Indications

Sodium Feredetate Trihydrate syrup is an oral solution for adults, children and babies to treat iron deficiency anemia caused by too little iron in the body. The form of iron used in this product means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not ... Read more Sodium Feredetate Trihydrate syrup is an oral solution for adults, children and babies to treat iron deficiency anemia caused by too little iron in the body. The form of iron used in this product means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not discolor teeth. It is indicated for: Iron Deficiency Anemia (especially in children) Pregnant women when other forms of oral iron may not be well tolerated People who have become anemic as a result of having rheumatoid arthritis.

Composition

Pharmacology

Sodium Feredetate is not an iron salt as it contains iron in an un-ionised form. In this compound the iron is "insulated" or "sequestered" with the sodium salt of Ethylenediamine Tetra-Acetic Acid (EDTA) to form a chelate so it does not discolor teeth. The iron chelate is split within the gastro-intestinal tract and releases elemental iron. Post-absorption distribution of elemental iron is as follows: 60% to 70% is incorporated into haemoglobin and most of the remainder is present in storage forms, either as ferritin or haemosiderin, in the reticulo-endothelial system and to a lesser extent, hepatocytes. A further 4% is present in myoglobin and haeme-containing enzymes, or bound to transferrin in plasma. EDTA is poorly absorbed and passes through the body unchanged after reaching the bloodstream.

Dosage & Administration

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.

Contraindications

Sodium Feredetate Trihydrate is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients. Haemochromatosis, haemosiderosis and other Iron overload syndromes. Receiving repeated blood transfusions.

Side Effects

Allergic reactions: e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Pregnancy & Lactation

Administration of drugs during the 1st trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained. No adverse events associated with Sodium Feredetate Trihydrate administration during pregnancy and lactation have been reported.

Precautions & Warnings

Care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases or existing gastrointestinal diseases. Iron preparations color the faeces black, which may interfere with tests used for detection of occult blood in the stools. Prolonged or excessive use in children may lead to toxic accumulation.

Therapeutic Class

Oral Iron preparations

Storage Conditions

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