CosmoFer - Instructions For Use, Ampoule Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

CosmoFer

CosmoFer: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: CosmoFer

ATX code: B03AC06

Active ingredient: iron (III) hydroxide dextran [Ferric (III) hydroxide destrane]

Manufacturer: PHARMACOSMOS A / S (Denmark)

Description and photo update: 2019-24-07

Prices in pharmacies: from 3790 rubles.

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CosmoFer is an antianemic drug (stimulates hematopoiesis and replenishes the lack of iron in the body).

Release form and composition

The drug is available in the form of a solution for intravenous and intramuscular administration. The solution is dark brown. Packaged in 2 ml ampoules; in a contour acheikova packing 5 ampoules; in a pack of cardboard one blister strip and instructions for use of CosmoFer.

Composition for 1 ml:

• active substance: iron (III) hydroxide dextran - 312.5 mg (which corresponds to 50 mg of elemental iron);
• auxiliary components: water for injection, sodium hydroxide or 10% hydrochloric acid (to obtain a solution with a pH of 5.5).

Pharmacological properties

Pharmacodynamics

In CosmoFer, iron is contained in the form of a stable iron (III) complex, dextran hydroxide. It is suitable for both IV (intravenous) and IV (intramuscular) administration. The main advantage of the drug is that the complex contains iron in a non-ionic water-soluble form and has a very low toxicity. In terms of the chemical structure of iron (III), dextran hydroxide is analogous to the physiological complex of ferritin with iron (III) hydroxide. In the human body, ferritin binds to iron (III) hydroxide, due to which toxic iron ions are rendered harmless.

Pharmacokinetics

After intravenous administration of CosmoFer, iron is rapidly absorbed by the SFM (system of phagocytic macrophages), especially by the spleen, bone marrow and liver. After the capture of iron (III) dextran hydroxide by the SFM cells, iron is cleaved from the carbohydrate compound of dextran and becomes available to the body. Then, elemental iron again enters the blood plasma, where it binds to transferrin, after which it is deposited in the form of hemosiderin or ferritin (physiological forms of iron). In the bone marrow, elemental iron is involved in the synthesis of hemoglobin.

The maximum concentration of ferritin in serum is reached about 7-9 days after IV administration of the drug and returns to the initial level after about 3 weeks. Within 6-8 weeks after the application of CosmoFer, increased hematopoiesis is observed.

After the i / m administration of iron (III), dextran hydroxide enters the general bloodstream through the lymphatic system and capillaries. Approximately 60% of iron (III) dextran, administered intramuscularly, is absorbed within 3 days and more than 90% within 3 weeks. The remaining 10% of iron (III) dextran is absorbed within a few months.

About 70% of iron is excreted through the gastrointestinal tract with bile, dead epithelial cells and erythrocytes. Due to its large size (165,000 Da), the complex is practically not excreted by the kidneys.

Indications for use

CosmoFer is used for severe iron deficiency anemia in patients with intolerance to iron preparations for oral administration, as well as in cases where rapid replenishment of iron reserves in the body is required.

Contraindications

Absolute:

• anemias not associated with iron deficiency (including lead, sideroblastic and hemolytic anemias);
• acute renal failure;
• hepatitis and decompensated liver cirrhosis;
• rheumatoid arthritis with signs of active inflammation;
• infectious diseases;
• bronchial asthma;
• allergic skin diseases (including eczema);
• hemosiderosis and / or hemochromatosis (iron overload);
• children and adolescents under the age of 14;
• first trimester of pregnancy;
• hypersensitivity to drugs that include dextran complexes and monosaccharide or disaccharide iron complexes.

Relative (CosmoFer is used with caution):

• impaired renal function;
• second and third trimesters of pregnancy;
• breast-feeding.

CosmoFer, instructions for use: method and dosage

Solution in ampoules CosmoFer is injected intravenously (infusion) or in the form of injections (intramuscular or intravenous). The drug is used exclusively in stationary conditions with the immediate availability of anti-shock therapy methods. During the administration of the drug, as well as within 1 hour after the patient should be closely monitored. The introduction of the solution should be stopped immediately if any reactions of intolerance or hypersensitivity appear.

Usually CosmoFer is administered in a dose of 2-4 ml (corresponds to 100-200 mg of iron) 2-3 times a week. The dose size and frequency of administration depend on the hemoglobin level.

