Medofer

Medofer

Manufacturer:

I.E. Medica

Distributor:

I.E. Medica
Full Prescribing Info
Contents
Iron sucrose.
Description
Each mL contains Iron (as Iron Sucrose) 20 mg. Iron Sucrose is a clear reddish brown liquid, sterile, containing complex of polynuclear iron (III)-hydroxide in sucrose (Iron Sucrose) for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000-60,000 daltons. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. The product contains no preservatives. The osmolarity is not less than 1150 and not more than 1350 mOsmol/L.
Action
Pharmacology: Pharmacodynamics: Following intravenous administration, iron sucrose is dissociated by the reticuloendothelial system into iron and sucrose.
Pharmacokinetics: Following intravenous doses of Iron sucrose, the iron component exhibits first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, non-steady state apparent volume of distributed of 10.0 L and steady state apparent volume of distribution of 7.9 L. Since iron disappearance from serum depends on the need for iron in the iron stores and iron utilizing tissues of the body, serum clearance of iron is expected to be more rapid in iron deficient patients treated with iron sucrose as compared to healthy individuals. The effects of age and gender on the pharmacokinetics of Iron sucrose have not been studied.
Distribution: Following intravenous administration of Iron sucrose, the iron component appears to distribute mainly in blood and to some extent in extravascular fluid. Significant amount of administered iron is distributed in the liver, spleen and bone marrow.
Metabolism and Elimination: Following intravenous administration, Iron sucrose dissociates into iron and sucrose by the reticuloendothelial system. The sucrose component is eliminated mainly by urinary excretion.
Indications/Uses
Indicated for the treatment of iron deficiency anemia in adult patients with: Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD), Peritoneal Dialysis Dependent Chronic Kidney Disease (PDD-CKD), Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD).
Dosage/Direction for Use
The dosage of Iron sucrose is expressed in terms of mg of elemental iron. Each mL contains 20 mg of elemental iron.
Hemodialysis Dependent Chronic Kidney Disease Patients (HDD-CKD): The recommended dose of Iron sucrose is 100 mg (5 mL) administered one to three times per week; most patients will require a minimum cumulative dose of 1000 mg over 10 sequential dialysis sessions. Patients may continue to require therapy with Iron sucrose at the lowest dose necessary to maintain target levels of haemoglobin, haematocrit and laboratory parameters of iron storage within acceptable limits. Iron sucrose can be administered as slow intravenous injection or as an intravenous infusion.
Slow intravenous injection: Iron Sucrose may be administered undiluted by slow intravenous injection into the dialysis line over 2 to 5 minutes.
Infusion: Iron sucrose may be administered by infusion (into the dialysis line for hemodialysis patients) as every 5 mL Iron sucrose diluted exclusively in a maximum of 100 mL of 0.9% NaCl. Immediately prior to infusion. The solution must be infused at a rate of 100 mg of iron over a period of at least 15 minutes. Unused diluted solution must be discarded.
Non-Dialysis Dependent Chronic Kidney Disease Patients (NDD-CKD): Iron Sucrose is administered as a total cumulative dose of 1,000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period. There is limited experience with administration of an infusion of 500 mg Iron Sucrose, diluted in a maximum of 250 mL of 0.9% NaCl over a period of 3- 5.4 hours on day 1 and day 14.
Peritoneal Dialysis Dependent Chronic Kidney Disease Patients (PDD-CKD): Iron sucrose is infused intravenously in three divided doses for a total dose of 1000 mg during a 28-day period: two infusions of 300 mg over 1.5 hours 14 days apart, followed by one 400-mg infusion over 2.5 hours 14 days later.
NOTE: Do not mix Iron sucrose with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
Administration: Iron sucrose must only be administered intravenously either by slow injection or by infusion.
Overdosage
Dosages of Iron sucrose 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 over dosage or infusing iron sucrose too rapidly included hypotension, dyspnoea, 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.
Contraindications
The use of Iron sucrose is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to it or any of its inactive components and in patients with anaemia not caused by iron deficiency. Contraindicated in patients with a history of asthma, eczema, anaphylaxis, or other allergic disorders.
Special Precautions
Use in Pregnancy: Pregnancy Category B: No adequate and well controlled studies in pregnant women have been reported. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in Lactation: It is not known whether this drug 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.
Use in Children: Safety and effectiveness of Iron sucrose in pediatric patients have not been established.
Use in Elderly: There are no identified differences responses between elderly and younger patients, but greater sensitivity of some of the older individuals cannot be ruled out.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category B: No adequate and well controlled studies in pregnant women have been reported. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether this drug 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.
Adverse Reactions
Side effects include hypotension, chest pain, hypertension, hypervolemia, Congestive Heart Failure (CHF), cramps, musculoskeletal pain, diarrhea, nausea, vomiting, abdominal pain, elevated liver enzymes, skin irritation, pruritus, application site reaction, dizziness, dyspnea, pneumonia, cough, headache, fever, asthenia, malaise.
Cardiovascular effects such as chest pain or tightness, shock, myocardial infarction, hypertension, tachycardia, bradycardia, and arrhythmias may occur with either route. Rashes, urticaria, purpura, and pruritus have been reported. Other reactions include gastrointestinal disturbances, haematuria, dyspnoea, and taste disturbance. Patients may also experience delayed reactions 1 to 2 days after injection of iron dextran, such as backache, arthralgia, myalgia, lymphadenopathy, chills, fever, paraesthesia, dizziness, malaise, headache, nausea, and vomiting. Overdose of parenteral iron is unlikely to be associated with any acute manifestations.
Unwarranted parenteral iron therapy will result in iron overload and excess storage of iron (haemochromatosis) in the long term. The consequences of this include liver and endocrine dysfunction and heart disease, and possibly an increased risk of infection. Iron overload may require chelation therapy with desferrioxamine.
Drug Interactions
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 hematinic parameters. Iron therapy should be withheld in patients with evidence of iron overload. Transferring saturation values increase rapidly after IV administration of iron sucrose: thus, serum iron values may reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron sucrose
Hypotension: 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.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: No long-term studies in animals have been performed to evaluate the carcinogenic potential of Iron sucrose.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Presentation/Packing
Soln for inj (amp) 20 mg/mL x 5 mL x 5's.
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