Encifer

Encifer

iron sucrose

Manufacturer:

Emcure Pharma

Distributor:

Alliance Pharma
Full Prescribing Info
Contents
Ferric hydroxide in complex with sucrose equivalent to elemental Iron 100 mg.
Description
Encifer: Each 5 mL contains Ferric hydroxide in complex with sucrose equivalent to elemental Iron 100 mg.
The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5-11.1. Encifer 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 distribution 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 extra vascular fluid. Following IV administration iron may also distributes to some extents in the liver, spleen and bone marrow.
Metabolism and Elimination: Following intravenous administration of iron sucrose, is dissociated into iron and sucrose by the reticuloendothelial system. The sucrose component is eliminated mainly by urinary excretion.
Indications/Uses
Iron sucrose is indicated in the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis in CRF who are receiving supplemental erythropoietin therapy.
Dosage/Direction for Use
The dosage of iron sucrose is expressed in terms of mg elemental iron. Each mL contains 20 mg of elemental iron.
The recommended dosage of iron sucrose for the repletion treatment of iron deficiency in hemodialysis patients is 5 mL of iron sucrose (100 mg of elemental iron) delivered intravenously during the dialysis session. Most patients will require a minimum cumulative dose of 1000 mg of elemental iron, administered over 10 sequential dialysis sessions, to achieve a favorable hemoglobin or hematocrit response. Patients may continue to require therapy with Iron sucrose or other intravenous iron preparations at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit and laboratory parameters of iron storage within acceptable limits.
Recommended Dosage: Adults: 100 mg iron administered one to three times per week to a total dose of 1000 mg in 10 doses, repeat if needed. Frequency of dosing should be not more than three times weekly. Patients may continue to require therapy with intravenous Iron at the lowest dose necessary to maintain levels of hemoglobin, hematocrit and laboratory parameters of iron storage within acceptable limits.
Administration: Iron sucrose must only be administered intravenously either by slow injection or by infusion.
Slow intravenous injection: In chronic renal failure (CRF) patients, Iron sucrose may be administered undiluted by slow intravenous injection into the dialysis line at a rate of 1 mL (20 mg iron) solution per minute (i.e., 5 minutes per ampoule) not exceeding one ampoule iron sucrose (100 mg iron) per injection. Discard any unused portion.
Infusion: Iron sucrose may also be administered by infusion (into the dialysis line for hemodialysis patients). The content of each vial must be diluted exclusively in a maximum of 100 mL of 0.9% NaCl, immediately prior to infusion.
The solution should be infused at a rate of 100 mg of iron over a period of at least 15 minutes. Unused diluted solution should be discarded.
NOTE: Do not mix Encifer 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.
Overdosage
Dosage of iron sucrose in excess of iron need 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 to avoid iron overload where anemia unresponsive treatment has been incorrectly diagnosed as iron deficiency anemia.
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.
Contraindications
The use of iron sucrose is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to iron preparations or any of its inactive components and in patients with anemia not caused by iron deficiency.
Warnings
Hypersensitivity reactions have been reported with injectable iron products products.
Before using check for absence of sediments.
Special Precautions
General: Because body iron excretion is limited and excess tissue can be hazardous, caution should be exercised to withhold iron administration in the 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 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.
Hypotension: Hypotension has been reported 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.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: No long-term studies in animals have been performed to evaluate the carcinogenic potential of iron sucrose.
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, Encifer should be used during pregnancy only if clearly needed.
Use in Lactation: It is 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.
Use in Children: Safety and effectiveness of iron sucrose in paediatric patients have not been established.
Use in the Elderly: Safety and effectiveness of iron sucrose in geriatric patients have not been established.
Use In Pregnancy & Lactation
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, Encifer should be used during pregnancy only if clearly needed.
Use in Lactation: It is 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.
Side Effects
Side effects include hypotension, chest pain, hypertension, hypervolemia, CHF, cramps, musculoskeletal pain, diarrhea, nausea, vomiting, abdominal pain, elevated liver enzymes, skin irritation, pruritis, application site reaction, dizziness, dyspnea, pneumonia, cough, headache, fever, asthenia, unwell malaise, pain.
Drug Interactions
Iron sucrose should not be administered concomitantly with oral iron preparations since absorption of oral iron is reduced.
Storage
Store in a dark place, below 30°C. Do not freeze.
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Presentation/Packing
Infusion (brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose) (amp) 5 mL x 1's.
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