Indications

This is indicated for the treatment and prophylaxis of iron, folic acid and zinc deficiency specially during pregnancy and lactation.

Therapeutic Class

Iron, Vitamin & Mineral Combined preparation

Pharmacology

Iron: Essential component in the formation of hemoglobin; adequate amounts of iron are necessary for effective erythropoiesis; also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin.

Zinc Sulphate is essential to numerous physiological processes, including the function of many enzymes in the body. Deficiency may lead to poor night vision, slow healing of wounds, poor sexual development and function in males, poor appetite (perhaps owing to a decrease in the sense of taste and smell), a reduced ability to ward off infections, diarrhea, dermatitis and in children, retarded growth.

Folic acid: Required for nucleoprotein synthesis and the maintenance of normal erythropoiesis; folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase; prevents neural tube defects in women of childbearing potential and higher doses required during pregnancy.

Dosage & Administration

Adults or Elderly: 1 capsule or tablet daily. In more severe cases, 2 capsules or table daily may be required.

Children: Aged over 1 year: 1 capsule or tablet daily. The capsule may be opened and the pellets to be mixed with soft, cool food, but they must not be chewed.

Interaction

Iron and zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of zinc may be reduced in the presence of iron. Absorption of iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating administration of each product by several hours. In patients with renal failure a risk of zinc accumulation could exist.

Contraindications

It is contraindicated in patients with haemolytic anaemia and in conditions with hypersensitivity to any of its components and increased body iron content.

Side Effects

Dark stools are usual during iron therapy, and nausea and other symptoms of gastrointestinal irritation, such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce gastrointestinal upset. These timed release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions.

Pregnancy & Lactation

Pregnancy: Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required.

Precautions & Warnings

Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. In patients with renal failure, a risk of zinc accumulation may exist.

Overdose Effects

Iron overdosage is dangerous, particularly in children, and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible, vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 g for a child or 5 g for an adult and demulcent. If serum iron levels at 4 hours or more post-ingestion are over 5 mg/l in a child or 8 mg/l in an adult, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc sulphate in gross overdosage is corrosive. Symptoms are those of gastrointestinal irritation, leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as dimercaprol, penicillamine or edetic acid have been recommended. Symptomatic and supportive measures should be given as required. The timed release capsule presentation may delay excessive absorption of iron and zinc and allow more time for initiation of appropriate counter measure.

Storage Conditions

Store in a dry place below 25˚C and protect from light. Keep out of children’s reach to avoid accidental iron poisoning.