Iron sucrose Injection 20 mg/mL

Iron Sucrose Injection 20 mg/mL


Iron Sucrose Injection 20 mg/mL


Description

Iron Sucrose Injection 20 mg/mL is a sterile, aqueous, dark brown colloidal solution containing iron(III)-hydroxide in complex with sucrose. Each milliliter of the solution provides 20 milligrams (mg) of elemental iron. It is administered intravenously (IV) and is a widely used form of parenteral iron replacement therapy, particularly when oral iron supplements are ineffective, not tolerated, or when rapid iron repletion is clinically necessary.

Advantages

  • Effective for Iron Deficiency Anemia: Rapidly replenishes iron stores and increases hemoglobin levels, effectively treating iron deficiency anemia, especially in severe cases.
  • Bypasses Gastrointestinal Issues: Ideal for patients with malabsorption syndromes (e.g., inflammatory bowel disease, celiac disease, post-gastric surgery) or those experiencing severe gastrointestinal side effects with oral iron, as it bypasses the digestive system.
  • Preferred in Chronic Kidney Disease (CKD): Widely used and often the preferred choice for iron deficiency anemia in patients with chronic kidney disease (both dialysis-dependent and non-dialysis-dependent), as oral iron is often poorly absorbed or tolerated in this population. It’s often used in conjunction with erythropoiesis-stimulating agents (ESAs).
  • Reduced Allergic Reaction Risk: Compared to older iron formulations like high-molecular-weight iron dextran, iron sucrose generally has a lower risk of severe anaphylactic reactions, making a test dose usually unnecessary (though initial doses are still given under medical observation).
  • Quick Response: Provides a quick physiological response, leading to a faster improvement in symptoms of anemia such as fatigue, weakness, and shortness of breath.

Uses

  • Oral iron therapy is ineffective or not tolerated: This includes patients with severe gastrointestinal intolerance, non-compliance with oral regimens, or malabsorption.
  • There is a clinical need for rapid iron supply: Such as in cases of severe anemia, pre-operative optimization, or postpartum anemia.
  • Chronic Kidney Disease (CKD): A significant indication, for both hemodialysis-dependent and non-dialysis-dependent CKD patients requiring iron repletion, often in conjunction with erythropoietin therapy.
  • Active Inflammatory Bowel Disease (IBD): Where oral iron may exacerbate inflammation or is poorly absorbed.
  • Certain other chronic conditions: Leading to persistent iron loss or impaired absorption.

Nature

Iron Sucrose is a polynuclear iron(III)-hydroxide complex with sucrose. In this complex, iron is in its ferric (Fe$^{3+}$) state, stabilized by a carbohydrate (sucrose) shell.

Its mechanism of action involves:

  1. Intravenous Delivery: When administered intravenously, the iron sucrose complex is delivered directly into the bloodstream, bypassing the intestinal absorption pathway.
  2. Uptake by Reticuloendothelial System (RES): The complex is primarily taken up by the reticuloendothelial system (RES) cells, particularly macrophages in the liver, spleen, and bone marrow. These cells have receptors for the iron-sucrose complex.
  3. Controlled Iron Release: Inside the RES cells, the iron is slowly released from the sucrose complex. The sucrose component is metabolized, allowing for the gradual release of ferric iron (Fe3+).
  4. Binding to Transferrin: The released iron is then transported from the macrophages to the plasma, where it binds to transferrin, the body’s main iron transport protein.
  5. Delivery to Erythroid Precursors: Transferrin delivers the iron to erythroid precursor cells in the bone marrow, where it is incorporated into the heme moiety of hemoglobin for new red blood cell production

Storage

  • Room Temperature: Store Iron Sucrose Injection 20 mg/mL at controlled room temperature, typically between 20∘C to 25∘C (68∘F to 77∘F). Excursions are permitted to 15∘C to 30∘C (59∘F to 86∘F).
  • Protect from Light: Keep the vials or ampoules in their original carton to protect them from light, which can cause degradation.
  • Do Not Freeze: Freezing can compromise the integrity of the solution and should be strictly avoided.
  • Single-Dose Vial: Most presentations are for single-dose use and do not contain preservatives. Any unused portion must be discarded immediately after opening.
  • Visual Inspection: Before use, the solution should be visually inspected for particulate matter and discoloration. Only clear, sediment-free solutions should be used.
  • Keep Out of Reach of Children: Store securely, completely out of the sight and reach of children and unauthorized individuals.
  • Check Expiry Date: Always check the expiry date on the packaging. Do not use the injection beyond this date.

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