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

Interactions
PK
Renal impairment
References

Ferroglysinsulfat

Generic name
Ferroglysinsulfat
Brand name
ATC Code
B03AA01

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
      [1] [2] [3] [5] [6] [7] [11] [20] [22]
      • Initial dose: Elemental iron (Fe2+):  1 mg/kg/day in 1 dose. Max: 60 mg/day. Zo nodig ophogen tot 3 mg/kg/dag op basis van de ernst van de anemie en klinische respons..
      • 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.

      • Directions for administration:

        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 elemental iron Fe2+ =  5,67 mg ferroglycinesulphate complex

        • The dosage has been reduced  according to the guidelines of the Dutch Society for Hematology (1 mg/kg/day elemental iron (Fe2+)). 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 deficiency anemia (GERMAN DOSING)
  • Oral
    • 0 months up to 18 years and ≥ 2 kg
      [4]
      • Ferroglycinesulphate: 10.8 - 16.2 mg/kg/day in 1 dose. Max: 324 mg/day. equivalent to 2-3 Fe mg/kg/day.

      • There are indications that a less frequent and lower dosage results in better intestinal iron uptake and fewer side effects. (Moretti 2015)
Iron supplementation after birth
  • Oral
    • weight at birth < 2000 g
      [8] [9] [10] [12] [13] [15] [16] [17] [19] [21]
      • 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 elemental iron (Fe2+) = 5,67 mg ferroglycinesulphate complex

        • During admission with any type of feeding. After discharge suppletion only indicated with breastfeeding or normal infant feeding, not with post-discharge feeding.
        • Optimal iron supplementation for premature infants and preterm infants has not been established.
    • weight at birth 2000 up to 2500 g
      [8] [9] [10] [12] [13] [15] [16] [17] [19] [21]
      • 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 elemental iron (Fe2+) = 5,67 mg ferroglycinesulphate complex

        Optimal iron supplementation for premature infants and preterm infants has not been established.

    • weight at birth ≥ 2500 g
      [8] [9] [10] [12] [13] [15] [16] [17] [19] [21]
      • 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 elemental iron (Fe2+) = 5,67 mg ferroglycinesulfaat complex

        Optimal iron supplementation for premature infants and preterm infants has not been established.

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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.

(Administration in the Norwegian database: 

Method of administration: Drops and capsules:

  • Drops:
    • Niferex drops 30 mg / ml: 1 drop = 1.5 mg Fe2 + (SmPC Niferex drops).
    • To avoid discoloration of the teeth, the drops should be diluted well with water and swallowed through a straw. When the drops are given to newborns, they can be mixed in a little volume of sterile water.
    • For small children, they can be mixed in water or fruit juice, possibly mixed with some mashed fruit just before ingestion.
  • Capsules: The capsule can be opened, but the contents must be swallowed completely. The grains must not be chewed or crushed.

Ingestion and food: Because the absorption of the ingredients in the food may be reduced, the medicine should be taken at sufficient time intervals from meals (eg on an empty stomach in the morning or between two main meals). If this is not feasible and the child takes the iron supplement with food, the dose must be adjusted based on test results.

(Norwegian SmPC: Niferex drops and capsules)).

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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
B03AA02
B03AA07
B03AA05

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References

  1. 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 , Oct 22;126(17), 1981-9.
  2. Stichting NKFK, Kinderformularium- monografie ferrofumaraat, https://www.kinderformularium.nl/geneesmiddel/373/ferrofumaraat
  3. Dors, N. et al., Achtergrondinformatie per ziektebeeld: IJzergebreksanemie, achtergrondinformatie-per-ziektebeeld, 2019, July
  4. UCB Pharma GmbH, SmPC Ferro Sanol Tropfen 30 mg/ml (6160465.00.00) , 07-2020
  5. 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
  6. Vifor Pharma., SmPC Ferrum Hausmann, Lösung 50 mg Eisen/ml., Available from: https://www.fachinfo.de/suche/fi/005720, 09-2022
  7. Stoffel NU, et al., Oral iron supplementation in iron-deficient women: How much and how often, Mol Aspects Med, 202, 75, 100865
  8. 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
  9. Edmond K, et al., Optimal feeding of low-birth-weight infants. Technical review, World Health Organization, 2006
  10. Mills RJ, et al., Enteral iron supplementation in preterm and low birth weight infants,, Cochrane Database Syst Rev, 2012, Mar 14;3, CD005095
  11. von Siebenthal HK, et al., Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
  12. 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
  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. 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
  15. Long H, et al., Benefits of iron supplementation for low birth weight infants: a systematic review, BMC Pediatr, 2012, Jul 16, 12:99
  16. Oski FA. , Iron deficiency in infancy and childhood, N Engl J Med, 1993, Jul 15;329(3), 190-3
  17. Teva Nederland B.V., SmPC Ferrofumaraat (RVG 51411) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  18. Teva Nederland BV, SmPC Ferrofumaraat (RVG 33291) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  19. Rao R, et al,, Iron therapy for preterm infants, Clin Perinatol, 2009, Mar;36(1), 27-42
  20. 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
  21. World Health Organization., Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers, WHO_NHD_01.3.pdf
  22. Domellöf M, et al. , Iron requirements of infants and toddlers., J Pediatr Gastroenterol Nutr., 2014, 58(1), 119-29

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Changes

Changes