Drugs List

Therapeutic Indications

Uses

Prophylaxis of iron deficiency anaemia
Treatment of iron deficiency anaemia

Contraindications

Neonates under 1 month
Galactosaemia
Gastrointestinal obstruction
Haemochromatosis
Haemosiderosis
Hereditary fructose intolerance
Peptic ulcer
Repeated blood transfusions

Precautions and Warnings

Elderly
Diabetes mellitus
Dysphagia
First trimester of pregnancy
Gastrectomy
Gastrointestinal diverticula
Gastrointestinal stenosis
Glucose-galactose malabsorption syndrome
Haemoglobinopathies
Haemolytic anaemia
History of peptic ulcer
Inflammatory bowel disease
Lactose intolerance

Consider alternative formulations to tablet if risk of aspiration
Exclude non-iron deficiency anaemia
Not all available brands are licensed for all age groups
Oral solution contains sodium metabisulfite: May cause allergic reaction
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain glucose
Some formulations contain lactose
Some formulations contain sucrose
Tablet formulation not suitable for children under 6 years
Check B12 and folate levels if no response in microcytic anaemias
Oral iron may mask signs of occult blood loss
Continue treatment for 3 months once haemoglobin levels are normalised
Advise patient to seek medical attention if suspected aspiration of tablet
Advise patient to take after food to reduce gastro-intestinal disturbances

Pregnancy and Lactation

Pregnancy

Use ferrous sulfate with caution during the first trimester of pregnancy.

Plasma volume expansion during pregnancy results in a physiological decrease in haemoglobin concentrations ([Hb]) which typically fall in the second trimester and then rise to approach pre-pregnancy levels at term. Mean Cell Volume (MCV) is unaffected during pregnancy and offers a better indicator of iron-deficiency anaemia. Iron treatment of low [Hb] in the absence of other signs of deficiency is seldom required.

Adverse outcomes in pregnancy such as low birth-weight, pre-term birth and perinatal death in states of mild to moderate anaemia have been found in studies, although the causality and also preventability by iron supplements remain unclear. Additionally, iron supplements have been shown to result in an increase in low birth-weight and pre-term delivery.

Iron should be given if there is evidence of deficiency in the first trimester and later based on [Hb] below 10g/dL or MCV below 82fL.

Iron supplements should be considered in women with increased risk of iron deficiency anaemia such as those who have had recent menorrhagia, repeated closely spaced pregnancies or miscarriages and those with poor dietary intake.

Some manufacturers note that the administration of iron during the first trimester requires definite evidence of iron deficiency but that prophylaxis of iron deficiency during the remainder of pregnancy is justified.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ferrous sulfate is considered safe for use in breastfeeding.

No adverse effects have been reported in breastfeeding.

The use of relatively high doses in breastfeeding mothers is probably not contraindicated, due to the fact that iron transports very poorly into the milk compartment.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylaxis
Anorexia
Black faeces
Bronchial stenosis
Bronchospasm
Constipation
Diarrhoea
Epigastric pain
Faecal impaction
Gastric erosions
Gastric ulceration
Gastro-intestinal discomfort
Hypersensitivity reactions
Increase in dental caries
Nausea
Rash
Staining of teeth
Vomiting

Presentation

Oral formulations containing ferrous sulfate.

Drugs List

Therapeutic Indications

Uses

Prophylaxis of iron deficiency anaemia
Treatment of iron deficiency anaemia

Dosage

Adults

Children

Contraindications

Neonates under 1 month
Galactosaemia
Gastrointestinal obstruction
Haemochromatosis
Haemosiderosis
Hereditary fructose intolerance
Peptic ulcer
Repeated blood transfusions

Precautions and Warnings

Elderly
Diabetes mellitus
Dysphagia
First trimester of pregnancy
Gastrectomy
Gastrointestinal diverticula
Gastrointestinal stenosis
Glucose-galactose malabsorption syndrome
Haemoglobinopathies
Haemolytic anaemia
History of peptic ulcer
Inflammatory bowel disease
Lactose intolerance

Consider alternative formulations to tablet if risk of aspiration
Exclude non-iron deficiency anaemia
Not all available brands are licensed for all age groups
Oral solution contains sodium metabisulfite: May cause allergic reaction
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain glucose
Some formulations contain lactose
Some formulations contain sucrose
Tablet formulation not suitable for children under 6 years
Check B12 and folate levels if no response in microcytic anaemias
Oral iron may mask signs of occult blood loss
Continue treatment for 3 months once haemoglobin levels are normalised
Advise patient to seek medical attention if suspected aspiration of tablet
Advise patient to take after food to reduce gastro-intestinal disturbances

Pregnancy and Lactation

Pregnancy

Use ferrous sulfate with caution during the first trimester of pregnancy.

Plasma volume expansion during pregnancy results in a physiological decrease in haemoglobin concentrations ([Hb]) which typically fall in the second trimester and then rise to approach pre-pregnancy levels at term. Mean Cell Volume (MCV) is unaffected during pregnancy and offers a better indicator of iron-deficiency anaemia. Iron treatment of low [Hb] in the absence of other signs of deficiency is seldom required.

Adverse outcomes in pregnancy such as low birth-weight, pre-term birth and perinatal death in states of mild to moderate anaemia have been found in studies, although the causality and also preventability by iron supplements remain unclear. Additionally, iron supplements have been shown to result in an increase in low birth-weight and pre-term delivery.

Iron should be given if there is evidence of deficiency in the first trimester and later based on [Hb] below 10g/dL or MCV below 82fL.

Iron supplements should be considered in women with increased risk of iron deficiency anaemia such as those who have had recent menorrhagia, repeated closely spaced pregnancies or miscarriages and those with poor dietary intake.

Some manufacturers note that the administration of iron during the first trimester requires definite evidence of iron deficiency but that prophylaxis of iron deficiency during the remainder of pregnancy is justified.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ferrous sulfate is considered safe for use in breastfeeding.

No adverse effects have been reported in breastfeeding.

The use of relatively high doses in breastfeeding mothers is probably not contraindicated, due to the fact that iron transports very poorly into the milk compartment.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylaxis
Anorexia
Black faeces
Bronchial stenosis
Bronchospasm
Constipation
Diarrhoea
Epigastric pain
Faecal impaction
Gastric erosions
Gastric ulceration
Gastro-intestinal discomfort
Hypersensitivity reactions
Increase in dental caries
Nausea
Rash
Staining of teeth
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2016

Reference Sources

Summary of Product Characteristics: Feospan Spansule Capsules. Intrapharm Laboratories Limited. Revised April 2013.

Summary of Product Characteristics: Ferrograd Tablets. Teofarma S.r.l. Revised March 2008.

Summary of Product Characteristics: Ironorm Drops. Wallace Manufacturing Chemists Ltd. Revised April 2015.

Summary of Product Characteristics: Ferrous Sulphate 200mg tablets. Accord UK Ltd. Revised June 2018.

Summary of Product Characteristics: Ferrous Sulfate tablets 200mg. Sandoz Limited. Revised December 2018.

Summary of Product Characteristics: Ferrous Sulfate 200mg coated tablets. Wockhardt UK Ltd. Revised September 2017.

Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 July 2019