Buy CosmoFer ampoules 50 mg/ml 2 ml, 5 pcs
  • Buy CosmoFer ampoules 50 mg/ml 2 ml, 5 pcs

CosmoFer® [Iron III Dextran]

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2019-09-19
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Clinical Pharmacology

CosmoFer contains iron in the form of a stable iron (III) complex - dextran hydroxide, suitable for both intravenous and intramuscular administration. An important advantage of the drug is that the iron in the complex is presented in non-ionic water-soluble form and has very low toxicity. The complex of iron (III) - dextran hydroxide in its chemical structure is similar to the physiological complex of ferritin with iron (III) - hydroxide. In the body, ferritin, by binding Fe (III) hydroxide, provides neutralization of toxic iron ions.

Pharmacokinetics

The absorption of iron to replenish its reserves in the body and the synthesis of hemoglobin begins immediately after the introduction of the complex of iron (III) dextran hydroxide.

Iron, administered intravenously in the form of iron dextran, is rapidly absorbed by the system of phagocytic macrophages (SFM), especially by the liver, spleen, and bone marrow. SFM cells capture iron (III) dextran hydroxide and cleave iron from the carbohydrate compound dextran, making it accessible to the body. Elemental iron returns to the plasma, binds to transferrin and is deposited in the form of ferritin or hemosiderin - physiological forms of iron, and while entering the bone marrow, it participates in the synthesis of hemoglobin.

The serum ferritin content peaks at approximately 7–9 days after intravenous administration and returns to baseline after approximately 3 weeks.

Increased hemopoiesis can be observed over the next 6–8 weeks.

After intramuscular administration, the iron (III) complex hydroxide dextran enters the bloodstream through the capillaries and the lymphatic system.

About 60% of the intramuscularly injected drug is absorbed within 3 days and more than 90% within 3 weeks. The remaining amount is absorbed within a few months. 2/3 of the iron is removed through the digestive tract with red blood cells, bile and peeling epithelial cells.

Due to the size of the complex (165,000 Da), it is practically not excreted by the kidneys.

Indications

Iron deficiency anemia severe in case of intolerance to oral iron preparations and in cases of the need for rapid replenishment of iron stores.

Composition

1 ml solution for intravenous and intramuscular administration contains:
active substance: iron (III) - dextran hydroxide complex 312.5 mg (equivalent to 50 mg of elemental iron);
Excipients: hydrochloric acid or sodium hydroxide to pH 5.5, water for injection.

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CosmoFer® [Iron III Dextran]

Dosage and Administration

CosmoFer is used in the form of intravenous drip infusions or slow intravenous or intramuscular injections.

The use of CosmoFer is possible only in the hospital with the condition of availability of resuscitation and anti-shock therapy. Patients should be under close medical supervision during the administration of the drug and immediately after it for 1 hour.

The use of CosmoFer should be immediately discontinued, for any manifestation of a hypersensitivity or intolerance reaction detected during administration.

Usually the recommended dose of CosmoFera: 100-200 mg of iron (corresponds to 2-4 ml of the drug) 2-3 times a week, depending on the hemoglobin content.
However, if the clinical situation requires rapid replacement of iron, intravenous drip of a total dose of Cosmofer is possible — up to 20 mg / kg of the patient’s body weight.

At the first use of the drug, the recommended initial dose is 25 mg of iron or 0.5 ml of solution. If within the next 60 minutes no negative reactions appear, you can enter the remaining dose.

For intravenous infusion CosmoFer can be diluted only in 0.9% sodium chloride solution or in 5% glucose solution.

For intramuscular injection use undiluted preparation (2.0 ml, maximum - 4.0 ml) in the form of a series of injections: the volume of each series is usually determined by the patient's body weight. For patients who lead a moderately active lifestyle, injections are given daily, alternately in different buttocks. Patients leading an inactive lifestyle, or lying patient, reduce the frequency of injections: up to one or two per week.

Adverse reactions

Approximately 5% of patients may experience adverse reactions.
The most frequent adverse reactions are pruritus, shortness of breath.
In rare cases, there may be a decrease in blood pressure, nausea, dyspeptic disorders, headache, pain in the joints and muscles, an increase in lymph nodes, an increase in bilirubin, and a decrease in serum calcium.
Local reactions - pain and inflammation at the injection site, in addition with intravenous administration - phlebitis, thrombophlebitis.

Large doses of iron dextran (5 ml or more) impart a brown color to serum taken 4 hours after the use of the drug.
Anaphylactoid reactions are possible, up to the development of anaphylactic shock with a fatal outcome.

Carefully: impaired renal function; pregnancy (II – III trimesters); lactation period.

Drug interactions

CosmoFer for parenteral administration is not prescribed together with oral iron preparations, since absorption of oral iron will be reduced. The interval between the parenteral administration of CosmoFeer and the start of the use of oral forms of iron should be at least 5 days.

CosmoFer should be mixed with only 0.9% sodium chloride solution or 5% glucose solution. Do not mix with solutions of other drugs.