In cases where rapid replacement of iron is required, the total dose of CosmoFer is injected intravenously (up to 20 mg / kg of the patient's body weight).

Intravenous drip infusion

With intravenous infusion, the first 25 mg of iron is infused evenly over 15 minutes. If there are no negative reactions, the remaining dose is administered faster, but not more than 100 ml in 30 minutes. To prepare the infusion solution, you can use only 5% glucose solution or 0.9% sodium chloride solution (at the rate of 2-4 ml of solution per 100 ml of solvent).

IV injection

CosmoFer can be administered intravenously slowly (at a rate of 0.2 ml / min) at a dose of 2-4 ml (corresponds to 100-200 mg of iron). It is recommended to dilute the drug in 10–20 ml of 5% glucose solution or 0.9% sodium chloride solution before administration.

The initial dose is 0.5 ml of solution (or 25 mg of iron) and is administered intravenously slowly over 1–2 minutes. If there are no negative reactions within 15 minutes, the remaining dose is administered.

The total dose of the drug is calculated by the formula or determined according to a special table that takes into account the patient's body weight and hemoglobin content. Immediately before administration, the calculated total dose of CosmoFer is added to the required volume of sterile 0.9% sodium chloride solution or 5% glucose solution (usually this volume is 500 ml). The total amount of the drug (no more than 20 mg / kg of body weight) is injected intravenously for 4–6 hours.

Gradually, the rate of administration can be increased to 45–60 drops per minute (with an increase in the rate of administration of the solution, it is necessary to monitor the patient for 1 hour after injection).

Intravenous drip of CosmoFer is more preferable, as it reduces the risk of arterial hypotension.

IM injection

The total dose of the drug is determined by the formula or table. For intramuscular injections, CosmoFer in ampoules is used undiluted. Usually, a series of injections are performed, the volume of each of which is determined by the patient's body weight.

Injections are carried out daily (for moderately active patients) or 1-2 times a week (for bedridden patients or patients who lead an inactive lifestyle).

The drug is injected deep into the muscle to reduce the risk of subcutaneous staining. CosmoFer should be injected only into the upper outer quadrant of the buttocks (it is forbidden to inject the drug into the muscle mass of the arms or other external areas of the body).

Needle size for adults - 20-21G, for teenagers - 23G; the length of the needle for adults should be at least 50 mm (for obese patients - at least 80–100 mm), and for adolescents - 32 mm or less. During the introduction of CosmoFer, the patient should lie on his side (upwards with the buttock into which the injection is performed) or stand (the body weight should be transferred to the leg that is free from the injection). In order to avoid penetration of the solution under the skin, the Z-shaped technique of skin displacement before injection is recommended.

The drug should be administered carefully and slowly. The needle is not pulled out immediately, but after a few seconds, so that the muscles adapt to the volume of the injected solution. It is undesirable to rub the injection site.

Dialyzer injections

The drug can be used in patients on hemodialysis. To do this, the solution should be injected directly into the venous circuit of the artificial filter (dialyzer). The introduction procedure does not differ from the analogous procedure for intravenous administration of CosmoFer.

Calculation of the drug dose

With iron deficiency anemia, the required dose can be calculated using a special formula to determine the total iron deficiency - patient's body weight (in kg) × [desired Hb (in g / l) - actual Hb (in g / l)] × 0.24 + 1 mg Fe for replenishment.

The factor 0.24 used in this formula is obtained as follows:

1. The approximate amount of blood is calculated in relation to body weight (70 ml / kg ≈ 7%).
2. The approximate iron content in hemoglobin (in%) is calculated - 0.34%.
3. A factor of 1000 allows you to go from g to mg.

Total: factor 0.24 = 0.003 4 × 0.07 × 1000.

The amount of the drug (in ml) required for various degrees of iron deficiency anemia can also be determined using already specially calculated values. The results below are based on an attainable Hb level of 150 g / L and an iron store of 500 mg in patients weighing over 35 kg.

