Lack of iron in the human body can lead to decreased hemoglobin and anemia. The level of the substance in the body must be maintained proper nutrition and management healthy image life. In emergency cases with abnormal reduced level A drug such as Ferrum Lek will help replenish iron reserves.
Description, purpose and composition
Ferrum Lek – medicinal composition, one of the antianemic medications. It is used for anemia, as well as to prevent iron deficiency resulting from pathological changes.
The medication is a brown liquid without sediment or impurities. The main component of the composition is iron hydroxide polyisomaltose, the content of which in one milliliter is fifty milligrams. The solvent of the drug is water; other components also include sodium hydroxide and hydrochloric acid.
The solution is produced in two-milliliter glass bottles and sold through pharmacy chains in boxes containing from five to fifty ampoules. Instructions included. Ferrum Lek is also available in the form of tablets and syrup for oral administration.
The medication must be stored in a closed place at a temperature of no more than twenty-five degrees Celsius. Shelf life is five years. Purchase in pharmacy chains is possible only upon presentation of a doctor's prescription. The cost of packaging in Russian pharmacies is from one hundred rubles.
Pharmacological characteristics of the drug
Basics active substance The drug contains ferric iron, due to which almost immediately after administration the solution replenishes a significant deficiency of the element in the body. As a result, the production of hemoglobin and the formation of red cells in the bone marrow. After application, the substance is absorbed into the blood and accumulates in the liver, muscle tissue and bone marrow.
The half-life process of the composition takes from three to four days. The composition is not excreted through the kidneys due to the size of the complex of ferric hydroxide with dextran.
Indications for use
Ferrum Lek, according to the instructions for use, is used to eliminate and prevent iron deficiency in humans, including the following disorders:
- serious blood loss resulting in a significant deficiency of the element;
- impaired absorption and absorption in the human intestine.
The drug is used in liquid form for intramuscular injection in situations where iron intake is urgently needed, as well as when oral tablets and syrup are insufficiently effective.
The solution for injection is not administered intravenously. Intramuscular administration of Ferrum Lek is carried out in two stages: first, only a quarter or half of the drug ampoule is used, then, if no negative manifestations, the entire dosage is applied. The amount of the drug per day and single dose for each patient is calculated in individual system depending on the causes of iron deficiency. The calculation uses a specialized formula that takes into account the patient’s weight and the level of deficiency, which is determined by laboratory tests, as well as the hemoglobin level.
As a rule, the medication is administered twice a day. When using, you must adhere to the following rules:
- for the injection, select the upper quadrant of the buttock and a needle five to six centimeters long;
- to prevent leakage of the product, it is necessary to move the tissue one or two centimeters down before the injection;
- After administering the medication, the injection site is pressed with a sterile swab.
Important: Before giving the injection, you must make sure that there is no sediment or impurities in the ampoule. It is prohibited to store an opened bottle for more than a day.
Contraindications and restrictions on use
The main restrictions and contraindications to the use of Ferrum Lek injections include:
- uncontrolled hyperparathyroidism (increased activity of the parathyroid glands that cannot be controlled with medications);
- hemochromatosis, hemosiderosis (conditions in which there is increased level element content in the body);
- sideroachrestic anemia, lead poisoning anemia, hemoglobin filling disorders;
- hypersensitivity to the composition of the drug;
- cirrhosis of the liver, accompanied by proliferation of connective tissue;
- kidney infections;
- pregnancy (only in the first trimester);
- anemia not caused by iron deficiency;
- telangiectasia of hereditary form.
Under the supervision and supervision of a physician, it is possible to use Ferrum Lek for asthma, polyarthritis, serious illnesses of cardio-vascular system, lack folic acid. The medication is prescribed to children under four months of age on an individual basis and there are no restrictions on use.
Features and rules of use
Before starting treatment, it is important to carefully study the instructions and take into account the nuances and features of using the product:
- injections are allowed to be given only in hospital settings;
- before prescribing a course of treatment mandatory are carried out laboratory research on the level of iron, ferritin and hemoglobin in general;
- It is important to observe precautions: when using the solution together with angiotensin-converting enzyme inhibitors, reactions caused by iron are likely to occur;
- abnormal impairment of iron absorption should be excluded before a course of therapy;
- the solution should be used only in its original form; mixing the composition with other medications is prohibited;
- taking oral medications containing iron components is allowed only five days after the last injection;
- The simultaneous use of injections and iron medications for oral administration is prohibited.
The consumption of alcoholic beverages during therapy is permitted. However, it is not recommended to take too much of the product.
Use during pregnancy and lactation
During pregnancy in the initial stages of gestation (first trimester), the use of Ferrum Lek is prohibited. In other cases, including the period of breastfeeding, the medication is permitted conditionally. As a rule, it is prescribed in situations where possible benefit for the mother exceeds the expected harm for the child. Therapy problems are discussed with the attending physician.
Side effects
Serious excess of the dosage leads to an acute overload of iron in the body. In cases of overdose, it is carried out symptomatic treatment, including intravenous injections Deferoxamine. The dosage of the drug is calculated for each case individually.
In other situations, the following negative reactions of the body to injections are possible:
- Digestion: nausea, vomiting, abdominal pain, disturbance digestive processes, change in stool.
