Instructions for medical use

medicine

Ferrum Lek®

Trade name

Ferrum Lek®

International nonproprietary name

Dosage form

Syrup 50 mg/5 ml, 100 ml

Compound

5 ml syrup contains (1 scoop)

active substance - iron (in the form of iron (III) hydroxide polymaltose complex) 50.00 mg,

excipients: sucrose, liquid sorbitol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethyl alcohol 96%, cream essence, purified water, sodium hydroxide.

Description

Clear liquid brown

Pharmacotherapeutic group

Hematopoiesis stimulants. Iron supplements. Iron preparations (trivalent) for oral administration. Iron polyisomaltosate

Code ATX В03АВ05

Pharmacological properties

Pharmacokinetics

Iron in Ferrum Lek® syrup is contained in the form of a complex of iron (III) hydroxide and polymaltose, in which its particles are embedded in polymer carbohydrate molecules (polymaltose). In this form, iron does not have any effect harmful effects on the gastrointestinal tract and does not interact with food. At the same time, the bioavailability of iron also increases. Iron absorption, determined by the level of hemoglobin in red blood cells, is inversely proportional to the administered dose (the higher the dose, the lower the level of absorption). The structure of the complex of iron (III) hydroxide and polymaltose is similar to the structure of ferritin, the natural iron-storing protein found in the body. Due to this similarity, iron (III) from this complex is absorbed through the process of active absorption. Most high level absorption is noted in the duodenum and jejunum. Absorbed iron is mainly stored in the liver in combination with ferritin, then in the bone marrow it is incorporated into hemoglobin. Unabsorbed iron is excreted in feces. The amount of iron excreted from the body along with exfoliated epithelial cells 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 be taken into account.

Pharmacodynamics

Multinuclear molecules of iron (III) hydroxide, in the Ferrum Lek® preparation, are surrounded non-covalently with associated polymaltose molecules, forming a complex with a molecular weight of about 50 kDa, which, due to its size, is 40 times weaker in comparison with divalent iron (II). passes through the membrane of the intestinal mucosa using the mechanism of simple diffusion. The complex is stable, in physiological conditions, iron ions are not released from it.

In the Ferrum Lek® preparation, the complex of iron (III) hydroxide and polymaltose does not have the pro-oxidant properties inherent in salts ferrous iron. The sensitivity of very low and low density lipoproteins to oxidizing factors is therefore reduced.

Iron, which is part of the drug, is deposited in the liver in the form of a complex with ferritin, then included in hemoglobin, thereby quickly replenishing iron deficiency and restoring hemoglobin levels in the body. When treated with the drug, there is a gradual regression of clinical symptoms (weakness, fatigue, dizziness, tachycardia, pain and dryness). skin) And laboratory symptoms iron deficiency.

Indications for use

- treatment of latent iron deficiency anemia

- treatment of iron deficiency anemia (with clinical manifestations)

• iron deficiency during pregnancy

Directions for use and doses

Ferrum Lek® syrup is taken orally, daily dose can be taken simultaneously or divided into several doses.

Ferrum Lek® syrup is given to children during meals or immediately after meals; you can mix it with fruit or vegetable juice in a feeding bottle.

The slight color change does not harm the taste of the juice/baby food or the effectiveness of the product.

Iron deficiency anemia with clinical manifestations

Treatment continues for 3-5 months until hemoglobin levels normalize. After this, the drug is prescribed for several more weeks to replenish iron reserves in the body.

Childrenup to 1 year: the initial dose is 2.5 ml (½ measuring spoon) of Ferrum Lek® syrup, the dose is gradually increased to 5 ml (1 measuring spoon) of syrup per day.

Children from 1 to 12years: 5-10 ml (1-2 measuring spoons) syrup per day.

10-30 ml (2-6 scoops) Ferrum Lek® syrup.

Pregnant women

20-30 ml (4-6 scoops) of Ferrum Lek® syrup per day until hemoglobin levels normalize. After this, the drug is prescribed in a dose of 10 ml (2 scoops) of Ferrum Lek® syrup per day at least until the end of pregnancy to replenish iron reserves in the body.

Latent iron deficiency anemia

Duration of therapy is from 1 to 2 months.

Children under 1 year: are not prescribed due to the low recommended dosage of the drug.

Children from 1 to 12 years: 2.5-5 ml (½-1 scoop) Ferrum Lek® syrup per day.

Children over 12 years old, adults, nursing mothers:

Pregnant women(latent iron deficiency anemia and prevention of iron deficiency)

5-10 ml (1-2 scoops) of Ferrum Lek® syrup per day.

Table: Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency

	Dosage form	Iron deficiency anemia with clinical manifestations	Latent iron deficiency anemia	Prevention
Children under 1 year		(25-50 mg iron)
Children (1-12 years old)		(50-100 mg iron)	(25-50 mg iron)
Children (> 12 years old) Adults Nursing mothers		(100-300 mg iron)	(50-100 mg iron)
Pregnant women		(200-300 mg iron)	(100 mg iron)	(50-100 mg iron)

(--) The dosage is very low, so syrup is not prescribed for this indication.

