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Indications/Uses
Indicated in the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.
Dosage/Direction for Use
Adults and the Elderly: The total cumulative dose of Iron sucrose Injection USP, equivalent to the total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose for Iron sucrose Injection USP must be individually determined for each patient according to the total iron deficit calculated with the following equation: See equation. (See equation.)
The total amount of Iron sucrose Injection USP required is determined from above calculation.
Alternatively, the total amount of Iron sucrose Injection USP required in mL is determined from the following equation or dosage table. (See equation.)
Alternatively, the total amount of Iron sucrose Injection USP required in mL is determined from the following equation or dosage table. (See equation.)
Maximum recommended dose: 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.
Children: The use of Iron sucrose Injection USP has not been adequately studied in children and, therefore, Iron sucrose Injection USP is not recommended for use in children.
Administration: Iron sucrose Injection USP 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 Injection USP should be given. Iron sucrose Injection USP must not be used for intramuscular injection.
Children: The use of Iron sucrose Injection USP has not been adequately studied in children and, therefore, Iron sucrose Injection USP is not recommended for use in children.
Administration: Iron sucrose Injection USP 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 Injection USP should be given. Iron sucrose Injection USP must not be used for intramuscular injection.
Overdosage
Overdosage can cause acute iron overloading which may manifest itself as hemosiderosis. Overdosage should be treated, if required, with an iron chelating agent.
Contraindications
The use of Iron sucrose Injection USP is contraindicated in case of: Known hypersensitivity to Iron Sucrose Injection USP or any of its excipients.
Anemias not attributable to iron deficiency.
Iron overload or disturbances in utilisation of iron.
Patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions.
Pregnancy first trimester.
Anemias not attributable to iron deficiency.
Iron overload or disturbances in utilisation of iron.
Patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions.
Pregnancy first trimester.
Warnings
Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, loss of consciousness, collapse and hypotension, which may be potentially fatal. Therefore, treatment for serious allergic reactions and facilities with the established cardio-pulmonary resuscitation procedures should be available.
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload.
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload.
Special Precautions
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 require periodic monitoring of hematologic and anti-anemia 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.
Parenteral iron must be used with caution in case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with ongoing bacteremia. In patients with chronic infection a risk/benefit evaluations has to be performed, taking into account the suppression of erythropoiesis.
Hypotensive episodes may occur if the injection is administered too rapidly. Allergic reactions, sometimes involving arthralgia, have been more commonly observed when the recommended dose is exceeded,
Paravenous leakage must be avoided because leakage of Iron Sucrose Injection USP at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin.
Caution required in pregnancy, safety has not been established to administer in nursing mother, children and geriatric.
Parenteral iron must be used with caution in case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with ongoing bacteremia. In patients with chronic infection a risk/benefit evaluations has to be performed, taking into account the suppression of erythropoiesis.
Hypotensive episodes may occur if the injection is administered too rapidly. Allergic reactions, sometimes involving arthralgia, have been more commonly observed when the recommended dose is exceeded,
Paravenous leakage must be avoided because leakage of Iron Sucrose Injection USP at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin.
Caution required in pregnancy, safety has not been established to administer in nursing mother, children and geriatric.
Use In Pregnancy & Lactation
Data on a limited number of exposed pregnancies indicated no adverse effects of Iron Sucrose Injection USP on pregnancy or on the health of the foetus/newborn child. No well-controlled studies in pregnant women are available to date. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Nevertheless, risk/benefit evaluation is required.
Iron Sucrose Injection USP should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put the mother or foetus at risk.
Non metabolised Iron Sucrose Injection USP is unlikely to pass into the mother's milk. No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.
Nevertheless, risk/benefit evaluation is required.
Iron Sucrose Injection USP should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put the mother or foetus at risk.
Non metabolised Iron Sucrose Injection USP is unlikely to pass into the mother's milk. No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.
Adverse Reactions
The most frequently reported adverse drug reactions (ADRs) of Iron Sucrose Injection USP in clinical trials were transient taste perversion, hypotension, fever and shivering, injection site reactions and nausea, occurring in 0.5 to 1.5% of the patients. Non-serious anaphylactoid reactions occurred rarely.
In general anaphylactoid reactions are potentially the most serious adverse reactions.
In clinical trials, the following adverse drug reactions have been reported in temporal relationship with the administration of Iron sucrose Injection USP, with at least a possible causal relationship: Nervous system disorders: Common (>1/100, <1/10): transient taste perversion (in particular metallic taste). Uncommon (>1/1000, <1/100): headache; dizziness. Rare (>1/10000, <1/1000): paresthesia.
Cardio-vascular disorders: Uncommon (>1/1000, <1/100): hypotension and collapse; tachycardia and palpitations.
Respiratory, thoracic and mediastinal disorders: Uncommon (>1/1000, <1/100): bronchospasm, dyspnea.
Gastrointestinal disorders: Uncommon (>1/1000, <1/100): nausea; vomiting; abdominal pain; diarrhea.
Skin and subcutaneous tissue disorders: Uncommon (>1/1000, <1/100): pruritus; urticaria; rash, exanthema, erythema.
Musculoskeletal, connective tissue and bone disorders: Uncommon (>1/1000, <1/100): muscle cramps, myalgia.
General disorders and administration site disorders: Uncommon (>1/1000, <1/100): fever, shivering, flushing; chest pain and tightness. Injection site disorders such as superficial phlebitis, burning, swelling. Rare (>1/10000, <1/1000): anaphylactoid reactions (rarely involving arthralgia); peripheral edema; fatigue, asthenia; malaise.
Moreover, in spontaneous reports the following adverse reactions have been reported: Isolated cases: reduced level of consciousness, light-headed feeling, confusion; angioedema; swelling of joints, hyperhidrosis, and back pain.
