Ferrous sulfate


Concise Prescribing Info
Indications/Uses
Iron-deficiency anaemia.
Dosage/Direction for Use
Adult : PO As elemental iron: Treatment: 65-200 mg/day, in 2-3 divided doses. Prevention: 65 mg/day.
Dosage Details
Oral
Iron-deficiency anaemia
Adult: As elemental iron: Treatment: 65-200 mg daily, in 2-3 divided doses. Prevention: 65 mg daily.
Child: As elemental iron: Treatment: 3-6 mg/kg daily in 3 divided doses. Max: 200 mg daily. Prevention: ≥4 months Solely breastfed infants: 1 mg/kg daily; ≥6 months to <2 years 10-12.5 mg daily for 3 consecutive months; 2-<5 years 30 mg daily for 3 consecutive months; ≥5 years 30-60 mg daily for 3 consecutive months.
Elderly: As elemental iron: 15-50 mg daily.
Administration
Should be taken on an empty stomach. Best taken on an empty stomach. May be taken w/ meals to reduce GI discomfort.
Contraindications
Haemochromatosis, other iron overload syndromes. Blood disorders (e.g. paroxysmal nocturnal haemoglobinuria, haemolytic anaemia, haemosiderosis, other anaemias); active peptic ulcer, regional enteritis and ulcerative colitis. Patient receiving frequent blood transfusions. Concomitant parenteral iron therapy.
Special Precautions
Patient with haemoglobinopathies, iron storage or iron absorption diseases, existing gastrointestinal disease, history of peptic ulcer, intestinal strictures or diverticula. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Gastrointestinal disorders: Gastrointestinal irritation, nausea, vomiting, epigastric pain, diarrhoea, constipation, blackening of stool, tooth discolouration, abdominal discomfort.
Immune system disorders: Hypersensitivity.
MonitoringParameters
Monitor Hb and haematocrit; RBC count and indices, serum ferritin, transferrin saturation, total iron-binding capacity, serum iron concentration and erythrocyte protoporphyrin concentration.
Overdosage
Symptoms: 1st phase (6 hours after ingestion): Gastrointestinal toxicity (e.g. vomiting and diarrhoea), cardiovascular disorders (e.g. hypotension, tachycardia), metabolic changes (e.g. acidosis, hyperglycaemia), CNS depression ranging from lethargy to coma. 2nd phase (6-24 hours after ingestion): Temporary remission or clinical stabilisation. 3rd phase: Gastrointestinal toxicity recurs with shock, metabolic acidosis, convulsions, coma, hepatic necrosis, jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure and pulmonary oedema. 4th phase (several weeks after ingestion): Gastrointestinal obstruction and possibly, late hepatic damage. Management: Supportive and symptomatic treatment. Perform gastric lavage followed by instillation of 5g desferrioxamine into the stomach. In severe cases, IV desferrioxamine may be given. Monitor iron levels. Consider performing gastric lavage with 5% sodium bicarbonate and saline cathartics (e.g. sodium sulfate 30 g for adults) and administration of milk and eggs with 5g bismuth carbonate every hour as demulcents. For shock and respiratory embarrassment, may give blood or plasma transfusion and oxygen, respectively. May consider administration of continuous IV infusion of chelating agents (e.g. disodium calcium edetate). Dimercaprol forms a toxic complex with iron and enhances the nephrotoxic effect of iron, avoid use. For severe poisoning in infants, administer desferrioxamine at a dose of 90 mg/kg via IM inj then 15 mg/kg/hr via IV inj until serum iron is within plasma binding capacity.
Drug Interactions
May decrease the absorption of tetracyclines, fluoroquinolones (e.g. ciprofloxacin, norfloxacin, ofloxacin), bisphosphonates, levodopa, methyldopa, penicillamine, entacapone and levothyroxine. Reduced absorption with antacids, products containing zinc, magnesium, calcium, phosphorus, and trientine. Colestyramine binds iron to the gastrointestinal tract thus preventing its absorption. Delayed plasma clearance with chloramphenicol.
Food Interaction
Decreased absorption with tea, coffee, milk, eggs and whole grains.
Lab Interference
May give false-positive result for blood in stool by the guaiac test.
Action
Description: Ferrous sulfate facilitates oxygen transport via Hb. It is used as iron source as it replaces iron found in Hb, myoglobin and other enzymes.
Onset: Haematologic response: Approx 3-10 days (oral). Peak effect: Reticulocytosis: 5-10 days; increased Hb: Within 2-4 weeks.
Pharmacokinetics:
Absorption: Absorbed mainly in the duodenum and upper jejunum. Food and achlorhydria may decrease absorption.
Distribution: Majority binds to transferrin and transported to the bone marrow.
Excretion: Via urine, sweat, sloughing of the intestinal mucosa, and menses.
Chemical Structure

Chemical Structure Image
Ferrous sulfate

Source: National Center for Biotechnology Information. PubChem Database. Ferrous sulfate, CID=24393, https://pubchem.ncbi.nlm.nih.gov/compound/Ferrous-sulfate (accessed on Mar. 24, 2020)

Storage
Store below 25°C.
ATC Classification
B03AA07 - ferrous sulfate ; Belongs to the class of oral iron bivalent preparations. Used in the treatment of anemia.
References
Anon. Ferrous Sulfate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 17/12/2019.

Buckingham R (ed). Ferrous Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/12/2019.

Ferrous Sulfate Elixir (Rij Pharmaceutical Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/12/2019.

Ferrous Sulfate Tablet (Marlex Pharmaceuticals Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/12/2019.

Ferrous Sulfate Tablet (Paddock Laboratories, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/12/2019.

Ferrous Sulfate Tablets (Wockhardt UK Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 17/12/2019.

Joint Formulary Committee. Ferrous Sulfate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/12/2019.

Mylan New Zealand Ltd. Ferodan Oral Solution data sheet 6 August 2019. Medsafe. http://www.medsafe.govt.nz/. Accessed 17/12/2019.

Disclaimer: This information is independently developed by MIMS based on Ferrous sulfate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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