36(1), 27-42
  12. Embleton ND, et al., Enteral Nutrition in Preterm Infants (2022): A Position Paper From the ESPGHAN Committee on Nutrition and Invited Experts., Journal of Pediatric Gastroenterology and Nutrition, 2023, 76(2), 248-68
  13. Baker RD, et al,, Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age), Pediatrics, 2010, Nov;126(5), 1040-50
  14. Berglund S, et al,, Iron supplements reduce the risk of iron deficiency anemia in marginally low birth weight infants,, Pediatrics, 2010, Oct;126(4), e874-83
  15. Edmond K, et al,, Optimal feeding of low-birth-weight infants. Technical review., World Health Organization, 2006
  16. Mills RJ, et al,, Enteral iron supplementation in preterm and low birth weight infants, Cochrane Database Syst Rev, 2012, Mar 14;3, CD005095
  17. Oski FA,, Iron deficiency in infancy and childhood,, N Engl J Med,, 1993, Jul 15;329(3), 190-3
  18. World Health Organization, Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers, WHO_NHD_01.3.pdf
  19. Vifor Fresenius France, SmPC Velphoro (EU/1/14/943/005) 26-11-2020, www.geneesmiddeleninformatiebank.nl
  20. Dors, N. et al., Achtergrondinformatie per ziektebeeld: IJzergebreksanemie, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld/, Juli 2019

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Changes

Changes