Sodium Feredetate Trihydrate syrup is an oral preparation suitable for adults, children, and infants for the management of iron deficiency anemia caused by inadequate iron levels in the body. This formulation of iron is less likely to cause gastrointestinal irritation compared to other iron products and does not stain the teeth. It is indicated for:

• Iron deficiency anemia (particularly in children)
• Use in pregnancy when other oral iron preparations are not well tolerated
• Patients who develop anemia associated with conditions such as rheumatoid arthritis

Sodium Feredetate is not a conventional iron salt; it contains iron in a non-ionized form. In this compound, iron is bound (chelated) with the sodium salt of Ethylenediamine Tetra-Acetic Acid (EDTA), which prevents tooth discoloration. Once in the gastrointestinal tract, the chelate complex breaks down and releases elemental iron.

After absorption, approximately 60–70% of the iron is incorporated into hemoglobin, while the remaining portion is stored mainly as ferritin or haemosiderin in the reticuloendothelial system and liver cells. A smaller fraction (about 4%) is present in myoglobin and heme-containing enzymes or transported in plasma bound to transferrin.

EDTA has minimal absorption and is largely excreted unchanged after entering the bloodstream.

Iron-deficiency anaemia (therapeutic): By mouth using oral solution

• Neonate: Up to 2.5 mL twice daily, smaller doses to be used initially.
• Child 1-11 months: Up to 2.5 mL twice daily, smaller doses to be used initially.
• Child 1-4 years: 2.5 mL 3 times a day
• Child 5-11 years: 5 mL 3 times a day
• Child 12-17 years: 5 mL 3 times a day, increased to 10 mL 3 times a day, dose to be increased gradually

Iron-deficiency anaemia (prophylactic): By mouth using oral solution

• Neonate: 1 mL daily, prophylactic iron supplementation may be required in babies of low birth-weight who are solely breast-fed; supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.
• Child 1-11 months: 1 mL daily, prophylactic iron supplementation may be required in babies of low birth-weight who are solely breast-fed; supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.

Concomitant use of oral iron with dimercaprol should be avoided due to the risk of forming toxic complexes. Iron may decrease the absorption of penicillamine, mycophenolate, fluoroquinolones, levodopa, carbidopa, thyroxine, and bisphosphonates. Oral iron can also reduce the antihypertensive effect of methyldopa. Additionally, iron and tetracyclines interfere with each other’s absorption, and a similar interaction occurs between iron and zinc.

Sodium Feredetate Trihydrate is contraindicated in patients with:

• Known hypersensitivity to the active ingredient or any excipients
• Conditions of iron overload such as haemochromatosis or haemosiderosis
• Patients receiving repeated blood transfusions

Hypersensitivity reactions may occur, including itching, skin rash, swelling of the face, lips, tongue or throat, and difficulty in breathing or swallowing.

Use during the first trimester of pregnancy should be based on a careful evaluation of benefits versus risks. No harmful effects have been reported with Sodium Feredetate Trihydrate during pregnancy or breastfeeding.

Caution is advised in patients with haemolytic anemia, disorders of iron storage or absorption, or existing gastrointestinal diseases. Iron supplements may cause black discoloration of stools, which can interfere with occult blood tests. Prolonged or excessive use in children may result in toxic accumulation.

Early signs of iron overdose include nausea, vomiting, diarrhea, abdominal pain, haematemesis, rectal bleeding, lethargy, and circulatory collapse. Hyperglycemia and metabolic acidosis may also develop.

Oral iron preparations

Store below 25°C, protected from light. Keep all medicines out of the reach of children. Once opened, the product should be used within 3 months.