Likferr 100
Likferr 100: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Likferr 100
ATX code: B03AC02 (solution), B03AB05 (syrup)
Active ingredient: solution - iron sucrose complex, syrup - iron III hydroxide polymaltosate (Ferric III hydroxide polymaltosate)
Manufacturer: Help A. P. T. K. (Greece), Samrudh Pharmaceuticals Pvt. Ltd. (India), Emkur Pharmaceuticals Ltd. (India)
Description and photo update: 28.11.2018
Likferr 100 is a drug for replenishing iron deficiency, has an anti-anemic effect.
Release form and composition
Dosage forms:
- solution for intravenous (intravenous) administration: colloidal mass from brown to red-brown color (5 ml in dark glass ampoules: 3 ampoules in blister strip packs, in a cardboard box 1, 2 or 8 packages; 5 ampoules each in blister packs or plastic pallets, in a cardboard box 1 package or pallet; for hospitals - in a cardboard box 270 or 1155 ampoules; 5 ml each in glass bottles, in a cardboard box 1, 3 or 5 bottles, in a cardboard box 320 bottles);
- syrup: a viscous liquid of dark brown color with a characteristic odor (150 ml each in brown polyethylene terephthalate bottles, complete with a measuring cup, 1 bottle in a cardboard box; for hospitals - in a cardboard box 30 bottles).
Each pack also contains instructions for the use of Likferra 100.
1 ml of solution contains:
- active substance: iron III - 20 mg (in the form of a hydroxide of a sucrose complex);
- auxiliary components: sodium hydroxide, water for injection.
5 ml of syrup contains:
- active ingredient: iron (III) hydroxide polymaltose - 208.3 mg, which is equivalent to 50 mg of elemental iron;
- auxiliary components: sucrose, sorbitol 70%, propyl parahydroxybenzoate, methyl parahydroxybenzoate, cream essence "golden taste" (butyric acid, sucrose, vanillin, ethyl vanillin, propylene glycol, butanedione, purified water), purified water.
Pharmacological properties
Pharmacodynamics
Likferr 100 is an antianemic drug that regulates metabolic processes in the body. The dosage form for parenteral administration is a colloidal solution consisting of iron-carbohydrate spheroidal nanoparticles. The core of each particle contains iron III hydroxide surrounded by a sucrose shell. By stabilizing the iron III hydroxide, the shell promotes a slow release of bioactive iron and the preservation of the resulting particles in a colloidal solution. Iron III is associated with structures similar to natural ferritin. The molecular weight of the formed complex is approximately 43 kDa, which does not allow its excretion unchanged through the kidneys. When iron III enters the body, the hydroxide sucrose complex in the reticuloendothelial system dissociates into iron and sucrose. Iron saccharate has a lower stability than transferrin, which allows a competitive exchange of iron in favor of transferrin, as a result of which approximately 31 mg of iron is transferred in 24 hours. After complexation with apoferritin of liver mitochondria (protein ligand), polycyclic iron III hydroxide is retained partially in the form of ferritin. An increase in the hemoglobin index during therapy with Likferrom 100 occurs faster and with a higher reliability than after the use of agents containing iron II. An increase in hemoglobin by 2-3% is achieved after intravenous administration of 100 mg of iron III. After complexation with apoferritin of liver mitochondria (protein ligand), polycyclic iron III hydroxide is retained partially in the form of ferritin. An increase in the hemoglobin index during therapy with Likferrom 100 occurs faster and with a higher reliability than after the use of agents containing iron II. An increase in hemoglobin by 2-3% is achieved after intravenous administration of 100 mg of iron III. After complexation with apoferritin of liver mitochondria (protein ligand), polycyclic iron III hydroxide is retained partially in the form of ferritin. An increase in the hemoglobin index during therapy with Likferrom 100 occurs faster and with a higher reliability than after the use of agents containing iron II. An increase in hemoglobin by 2-3% is achieved after intravenous administration of 100 mg of iron III.
The toxicity of the solution is very low.