- Immunity: enlargement and inflammation of the lymph nodes, anaphylactoid reactions, delayed reactions (fever, arthralgia), rashes on the skin.
- Central nervous system: dizziness, disturbance taste sensations, convulsions, migraines, loss of consciousness, paresthesia.
- System respiratory organs: shortness of breath, bronchospasms.
- Cardiovascular system: abnormal changes heart rate, surges and changes in blood pressure.
- Musculoskeletal system: acute joint pain, myalgia.
In addition, there may be general malaise and deterioration in well-being, increased fatigue, sweating, hot flashes, and fever. In rare severe cases, abscesses, bleeding, tissue necrosis, changes in the color of the dermis occur at the injection site, pain syndrome. As a rule, such reactions are characteristic of a violation of the technology for administering drugs intramuscularly.
Analogues of Ferrum Lek solution
In the event that treatment using the drug Ferrum Lek is impossible, it is recommended to replace it with similar medications. IN liquid form the following means are used:
- Maltofer. average price per package - two hundred and forty rubles. The active component of the composition is ferric hydroxide polymaltosate. The medication is used in severe situations that provoke iron deficiency, and also as a prophylactic for children and pregnant women.
- Fenyuls Complex. Cost - from one hundred rubles per box. The main component is a complex of ferric hydroxide with polymaltose. Prescribed for severe iron deficiency, as well as for its prevention.
- Cosmopher. The price per package is from three and a half thousand rubles. The main substance of the composition is ferric hydroxide dextran. The medication is used in cases of individual intolerance to iron medications taken orally.
- Venofer. The cost is from two and a half thousand rubles in Russian pharmacies. The main component is ferric hydroxide sucrose complex. The product is used for quick recovery normal level element in the body with severe anemia, as well as with damage to the gastrointestinal tract that prohibits oral administration of medications.
Important: The selection and replacement of similar medications can only be carried out by the attending physician.
Conclusion
Ferrum Lek in solution form – effective drug to eliminate iron deficiency in the body in non-trivial emergency situations. The medication is a potent medicine, which is important to use only as prescribed by a doctor. Despite large list contraindications and possible adverse reactions the use of this drug can improve the patient’s condition quickly and effectively if this is really necessary.
Description
Brown is not clear solution.
Compound
Each ampoule (2 ml) contains 100 mg of iron (III) in the form of a complex compound of dextran with iron (III) hydroxide.
Excipients: sodium hydroxide, hydrochloric acid (to adjust pH), water for injection.
Pharmacological group
Antianemic drugs. Products based on ferric iron for parenteral administration.
ATX code: B03AC.
Pharmacological properties
Pharmacodynamic properties
After intramuscular administration, part of the iron (III) hydroxide is stored in the form of ferritin, formed in liver mitochondria. Ferritin consists of a protein shell - apoferritin, in which iron is in the form of hydrated micelles of iron oxide phosphate.
Iron transport in plasma is carried out using beta-globulin transferrin, synthesized in the liver. Each transferrin molecule binds two iron atoms. Iron, in combination with transferrin, is transported to the body's cells, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. Transferrin also plays an indirect role in protecting the body against infections.
After parenteral administration of a complex compound of dextran with iron (III) hydroxide, the hemoglobin concentration increases faster than after oral administration of iron (II) salts, despite the fact that the kinetics of iron absorption does not depend on the method of its administration.
The complex of dextran with iron (III) hydroxide is quite large in size and therefore is not excreted through the kidneys. The resulting complex compound is stable and does not release iron ions under physiological conditions. Iron in polynuclear nuclei is bound in a structure similar to that of ferritin under physiological conditions.
Available data support the view that Ferrum Lek provides the same physiological changes that are observed with the natural absorption of iron.
Pharmacokinetic properties
After intramuscular administration, the complex compound of dextran with iron (III) hydroxide is absorbed mainly in the lymphatic system and penetrates the circulating blood system after 3 days. Despite the lack of data on bioavailability, it is known that a relatively large part of the intramuscularly administered dextran complex with iron (III) hydroxide is not absorbed into muscle tissue even after a longer period of time. The biological half-life of the complex compound of dextran with iron (III) hydroxide is 3-4 days.
The macromolecular complex of dextran with iron (III) hydroxide is captured by the reticuloendothelial system and breaks down into components - iron and dextran. The iron then binds to ferritin and, to a lesser extent, to transferrin. This iron is then used in the bone marrow to synthesize hemoglobin, i.e. participates in erythropoiesis.
Dextran is either metabolized or excreted.
Iron is excreted in small quantities.
Preclinical Safety Data
Iron dextran has been reported to be teratogenic and embryocidal in non-anemic pregnant animals at high single doses above 125 mg/kg. The highest recommended dose in clinical use is 20 mg/kg. However, detailed information about these studies is not available.
In vitro And in vivo genotoxicity studies have shown mutagenic activity after administration of high doses of dextran iron complexes. However, the significance of these results is unclear. The dextran iron complex was not mutagenic when administered at subtoxic doses.
Indications
Treatment of all forms of iron deficiency when oral iron supplements are ineffective and/or not tolerated by patients.
Contraindications
Hypersensitivity to the active substance or auxiliary components of the drug;
- anemia not associated with iron deficiency;
- iron overload or hereditary disorders of iron utilization;
- history of severe hypersensitivity reactions to other iron-based drugs for parenteral administration.
