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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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.
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