Pediatric Formulary

Ferrosulphate

Generic name

Ferrosulphate

Brand name

ATC Code

B03AA07

Compare …

Dosages

Side effects in children

Warnings & precautions in children

Contra-indications in children

Interactions

Renal impairment

References

Pharmacokinetics in children

No information available

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] [13] [16] [17] [18]} Initial dose: Elemental iron (Fe²⁺): 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 = 2.72 mg ferrosulphate 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 (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 anaemia

Oral
- 1 month up to 18 years
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  - Initial dose: Elemental iron (Fe²⁺): 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 = 2.72 mg ferrosulphate
    - 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 (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 neonates weight at birth < 2000 g ^{[5] [6] [7] [8] [9] [10] [11] [12] [14] [15]} 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 Fe = 2.72 mg ferrosulphate 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 a term born neonates has not been established. Premature neonates weight at birth 2000 up to 2500 g ^{[5] [6] [7] [9] [10] [11] [12] [14] [15]} 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 Fe = 2.72 mg ferrosulphate Optimal iron supplementation for premature a term born neonates has not been established. Premature and term neonates weight at birth ≥ 2500 g ^{[5] [6] [7] [8] [9] [10] [11] [12] [14] [15]} 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 Fe = 2.72 mg ferrosulphate Optimal iron supplementation for premature a term born neonates has not been established.

Iron supplementation after birth

Oral
- Premature neonates weight at birth < 2000 g
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  - 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 Fe = 2.72 mg ferrosulphate
    - 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 a term born neonates has not been established.
- Premature neonates weight at birth 2000 up to 2500 g
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  - 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 Fe = 2.72 mg ferrosulphate
    - Optimal iron supplementation for premature a term born neonates has not been established.
- Premature and term neonates weight at birth ≥ 2500 g
  ^{[5]
  
  [6]
  
  [7]
  
  [8]
  
  [9]
  
  [10]
  
  [11]
  
  [12]
  
  [14]
  
  [15]}
  - 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 Fe = 2.72 mg ferrosulphate
    - Optimal iron supplementation for premature a term born 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.

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
	Ferrofumarate Related Medicines Menu">	B03AA02
	Ferroglysinsulfat Related Medicines Menu">	B03AA01
	Ferrous chloride Related Medicines Menu">	B03AA05

References

Domellöf M, et al., Iron requirements of infants and toddlers, J Pediatr Gastroenterol Nutr., 2014, 58(1), 119-29
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
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
Vifor Pharma. , SmPC Ferrum Hausmann, Lösung 50 mg Fe/ml., https://www.fachinfo.de/suche/fi/005720, 09-2022.
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
Edmond K, et al., Optimal feeding of low-birth-weight infants. Technical review, World Health Organization, 2006
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
World Health Organization, Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers, WHO_NHD_01.3.pdf
Mills RJ, et al., Enteral iron supplementation in preterm and low birth weight infants,, Cochrane Database Syst Rev, 2012, Mar 14;3, CD005095
Oski FA., Iron deficiency in infancy and childhood, N Engl J Med, 1993, Jul 15;329(3), 190-3
Teva Nederland BV, SmPC Ferrofumaraat (RVG 51411) 28-06-2023, www.geneesmiddeleninformatiebank.nl
Rao R, et al., Iron therapy for preterm infants, Clin Perinatol, 2009, Mar;36(1), 27-42
von Siebenthal HK, et al., Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
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
Long H, et al., Benefits of iron supplementation for low birth weight infants: a systematic review, BMC Pediatr,, 2012, Jul 16, 12:99
Dors, N. et al, , Achtergrondinformatie per ziektebeeld: IJzergebreksanemie, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld/, Juli 2019
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
Stoffel NU,et al., Oral iron supplementation in iron-deficient women: How much and how often?, Mol Aspects Med, 2020, 75, 100865

Ferrosulphate

Ferrosulphate

Ferrosulphate

Pharmacokinetics in children

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

Available formulations

Dosages

Renal impaiment in children > 3 months

Side effects in children

Contra-indications

Warnings & precautions in children

Interactions

IRON PREPARATIONS

References

Changes

Therapeutic Drug Monitoring

Overdose