Precautionary measures
Parenteral administration of iron may cause hypersensitivity reactions, including severe and potentially fatal anaphylactic/anaphylactoid reactions. There are reports of the occurrence of hypersensitivity reactions after administration of parenteral iron complexes, which previously occurred without complications.
The risk of hypersensitivity reactions increases in patients with known allergies, including drug allergies, severe asthma, eczema, or a history of other atopic allergies.
There is also an increased risk of hypersensitivity reactions to parenteral iron in patients with immune or inflammatory diseases (eg, systemic lupus erythematosus, rheumatoid arthritis).
This drug should only be administered by personnel trained to recognize anaphylactic reactions and provide emergency care in settings where full resuscitation equipment is available. Adverse reactions in each patient should be assessed for at least 30 minutes after each administration of the drug. If hypersensitivity reactions or signs of intolerance occur when using the drug, treatment should be stopped immediately. Cardiopulmonary resuscitation and equipment to manage acute anaphylactic/anaphylactoid reactions, including 1:1000 epinephrine injection, should be available. If necessary, additional treatment with antihistamines and/or corticosteroids should be prescribed.
In patients with impaired liver function, parenteral iron administration should only be performed after a careful assessment of the risk/benefit ratio. And in patients with impaired liver function, where the provoking factor is iron overload, it should be avoided. To avoid iron overload, it is recommended that iron levels be carefully monitored.
Parenteral iron should be administered with caution in acute or chronic infections. In case of bacteremia, this drug is discontinued. In patients with chronic infection, the benefit-risk ratio must be assessed.
Hypotensive reactions may occur if intramuscular administration is too rapid. In the case of intramuscular administration of iron-carbohydrate complexes, the risk of carcinogenesis cannot be excluded. Such complications were found in experimental settings of sarcoma reproduction, where in animal studies intramuscular and subcutaneous injections of iron-carbohydrate complexes led to the development of sarcomas in rats, mice, rabbits and hamsters, but not in guinea pigs. Accumulated information and independent assessments show that the risk of developing sarcoma in humans is minimal. The long latency period between a potentially carcinogenic injection and the appearance of a tumor makes it impossible to accurately assess the risk to humans.
Adverse reactions that occur after the administration of iron supplements can lead to increased cardiovascular complications in patients with pre-existing cardiovascular pathology.
Due to lack of experience, the use of intramuscular injections of Ferrum Lek in children under 4 months is not recommended.
Pregnancy and lactation
Pregnancy
Based on a moderate amount of data (300-1000 pregnancies), there were no adverse effects of parenteral iron supplements on the mother or newborn when used by women in the second and third trimester of pregnancy.
Adequate and well-controlled trials of the effectiveness and safety of the drug in pregnant women have not been conducted. Therefore, a careful benefit/risk assessment is required before using Ferrum Lek during pregnancy and it should not be used during pregnancy unless clearly necessary (see Precautions). To treat iron deficiency anemia that occurs in the first trimester of pregnancy, oral iron supplements can be used in many cases. Treatment with Ferrum Lek should be limited to the second and third trimesters if the benefits outweigh the potential risks to both mother and fetus.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Preclinical Safety Data).
Lactation
Preclinical data do not indicate direct or indirect harmful effects in breast-fed infants.
Impact on the ability to drive vehicles and machinery
The use of Ferrum Lek does not affect the ability to drive vehicles or operate machinery.
However, if symptoms such as dizziness, confusion, and lightheadedness occur after using this drug, the patient should not drive or operate machinery until they disappear completely.
Interaction with other drugs
This drug should not be prescribed simultaneously with oral iron supplements, since the absorption of the latter will be reduced. Therapy with iron preparations for oral administration should begin no earlier than 5 days after the last parenteral administration of iron.
High doses of iron dextran (5 ml or more) cause serum samples taken four hours after iron dextran administration to turn brown. The drug may cause a false increase in bilirubin concentration and a false decrease in serum calcium concentration.
Directions for use and doses
During and after each administration of this drug, carefully monitor for signs and symptoms of hypersensitivity reactions.
This drug should only be administered by personnel trained to recognize anaphylactic reactions and provide emergency care in an environment where resuscitation can be performed. Adverse reactions should be assessed for at least 30 minutes after each administration of the drug.
This drug can only be administered intramuscularly. It cannot be used for intravenous administration, either by injection or by infusion.
Dose calculation
Iron replenishment for iron deficiency anemia
Doses of Ferrum Lek must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula:
total iron deficiency (mg)= body weight (kg) x (target hemoglobin level (g/l) - actual hemoglobin level (g/l)) x 0.24* + deposited iron (mg)
Body weight up to 35 kg: target hemoglobin level = 130 g/l and stored iron = 15 mg/kg body weight
Body weight 35 kg or more: target hemoglobin level = 150 g/l and stored iron = 500 mg
*Coefficient 0.24 = 0.0034 x 0.07 x 1000
(Iron content in hemoglobin = 0.34%; total blood volume = 7% of body weight; factor 1000 = conversion from grams to milligrams).