In syrup, iron is in the form of a macromolecular complex of iron III hydroxide with polymaltose. Since iron is not released in the form of free ions, the compound remains stable. The structure of the syrup is similar to the natural combination of iron with ferritin in the body. After oral administration, iron III is actively absorbed from the intestines and enters the bloodstream, therefore, neither an overdose, nor drug poisoning is practically impossible. The syrup does not have the prooxidant properties of iron II salts. In plasma, iron is transported by gamma globulin transferrin, which is synthesized in the liver. The iron-transferrin complex is transported to cells, where iron is used to synthesize hemoglobin, myoglobin, and some enzymes. The absorbed iron in the form associated with ferritin is stored mainly in the liver. It participates in the formation of heme, helping to increase the level of hemoglobin.
The syrup does not stain the teeth.
Pharmacokinetics
After a single intravenous injection of 100 mg of iron, its maximum concentration is reached in 1/6 hour and is about 538 μmol.
The volume of distribution at equilibrium is 8 liters.
The half-life is 6 hours.
In urine during the first 4 hours after injection, up to 5% of iron from the total clearance is found. The serum iron content after 24 hours returns to the initial level (before administration), sucrose leaves the vascular bed in a volume of 75%.
Indications for use
Solution for intravenous administration
- the need for rapid replenishment of iron in patients with iron deficiency conditions, including iron deficiency and acute post-hemorrhagic anemia;
- patients with individual intolerance to oral forms of iron preparations;
- the inability to use iron preparations for oral administration due to the presence of diseases of the gastrointestinal tract.
Syrup
The use of Likferr 100 syrup is indicated for the treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia).
In addition, the drug is prescribed to prevent iron deficiency, including when following a vegetarian diet, in women of childbearing age, during gestation and lactation, in children and adolescents.
Contraindications
- anemia not associated with iron deficiency (including megaloblastic anemia, hemolytic anemias);
- the presence of signs of excess iron in the body (hemochromatosis, hemosiderosis);
- the presence of pathologies that disrupt the mechanism of iron utilization (including sideroachrestic anemia, lead anemia);
- hypersensitivity to the components of the drug.
In addition, additional contraindications to the use of certain forms of Likferra 100:
- solution for intravenous administration: I trimester of pregnancy, lactation period;
- syrup: children weighing less than 5 kg.
It is recommended with caution to prescribe the use of a solution for intravenous administration in case of bronchial asthma, polyvalent allergies, the development of allergic reactions to parenteral administration of other iron preparations, eczema, liver failure, acute infectious diseases, to patients with folic acid deficiency and / or low iron-binding capacity of serum, patients with diabetes mellitus, in the II and III trimesters of pregnancy (only if the expected benefits exceed the possible risks), under the age of 18 years.
Likferr 100, instructions for use: method and dosage
Solution for intravenous administration
Do not inject Likferr 100 solution intramuscularly!
The solution is intended only for intravenous administration by slow jet injection, infusion, or injection into the venous section of the dialysis system.
Simultaneous administration of a cumulative (course) therapeutic dose of Likferra 100 is categorically unacceptable!
You can use only a brown solution without signs of sediment, therefore, if a visual inspection of the ampoule before opening reveals its damage or the presence of sediment in the solution, the drug should be disposed of.
To determine the individual tolerance of the solution, a test dose should be administered to the patient before starting treatment. For adults and children with a body weight of more than 14 kg, the test dose is 20 mg of iron (1 ml of solution), for children with a body weight of up to 14 kg - 1/2 daily dose, corresponding to 1.5 mg of iron per 1 kg of body weight. In the event of intolerance phenomena, the administration of a therapeutic dose is contraindicated, the use of the drug must be canceled.
Drip infusion is considered the most preferable, it provides a decrease in the likelihood of the solution entering the peri-venous space and a pronounced decrease in blood pressure (BP). The infusion solution is prepared just before the procedure. To dilute the drug, use a 0.9% sodium chloride solution in a ratio of 1:20, that is, for 1 ml of Likferra100 (or 20 mg of iron), there should be 20 ml of solvent. The infusion rate is: for 100 mg of iron - at least 15 minutes, 200 mg - 0.5 hours, 300 mg - 1.5 hours, 400 mg - 2.5 hours, 500 mg - 3.5 hours. The maximum single dose is 7 mg of iron per 1 kg of body weight. When the maximum tolerated dose is prescribed (regardless of the total dose of the drug), it should be administered for 3.5 hours or longer.
