Home » Finished Formulation » Iron Sucrose Injection

Iron Sucrose Injection

Capitalizing on strong industrial experience, we offer well formulated range of Yashifer (Iron Sucrose Injection). Our injection is brown in color and is an aqueous, complex of polynuclear Iron (III)-hydroxide in sucrose (Iron Sucrose) that can be used for intravenously. It has a molecular weight of approximately 34,000-60,000 daltons and each ml includes 20 mg elemental Iron as Iron Sucrose is water for injection. The dosage is available in 5 mL single dose ampoule (100 mg elemental Iron per 5 mL). It has 30% sucrose w/v (300 mg/mL) with a pH of 10.5-11.1. Yashifer is free from harmful preservatives and is extremely safe for health. It fulfills the required iron content in the body and increases RBC count. Additionally, it has Osmolarity is not less than 1150 and 1350 mOsmol/L.

Composition:	Each 5 mL contains: ferric hydroxide in complex with sucrose, equivalent to elemental iron 100 mg, water for injection Ph. Eur. q. s. to 5 mL
Theraupeutic category:	Iron Supplement

Clinical 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 5 hours, total clearance of 1.2L/h, non-steady state apparent volume of distribution of 10.0L 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 the 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 to some extent in extra vascular 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 and usage:	Hemodialysis dependant chronic kidney disease (HDD-CKD) patients receiving an erythropoietin Peritoneal dialysis dependant chronic kidney disease (PDD-CKD) patients receiving an erythropoietin Non-dialysis dependant chronic kidney disease (NDD-CKD) patients receiving or not an erythropoietin Other conditions where oral Iron therapy is considered inadequate and parenteral iron therapy is indicated
Dosage and administration:	The dosage of Iron sucrose is expressed in terms of mg of elemental iron. Each mL contains 20 mg of elemental iron.
Administration:	Iron sucrose must only be administered intravenously either by slow injection or by Infusion.
Hemodialysis dependant chronic kidney disease patients (HDD-CKD):	The recommended dose of 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 required therapy with iron sucrose at the lowest dose necessary to maintain largest levels of haemoglobin, hematocrit and laboratory parameters of iron storage within acceptable limits.
Slow Intravenous Injection:	In chronic kidney disease patients, iron sucrose may be administered undiluted by slow intravenous injection into the dialysis line at a rate of 1mL (20 mg Iron) solution per minute not exceeding 5 mL of iron Sucrose (100 mg) per injection.
Infusion:	Iron sucrose may be administered by infusion (into dialysis line for hemodialysis patients). Infusion must be administered as every 5 mL Iron Sucrose diluted exclusively in a mixture of100 mL of 0.9% NaCl, immediately prior to infusion. The solution must be infused at the rate of 100 mg of iron over a period of at least 15 minutes. Unused diluted solution must be discarded.
Non-dialysis dependant chronic kidney disease patients (NDD-CKD):	Iron Sucrose is administered as total cumulative doses of 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on the 5 different occasions within 14 day period. There is limited experience with administered 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 1 and 14.
Peritoneal dialysis dependant chronic kidney disease patients (NDD-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 Yashifer 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.
SIDE EFFECTS:	Side effects include hypotension, chest pain, hypertension, hypervolemia, CHF, cramps, musculoskeletal pain, diarrhea, nausea, vomiting, abdominal pain, elevated liver enzyme, skin irritation, pruritis, application site reaction, dizziness, dysprea, pneumonia, cough, headache, fever, asthenia, malaise
Drug interaction:	Iron sucrose should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced.
Warning:	Hypersensitivity reactions have been reported with injectable iron products.

Precautions:
General:	Because body iron excretion is limited and excess tissue iron can be hazardous, caution should be exercised to withhold iron administration in presence of evidence of tissue iron overload. Patients receiving iron sucrose requires periodic monitoring of hematologic and hematinic parameters. Iron therapy should be withheld in patients with evidence of iron over load transferrin saturation values increase rapidly after IV administration of iron sucrose; 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.
Hypotension:	Hypotension has been reported in chronic kidney disease 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.
Carcinogenesis, mutagenesis and impairment of fertility:	No long term studies in animals have been performed to evaluate the carcinogenic potential of iron sucrose.
Pregnancy category B:	No adequate and well controlled studies in pregnant woman 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 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 patients have not been established.
Geriatric use:	There are no identified differences in responses between elderly and younger patients, but greatly sensitivity of some of the older individuals cannot be ruled out. Strict aseptic administration shall be followed.
Caution:	Before using check for absence of sediments. The injection should be discarded if any visible particles appear.
Overdose:	Dosages of Iron sucrose in excess of iron needs may lead to accumulation of iron in storage site 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 ferrin levels equal or exceed established guidelines. Particular caution should be exercised to avoid iron overload where anemia unresponsive to treatment has been incorrectly diagnosed as iron deficiency anemia. Symptoms associated with over dosage or infusing Iron sucrose to 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 fluid, hydrocortisone and/or antihistamines. Infusing the solution as recommended or at a slower rate may also be alleviating 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 anemia not caused by iron deficiency.
Presentation:	Pack of 5 ampoules in a tray
Storage:	Store at controlled room temperature between 20℃ to 25℃ Do not freeze Keep out of reach of children

Yes! I am Interested