Iron (III) polymaltose

Generic name
Iron (III) polymaltose
Brand name
ATC Code
B03AB05
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Iron (III) polymaltose

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No pharmacokinetic data are available on the use of iron salts in children.

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

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.

        • 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.
        Elemantal iron (Fe3+): 2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        6-12 months

        • 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 aterm 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.
        Elemantal iron (Fe3+): 2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
        • Optimal iron supplementation for premature and aterm neonates has not been established.
    • Premature and term neonates weight at birth ≥ 2500 g
      • In principle, no supplementation is necessary. If Hb < 6.0 mmol/l and ferritin < 20 μg/l supplement Fe on individual indication.
        Elemantal iron (Fe3+): 2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
        • 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.
        • Optimal iron supplementation for premature and aterm neonates has not been established.

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

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

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.

Interactions

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

IRON PREPARATIONS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

References

  1. Vifor Pharma, SmPC Ferrum Hausmann®, 50 mg Eisen/ml, Tropfen zum Einnehmen, Lösung (6024673.00.00), Januar 2016
  2. Vifor Pharma, SmPC Ferrum Hausmann®, 50 mg Eisen/5 ml, Sirup (6024644.00.00), Januar 2016
  3. Edmond K, et al., Optimal feeding of low-birth-weight infants. Technical review., World Health Organization, 2006
  4. World Health Organization, Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers, WHO_NHD_01.3.pdf
  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. Dors, N. et al., Achtergrondinformatie per ziektebeeld: IJzergebreksanemie, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld/, Juli 2019
  7. Rao R, et al., Iron therapy for preterm infants, Clin Perinatol, 2009, Mar;36(1), 27-42
  8. 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
  9. Stoffel NU, et al., Oral iron supplementation in iron-deficient women: How much and how often?, Mol Aspects Med, 2020, 75, 100865
  10. Domellöf M, et al., Iron requirements of infants and toddlers., J Pediatr Gastroenterol Nutr., 2014, 58(1), 119-29
  11. 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
  12. Mills RJ, et al,., Enteral iron supplementation in preterm and low birth weight infants., Cochrane Database Syst Rev, 2012, Mar 14;3, CD005095
  13. 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
  14. 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
  15. Vifor Pharma., SmPC Ferrum Hausmann, Lösung 50 mg Fe/ml., https://www.fachinfo.de/suche/fi/005720, 09-2022
  16. 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
  17. 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
  18. Oski FA,, Iron deficiency in infancy and childhood., N Engl J Med, 1993, Jul 15;329(3), 190-3
  19. von Siebenthal HK, et al., Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
  20. Teva Nederland BV, SmPC Ferrofumaraat (RVG 51411) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  21. 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
  22. 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
  23. Oski FA,, Iron deficiency in infancy and childhood., N Engl J Med, 1993, Jul 15;329(3), 190-3

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