To dose the syrup correctly, use a measuring spoon.

Side effects

Ferrum Lek® is generally well tolerated by patients. For the most part, unwanted effects were mild and transient.

Very rarely

Abdominal pain, constipation, diarrhea, nausea, stomach pain, dyspepsia, vomiting

Urticaria, rash, exanthema, itching

Contraindications

Increased individual sensitivity to any of the components of the drug

Patients with iron overload (eg, hemochromatosis, hemosiderosis)

Hereditary fructose intolerance or glucose-galactose malabsorption

Disorders of iron utilization (anemia caused by lead intoxication, sideroachrestic anemia, thalassemia)

Anemia not due to iron deficiency ( hemolytic anemia, B12 deficiency megaloblastic anemia)

Drug interactions

So far, no interactions have been observed. Since iron is bound to the complex, there is little likelihood that ionic interaction will occur with food components (phytin, oxalates, tannin, etc.) and concomitantly taken medications (tetracyclines, antacids). Detection test hidden blood(selective for Hb) is not impaired and therefore there is no need to interrupt iron therapy.

Special instructions

Oral medicinal products Ferrum Lek® and other iron preparations may discolor stool dark color. This has no clinical significance.

Ferrum Lek® syrup and chewable tablets do not stain tooth enamel. Note for patients with diabetes: 1 ml of syrup contains 0.04 bread units.

In cases of anemia caused by infection or malignant neoplasm, the replaced iron is stored in the reticuloendothelial system, from which it is mobilized, and is used only after the primary disease has been cured.

Ferrum Lek® syrup contains sucrose and sorbitol. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency should not take this medicine.

Given medicinal product contains small amounts of ethanol, less than 100 mg per 30 ml.

The fillers methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

Pregnancy and lactation

The use of Ferrum Lek®, syrup during pregnancy and lactation is possible only after consultation with a doctor. It is recommended to evaluate the benefit/risk ratio of using the drug.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Does not affect

Overdose

Not identified

Release form and packaging

100 ml of syrup in 125 ml amber glass bottles, closed with a screw-on polyethylene cap, with first opening control. One bottle each, along with a plastic measuring spoon and instructions for medical use in the state and Russian languages, is placed in a cardboard box

Storage conditions

• wound at a temperature not exceeding 25°C. The period of use after opening the bottle is 3 months.

Keep out of the reach of children!

Shelf life

Do not use after expiration date.

Conditions for dispensing from pharmacies

By prescription

Manufacturer/Packager

Sandoz Ilak Sanai ve Ticaret AS, Türkiye

Gebze Plastikler Organize Sanayi Bolgesi,Ataturk Bulvari,9, Cadde No.1

Registration Certificate Holder

Lek Pharmaceuticals d.d., Slovenia

Verovskova, 57, 1526 Ljubljana, Slovenia

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Representative office of JSC Sandoz Pharmaceuticals d.d. in the Republic of Kazakhstan

Almaty, st. Luganskogo 96,

Phone number - 258 10 48, fax: +7 727 258 10 47

Active ingredient

Iron hydroxide polymaltose (iron polymaltose)

Release form, composition and packaging

Chewable tablets dark brown, interspersed with light brown color, round, flat, chamfered.

Excipients: macrogol 6000, aspartame, chocolate flavor, talc, dextrates.

10 pcs. - strips (3) - cardboard packs.

Syrup transparent, brown.

Excipients: sucrose, sorbitol (solution), methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, cream flavor, sodium hydroxide, water.

100 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.

Pharmacological action

Antianemic drug. In the preparation, iron is in the form of a complex compound of iron (III) hydroxide polymaltosate.

The molecular mass of the complex is so large (about 50 kDa) that its diffusion through the gastrointestinal mucosa 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 in this complex is absorbed only through active absorption. Iron-binding proteins located on the surface of the intestinal epithelium 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. Iron (III) complex hydroxide polymaltosate does not have the pro-oxidant properties inherent in iron (II) salts.

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 related to dose taken(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 greater the iron deficiency, the better the absorption). Iron is absorbed to the greatest extent in the duodenum and jejunum. The remaining (unabsorbed) iron is excreted in the feces. Its excretion with exfoliating epithelial cells of the gastrointestinal tract and skin, as well as with sweat, bile and urine is approximately 1 mg of iron/day. Women experience additional iron loss during menstruation, which must be taken into account.

Indications

- treatment of latent iron deficiency;

- treatment of iron deficiency;

- prevention of iron deficiency during pregnancy.

Contraindications

- excess iron content in the body (for example, hemochromatosis);

- disorders of iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia);

- anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by iron deficiency);

— increased sensitivity to the components of the drug.

Dosage

Doses and duration of treatment depend on the degree of iron deficiency.

The syrup can be mixed with fruit or vegetable juices or add to baby food. The measuring spoon included in the package is used for precise dosing of syrup.