Example:
Patient body weight: 70 kg
Actual hemoglobin level: 80 g/l
Total iron dose = 70 x (150 - 80) x 0.24 + 500 = 1700 mg iron.
Total number of Ferrum Lek ampoules to be administered = total iron deficiency (mg) / 100 mg
Table: total dose of Ferrum Lek in milliliters (number of ampoules) to be administered, based on actual hemoglobin level and body weight
|
Body mass |
The total dose of Ferrum Lek in milliliters (number of ampoules) to be administered: |
|||
| Hb 60 g/l | Hb 75 g/l | Hb 90 g/l | Hb 105 g/l | |
| 5 | 3 (1,5) | 3(1,5) | 3 (1,5) | 2(1,0) |
| 10 | 6 (3,0) | 6(3,0) | 5 (2,5) | 4(2,0) |
| 15 | 10 (5,0) | 9 (4,5) | 7(3,5) | 6 (3,0) |
| 20 | 13 (6,5) | 11(5,5) | Yu (5.0) | 8 (4,0) |
| 25 | 16(8,0) | 14 (7,0) | 12 (6,0) | 11(5,5) |
| 30 | 19(9,5) | 17 (8,5) | 15 (7,5) | 13 (6,5) |
| 35 | 25 (12,5) | 23 (11,5) | 20 (10,0) | 18 (9,0) |
| 40 | 27(13,5) | 24 (12,0) | 22(11,0) | 19 (9,5) |
| 45 | 30 (15,0) | 26 (13,0) | 23(11,5) | 20 (10,0) |
| 50 | 32 (16,0) | 28 (14,0) | 24 (12,0) | 21 (10,5) |
| 55 | 34 (17,0) | 30 (15,0) | 26(13,0) | 22(11,0) |
| 60 | 36 (18,0) | 32 (16,0) | 27(13,5) | 23 (11,5) |
| 65 | 38 (19,0) | 33 (16,5) | 29(14,5) | 24 (12,0) |
| 70 | 40 (20,0) | 35 (17,5) | 30(15,0) | 25 (12,5) |
| 75 | 42 (21,0) | 37(18,5) | 32 (16,0) | 26 (13,0) |
| 80 | 45 (22,5) | 39(19,5) | 33 (16,5) | 27 (13,5) |
| 85 | 47 (23,5) | 41 (20,5) | 34 (17,0) | 28 (14,0) |
| 90 | 49 (24,5) | 43 (21,5) | 36(18,0) | 29 (14,5) |
Calculation of the total dose for iron replacement due to blood loss
The dose of Ferrum Lek to compensate for post-hemorrhagic iron deficiency is calculated using the following formula:
if the amount of lost blood is known: administration of 200 mg IM (4 ml or 2 ampoules of Ferrum Lek) leads to an increase in hemoglobin level, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l)
Amount of iron to be replaced (mg) = number of units of blood lost x 200
or
Ferrum Lek volume in milliliters (number of ampoules) = number of lost units of blood x 4 (x 2);
if a reduced hemoglobin level is known, use the following formula, taking into account that deposited iron does not need to be replaced:
iron to be replaced (mg) = body weight (kg) x (target hemoglobin level (g/l) - actual hemoglobin level (g/l)) x 0.24
For example, a patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1 1/2 ampoules of Ferrum Lek (3 ml).
Usual daily doses
Children from 4 months of life: 0.06 ml Ferrum Lek/kg body weight/day (3 mg iron/kg/day).
Adults and elderly patients: 1-2 ampoules of Ferrum Lek (100-200 mg iron), depending on the hemoglobin level.
If there are no adverse reactions, the drug is administered according to an individually selected regimen until the total required dose is reached.
The daily dose should generally not exceed 0.5 ml (25 mg iron) for children weighing up to 5 kg, 1.0 ml (50 mg iron) for children weighing up to 10 kg and 2.0 ml (100 mg iron) for other patients.
If the calculated total dose of Ferrum Lek to be administered exceeds the maximum daily dose, it should be divided over several days and administered daily to active patients or 1-2 times a week to inactive/immobilized patients.
Directions for use/handling and administration
| Improper storage of ampoules can lead to sedimentation. The ampoules should be carefully inspected before use. You can only use ampoules that contain a homogeneous solution without sediment. If sediment appears in the ampoules or the shelf life has expired, they must be destroyed. An opened ampoule should be used immediately. The contents of Ferrum Lek ampoules should not be mixed with other medications. To avoid pain and discoloration of the skin, it is very important to administer intramuscular injections carefully and correctly. Ferrum Lek is injected only intramuscularly (in no case intravenously!) deep into the gluteal muscle, alternating between the right and left. Intramuscular injections of Ferrum Lek are carried out in the upper outer quadrant of the gluteal muscle. The minimum needle length for adults is 50 mm, for overweight patients - from 80 to 100 mm, for children - 32 mm. Before injection, the skin should be disinfected and moved down 2 cm to reduce the leakage of medication after injection. After injection, the skin is released and the injection site is held under pressure for 1 minute. If the patient is standing during the injection, he should shift his weight to the leg opposite the injection site; if lying down, he should lie in a lateral position on the side opposite the injection site. |
Adverse reactions that have been reported following the administration of parenteral iron supplements in clinical trials and spontaneously in post-marketing settings.
Immune system disorders
Uncommon: hypersensitivity reactions.
