Generic Name : ( Iron Sucrose )
Therapeutic Group : Vitamins and Minerals
Overview:
Intravenous Iron Sucrose is more effective and well tolerated in comparison with oral Iron preparations and it is the treatment of choice for anemia due to Iron deficiency. Administration of Iron Sucrose replenishes tissue Iron stores, reverses Iron depletion and Iron-deficient erythropoiesis and corrects or prevents Iron deficiency anemia.
Preparation
Injection : 100 mg IV
HemoMax IV Injection:
Each 5 ml ampoule contains iron sucrose USP equivalent to 100 mg elemental iron.
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, HemoMax 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 half-life 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.
HemoMax 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 cannot 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 anemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Adults and the elderly: The total cumulative dose of Iron Sucrose, equivalent to the total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose for Iron Sucrose must be individually determined for each patient according to the total iron deficit calculated with the following formula: Total iron deficit [mg]= body weight [kg] x (target Hb - actual Hb) [g/l] x 0.24* + depot iron [mg] •Below 35 kg body weight: target Hb = 130 g/l and depot iron = 15 mg/kg body weight •35 kg body weight and above: target Hb = 150 g/l and depot iron = 500 mg *Factor 0.24 = 0.0034 x 0.07 x 1000 (Iron content of haemoglobin 0.34%; Blood volume 7% of body weight; Factor 1000 = conversion from g to mg) The total single dose must not exceed 200 mg of iron given not more than three times per week. If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split. Iron Sucrose must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Before administering the first dose to a new patient, a test dose of Iron Sucrose should be given. Iron Sucrose must not be used for intramuscular injection. Intravenous drip infusion: Iron Sucrose must be diluted only in sterile 0.9% m/V sodium chloride solution: • 5 ml Iron Sucrose (100 mg iron) in max. 100 ml sterile 0.9% m/V sodium chloride solution • 10 ml Iron Sucrose (200 mg iron) in max. 200 ml sterile 0.9% m/V sodium chloride solution For stability reasons, dilutions to lower Iron Sucrose concentrations are not permissible. Dilution must take place immediately prior to infusion and the solution should be administered as follows: • 100 mg iron (5 ml Iron Sucrose) in at least 15 minutes • 200 mg iron (10 ml Iron Sucrose) in at least 30 minutes The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 50 ml in 15 minutes. Intravenous injection: Iron Sucrose may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute (i.e. 5 minutes per ampoule) and not exceeding 2 ampoules Iron Sucrose (200 mg iron) per injection. Before administering a slow intravenous injection, a test dose of 1 ml (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse events occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given. Injection into dialyser: Iron Sucrose may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
General:
Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions:
Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension:
Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.
Occasionally metallic taste, headache, nausea, vomiting, hypotension may occur. Parasthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactoid (pseudoallergic) reactions may occur rarely
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.
Use in Pregnancy: Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Use in Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
The use of HemoMax 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.
Store below 25⁰C, protected from light. Keep out of the reach of children. Do not freeze.
HemoMax Injection: Each combi pack contains 1 ampoule of Iron Sucrose Injection USP (5 ml), 100 ml sterile intravenous infusion of 0.9% sodium chloride BP, one sterile disposable syringe (5 ml) & an alcohol pad, one infusion set.
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