This is indicated for the treatment of Iron deficiency in the following indications: Where there is a clinical need for a rapid Iron supply In patients who can not tolerate oral Iron therapy or who are non-compliant In active inflammatory bowel disease where oral Iron preparations are ineffective Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin It is also indicated in the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Parenteral Iron Preparations
The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.
Adults and Elderly: 5-10 ml (100-200 mg Iron) once to three times a week depending on the hemoglobin level. Iron Sucrose has exclusively to be administered intravenously by slow injection or by drip infusion or directly into the venous limb of the dialyzer. Iron Sucrose must not be used for intramuscular injection. Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level. As injection: Iron Sucrose can also be administered undiluted by slow IV injection at a rate of 1 ml Iron Sucrose (20 mg Iron) in at least 1 minute a maximum of 10 ml Iron Sucrose (200 mg Iron) can be administered per injection in at least 10 minutes. As infusion: Iron Sucrose should preferably be administered by drip infusion ( in order to reduce hypotensive episodes) in a dilution of 1 ml Iron Sucrose in maximum 20 ml 0.9% NaCl etc up to 25 ml Iron Sucrose in maximum 500 ml 0.9% NaCl. Dilution must take place immediately prior to infusion and solution must be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes ete. Normal posology is to use 5-10 ml Iron Sucrose 1-3 times a week depending on the Hemoglobin level. For the administration of the maximum tolerable dose of 7 mg Iron/kg body weight an infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.
The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.
Iron Sucrose is generally well tolerated. However, occasionally metallic taste, headache, nausea, vomiting and hypotension may occur. Less frequently side-effects are paresthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactic (pseudoallergic) reactions and in the region of the punctured vein, phlebitis and venous spasm have been observed.
Pregnant women: FDA pregnancy category B. Lactating mothers: It is not known whether this drug is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.
Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.
Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.
.png&w=384&q=75)