Before the first drip of a therapeutic dose, the patient must enter the test dose within 15 minutes. If there are no undesirable effects, then the introduction of the remainder of the daily dose of the solution is continued at the recommended rate.
Likferr 100 solution can be injected into the venous site of the dialysis system.
Jet intravenous administration of a solution in undiluted form can be performed in a dose not exceeding 10 ml of the drug (or 200 mg of iron) per injection. The procedure is carried out at a rate of 1 ml of Likferra 100 for one minute. For some time after the injection, the patient is advised to keep the arm in an extended position.
Before the first jet injection of a therapeutic dose of the drug, a test dose should be administered within 1–2 minutes. If the patient does not observe the appearance of adverse reactions within the next 15 minutes, the administration of the remainder of the solution should be resumed at the recommended rate.
The total iron deficiency in the body is calculated as follows: the patient's body weight (kg) is multiplied by the difference of two numbers, in which the reduced is the normal hemoglobin level (Hb), and the subtracted is the patient's Hb, and then multiplied by a factor of 0.24. The deposited iron (mg) is added to the result obtained.
The amount of deposited iron in persons with a body weight of more than 35 kg is 500 mg, in persons with a body weight of up to 35 kg it is determined at the rate of 15 mg per 1 kg of body weight.
The normal Hb index is set for patients with a body weight of up to 35 kg in the amount of 130 g / l, for patients with a body weight of more than 35 kg - 150 g / l.
To determine the volume of the cumulative (course) dose of Likferr 100, which is required to replenish the iron deficiency in the body, the total iron deficiency (mg) must be divided by 20 mg / ml.
After determining the total dose of Likferra 100, the doctor prescribes the frequency of procedures. The frequency of intravenous administration is 1 time in 2 days (should not be exceeded).
Recommended dosage:
- adults, including patients over the age of 65: 5-10 ml (100-200 mg of iron) 1-3 times within 7 days;
- children: at the rate of no more than 0.15 ml (3 mg of iron) per 1 kg of body weight 1-3 times within 7 days.
The maximum permissible single dose for drip administration should not exceed 500 mg of iron.
Typically, high doses are associated with an increased incidence of adverse events.
If the total therapeutic dose is higher than the maximum allowable single dose, it is recommended to use fractional administration of the solution.
If there is no improvement in hematological parameters after 7-14 days of therapy, additional research is needed to clarify the initial diagnosis.
If it is necessary to replenish the iron deficiency resulting from blood loss or donation of autologous blood, the dose is set taking into account the patient's blood loss or Hb. Intravenous administration of 10 ml of Likferra 100 (200 mg of iron) causes an increase in Hb concentration, similar to the transfusion of 1 unit of blood (400 ml with an Hb concentration of 150 g / l). To determine the dose (ml) of the solution, the number of units of lost blood should be multiplied by 10. If the amount of lost blood cannot be established, then the usual formula is used to determine the total iron deficiency in the body (mg), provided that it is not required to replenish the iron depot, that is, weight body (kg) is multiplied by 0.24, and then multiplied by the difference between the normal Hb and Hb of the patient.
In patients with chronic renal diseases who are on hemodialysis and receiving additional treatment with erythropoietin, the procedure is not particularly difficult. The drug, diluted in 0.9% sodium chloride solution, is administered for at least 15 minutes through the venous section of the dialysis system. The procedure should be carried out within the last two hours of the hemodialysis session. The injection should be carried out very slowly, its duration may increase as the dose is increased.
Recommended dosage of Likferra 100 for patients with chronic renal diseases on hemodialysis:
- phase of correction of anemia with absolute iron deficiency: 30–50 mg of iron for 1 dialysis session or 1000 mg of iron for 42–70 days;
- phase of maintenance treatment: the dosage regimen depends on the concentration of serum ferritin - 10–25 mg of iron per 1 dialysis session or 100 mg of iron 1 time in 30 days;
- hemoglobin correction phase: to increase the Hb concentration by 10 g / l - 150 mg of iron.
