Drugs List

Therapeutic Indications

Uses

Rapid replenishment of depleted iron stores
Treatment of iron deficiency anaemia

Administration

Iron hydroxide dextran complex solution may be administered by an intravenous infusion, by a slow intravenous injection or as an undiluted solution intramuscularly. Intravenous infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes.

Iron dextran must be diluted only in 0.9% sodium chloride solution or in 5% glucose solution.

Intravenous infusion
Iron dextran may be administered in a dose of 100mg to 200mg iron (2ml to 4ml) diluted in 100ml 0.9% sodium chloride solution or in 5% glucose solution. The manufacturer advises to infuse the first 25mg of iron over a period of 15 minutes. If no adverse reactions occur during this time, the remaining portion of the infusion should be given at an infusion rate of not more than 100ml in 30 minutes.

Intravenous injection
Iron dextran may be administered in a dose of 100mg to 200mg iron (2ml to 4ml) by slow intravenous injection (0.2ml/min) diluted in 10ml to 20ml 0.9% sodium chloride or 5% glucose solution. The manufacturer advises that, on each occasion, the first 25mg should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes, the remaining portion of the injection may be given.

Total dose infusion
The total amount of iron hydroxide dextran complex, up to 20mg/kg bodyweight, is infused intravenously over 4 to 6 hours. The first 25mg of iron should be infused over a period of 15 minutes. If no reactions occur during this time, then the remaining portion of the infusion should be given. The rate of infusion may be increased progressively to 45 to 60 drops per minute. Patients should be observed during the infusion and for at least 30 minutes after completion. This method should be restricted to hospital use only.

Injection into dialyser
Iron hydroxide dextran complex may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedure as outlined for intravenous administration.

Deep Intramuscular injection
The injections must be given by deep intramuscular injection into the muscle mass of the upper outer quadrant of the buttock only. For moderately active patients, the injections may be given daily into alternate buttocks. In inactive or bedridden patients the injections should be reduced to once or twice weekly.

Contraindications

Children under 14 years
Infection
Acute renal failure
Decompensated liver disease
First trimester of pregnancy
Haemochromatosis
Haemolytic anaemia
Haemosiderosis
Hepatitis

Precautions and Warnings

Allergic disposition
Atopy
Autoimmune disease
Inflammatory disorder
Breastfeeding
Eczema
Second trimester of pregnancy
Severe asthma
Third trimester of pregnancy

Exclude non-iron deficiency anaemia
Have available adrenaline injection 1:1000 for anaphylaxis
Treat and control infections prior to commencing therapy
Do not start oral iron therapy until at least 5 days after last injection
Observe patient closely during and immediately after administration
Rapid intravenous administration may cause acute short-lasting hypotension
Resuscitation facilities must be immediately available
Diagnosis of iron deficiency must be based on appropriate laboratory tests
Caution with every dose of IV iron even if previously well tolerated
Monitor for hypersensitivity reactions for at least 30 mins after admin
Large doses may impart brown colour to serum from blood sample after admin.
May give falsely decreased values of serum calcium
May give falsely elevated values of serum bilirubin
Discontinue if anaphylactoid reaction occurs
Do not take oral iron preparations during treatment
Advise patients that hypersensitivity reactions may be life threatening

Pregnancy and Lactation

Pregnancy

Iron dextran is contraindicated during the first trimester of pregnancy and should be used with caution during the second and third trimester of pregnancy.

The manufacturer advises that iron deficiency anaemia occurring in the first trimester of pregnancy can normally be adequately treated with oral iron. It is recommended that treatment with intravenous iron should be confined to the second and third trimester if oral iron therapy is unsuitable.

There is no adequate data from the use of iron hydroxide dextran complex during pregnancy. Studies in animals have shown teratogenicity and reproductive toxicity.

Following administration of parental irons, foetal bradycardia may occur. This is usually due to a hypersensitivity reaction in the mother. As a result, if parental irons are intravenously administered to a pregnant woman, the unborn baby should be carefully monitored.

Lactation

Use iron hydroxide dextran complex with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst using iron hydroxide dextran complex.

Limited data indicates that trace amounts of iron dextran are expressed into breast milk. The information on the clinical use of iron dextran during breastfeeding is not available. However, intravenous iron dextran has been used in preterm infants for anaemia of prematurity and would not be expected to cause any adverse effects in breastfed infants.

Side Effects

Abdominal pain
Abscess formation (injection site)
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Arrhythmias
Arthralgia
Atrophy (localised)
Blurred vision
Cardiovascular collapse
Chest pain
Cramp
Deafness (transient)
Diarrhoea
Dizziness
Dyspnoea
Exacerbation of rheumatoid arthritis
Fatigue
Feeling hot
Fever
Flushing
Foetal bradycardia
Haemolysis
Haemorrhage (injection site)
Headache
Hypersensitivity reactions
Hypertension
Hypotension
Inflammation (injection site)
Influenza-like symptoms
Itching
Kounis syndrome
Local pain (injection site)
Loss of consciousness (transient)
Mental status changes
Myalgia
Nausea
Necrosis (injection site)
Numbness
Palpitations
Paraesthesia
Phlebitis (injection site)
Pruritus
Rash
Restlessness
Seizures
Shivering
Stains skin brown
Sweating
Tachycardia
Tremor
Urticaria
Vomiting

Presentation

Solution for injection containing iron (III) as iron (III)-hydroxide dextran complex.

