FERROUS GLUCONATE Coated tablet Ref.[6827] Active ingredients: Ferrous gluconate

Adults and the elderly

Prophylactic: 2 tablets daily.

Therapeutic: 4-6 tablets daily in divided doses.

Children (aged 6-12 years)

Prophylactic: 1 or 2 tablets daily.

Therapeutic: 3 tablets daily in divided doses.

Ferrous Gluconate 300mg Tablets are best taken about one hour before meals.

Method of administration

The route of administration for Ferrous Gluconate 300mg tablets is oral.

Large amounts of Ferrous gluconate are toxic, but in adults rarely prove fatal. In children between 1 and 2 years of age as little as 1 to 2 g of iron can cause death.

Symptoms

Iron poisoning is commonest in childhood and is usually accidental.

In the first phase of acute iron overdosage, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea, predominates. Other effects may include abdominal pain, haematemesis, rectal bleeding, cardiovascular disorders, such as hypotension, tachycardia and circulatory collapse, metabolic changes, including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally progress past this phase.

The second phase may occur at 6 to 24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation.

In the third phase, gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. The fourth phase may occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly latehepaticdamage.

Management

Local guidelines should be used or the National Poisons Information Centre should be contactedabout individualpatientmanagement.

The following steps are recommended to minimise or prevent further absorption of the medication.

Children:

1. Administer an emetic such as Syrup of Ipecac.
2. Emesis should be followed by gastric lavage with desferrioxamine solution (2 g/l). This should then be followed by the instillation of desferrioxamine 5 g in 50–100 ml water, to be retained in the stomach. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children. Keep the patients under constant surveillance to detect possible aspiration of vomitus – maintain suction apparatus and standby emergency oxygen in case of need.
3. Severe Poisoning: In the presence of shock and/or coma with high serum Iron levels (serum Iron 90 µmol/l) immediate supportive measures plus I.V. infusion of desferrioxamine should be instituted. Desferrioxamine 15 mg/kg body weight should be administered every hour by slow I.V. infusion to a maximum 80 mg/kg/24 hours. Warning: Hypotension may occur if the infusion rate is too rapid.
4. Less severe poisoning I.M. desferrioxamine 1 g, 4–6 hourly is recommended.
5. Serum iron levels should be monitored throughout.

Adults:

1. Administer an emetic.
2. In less severe cases gastric lavage may be employed to remove unabsorbed iron from the stomach if the patient presents within one hour of ingestion. The serum-iron concentration should be measured as an emergency. This should be undertaken using a desferrioxamine solution (2 g/l). Desferrioxamine 5 g in 50–100 ml water should be introduced to the stomach following gastric emptying. Keep the patient under constant surveillance to detect possible aspiration of vomitus. Maintain suction apparatus and standby emergency oxygen in case of need.
3. A drink of mannitol or sorbitol should be given to include small bowel emptying.
4. Severe Poisoning: In the presence of shock and/or coma with high serum Iron levels (140 µmol/l) immediate supportive measures plus I.V. infusion of desferrioxamine should be instituted without waiting for the results of the serum iron measurement. Desferrioxamine is a specific iron chelating agent which may be administered by intravenous injection. The dose should be adjusted according to the severity of the poisoning. A solution of 10g of desferrioxamine mesylate in 50ml water should be left in the stomach. Absorbed iron can be chelated by an intramuscular injection of 2g of desferrioxamine mesylate in 10ml of water. The recommended dose of desferrioxamine is 5 mg/kg/h by slow I.V. infusion to a maximum 80 mg/kg/24 hours. Warning: Hypotension may occur if the infusion rate is too

rapid.

1. Less severe poisoning: I.M. desferrioxamine 50 mg/kg up to a maximum dose of 4 g should be given.
2. Serum levels should be monitored throughout.

Dimercaprol should not be used in the treatment of iron poisoning.

3 years.

Do not store above 25°C.

Keep the container tightly closed. Store in theoriginal container.

Polypropylene tubes with high-density/low-density polyethylene caps and a silica gel desiccant. A low-density polyethylene bag contains the leaflet in the pot.

Pack sizes: 28, 100, 250,500, 1000 and 5000 tablets.

White opaque PVC 250μm and 9μm soft aluminium/35 gm 2 glassine paper child resistant foil.

Pack size: 28.

Not applicable.