Syrup
Likferr 100 syrup is taken orally during or immediately after a meal, including mixing it with fruit or vegetable juices, artificial nutritional mixtures. This does not affect the activity of the drug.
The daily dose can be taken once or in several doses.
The dose and period of treatment is determined by the attending physician, taking into account the degree of iron deficiency.
The recommended daily dosage of Likferra 100 for the prevention and treatment of iron deficiency states has the following age restrictions:
- iron deficiency anemia: age up to 1 year (for children weighing 5 kg and above) - 2.5–5 ml, 1–12 years old - 5–10 ml, patients over 12 years old (including breastfeeding women) - 10–30 ml, pregnant women - 20-30 ml. The duration of the course of therapy is from 56 to 84 days, it is determined individually based on the hemoglobin level in the blood. After its normalization, treatment is continued for 14–21 days at an age-appropriate dose for the treatment of latent iron deficiency;
- treatment of latent iron deficiency and prevention of iron deficiency: children from 1 to 12 years old - 2.5–5 ml, patients over 12 years old (including breastfeeding women) - 5–10 ml, pregnant women - 10 ml.
Side effects
Solution for intravenous administration
- from the respiratory system: shortness of breath, bronchospasm;
- from the central nervous system: headache, dizziness, paresthesia, loss of consciousness;
- from the digestive system: nausea, vomiting, metal taste in the mouth and other transient disturbances in taste, abdominal pain, diarrhea, taste perversion, pain in the epigastric region;
- on the part of the cardiovascular system: lowering blood pressure, flushing of the face, palpitations, tachycardia, feeling of heat, collaptoid conditions, peripheral edema;
- from the musculoskeletal system: back and / or limb pain, arthralgia, myalgia, joint swelling;
- dermatological reactions: increased sweating, itching, rash, erythema, pigmentation disorders;
- allergic reactions: swelling of the face and / or larynx, anaphylactoid reactions;
- local reactions: burning sensation, pain and swelling at the injection site (more often with extravasal ingestion of the solution), hematoma, phlebitis;
- others: weakness, pallor, fever, back pain, feeling unwell, asthenia, pain and / or a feeling of heaviness in the chest, chills.
Syrup
In some cases, while taking syrup, there may be undesirable phenomena from the digestive system in the form of nausea, a feeling of fullness in the stomach, discomfort, constipation or diarrhea.
Taking iron preparations causes the staining of feces in a dark color, which has no clinical significance.
Overdose
Solution for intravenous administration
Symptoms: lowering blood pressure, signs of collapse, symptoms of hemosiderosis appear within 0.5 hours after the administration of a high dose of the solution.
Treatment: the appointment of symptomatic therapy. The use of deferoxamine and other drugs that bind iron (chelators).
Syrup
Overdose symptoms against the background of syrup use have not been established.
special instructions
The appointment of Likferra 100 in the form of a solution should be made to patients with a diagnosis of anemia confirmed by the corresponding laboratory results, including data on the determination of serum ferritin, hemoglobin and hematocrit, the number of erythrocytes and their parameters (average erythrocyte volume or average hemoglobin in erythrocyte).
When using the solution, it is necessary to strictly follow the recommendations on the rate of administration and control the hemodynamic parameters.
Intravenous iron supplementation can cause potentially life-threatening allergic and anaphylactoid reactions. Patients with polyvalent allergies, bronchial asthma and other atopic diseases, eczema, known allergic reactions to other iron preparations, low serum iron-binding capacity, or folic acid deficiency are at an increased risk of developing allergic or anaphylactoid reactions. Therefore, special care should be taken when treating them.
Penetration of the solution into the perineous space leads to tissue necrosis and brown skin staining. If Likferr 100 gets outside the vessel and if the needle is still in the vessel, it is recommended to inject a small amount of 0.9% sodium chloride solution. This will avoid the development of these complications. To prevent further penetration of iron into the surrounding tissue and faster removal of it to the injection site, apply a heparin-containing gel or ointment with light movements.
