SYTRON Oral solution Ref.[27557] Active ingredients: Sodium feredetate

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. This accounts for the fact that Sytron is not astringent and does not discolour teeth. Studies using radioactive tracers have shown that the iron chelate is split within the gastro-intestinal tract, releasing elemental iron which is absorbed and rendered available for haemoglobin regeneration.

Iron absorption is enhanced in iron-deficiency states. 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. Excretion is mainly in the faeces.

EDTA passes through the body unchanged. The compound is poorly absorbed, and that which reaches the bloodstream is eliminated by both glomerular filtration and tubular excretion.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.