Frequency unknown 1: anaphylactoid reactions, including shortness of breath, urticaria, rash, itching, nausea and chills; angioedema.
Acute severe anaphylactoid reactions (sudden difficulty breathing and/or acute cardiovascular failure); there are reports of deaths.
Severe delayed reactions characterized by arthralgia, myalgia and sometimes fever have been described.
Nervous system disorders
Common: dysgeusia.
Uncommon: blurred vision, numbness, headache, dizziness, paresthesia, hypoesthesia.
Rarely: paroxysm, anxiety, fainting, drowsiness.
Frequency unknown 1: depressed state of consciousness, confusion, loss of consciousness, anxiety, tremors, convulsions.
Disorders of the hearing organ and labyrinth
Very rare: temporary deafness.
Blood and lymphatic system disorders
Very rare: hemolysis, lymphadenopathy.
Frequency unknown: leukocytosis.
Heart disorders
Rarely: arrhythmia, palpitations.
Frequency unknown 1: tachycardia, bradycardia, heart failure.
Vascular disorders
Common: arterial hypertension, arterial hypotension.
Uncommon: hot flashes, vascular insufficiency.
Frequency unknown 1: vascular insufficiency.
Disorders of the respiratory system, chest and mediastinal organs
Uncommon: shortness of breath.
Frequency unknown 1: bronchospasm.
Gastrointestinal disorders
Common: nausea.
Uncommon: vomiting, abdominal pain, diarrhea, constipation.
Skin and subcutaneous tissue disorders
Uncommon: itching, rash.
Frequency unknown 1: urticaria, erythema.
Muscle, skeletal and connective tissue disorders
Uncommon: muscle spasms, myalgia, arthralgia, pain in the limbs, back pain.
Renal and urinary tract disorders
Rarely: chromaturia.
General disorders and reactions at the injection site
Common: reactions at the injection site 2.
Uncommon: fever, chills, asthenia, fatigue, peripheral edema, pain, phlebitis, thrombophlebitis.
Rarely: chest pain, hyperhidrosis, pyrexia.
Frequency unknown 1: cold sweat, malaise, pallor, thrombophlebitis, pain and burning at the injection site.
Laboratory and instrumental data
Uncommon: increased levels of alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, serum ferritin.
Rarely: increased blood lactate dehydrogenase levels.
1 Spontaneous reports in the post-marketing period.
2 The most commonly reported local complications with IV/IM administration include pain, irritation, reaction, staining, hematoma, and burning at the injection site.
Reports of adverse reactions
It is important to report suspected adverse reactions after drug approval to ensure ongoing benefit-risk monitoring. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse reaction and drug failure reporting systems.
To the patient, if he experiences any unwanted reactions, you should consult your doctor. This recommendation applies to any adverse reactions, including those not listed in the package insert. By reporting adverse reactions, you can help provide more information about the safety of the drug.
Manufacturer information
Lek d.d., Verovshkova 57, Ljubljana, Slovenia.
Compound
Active ingredient: 100 mg of iron in the form of polymaltose iron hydroxide complex.
Excipients: dextrates, macrogol 6000, aspartame E951, chocolate essence, talc.
Description
White-brown marbled, round, flat tablets with beveled edges.
Pharmacotherapeutic group
Antianemic drugs. Products based on ferric iron for oral administration.
ATX code: В03АВ05.
Pharmacological properties
Pharmacodynamics
Iron is present in all cells of the body and is necessary for the functioning of enzymes that control vital processes. The administration of iron supplements reduces erythropoiesis disorders caused by iron deficiency.
Polynuclear iron hydroxide molecules are surrounded by non-covalently bound polymaltose molecules, which altogether constitute a complex with a molecular weight of approximately 50 kDa, which, due to its size, passes through the membrane of the mucous membranes by a simple diffusion mechanism 40 times less than the hexaaqueous iron ion. The complex is stable and does not release iron ions under physiological conditions.
The structure of the complex is similar to the structure of ferritin, a natural iron-storing protein found in the body. Due to this similarity, iron from this complex is absorbed through the process of active absorption. Any iron-binding protein in the gastrointestinal juice and on the surface of the epithelium can take up iron through a mechanism of competitive ligand exchange. Absorbed iron is mainly stored in the liver in combination with ferritin, then in the bone marrow it is incorporated into hemoglobin.
The complex of iron hydroxide and polymaltose does not have the pro-oxidant properties inherent in ferrous iron salts. The sensitivity of very low and low density lipoproteins to oxidizing factors is therefore reduced.
Ferrum Lek® in tablet form does not stain teeth.
Pharmacokinetics
Using the twin isotope method (55Fe and 59Fe), it was revealed that iron absorption, determined by the level of hemoglobin in erythrocytes, is inversely proportional to the administered dose (the higher the dose, the lower the level of absorption). There is a statistically significant inverse correlation between the degree of iron deficiency and the amount of absorbed iron (the higher the iron deficiency, the better the iron absorption). The highest level of absorption is observed in the duodenum and jejunum. The absorption of ferric iron complex is a controlled process. When using the drug Ferrum Lek®, the degree of absorption is about 10%. The bioavailability of iron from iron hydroxide polymaltose complex is worse, at least at the beginning of treatment, than from iron supplements.