When treating patients with diabetes mellitus, it should be borne in mind that 1 ml of solution contains from 260 to 340 mg of sucrose. In the maximum tolerated single dose (500 mg of iron), the amount of sucrose is 8.5 g, which in terms of bread units (XE) corresponds to 0.7 XE (1 XE is equal to 12 g of carbohydrates). 1 ml of syrup contains 0.04 XE.
To control iron metabolism during the period of therapy with erythropoiesis stimulants, such indicators as the concentration of ferritin in the blood serum and NTZh (saturation of transferrin with iron) should be used. The use of Likferra 100 in the form of a solution is indicated in the case of hyperferritinemia and low NTJ. Long-term persistence of serum ferritin levels above 500 μg / L (with normal C-reactive protein) may indicate iatrogenic iron overload. In this case, the iron preparation should be canceled, continuing therapy with erythropoiesis stimulants.
With the development of acute bacterial infections, the simultaneous use of iron preparations should be canceled, since iron potentiates the growth of most microorganisms.
When using permanent dialysis catheters, IV solution should be administered with caution.
Influence on the ability to drive vehicles and complex mechanisms
During the period in / in the use of Likferra 100 patients should be careful when driving vehicles and complex mechanisms.
Application during pregnancy and lactation
The use of Likferra 100 in the form of a solution in the first trimester of pregnancy and during breastfeeding is contraindicated.
In the II and III trimesters of the gestation period, the solution should be prescribed with caution and only in such conditions of a pregnant woman when the expected effect of therapy for her exceeds the potential threat to the fetus.
If it is necessary to use the solution during lactation, it is necessary to stop breastfeeding.
In the course of controlled studies, no negative effects on the body of a pregnant woman were noted when taking Likferra 100 in the form of a syrup.
Pediatric use
The use of syrup is contraindicated for the treatment of iron deficiency anemia or the prevention of iron deficiency in children weighing less than 5 kg.
Caution should be given to intravenous administration of the solution to patients under the age of 18 years due to the lack of information about the safety and efficacy of Likferr 100 in this category of patients.
With impaired renal function
Recommended dosage of Likferra 100 for patients with chronic renal diseases on hemodialysis and receiving additional treatment with erythropoietin:
- phase of correction of anemia with absolute iron deficiency: 30–50 mg of iron for 1 dialysis session or 1000 mg of iron for 42–70 days;
- phase of maintenance treatment: the dosage regimen depends on the concentration of serum ferritin - 10–25 mg of iron per 1 dialysis session or 100 mg of iron 1 time in 30 days;
- hemoglobin correction phase: to increase the Hb concentration by 10 g / l - 150 mg of iron.
For violations of liver function
With caution, it is recommended to prescribe a solution for intravenous administration to patients with hepatic insufficiency.
Drug interactions
The simultaneous use of Likferr 100 solution with iron preparations for oral administration should not be allowed, this causes a decrease in the absorption of iron from the gastrointestinal tract. The transition to oral dosage forms of iron can be made 5 days after the last intravenous administration of the solution.
The solution can only be added to 0.9% sodium chloride solution; its mixing with other solutions for intravenous administration or drugs is contraindicated.
When prescribing Likferra 100, the patient must inform the doctor about taking other drugs.
The interaction of the syrup with other agents has not been established.
Analogs
Likferr 100 analogs are: for oral administration - Maltofer, Sorbitrim, Ferrum Lek; for parenteral administration - Irondext, Argeferr, Vialfer, Venofer, Iron (III) hydroxide sucrose complex, Maltofer, FerMed, Fer-Rompharm.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, syrup - protected from moisture.
Shelf life: solution in ampoules, syrup - 3 years, solution in vials - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Likferr 100
Reviews about Likferr 100 are positive. The intravenous administration of the drug can quickly increase the level of iron in the body. Patients note that Likferra 100 is well tolerated.
Price for Likferr 100 in pharmacies
The price of Likferr 100 for a package containing 5 ampoules of 5 ml can range from 2227 to 3120 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!