Pregnancy and Lactation

It should not be prescribed during the first trimester of pregnancy, but can be used with caution during the second and third trimesters and during lactation.

Special instructions

The use of CosmoFer, like other iron-hydrocarbon complexes, carries the risk of anaphylactic reactions. During the introduction of the drug and immediately after taking the patients should be under the supervision of a physician.

There is an increased risk for patients with identified allergies. Acute anaphylactic reactions are extremely rare. They manifest themselves during the first minutes of use and are usually characterized by a sudden onset of difficulty breathing and / or cardiovascular collapse.

It should be possible to carry out anti-shock therapy (0.1% solution of epinephrine (adrenaline), antihistamines and / or corticosteroid drugs).

At the first signs of anaphylactic reactions, the use of CosmoFer should be immediately discontinued.

The use of CosmoFer in patients with autoimmune diseases or inflammatory conditions (systemic lupus erythematosus, rheumatoid arthritis) can cause type III allergic reactions. Cases of arterial hypotension may occur if IV injection is performed too quickly.

Delayed hypersensitivity reactions are characterized by arthralgia, anaphylactic myalgia, and sometimes fever, which can last from several hours to 4 days after drug administration. Symptoms usually appear within 2–4 days.

The diagnosis of iron deficiency should be based on appropriate laboratory tests (serum ferritin, serum iron, transferrin saturation with iron).

Before use, the ampoules should be checked visually for sediment and damage. Use only ampoules with a homogeneous solution that does not contain sediment.

Features of the drug at the first admission or cancellation

At the first use of the drug, the recommended initial dose is 25 mg of iron or 0.5 ml of solution. If within the next 60 minutes no negative reactions appear, you can enter the remaining dose.

Influence on the ability to drive vehicles, mechanisms. Does not affect the ability to drive vehicles and mechanisms.

Overdosage

Symptoms: hemosiderosis (acute iron overload).

Treatment: prescription of complexing drugs (chelators) that bind iron to the chelate complex.

With constantly repeated administration of iron in a large dose, its excess accumulates in the liver and causes an inflammatory process that can lead to fibrosis.

Studies and clinical trials of Iron III Dextran (Click to expand)
  1. Procedure for the analysis of sedative drugs with the use of an array of piezoelectric sensors (Exemplified in the determination of the drug Corvalol)
  2. Muonium formation and magnetic relaxation in dextran and iron–dextran
  3. Safety and efficacy of rapidly administered (one hour) one gram of low molecular weight iron dextran (INFeD) for the treatment of iron deficient anemia
  4. Effects of Intracerebroventricular Injection of Iron Dextran on the Iron Concentration and Divalent Metal Transporter 1 Expression in the Caudate Putamen and Substantia Nigra of Rats
  5. The adverse effect of intravenous iron-dextran in rheumatoid arthritis
  6. Rapid induction of hepatic fibrosis in the gerbil after the parenteral administration of iron-dextran complex
  7. Iron-dextran carcinogenesis in rats: Influence of dose on the number and types of neoplasm induced
  8. Iron-dextran induction of distant tumours in mice
  9. Uptake of dextran-coated monocrystalline iron oxides in tumor cells and macrophages
  10. The molecular formula and proposed structure of the iron–dextran complex, IMFERON
  11. Inhibitory effect of tannic acid on iron–dextran-augmented and 7,12-dimethyl benz(a)anthracene-initiated skin carcinogenesis
  12. Quadruple-Responsive Nanocomposite Based on Dextran–PMAA–PNIPAM, Iron Oxide Nanoparticles, and Gold Nanorods
  13. Iron–dextran as a magnetic susceptibility contrast agent: Flow-related contrast effects in the T2-weighted spin-echo MRI of normal rat and cat brain
  14. A model of lysosomal metabolism of dextran coated superparamagnetic iron oxide (SPIO) nanoparticles: implications for cellular magnetic resonance imaging
  15. Mössbauer spectroscopy of iron dextran: comparison of solid and frozen solution
  16. Physical investigations on colloidal iron-dextran complexes
  17. Structural variations in soluble iron complexes of models for ferritin: An x-ray absorption and mössbauer spectroscopy comparison of horse spleen ferritin to blutal (iron-chondroitin sulfate) and imferon (iron-dextran)
  18. A study of an iron dextran complex by Mössbauer spectroscopy and x-ray diffraction
  19. An analysis of iron-dextran complexes by Mössbauer spectroscopy and positron annihilation technique
  20. An investigation into the size of an iron dextran complex
  21. Pharmaceutically important iron-dextran complexes: A comparative study by Mössbauer and positron annihilation techniques
  22. Simultaneous visualization of nuclear yellow and iron—dextran complex for demonstration of branched neurons by retrograde axonal transport
  23. Differential proteomics analysis of the surface heterogeneity of dextran iron oxide nanoparticles and the implications for their in vivo clearance
  24. Interactions between iron(III) and sucrose, dextran, or starch in complexes
  25. Cell response to dextran-derivatised iron oxide nanoparticles post internalisation
  26. Dextran-modified iron oxide nanoparticles

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