The increase in serum iron levels after administration does not correlate with total absorption measured in red blood cells. Iron accumulates mainly in the liver, where it binds to ferritin and is incorporated into the hemoglobin structure in the bone marrow.
Unabsorbed iron is excreted in the feces. The amount of iron excreted from the body along with exfoliated epithelial cells of the gastrointestinal tract and skin, as well as with sweat, bile and urine, is about 1 mg per day. In women, iron loss through menstrual blood should also be taken into account.
Indications for use
Treatment latent deficiency gland.
Treatment of iron deficiency anemia (manifest iron deficiency).
Contraindications
Hypersensitivity to the active or excipients of the drug;
excess iron (eg, hemochromatosis, hemosiderosis) and disorders of iron utilization (eg, lead anemia, sideroachrestic anemia, thalassemia);
anemia not due to iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency).
Precautionary measures
Anemia should always be treated under medical supervision. If there is no effect (increase in hemoglobin level by approximately 20-30 g/l after 3 weeks), the treatment plan should be reconsidered.
Caution should be exercised when prescribing the drug to patients who have received multiple blood transfusions, since red blood cells carry iron, which can lead to iron oversaturation.
Anemia can be caused by infections or neoplasms. Since iron begins to be fully absorbed by the body only after the underlying disease has been cured, an assessment of the risk-benefit ratio is required.
Due to the fact that doses for children under 12 years of age are lower than for adults, they are prescribed syrup instead of tablets.
When taking the drug, stool may turn dark, which has no clinical significance.
Information for patients with diabetes: one tablet contains 0.04 bread units.
The drug contains aspartame E 951 (precursor of phenylalanine), in the amount of 1.5 mg per tablet. The substance may have harmful effects in patients with phenylketonuria.
Pregnancy and breastfeeding
Pregnancy
According to clinical studies on the use of the drug Ferrum Lek® in the second and third trimesters of pregnancy, no undesirable effects of the drug on the body of the mother and (or) newborns were noted. Animal studies have not shown any risk to the mother, embryo or fetus. Use during pregnancy, however, should be considered with caution.
Lactation
Breast milk normally contains iron bound to lactoferrin. It is unknown how much iron hydroxide in combination with polymaltose passes into breast milk. It is unlikely that taking Ferrum Lek® by nursing women can cause adverse reactions in infants.
As a precaution for women of childbearing potential and women during pregnancy or breastfeeding the use of Ferrum Lek® is recommended only after consultation with a doctor to assess the benefit/risk ratio.
Impact on the ability to drive vehicles and operate machinery
No relevant studies have been conducted. However, it is unlikely that Ferrum Lek® has any effect on the ability to drive a vehicle or use machinery.
Doses and method of administration
For oral administration. Take during or immediately after meals. The tablet can be chewed or swallowed whole.
The daily dose can be taken at one time or divided into several doses.
The dose of the drug and duration of administration depend on the degree of iron deficiency.
Manifest iron deficiency
The dose and duration of treatment depend on the degree of iron deficiency. Treatment of iron deficiency anemia continues until the hemoglobin (Hb) value normalizes, then for several more weeks at a dose corresponding to the dose for the treatment of latent (latent) iron deficiency (without anemia) to replenish iron stores, an average of 3-5 months.
Children 0-12 years old:
usually 1 – 3 chewable tablets per day (100 – 300 mg).
Latent iron deficiency
Treatment takes about one to two months.
Children under 1 year: Due to the prescription of very low doses, the drug in the form of tablets or syrup is not used for this indication.
Children from 1 to 12 years: take the drug in syrup form.
Children over 12 years old, adults: 1 chewable tablet per day (100 mg).
Table: Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency
If you forget to take Ferrum Lek® on time, continue taking the drug as usual. Do not take a double dose to make up for a separate missed dose.
Side effect
The safety and tolerability of iron were assessed based on a meta-analysis of 24 publications or clinical trial reports involving 1473 patients. The major adverse reactions that were reported in these studies occurred in 4 systemic organ classes.
Discoloration of stool is a well-known adverse drug reaction of oral iron supplements (affecting 23% of patients), but is not clinically significant. Other commonly reported side effects were gastrointestinal symptoms (nausea, constipation, diarrhea and abdominal pain).
The incidence of adverse reactions is determined as follows:
very common (≥1/10), frequent (≥1/100 and<1/10), нечастые (≥1/1 000 и <1/100), редкие (≥1/10 000 и <1/1 000), очень редкие (<1/10 000), частота неизвестна (не может быть оценена на основе имеющихся данных).
Immune system disorders
Very rare: allergic reactions.
Nervous system disorders
Uncommon: headache.
Gastrointestinal disorders
Very common: change in stool color 1.
Common: abdominal pain, constipation, diarrhea, nausea, dyspepsia.
Uncommon: vomiting 3, tooth staining, gastritis.
Skin and subcutaneous tissue disorders
Uncommon: itching, rash 5,6, urticaria 6, erythema 6.
Muscle, skeletal and connective tissue disorders
Rare: muscle spasms 4, myalgia.
1 “Change in stool color” occurred with less frequency in the meta-analysis but is a well-known drug effect of oral iron therapy in general. Therefore, it was classified as a “very common” adverse event.