In general anaphylactoid reactions are potentially the most serious adverse reactions.
In clinical trials, the following adverse drug reactions have been reported in temporal relationship with the administration of Iron sucrose Injection USP, with at least a possible causal relationship: Nervous system disorders: Common (>1/100, <1/10): transient taste perversion (in particular metallic taste). Uncommon (>1/1000, <1/100): headache; dizziness. Rare (>1/10000, <1/1000): paresthesia.
Cardio-vascular disorders: Uncommon (>1/1000, <1/100): hypotension and collapse; tachycardia and palpitations.
Respiratory, thoracic and mediastinal disorders: Uncommon (>1/1000, <1/100): bronchospasm, dyspnea.
Gastrointestinal disorders: Uncommon (>1/1000, <1/100): nausea; vomiting; abdominal pain; diarrhea.
Skin and subcutaneous tissue disorders: Uncommon (>1/1000, <1/100): pruritus; urticaria; rash, exanthema, erythema.
Musculoskeletal, connective tissue and bone disorders: Uncommon (>1/1000, <1/100): muscle cramps, myalgia.
General disorders and administration site disorders: Uncommon (>1/1000, <1/100): fever, shivering, flushing; chest pain and tightness. Injection site disorders such as superficial phlebitis, burning, swelling. Rare (>1/10000, <1/1000): anaphylactoid reactions (rarely involving arthralgia); peripheral edema; fatigue, asthenia; malaise.
Moreover, in spontaneous reports the following adverse reactions have been reported: Isolated cases: reduced level of consciousness, light-headed feeling, confusion; angioedema; swelling of joints, hyperhidrosis, and back pain.
Drug Interactions
As with all parenteral iron preparations, Iron Sucrose Injection USP should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection of Iron Sucrose Injection USP.
Caution For Usage
Intravenous Drip Infusion: Iron Sucrose Injection USP must be diluted only in sterile 0.9% w/v sodium chloride solution: 5 mL Iron Sucrose Injection USP (100 mg iron): In max. 100 mL sterile 0.9% w/v sodium chloride solution.
10 mL Iron Sucrose Injection USP (200 mg iron): In max. 200 mL sterile 0.9% w/v sodium chloride solution.
For stability reasons, dilutions to lower Iron Sucrose Injection USP 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 Injection USP) in at least 15 minutes.
200 mg iron (10 mL Iron Sucrose Injection USP) 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 note more than 50 mL in 15 minutes.
Intravenous Injection: Iron Sucrose Injection USP 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 Injection USP (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 Injection USP may be administered during a hemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
10 mL Iron Sucrose Injection USP (200 mg iron): In max. 200 mL sterile 0.9% w/v sodium chloride solution.
For stability reasons, dilutions to lower Iron Sucrose Injection USP 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 Injection USP) in at least 15 minutes.
200 mg iron (10 mL Iron Sucrose Injection USP) 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 note more than 50 mL in 15 minutes.
Intravenous Injection: Iron Sucrose Injection USP 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 Injection USP (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 Injection USP may be administered during a hemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
Storage
Store at temperatures not exceeding 30°C. Protect from light. Do not freeze.
Action
Pharmacology: Pharmacodynamics: Following intravenous administration of Iron sucrose Injection USP, iron sucrose is dissociated by the reticuloendothelial system into iron and sucrose. In 22 hemodialysis patients on erythropoietin (recombinant human erythropoietin) therapy treated with iron sucrose containing 100 mg of iron, three times weekly for three weeks, significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity occurred four weeks from the initiation of iron sucrose treatment.
Pharmacokinetics: Following intravenous injection of a single dose of Iron sucrose Injection USP containing 100 mg iron in healthy volunteers, maximum iron levels, averaging 538 μmol/l, were obtained 10 minutes after injection. The volume of distribution of the central compartment corresponded well to the volume of plasma (approximately 3 litres).
The iron injected was rapidly cleared from the plasma, the terminal half-life being approx. 6 h. The volume of distribution at steady state was about 8 litres, indicating a low iron distribution in the body fluid. Due to the lower stability of iron sucrose in comparison to transferrin, a competitive exchange of iron to transferrin was observed. This resulted in iron transport of approx. 31 mg iron/24h.
Renal elimination of iron, occurring in the first 4 h after injection, corresponds to less than 5% of the total body clearance. After 24 h the plasma levels of iron were reduced to the pre-dose iron level and about 75% of the dosage of sucrose was excreted.
Pharmacokinetics: Following intravenous injection of a single dose of Iron sucrose Injection USP containing 100 mg iron in healthy volunteers, maximum iron levels, averaging 538 μmol/l, were obtained 10 minutes after injection. The volume of distribution of the central compartment corresponded well to the volume of plasma (approximately 3 litres).
The iron injected was rapidly cleared from the plasma, the terminal half-life being approx. 6 h. The volume of distribution at steady state was about 8 litres, indicating a low iron distribution in the body fluid. Due to the lower stability of iron sucrose in comparison to transferrin, a competitive exchange of iron to transferrin was observed. This resulted in iron transport of approx. 31 mg iron/24h.
Renal elimination of iron, occurring in the first 4 h after injection, corresponds to less than 5% of the total body clearance. After 24 h the plasma levels of iron were reduced to the pre-dose iron level and about 75% of the dosage of sucrose was excreted.
MedsGo Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
Features
Dosage
20 mg / ml, (100 mg / 5 ml)
Ingredients
- Iron
Packaging
Solution for Injection 5ml x 5's
Generic Name
Iron Sucrose
Registration Number
DR-XY46232
Classification
Prescription Drug (RX)
Product Questions
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