Drugs List

Therapeutic Indications

Uses

Rapid replenishment of depleted iron stores
Treatment of iron deficiency anaemia

Dosage

The total cumulative dose of iron hydroxide dextran complex is determined by haemoglobin level and body weight. The dose and dosage schedule must be individually estimated for each patient based on a calculation of the total iron deficit.

Adults

Children

Administration

Iron hydroxide dextran complex solution may be administered by an intravenous infusion, by a slow intravenous injection or as an undiluted solution intramuscularly. Intravenous infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes.

Iron dextran must be diluted only in 0.9% sodium chloride solution or in 5% glucose solution.

Intravenous infusion
Iron dextran may be administered in a dose of 100mg to 200mg iron (2ml to 4ml) diluted in 100ml 0.9% sodium chloride solution or in 5% glucose solution. The manufacturer advises to infuse the first 25mg of iron over a period of 15 minutes. If no adverse reactions occur during this time, the remaining portion of the infusion should be given at an infusion rate of not more than 100ml in 30 minutes.

Intravenous injection
Iron dextran may be administered in a dose of 100mg to 200mg iron (2ml to 4ml) by slow intravenous injection (0.2ml/min) diluted in 10ml to 20ml 0.9% sodium chloride or 5% glucose solution. The manufacturer advises that, on each occasion, the first 25mg should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes, the remaining portion of the injection may be given.

Total dose infusion
The total amount of iron hydroxide dextran complex, up to 20mg/kg bodyweight, is infused intravenously over 4 to 6 hours. The first 25mg of iron should be infused over a period of 15 minutes. If no reactions occur during this time, then the remaining portion of the infusion should be given. The rate of infusion may be increased progressively to 45 to 60 drops per minute. Patients should be observed during the infusion and for at least 30 minutes after completion. This method should be restricted to hospital use only.

Injection into dialyser
Iron hydroxide dextran complex may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedure as outlined for intravenous administration.

Deep Intramuscular injection
The injections must be given by deep intramuscular injection into the muscle mass of the upper outer quadrant of the buttock only. For moderately active patients, the injections may be given daily into alternate buttocks. In inactive or bedridden patients the injections should be reduced to once or twice weekly.

Contraindications

Children under 14 years
Infection
Acute renal failure
Decompensated liver disease
First trimester of pregnancy
Haemochromatosis
Haemolytic anaemia
Haemosiderosis
Hepatitis

Precautions and Warnings

Allergic disposition
Atopy
Autoimmune disease
Inflammatory disorder
Breastfeeding
Eczema
Second trimester of pregnancy
Severe asthma
Third trimester of pregnancy

Exclude non-iron deficiency anaemia
Have available adrenaline injection 1:1000 for anaphylaxis
Treat and control infections prior to commencing therapy
Do not start oral iron therapy until at least 5 days after last injection
Observe patient closely during and immediately after administration
Rapid intravenous administration may cause acute short-lasting hypotension
Resuscitation facilities must be immediately available
Diagnosis of iron deficiency must be based on appropriate laboratory tests
Caution with every dose of IV iron even if previously well tolerated
Monitor for hypersensitivity reactions for at least 30 mins after admin
Large doses may impart brown colour to serum from blood sample after admin.
May give falsely decreased values of serum calcium
May give falsely elevated values of serum bilirubin
Discontinue if anaphylactoid reaction occurs
Do not take oral iron preparations during treatment
Advise patients that hypersensitivity reactions may be life threatening

Pregnancy and Lactation

Pregnancy

Iron dextran is contraindicated during the first trimester of pregnancy and should be used with caution during the second and third trimester of pregnancy.

The manufacturer advises that iron deficiency anaemia occurring in the first trimester of pregnancy can normally be adequately treated with oral iron. It is recommended that treatment with intravenous iron should be confined to the second and third trimester if oral iron therapy is unsuitable.

There is no adequate data from the use of iron hydroxide dextran complex during pregnancy. Studies in animals have shown teratogenicity and reproductive toxicity.

Following administration of parental irons, foetal bradycardia may occur. This is usually due to a hypersensitivity reaction in the mother. As a result, if parental irons are intravenously administered to a pregnant woman, the unborn baby should be carefully monitored.

Lactation

Use iron hydroxide dextran complex with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst using iron hydroxide dextran complex.

Limited data indicates that trace amounts of iron dextran are expressed into breast milk. The information on the clinical use of iron dextran during breastfeeding is not available. However, intravenous iron dextran has been used in preterm infants for anaemia of prematurity and would not be expected to cause any adverse effects in breastfed infants.

Side Effects

Abdominal pain
Abscess formation (injection site)
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Arrhythmias
Arthralgia
Atrophy (localised)
Blurred vision
Cardiovascular collapse
Chest pain
Cramp
Deafness (transient)
Diarrhoea
Dizziness
Dyspnoea
Exacerbation of rheumatoid arthritis
Fatigue
Feeling hot
Fever
Flushing
Foetal bradycardia
Haemolysis
Haemorrhage (injection site)
Headache
Hypersensitivity reactions
Hypertension
Hypotension
Inflammation (injection site)
Influenza-like symptoms
Itching
Kounis syndrome
Local pain (injection site)
Loss of consciousness (transient)
Mental status changes
Myalgia
Nausea
Necrosis (injection site)
Numbness
Palpitations
Paraesthesia
Phlebitis (injection site)
Pruritus
Rash
Restlessness
Seizures
Shivering
Stains skin brown
Sweating
Tachycardia
Tremor
Urticaria
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: November 2021

Reference Sources

Summary of Product Characteristics: CosmoFer. Pharmacosmos UK Limited. Revised January 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Iron Dextran Last revised: 21 June 2021
Last accessed: 08 November 2021