Ferrous Gluconate

Registered South African indications:

• Iron deficiency anaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Haemochromatosis
• Haemosiderosis
• Haemoglobinuria
• Patients receiving repeated blood transfusions
• Active peptic ulcer
• Coadministration with parenteral iron therapy

Cautions

• Pregnancy
• Elderly
• Haemolytic anaemia
• Peptic ulcer disease
• Inflammatory bowel disease
• Prolonged treatment
• Co-existing deficiency of vitamin B or folic acid
• Diabetes mellitus
• Fructose intolerance
• Glucose-galactose malabsorption
• Sucrase-isomaltase insufficiency

Forms avail. in SA and covered in this monograph: syr, tab

Prophylaxis of iron deficiency anaemia

• Oral (tab): 600mg, dly

Treatment of iron deficiency anaemia

• Oral (tab): 600mg, 8hrly
• Oral (syr): 350-700mg, 6-8hrly

Paed. forms avail. in SA and covered in this monograph: syr, tab

Prevention of iron deficiency anaemia - premature infants

Older than 15 days

• Oral (syr): 2mg Fe/kg, dly; Treatment duration: 1 year

Prevention of iron deficiency anaemia - term infants

Older than 2 months

• Oral (syr): 1mg Fe/kg, dly; Treatment duration: 1 year

Treatment of iron deficiency anaemia

• Oral (syr, tab): 3mg Fe/kg, 12hrly

Note: Syrup (350mg ferrous gluconate/5ml) contains 40mg elemental iron/5ml; Each 300mg tablet contains 300 mg ferrous gluconate equivalent to 34,75 mg elemental iron

Pregnancy

• Caution; no evidence of risk in studies
• The administration of iron during the first trimester requires definite evidence of iron deficiency. Prophylaxis of iron deficiency during the remainder of pregnancy is justified.  There is no evidence of any harmful effects due to normal doses of ferrous gluconate in pregnant women, but as with all medicines care should be exercised in administering this preparation during pregnancy

Breastfeeding

• Compatible
• Ferrous gluconate is excreted in breast milk but not in significant amounts  (about 0.5 mg/day). There is no evidence of any harmful effects due to normal doses of ferrous gluconate in breastfeeding mothers, but as with all medicines care should be exercised in administering this preparation during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended
  Lower doses (15-50mg elemental iron/ day) may have similar efficacy and less gastrointestinal adverse events

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders

• Gastrointestinal discomfort
• Epigastric pain
• Anorexia
• Nausea and vomiting
• Constipation
• Diarrhoea
• Darkening of the stools may occur
• Ulceration

Immune, Blood and Lymphatic System Disorders

• Allergic reactions

• IV iron products
• Antacids
• Penicillamine
• Antibacterials
• Bisphosphonates
• Dopaminergics
• Methyldopa
• Mycophenolate mofetil
• Zinc
• Cholestyramine
• Trientine
• Thyroxine 
• Dimercaprol
• Proton pump inhibitors 
• Carbidopa
• Food products (tea, eggs or milk)
• Coffee

• Haemoglobin

Specific cases may require

• Iron studies

Syrup - EML (Primary)

All other formulations - Non-EML

Iron is an essential component of myoglobin, hema enzymes and the mitochondrial enzyme, alpha glycerophosphate oxidase. Iron is necessary for haemoglobin formation and for the oxidative processes of living tissues. It is also involved in the support of red blood cell production.

Ferrous gluconate is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Tablet 28mg

• Puritan's pride ferrous gluconate (Dynamic Nutritional Advantage)

Tablet 300mg 

• Ferrous Gluconate (Lennon)

Syrup (per ml) 0.350g

• Barrs Ferrous Gluconate (Barrs)
• Elixir Ferrous Gluconate (Pharmacare)