The total dose of CosmoFer (in ml) for iron deficiency anemias of varying severity:

• Hb content 60 g / l: patients weighing 35 kg - 25 ml; 40 kg - 27 ml; 45 kg –29 ml; 50 kg - 32 ml; 55 kg - 34 ml; 60 kg - 36 ml; 65 kg - 38 ml; 70 kg - 40 ml; 75 kg - 42 ml; 80 kg - 45 ml; 85 kg - 47 ml; 90 kg - 49 ml;
• Hb content 75 g / l: patients weighing 35 kg - 23 ml; 40 kg - 24 ml; 45 kg –26 ml; 50 kg - 28 ml; 55 kg - 30 ml; 60 kg - 32 ml; 65 kg - 33 ml; 70 kg - 35 ml; 75 kg - 37 ml; 80 kg - 39 ml; 85 kg - 41 ml; 90 kg - 42 ml;
• Hb content 90 g / l: patients weighing 35 kg - 20 ml; 40 kg - 22 ml; 45 kg –23 ml; 50 kg - 24 ml; 55 kg - 26 ml; 60 kg - 27 ml; 65 kg - 29 ml; 70 kg - 30 ml; 75 kg - 32 ml; 80 kg - 33 ml; 85 kg - 34 ml; 90 kg - 36 ml;
• Hb content 105 g / l: patients weighing 35 kg - 18 ml; 40 kg - 19 ml; 45 kg –20 ml; 50 kg - 21 ml; 55 kg - 22 ml; 60 kg - 23 ml; 65 kg - 24 ml; 70 kg - 25 ml; 75 kg - 26 ml; 80 kg - 27 ml; 85 kg - 28 ml; 90 kg - 29 ml;
• Hb content 120 g / l: patients weighing 35 kg - 15 ml; 40 kg - 16 ml; 45 kg –16.5 ml; 50 kg - 17 ml; 55 kg - 18 ml; 60 kg - 18.5 ml; 65 kg - 19.5 ml; 70 kg - 20 ml; 75 kg - 21 ml; 80 kg - 21.5 ml; 85 kg - 22 ml; 90 kg - 23 ml;
• Hb content 135 g / l: patients weighing 35 kg - 12.5 ml; 40 kg - 13 ml; 45 kg - 13 ml; 50 kg - 13.5 ml; 55 kg - 14 ml; 60 kg - 14.5 ml; 65 kg - 14.5 ml; 70 kg - 15 ml; 75 kg - 15.5 ml; 80 kg - 16 ml; 85 kg - 16 ml; 90 kg - 16.5 ml.

Both the formula and ready-made calculations are applicable to determine the dose of the drug only in patients with iron deficiency anemia. These methods cannot be used to determine the dose of CosmoFer in patients with blood loss.

The total requirement for iron reflects the amount of this element that is required to restore the level of Hb to normal or close to normal values, plus some amount to replenish the iron store in people with excessive or moderate decreases in Hb. It should be borne in mind that iron deficiency anemia manifests itself only after all iron stores are exhausted, that is, anemia therapy is aimed not only at replenishing Hb with iron, but also at restoring iron stores in general.

If the calculated dose is higher than the maximum allowable daily dose, it is administered in several doses. The therapeutic effect of CosmoFer can be assessed within a few days (an increase in the number of reticulocytes is noted in the blood test). An increase in serum ferritin levels is also a good indicator. This correlation is not always evident in dialysis patients.

In patients with blood loss, treatment should be directed towards replenishing an amount of iron that is equivalent to the amount of iron in the lost blood. The above calculation methods are not suitable for situations where rapid iron replenishment is required. To calculate the required dose of CosmoFer, it is necessary to estimate the volume of lost blood and the value of the hematocrit in the patient during bleeding. To do this, you can use the following formulas:

• the volume of lost blood is unknown: with the introduction of 4 ml of the drug intravenously (corresponds to 200 mg of iron), the increase in hemoglobin is equal to the effect of 1 unit of blood (that is, equal to 400 ml of blood with an Hb level of 150 g / l, which corresponds to 0.34% of 0, 4 × 150 or 204 mg of iron); based on these calculations, it turns out that the amount of iron that must be replaced (in mg) is equal to the number of lost blood units × 4;
• the Hb level is reduced: the above formula is applied with a slight change (1 mg of iron is not taken into account, since the iron supply does not need to be restored); the amount of iron to be replaced (in mg) is equal to the patient's body weight (in kg) x 0.24 x (desired Hb in g / l - actual Hb in g / l); for example, the amount of iron required for replacement with a body weight of 60 kg and a hemoglobin deficiency of 10 g / l is 60 × 0.24 × 10 = 143 mg (corresponds to approximately 3 ml of the drug).