2 Includes: abdominal pain, dyspepsia, epigastric discomfort, bloating.
3 Includes: vomiting, regurgitation.
4 Includes: involuntary muscle contraction, tremors.
5 Includes: rash, macular rash, vasicular rash.
6 Reactions reported post-marketing, estimated incidence<1/491 пациентов (верхний предел 95% доверительного интервала).
Adverse events based on post-marketing spontaneous reporting
No additional adverse drug reactions were identified.
Influence on the results of laboratory and instrumental studies
No data available.
Reporting Adverse Reactions
It is important to report suspected adverse reactions after drug approval to ensure ongoing benefit-risk monitoring. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse reaction and drug failure reporting systems.
The patient should consult a doctor if he experiences any adverse reactions. This recommendation applies to any adverse reactions, including those not listed in the package insert. By reporting adverse reactions, you can help provide more information about the safety of the drug.
The drug does not affect the results of the test for the presence of occult blood (selective hemoglobin test), so there is no need to stop treatment for the test.
Concomitant use with other parenteral or oral dosage forms of iron should be avoided, as this leads to a significant reduction in the absorption of iron taken orally.
Studies in rats with tetracycline, aluminum, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillinamine, methyldopa, acetaminophen and auranofin showed no interaction with iron(III) hydroxide polymaltose complex.
In addition, there is no interaction of iron (III), polymaltose complex hydroxide with food components such as phytic acid, oxalic acid, tannin, sodium malginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean flour in in vitro studies. These results indicate that iron(III) hydroxide polymaltose complex can be taken during or immediately after meals.
The interactions of iron(III) hydroxide polymaltose complex with tetracyclines or aluminum hydroxide were investigated in three human trials (crossover study, 22 patients per study). No significant reduction in tetracycline absorption was observed. Plasma tetracycline concentrations did not fall below the minimum inhibitory concentration required for bacteriostasis. Iron absorption from iron(III) hydroxide polymaltose complex was not reduced when coadministered with aluminum hydroxide and tetracycline. Therefore, iron (III) hydroxide polymaltose complex can be taken simultaneously with tetracyclines or other phenolic compounds and aluminum hydroxide.
Dispensed by prescription.
Manufacturer information
Lek d.d., Verovshkova 57, Ljubljana, Slovenia.
Produces: Lek d.d., Verovškova 57, Ljubljana, Slovenia under license from Vifor (International) Inc., St. Gallen, Switzerland.
Read these instructions carefully before you start using this medicine. Save the instructions, you may need them again.
If you have any questions, consult your doctor. This medicine is for you personally and should not be given to others because it may harm them even if they have the same symptoms as you.
Registration number:
Trade name of the drug:
Ferrum Lek ®.
International nonproprietary name or generic name:
iron (III) hydroxide polymaltosate.
Dosage form
Compound
5 ml of syrup (1 measuring spoon) contains:
Active substance: iron 50.0 mg (corresponding to 200.00 mg of iron (III) hydroxide polymaltosate).
Excipients: sucrose – 1,000 g; sorbitol (solution) – 2,000 g; methyl parahydroxybenzoate – 2.915 mg; propyl parahydroxybenzoate – 0.830 mg; ethanol – 16.250 mg; cream flavoring – 15,000 mg; sodium hydroxide – up to pH 5.0-7.0; water – up to 5 ml.
Description
Transparent brown solution.
Pharmacotherapeutic group
Antianemic agent. Iron supplement.
ATX code: В03АВ05.
Pharmacological properties
Pharmacodynamics
The molecular mass of the complex is so large - about 50 kDa - that its diffusion through the mucous membrane of the gastrointestinal tract is 40 times slower than the diffusion of ferrous iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multinuclear active zones of the complex is bound into a structure similar to the structure of the natural iron compound - ferritin. Due to this similarity, the iron (III) of this complex is absorbed only by active absorption. Iron-binding proteins, located on the surface of the intestinal epithelium and in gastrointestinal fluid, absorb iron (III) from the complex through competitive ligand exchange. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow it is incorporated into hemoglobin.
The polymaltose complex of iron (III) hydroxide, unlike iron (II) salts, does not have pro-oxidant properties. The sensitivity of lipoproteins (eg, very low-density lipoproteins and low-density lipoproteins) to oxidation is reduced.
Pharmacokinetics
Studies using the dual isotope method (55 Fe and 59 Fe) have shown that iron absorption, measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). Maximum absorption of iron occurs in the duodenum and jejunum. Unabsorbed iron is excreted in the feces. Its excretion in exfoliated epithelial cells of the gastrointestinal tract and skin, as well as in sweat, bile and urine is approximately 1 mg of iron per day.
Women experience additional iron loss during menstruation, which must be taken into account.
Indications for use
Treatment of latent iron deficiency;
treatment of iron deficiency anemia;
prevention of iron deficiency during pregnancy.
Contraindications for use
Hypersensitivity to the components of the drug,
iron overload in the body (for example, in cases of hemochromatosis, hemosiderosis);
impaired iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia, thalassemia);
anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
rare hereditary forms of fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase deficiency (since the drug contains sucrose and sorbitol).
Carefully
Patients with diabetes.
