Adult: As elemental Fe: Treatment: 65-200 mg daily in 2-3 divided doses. Prevention: 65 mg daily. Elderly: As elemental Fe: 15-50 mg daily. Child: As elemental Fe: Treatment: 3-6 mg/kg daily in 3 divided doses. Max: 200 mg daily. Prevention: ≥4 months Exclusively breastfed infants: 1 mg/kg daily; ≥6 months to <2 years 10-12.5 mg daily for 3 consecutive months in a year; 2-<5 years 30 mg daily for 3 consecutive months; ≥5 years 30-60 mg daily for 3 consecutive months.
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 and other Fe overload syndromes. Blood disorders (e.g. paroxysmal nocturnal haemoglobinuria, haemolytic anaemia, haemosiderosis); active peptic ulcer, Crohn's disease, and ulcerative colitis. Patient receiving frequent blood transfusions. Concomitant parenteral Fe therapy and dimercaprol.
Special Precautions
Patients with haemoglobinopathies, Fe storage or Fe absorption diseases; existing gastrointestinal disease, intestinal strictures, or diverticula; history of peptic ulcer, inflammatory bowel disease. Children and elderly. Pregnancy and lactation.
Monitor Hb and haematocrit; RBC count and indices, serum ferritin, transferrin saturation, total Fe-binding capacity, serum Fe concentration, and erythrocyte protoporphyrin concentration.
Overdosage
Symptoms: 1st phase (6 hours after ingestion): Gastrointestinal toxicity (e.g. epigastric pain, nausea, vomiting, diarrhoea of green stools then subsequent melaena and haematemesis), 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, hepatic necrosis, jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema then may progress to cardiovascular collapse, coma, and death. 4th phase (several weeks after ingestion): Gastrointestinal obstruction, pyloric stenosis, severe gastric scarring, hepatic cirrhosis, and possibly, late hepatic damage. Management: Supportive and symptomatic treatment. Perform gastric lavage followed by the instillation of 5 g desferrioxamine into the stomach. In severe cases, IV desferrioxamine may be given. Monitor Fe 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 5 g bismuth carbonate every hour as demulcents. For control of shock and dehydration, may give IV fluids, blood or plasma transfusion, and oxygen for respiratory embarrassment. May consider administration of continuous IV infusion of chelating agents (e.g. disodium calcium edetate). Avoid the use of dimercaprol as it forms a toxic complex with Fe and enhances its nephrotoxic effect. For severe poisoning in infants, administer desferrioxamine at a dose of 90 mg/kg via IM inj then 15 mg/kg/hour via IV infusion until serum Fe is within plasma binding capacity.
Drug Interactions
May decrease the absorption of tetracyclines, fluoroquinolones (e.g. ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin, ofloxacin), bisphosphonates, levodopa, penicillamine, entacapone, mycophenolate mofetil. Reduced bioavailability of methyldopa. Decreased absorption of levothyroxine. Reduced absorption with antacids, products containing Zn, Mg, Ca, phosphorus, trientine, bicarbonates, carbonates, oxalates, or phosphates. Colestyramine may bind Fe to the gastrointestinal tract thereby preventing its absorption. Delayed plasma clearance with chloramphenicol. Increased absorption with ascorbic acid. Potentially Fatal: Forms a toxic complex with dimercaprol that enhances the nephrotoxic effect.
Food Interaction
Decreased absorption with tea, coffee, milk, eggs, and whole grains. Increased absorption with meat.
Lab Interference
May cause false-positive results for blood in stool by the guaiac test.
Action
Description: Mechanism of Action: Ferrous sulfate facilitates oxygen transport from the lungs to tissues via Hb. It is used as an Fe source as it replaces Fe found in Hb, myoglobin, and other enzymes. Onset: Haematologic response: Approx 3-10 days (oral). Pharmacokinetics: Absorption: Absorbed mainly in the duodenum and upper jejunum. Food and achlorhydria may decrease absorption. Distribution: Predominantly binds to transferrin and is transported to the bone marrow. Remnants are stored in ferritin or haemosiderin. Crosses the placenta, enters breast milk. Excretion: Via urine, sweat, sloughing of the intestinal mucosa, and menses.
Chemical Structure
Ferrous sulfate Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 24393, Ferrous Sulfate. https://pubchem.ncbi.nlm.nih.gov/compound/Ferrous-Sulfate. Accessed Nov. 22, 2023.
B03AA07 - ferrous sulfate ; Belongs to the class of oral iron bivalent preparations. Used in the treatment of anemia.
References
Anon. Ferrous Sulfate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/07/2023.Anon. Ferrous Sulfate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/07/2023.Buckingham R (ed). Ferrous Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/07/2023.Fe-Vite Iron Oral Solution (Akron Pharma). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/07/2023.Ferrous Sulfate 324 mg Enteric Coated Tablet, Delayed Release (Nationwide Pharmaceutical, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/07/2023.Ferrous Sulfate 325 mg Green Tablet, Film Coated (PD-Rx Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/07/2023.Ferrous Sulfate Tablets 200 mg (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 13/07/2023.Joint Formulary Committee. Ferrous Sulfate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/07/2023.Mylan New Zealand Limited. Ferodan 30 mg/mL Oral Solution data sheet 27 May 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 13/07/2023.
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