Side effects

Side effects on CosmoFer occur in approximately 5% of patients. Dyspnea and pruritus are most common.

In rare cases, the following adverse reactions may occur: dyspepsia, nausea, headache, decreased blood pressure, increased bilirubin levels, decreased serum calcium levels, enlarged lymph nodes, muscle and joint pain.

From local reactions, inflammation and pain at the injection site can be noted, and with intravenous administration, thrombophlebitis and phlebitis.

With the introduction of large doses of CosmoFer (5 ml or more), the blood serum taken 4 hours after injection or infusion becomes brown.

Sometimes anaphylactoid reactions can occur, up to fatal anaphylactic shock.

Overdose

Acute iron overload is usually accompanied by excessive deposition of hemosiderin pigment in body tissues. In this case, the patient is prescribed chelators (iron-binding drugs).

If large doses of iron are injected repeatedly, the iron begins to build up in the liver, where it causes inflammation and can eventually lead to liver fibrosis.

special instructions

The use of any iron-hydrocarbon complexes is associated with an increased risk of anaphylactic reactions, therefore the doctor should assess the patient's condition both during the administration of CosmoFer and immediately after the injection or infusion.

In patients with identified allergies, this risk is especially high, but in general, such reactions develop extremely rarely. Acute anaphylactic reactions usually occur in the first few minutes of drug administration and are usually characterized by sudden cardiovascular collapse and / or difficulty breathing. If necessary, emergency anti-shock therapy is carried out (the patient is injected with corticosteroids, antihistamines and / or adrenaline). The use of CosmoFer should be discontinued at the first signs of anaphylactic shock.

In persons with inflammatory conditions or autoimmune diseases, administration of the drug can lead to type III allergic reactions. With too rapid intravenous administration of the solution, cases of arterial hypotension have been identified.

Delayed hypersensitivity reactions usually appear 2-4 days after CosmoFer application and last from several hours to several days. These reactions include: anaphylactic myalgia, arthralgia, fever.

To diagnose iron deficiency, appropriate laboratory tests must be performed (to determine iron and serum ferritin, as well as iron saturation of transferrin).

Before use, the ampoule with the drug should be visually assessed for damage and sediment. For the introduction, you can use only a homogeneous solution that does not contain sediment.

Influence on the ability to drive vehicles and complex mechanisms

CosmoFer does not affect the psychomotor functions of a person (the ability to concentrate and react quickly).

Application during pregnancy and lactation

The drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, as well as during breastfeeding, CosmoFer is used with caution.

Pediatric use

CosmoFer should not be administered to children and adolescents under 14 years of age.

With impaired renal function

In patients with acute renal failure, the use of an iron-containing agent is contraindicated.

In case of impaired renal function, CosmoFer is used with caution.

For violations of liver function

Hepatitis and decompensated liver cirrhosis are contraindications to the use of CosmoFer.

Drug interactions

The drug is not recommended to be administered concurrently with iron-containing medicinal products for oral administration, since iron taken orally will be less absorbed. The interval between parenteral administration and the start of oral administration should not be less than 5 days.

For the preparation of injection and infusion solutions, you can use only 5% glucose solution or 0.9% sodium chloride solution. CosmoFer must not be mixed with other solutions.

Analogs

The analogues of CosmoFer are Ferrum Lek and Sorbitrim.

Terms and conditions of storage

Keep out of reach of children and protected from moisture at a temperature not exceeding 25 ° C. The solution must not be frozen.

The shelf life is 30 months.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about CosmoFer

According to reviews, CosmoFer is a very good remedy for treating anemia and replenishing iron deficiency in blood loss. It quickly restores hemoglobin levels and iron stores in the body. However, patients note that the solution should be administered only under the supervision of a physician, as individual intolerance is possible (shortness of breath, palpitations, increased blood pressure, etc.). The cost of the drug is quite high.

CosmoFer price in pharmacies

The price of CosmoFer in the form of a solution for intravenous and intramuscular administration of 50 mg / ml (5 ampoules per package) is 3800–4800 rubles.

CosmoFer: prices in online pharmacies

Drug name Price Pharmacy

CosmoFer 50 mg / ml solution for intravenous and intramuscular administration 2 ml 5 pcs. 3790 RUB Buy

Cosmofer rr d / in. 50mg / ml 2ml n5 5244 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!