Ferrous chloride

Generic name
Ferrous chloride
Brand name
ATC Code
B03AA05
Compare …

Ferrous chloride

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

There is no data known about the pharmacokinetic parameters of ferrous chloride 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
      [1] [2] [3] [4] [5] [7] [8] [9] [10]
      • Elemental iron (Fe2+)
        Starting dose 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.
        • 1 mg Fe2+ = 2,25 mg ferrochloride
        • The treatment should be continued until the Hb level is normalized. The therapy should be continued after normalization. The overall duration of the therapy should in principle not exceed three months.
        • Administer as much as possible between meals, preferably with drinks or foods containing vitamin C and in any case not combined with milk products.
        • 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 supplementation after birth
  • Oral
    • Premature infants weight at birth < 2000 g
      [1] [6] [12] [13] [15] [16] [17] [18] [19]
      • From 2-6 weeks after the 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+ = 2,25 mg ferrochloride
        • During admission in any type of feeding, after discharge only in breastfeeding or normal infant feeding, not in post-discharge feeding.
        • Optimum iron supplementation level is for premature babies and infants has not been established.
    • Premature infants weight at birth 2000 up to 2500 g
      [1] [6] [11] [12] [13] [14] [15] [16] [17] [18] [19]
      • From 2-6 weeks after birth, only 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+ = 2,25 ferrochloride
        • Optimum iron supplementation level for premature babies and infants has not been established.
    • weight at birth ≥ 2500 g
      [1] [6] [11] [12] [13] [14] [15] [16] [17] [18] [19]
      • In principle, no supplementation is needed. If Hb is < 6.0 mmol/l and ferritin is < 20 μg/l, supplement the Fe on individual indication.
        Elemental iron( Fe2+):
         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        The treatment should be continued until the Hb level is normalized. The therapy should be continued after normalization. The overall duration of the therapy should in principle not exceed three months.

         

        • 1 mg Fe2+ = 2,25 mg ferrochloride
        • Optimum iron supplementation level for premature babies and infants 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. 

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
B03AA02
B03AA01
B03AA07

References

  1. Omgerekend vanuit ijzerbehoefte ferrofumaraat
  2. Dors, N. et al, Background information on diseases: iron deficiency anemia, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld/, 2019, july
  3. 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
  4. 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
  5. Vifor Pharma., Ferrum Hausmann, Lösung 50 mg Eisen/ml., 005720, 09-2022
  6. Rao R, et al, Iron therapy for preterm infants, Clin Perinatol, 2009, Mar;36(1), 27-42
  7. Domellöf M, et al., Iron requirements of infants and toddlers, J Pediatr Gastroenterol Nutr., 2014, 58(1), 119-29
  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. von Siebenthal HK, et al., Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
  11. Berglund S, et al,, Iron supplements reduce the risk of iron deficiency anemia in marginally low birth weight infants,, Pediatrics, 2010, 126(4), e874-83
  12. Oski FA, Iron deficiency in infancy and childhood, N Engl J Med, 1993, Jul 15;329(3), 190-3
  13. 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
  14. Teva Nederland BV, SmPC Ferrofumaraat (RVG 51411) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  15. 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
  16. Edmond K, et al, Optimal feeding of low-birth-weight infants. Technical review., World Health Organization, 2006
  17. Long H, et al,, Benefits of iron supplementation for low birth weight infants: a systematic review,, BMC Pediatr,, 2012, Jul, 12:99
  18. Mills RJ, et al,, Enteral iron supplementation in preterm and low birth weight infants, Cochrane Database Syst Rev, 2012, Mar 14;3, CD005095
  19. World Health Organization, Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers, WHO_NHD_01.3.pd

Changes

Therapeutic Drug Monitoring


Overdose