Adult: Doses are expressed in terms of elemental Fe. Usual dose: Up to 200 mg daily. Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines). Child: Doses are expressed in terms of elemental Fe. Treatment: Infants and children 3-6 mg/kg daily in 2-3 divided doses. Prophylaxis: Infants ≥6 months to children<2 years 10-12.5 mg daily; 2-<5 years 30 mg daily; 5-12 years 30-60 mg daily. Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Administration
Should be taken on an empty stomach. Best taken on an empty stomach. May be taken w/ meals to reduce GI discomfort.
Contraindications
Haemosiderosis, haemochromatosis, paroxysmal nocturnal haemoglobinuria; active peptic ulcer, inflammatory bowel disease (including regional enteritis, ulcerative colitis, intestinal strictures, and diverticulae); anaemias not due to Fe deficiency. Patient undergoing repeated blood transfusions. Concomitant use with dimercaprol or parenteral Fe.
Special Precautions
Patient with history of peptic ulcer. Post-gastrectomy patient. Patient with microcytic anaemia resistant to Fe monotherapy must be screened for vitamin B12 or folate deficiency. Avoid administration of Fe for longer than 6 months. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Dark stools; haemosiderosis (long-term use of large amounts of Fe). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, gastrointestinal discomfort; constipation (occasionally leading to faecal impaction, particularly in elderly), dental discolouration. Immune system disorders: Allergic reactions. Metabolism and nutrition disorders: Anorexia.
Monitoring Parameters
Monitor Hb and haematocrit. Consider assessment of RBC count and indices, serum ferritin and Fe concentration, transferrin saturation, total Fe-binding capacity, and erythrocyte protoporphyrin concentration.
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, abdominal pain, haematemesis, melaena, rectal bleeding, lethargy, circulatory collapse, hyperglycaemia, and metabolic acidosis. Severe cases: Hypoperfusion (cool peripheries and hypotension), hypothermia, hepatocellular necrosis, renal failure, pulmonary oedema, diffuse vascular congestion, coagulopathy, convulsions, toxic encephalitis, CNS damage, and coma. Rarely, gastric scarring causing stricture or pyloric stenosis may result in partial or complete bowel obstruction after 2-5 weeks of ingestion. Management: Symptomatic and supportive treatment. Ensure a clear airway and adequate hydration. In case of ingestion exceeding 10 mg/kg elemental Fe has occurred within the previous 4 hours, empty the stomach immediately by inducing emesis or, preferably, performing gastric lavage. In case of persistent metabolic acidosis in adults, administer 50 mmol Na bicarbonate and repeat if necessary, monitor arterial blood gas (aim for pH of 7.4). Monitor serum Fe levels, cardiac rhythm, blood pressure, and urine output. Consider desferrioxamine use if the patient is symptomatic (other than nausea) and serum Fe level is between 3-5 mg/L (55-90 µmol/L) and still increasing.
Drug Interactions
May decrease the absorption of fluoroquinolones (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, moxifloxacin), penicillamine, levodopa, carbidopa, entacapone, bisphosphonates, levothyroxine, mycophenolic acid, Zn, and vitamin E. Decreased absorption with Ca salts, Mg salts (as Mg trisilicate), and other mineral supplements; bicarbonates, carbonates, trientine, antacids, and colestyramine. Concomitant use of Fe and tetracyclines may reduce the absorption of both the Fe and antibiotic. Increased absorption with ascorbic acid or citric acid. Concomitant use with chloramphenicol delays plasma Fe clearance and incorporation into RBC and interferes with erythropoiesis. May decrease the hypotensive effect of methyldopa. Potentially Fatal: Dimercaprol may form toxic complexes with Fe which may increase the risk of nephrotoxicity. Concomitant use of both oral and parenteral Fe preparations may increase the risk of Fe overload.
Food Interaction
Absorption may be decreased when given with cereals, dietary fibre, coffee, tea, soy products, eggs, and milk.
Lab Interference
May give false-positive results for blood in stool with guaiac test.
Action
Description: Mechanism of Action: Ferrous fumarate is an easily absorbed Fe source that replaces Fe present in Hb, myoglobin, and enzymes necessary for energy transfer. It allows oxygen transport via Hb, an oxygen carrier from the lungs to tissues. Onset: Haematologic response: Approx 3-10 days. Pharmacokinetics: Absorption: Absorbed in the duodenum and upper jejunum (10% in patients with normal serum Fe stores; 20-30% in patients with inadequate Fe stores). Food and achlorhydria may decrease absorption. Distribution: Binds to serum transferrin and passes onto the Fe stores in the bone marrow, liver, and spleen. Crosses the placenta and enters breast milk. Excretion: Via urine, faeces, sloughing of the intestinal mucosa, sweat, and menses.
Chemical Structure
Ferrous fumarate Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6433164, Ferrous Fumarate. https://pubchem.ncbi.nlm.nih.gov/compound/Ferrous-Fumarate. Accessed Nov. 22, 2023.
B03AA02 - ferrous fumarate ; Belongs to the class of oral iron bivalent preparations. Used in the treatment of anemia.
References
Anon. Ferrous Fumarate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/09/2023.Anon. Iron Preparations, Oral. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 18/09/2023.Buckingham R (ed). Ferrous Fumarate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/09/2023.Ferretts Tablet, Film Coated (Pharmics, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/09/2023.Ferromax Tablet 200 mg (Zontron Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/09/2023.Fersaday 322 mg Tablets (Mercury Pharma Group Ltd). MHRA. https://products.mhra.gov.uk. Accessed 18/09/2023.Fersamal 140 mg/5 mL Syrup (Mercury Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 18/09/2023.Fersamal 210 mg Tablets (Mercury Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 18/09/2023.Galfer Capsules (Thornton & Ross Limited). MHRA. https://products.mhra.gov.uk. Accessed 18/09/2023.Iron Salts. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 23/10/2023.Joint Formulary Committee. Ferrous Fumarate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/09/2023.Solidiron Tablet 200 mg (Idaman Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/11/2023.
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