Use during pregnancy and lactation
In controlled studies in pregnant women (2nd and 3rd trimesters of pregnancy), no negative effects on the mother and fetus were noted. Not found harmful effects on the fetus when taking drugs in the first trimester of pregnancy.
When a nursing mother uses the drug, only a small part of the iron from its complex with polymaltose enters breast milk; therefore, adverse effects are unlikely to occur in breastfed infants.
Directions for use and doses
Inside. It is recommended to take the drug during or immediately after meals. Ferrum Lek ® syrup can be mixed with fruit or vegetable juices or added to baby food. The daily dose can be divided into several doses.
The measuring spoon included in the package is used for precise dosing of Ferrum Lek ® syrup.
Doses and duration of treatment depend on the degree of iron deficiency.
Latent iron deficiency
The duration of treatment is about 1-2 months.
Children under 1 year of age:
Due to the low dosage, the use of syrup for this indication is impossible.
Children from 1 to 12 years old
2.5-5 ml (1/2-1 scoop) Ferrum Lek ® syrup per day.
Iron-deficiency anemia
The duration of treatment is about 3-5 months. After normalization of hemoglobin concentration, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under 1 year of age
The initial dose of Ferrum Lek ® syrup is 2.5 ml (1/2 measuring spoon) per day. The dose is gradually increased to 5 ml (1 scoop) of Ferrum Lek ® syrup per day.
Children from 1 to 12 years old
5-10 ml (1-2 scoops) of Ferrum Lek ® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
10-30 ml (2-6 scoops) of Ferrum Lek ® syrup per day.
Pregnant women
Latent iron deficiency 10 ml (2 measuring spoons) of Ferrum Lek ® syrup per day.
Preventing iron deficiency
5-10 ml (1-2 measuring spoons) Ferrum Lek ® syrup per day
Iron-deficiency anemia 20-30 ml (4-6 scoops) of Ferrum Lek ® syrup per day until the hemoglobin concentration normalizes. After this, you should continue to take 10 ml (2 scoops) of Ferrum Lek ® syrup per day, at least until the end of pregnancy to replenish iron reserves in the body.
Daily doses of Ferrum Lek ® syrup for the prevention and treatment of iron deficiency in the body
Side effect
Ferrum Lek ® is generally well tolerated. Side effects are predominantly mild and transient.
According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000) и очень редко (<1/10000); частота неизвестна – по имеющимся данным установить частоту возникновения не представлялось возможным.
From the gastrointestinal tract
very rarely: abdominal pain, nausea, constipation, diarrhea, dyspepsia, vomiting, change in color of feces (due to the excretion of unabsorbed iron, has no clinical significance).
From the skin and subcutaneous tissue
very rarely: hives, rash, itching skin.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects, not specified in the instructions - inform your doctor about this.
Overdose
In case of an overdose of Ferrum Lek ®, there were no signs of intoxication or excess iron in the body, since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.
Interaction with other drugs
No interactions with other drugs or food products have been identified.
Concomitant use of polymaltosate hydroxide with parenteral iron preparations and other oral iron (III) preparations is not recommended due to the pronounced inhibition of the absorption of orally administered iron.
special instructions
Ferrum Lek ® syrup does not stain tooth enamel.
In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the underlying disease has been cured.
When using the drug Ferrum Lek ®, the stool may turn dark, which does not have any clinical significance. The drug Ferrum Lek ® does not affect the results of the occult blood test (selective for hemoglobin); therefore, it is not necessary to interrupt iron therapy.
Due to the low dosage, Ferrum Lek ® should not be used in children under 1 year of age to treat latent iron deficiency.
Note for diabetic patients: 1 ml of Ferrum Lek ® syrup contains 0.04 XE.
Impact on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions
Ferrum Lek ® does not affect the ability to drive a car or operate machinery that requires increased concentration.
Special precautions when disposing of unused drugs
Not applicable.
Release form
Syrup 50mg/5ml
Primary packaging
Lek d.d., Slovenia
100 ml of syrup in dark glass bottles with or without a 100 ml graduated level, sealed with a metal screw cap with a first-opening control ring and a polyethylene gasket inside.
Sandoz Ilac Sanai ve Ticaret A.S., Türkiye
100 ml of syrup in dark glass bottles with or without a graduated level of 100 ml, sealed with a polyethylene screw cap with a first-opening control ring and a polyethylene seal inside.
Secondary packaging
One bottle in a cardboard box along with instructions for use, a measuring spoon with ring marks in the cavity for 2.5 ml and 5 ml (“2.5 SS” and “5 SS”, a maximum filling mark of 6 ml (“6 SS” ) on the handle of a spoon.
Storage conditions
At a temperature not higher than 25°C.
Keep out of the reach of children.
Best before date
3 years.
Do not use the drug after the expiration date.
Vacation conditions
On prescription.
Manufacturer
1. Lek d.d., Verovshkova 57, 1526, Ljubljana, Slovenia.
2. Sandoz Ilach Sanai Ve Tijaret A.S., Gebze Plasticchiler Organize
Sanay Bolgezi, Ataturk Boulevard 9, ca. No. 1, 41400 Gebze Kocaeli, Türkiye
Consumer complaints should be sent to Sandoz CJSC:
125315, Moscow, Leningradsky Prospekt, 72, bldg. 3.
