Eisen(II)-gluconat

Generic name
Eisen(II)-gluconat
Brand name
ATC Code
B03AA03
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Eisen(II)-gluconat

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Es sind keine spezifischen Informationen für Kinder vorhanden.

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 (Fe2+) 1 mg/kg/day in 1 dose. Max: 60 mg/day. If necessary, titrate to 3 mg/kg/day depending on the severity of the 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.
        • 1 mg Fe2+ = 8,6 mg Ferrous gluconat
        • The dosage has been 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
    • weight at birth < 2000 g
      • From 2-6 weeks after birth.
        elemental iron (Fe2+): 2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        6-12 months

        • 1 mg Fe2+ = 8,6 mg Ferrous gluconat
        • During admission with any type of feeding, after discharge only with breastfeeding or normal infant feeding, not with post-discharge feeding.
        • It is difficult to indicate optimal iron supplementation for premature infants and preterm infants.
    • 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 (Fe2+): 2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
        • 1 mg Fe2+ = 8,6 mg Ferrous gluconat
        • It is difficult to indicate optimal iron supplementation for  both preterm and term infants.
    • 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.
        elemental iron (Fe2+): 
         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • 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 Fe2+ = 8,6 mg Ferrous gluconat
        • It is difficult to indicate optimal iron supplementation for both preterm and term infants.

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

No information is present at this moment.

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

No information available on specific warnings and precautions in children.

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

References

  1. Dors, N. et al., Achtergrondinformatie per ziektebeeld: IJzergebreksanemie, , https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld, 2019, Juli
  2. Grant CC, et al., Policy statement on iron deficiency in pre-school-aged children., J Paediatr Child Health, 2007, Jul-Aug;43(7-8), 513-21
  3. Bhargava S, et al., Clinical inquiries. What is appropriate management of iron deficiency for young children?, J Fam Pract, 2006, Jul;55(7), 629-30
  4. 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
  5. 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
  6. Lafeber HN, et al., Werkboek Enterale en parenterale voeding bij pasgeborenen. (3e druk), VU Uitgeverij, Amsterdam, 2012
  7. Rao R, et al., Iron therapy for preterm infants, Clin Perinatol, 2009, Mar;36(1), 27-42
  8. Oski FA., Iron deficiency in infancy and childhood, N Engl J Med, 1993, Jul 15;329(3), 190-3
  9. 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
  10. Choudhury P, et al., Rationale of iron dosage and formulations in under three children., http://www.idpas.org/pdf/985Rationale.pdf
  11. Long H, et al., Benefits of iron supplementation for low birth weight infants: a systematic review, BMC Pediatr, 2012, Jul 16, 12:99
  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. Mills RJ, et al., Enteral iron supplementation in preterm and low birth weight infants, Cochrane Database Syst Rev, 2012, Mar 14;3, CD005095
  14. de Souza Queiroz S, et al., Iron deficiency anemia in children, J. pediatr. (Rio J.), 2000, 76 (Supl.3), S298-S304
  15. Oski FA., Iron deficiency in infancy and childhood, N Engl J Med, 1993, Jul 15;329(3), 190-3
  16. Domellöf M, et al., Iron requirements of infants and toddlers., J Pediatr Gastroenterol Nutr., 2014, 58(1), 119-29
  17. Bouma M. et al., NHG Standaard Anemie (M76), Huisarts Wet, Revisie datum: oktober 2014, Versie 2.1
  18. Wall CR, et al., Milk versus medicine for the treatment of iron deficiency anaemia in hospitalised infants., Arch Dis Child, 2005, Oct;90(10), 1033-8
  19. World Health Organization., Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers., http://whqlibdoc.who.int/hq/2001/WHO_NHD_01.3.pdf
  20. Stoffel NU, et al., Oral iron supplementation in iron-deficient women: How much and how often?, Mol Aspects Med, 2020, 75, 100865
  21. von Siebenthal HK, et al., Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
  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. 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
  24. Dors, N. et al., Achtergrondinformatie per ziektebeeld: IJzergebreksanemie,, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld, 2019, Juli
  25. 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

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