Ferrous fumarate


Concise Prescribing Info
Indications/Uses
Iron-deficiency anaemia.
Dosage/Direction for Use
Adult : PO As elemental Fe: Treatment: 65-200 mg/day. Prevention: 30-60 mg/day; alternative: 100 mg/day. Dosage recommendations may vary among different products.
Dosage Details
Oral
Iron-deficiency anaemia
Adult: As elemental Fe: Treatment: 65-200 mg daily, given in up to 3 divided doses. Prevention: 30-60 mg daily. Alternatively, 100 mg daily. Recommended duration: ≤6 months, or 3 months after correction of anaemia. Dosage recommendations may vary among different products.
Child: As elemental Fe: Treatment: 3-6 mg/kg daily in 2-3 divided doses. Max: 200 mg daily. Prevention: 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; >12 years Same as adult dose. Dosage recommendations may vary among different products.
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; active peptic ulcer, inflammatory bowel disease (including regional enteritis, ulcerative colitis, intestinal strictures, diverticulae), haemoglobinopathies. Patient undergoing repeated blood transfusion. Concomitant use with dimercaprol, parenteral Fe.
Special Precautions
Patient with history of peptic ulcer; microcytic anaemia resistant to Fe monotherapy, rheumatoid arthritis. Post-gastrectomy patient. Not indicated for the treatment of anaemia resulting from causes other than Fe deficiency. Renal and hepatic impairment. Children. Avoid use in premature infants with low vitamin E stores, until replenished. Pregnancy and lactation.
Adverse Reactions
Significant: Dark stools.
Cardiac disorders: Nausea, vomiting, constipation, faecal impaction (particularly in elderly), gastrointestinal discomfort, diarrhoea, dental discolouration, heartburn.
Immune system disorders: Allergic reactions.
Metabolism and nutrition disorders: Anorexia.
Renal and urinary disorders: Urinary discolouration.
MonitoringParameters
Monitor Hb, haematocrit. May consider monitoring of RBC count, RBC indices, serum ferritin, transferrin saturation, total Fe-binding capacity, serum Fe concentration, erythrocyte protoporphyrin concentration.
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, abdominal pain, haematemesis, melaena, rectal bleeding, lethargy, circulatory collapse, hyperglycaemia, metabolic acidosis; Severe cases: Hypotension, coma, hypothermia, hepatocellular necrosis, renal failure, pulmonary oedema, diffuse vascular congestion, coagulopathy, convulsions, toxic encephalitis, CNS damage, pyloric stenosis. Management: Symptomatic and supportive treatment. Ensure a clear airway. Induce emesis and perform gastric lavage with desferrioxamine solution (2 g/L). Administer desferrioxamine 5 g in 50-100 mL water to be retained in the stomach following gastric emptying. Administer mannitol or sorbitol to induce small bowel emptying. In case of shock and/or coma with high Fe serum levels of >90 µmol/L (children) or >142 µmol/L (adults), initiate supportive measures and slow IV infusion of desferrioxamine (5 mg/kg/hour up to Max of 80 mg/kg/24 hours). In case of less severe and symptomatic conditions, administer IM desferrioxamine 1 g 4-6 hourly in children, or 50 mg/kg up to Max 4 g in adults. Monitor serum Fe levels, cardiac rhythm, blood pressure, urine output. In case of persistent metabolic acidosis in adults, administer 50 mmol Na bicarbonate and repeat if necessary, monitor arterial blood gas.
Drug Interactions
May decrease the absorption of tetracyclines, Zn, penicillamine, fluoroquinolones (e.g. ciprofloxacin, norfloxacin, ofloxacin), levodopa, entacapone, bisphosphonates, levothyroxine, mycophenolic acid. Decreased absorption with Ca, Mg and other mineral supplements; bicarbonates, carbonates, Zn, trientine, tetracyclines, antacids, colestyramine. Concomitant use with chloramphenicol delays plasma clearance, incorporation into RBC, and interferes with erythropoiesis. May decrease the hypotensive effect of methyldopa. May reduce the absorption of vitamin E.
Potentially Fatal: Dimercaprol may increase the nephrotoxic effect of Fe. Increased risk of iron overload with parenteral Fe.
Food Interaction
Absorption may be decreased when given with food, particularly cereals, dietary fibre, coffee tea, eggs and milk.
Lab Interference
May interfere with tests for the detection of occult blood in the stools (e.g. guaiac test).
Action
Description: Ferrous fumarate replaces Fe found in myoglobin, Hb, and enzymes. It allows the transportation of oxygen via the Hb.
Onset: Haematologic response: Approx 3-10 days.
Pharmacokinetics:
Absorption: Absorbed in the duodenum and upper jejunum (10% in patient with normal serum Fe stores; 20-30% in patient with inadequate Fe stores). Decreased absorption with food.
Distribution: Enters breast milk. Binds to serum transferrin and passes onto the Fe stores in the spleen, liver, and bone marrow.
Excretion: Via urine, sweat, sloughing of intestinal mucosa, menses.
Chemical Structure

Chemical Structure Image
Ferrous fumarate_01

Source: National Center for Biotechnology Information. PubChem Database. Ferrous fumarate, CID=6433164, https://pubchem.ncbi.nlm.nih.gov/compound/Iron_II_-fumarate (accessed on May 26, 2020)

Storage
Store between 15-30°C. Protect from light.
ATC Classification
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 13/05/2020.

Anon. Iron Preparations, Oral. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/05/2020.

Buckingham R (ed). Ferrous Fumarate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/05/2020.

Dyna Ferrous Fumarate Tablet (Dynapharm Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/ . Accessed 13/05/2020.

Ferrous Fumarate 200 mg Tablet (Idaman Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 13/05/2020.

Ferrous Fumarate Tablet, Film-Coated (Pharmics, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 13/05/2020.

Fersadat 322 mg Tablets (Mercury Pharma Group Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 13/05/2020.

Galfer Capsules (Thornton & Ross Limited). MHRA. https://products.mhra.gov.uk/. Accessed 13/05/2020.

Galfer Syrup (Thornton & Ross Limited). MHRA. https://products.mhra.gov.uk/. Accessed 13/05/2020.

Joint Formulary Committee. Ferrous Fumarate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/05/2020.

Disclaimer: This information is independently developed by MIMS based on Ferrous fumarate 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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