At iron deficiency anemia The duration of treatment is about 3-5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.

Children under 1 year of age Prescribe 2.5-5 ml (1/2-1 measuring spoon) of syrup/day.

5-10 ml (1-2 measuring spoons) syrup/day.

1-3 tab. chewing or 10-30 ml (2-6 scoops) syrup/day.

Pregnant women Prescribe 2-3 tablets. chewing or 20-30 ml (4-6 scoops) of syrup until hemoglobin levels normalize. After this, you should continue to take 1 tablet. chewing or 10 ml (2 scoops) syrup/day, at least until the end to replenish iron reserves in the body.

At latent iron deficiency The duration of treatment is about 1-2 months.

Children aged 1 to 12 years- 2.5-5 ml (1/2-1 measuring spoon) syrup/day.

Children over 12 years old, adults and nursing mothers breastfeeding baby, - 1 tab. chewing or 5-10 ml (1-2 scoops) syrup/day.

Pregnant women 1 tablet is prescribed. chewable or 5-10 ml (1-2 scoops) syrup/day.

Daily doses of Ferrum Lek for the prevention and treatment of iron deficiency in the body.

* - due to the fact that this group of patients requires low doses of iron, it is not recommended in these cases to prescribe the drug in the form of tablets or syrup.

Side effects

From the outside digestive system: very rarely - a feeling of heaviness, a feeling of fullness and pressure in the epigastric region, nausea, diarrhea. When taking the drug, stool becomes dark in color, which is due to the excretion of unabsorbed iron and does not have clinical significance.

The side effects reported were mostly mild and transient.

Overdose

In cases of overdose of Ferrum Lek for oral administration, no signs of intoxication or signs of excess iron intake into the body have been described to date, since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Drug interactions

No interaction with others noted medicines or food products.

Special instructions

Chewable tablets and syrup do not stain tooth enamel.

When prescribing Ferrum Lek to patients with diabetes mellitus, it should be taken into account that 1 tablet. chewable and 1 ml of syrup contains 0.04 XE.

In cases of anemia caused by 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.

Taking the drug does not affect the results of stool tests for occult blood (selectively for hemoglobin).

Use in pediatrics

Children under 12 years of age Due to the need to prescribe the drug in low doses, it is preferable to use it in the form of syrup.

Impact on the ability to drive vehicles and operate machinery

Does not affect the ability to concentrate.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. The shelf life of chewable tablets is 5 years, syrup - 3 years. Do not use after expiration date.

Lek D.D.

Country of origin

Slovenia

Product group

Blood and circulation

Antianemic agent. Iron preparation.

Release forms

• 5 ampoules of 2.0 ml per package

Description of the dosage form

• brown opaque solution with virtually no visible particles

Pharmacokinetics

After intramuscular injection of the drug, iron quickly enters the bloodstream: 15% of the dose after 15 minutes, 44% after 30 minutes. Biological period half-life is 3-4 days. Iron, in combination with transferrin, is transported to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The complex of iron (III) hydroxide with dextran is large enough and therefore is not excreted through the kidneys.

Special conditions

Use only in hospital settings. When using the drug Ferrum Lek®, laboratory tests are required: general clinical analysis blood and determination of serum ferritin; it is necessary to exclude impaired iron absorption. Ferrum Lek® is intended for intramuscular administration only. Injection technique: it is necessary to insert deeply into the gluteal muscle (a needle 5-6 cm long), as well as shifting the tissue when inserting the needle and squeezing the tissue after removing the needle; injected in turn into the right and left gluteal muscles. An opened ampoule must be used immediately. Parenterally administered iron supplements can cause hypersensitivity reactions, including anaphylactoid reactions, which can be potentially life-threatening, so appropriate cardiopulmonary resuscitation facilities should be available. The risk of developing anaphylactoid reactions is increased in patients with a history of allergies (including drug allergies), in patients with a history of severe bronchial asthma, eczema or other allergic manifestations, as well as in patients with immune-inflammatory diseases (for example, systemic lupus erythematosus, rheumatoid arthritis). In patients with impaired liver function, the use of parenteral iron should be carried out only after a careful assessment of the benefit/risk ratio. Parenteral administration of iron should be avoided in patients with impaired liver function, where iron overload may be a pathogenetic factor in the development of adverse events (in particular porphyria cutanea tarda). Careful monitoring of iron concentrations is recommended. The contents of Ferrum Lek® ampoules should not be mixed with other drugs. Treatment oral forms Iron-containing preparations should be started no earlier than 5 days after the last injection of Ferrum Lek®. If the drug is stored incorrectly, sediment may form; the use of such ampoules is unacceptable.

Compound

• 1 ampoule (2 ml) contains:
• active substance: Iron (III) in the form of iron (III) hydroxide complex with dextran – 100 mg;
• excipient: water for injection.
• Note. To adjust the pH value of the solution, use sodium hydroxide in the form of 6 M
• solution or concentrated hydrochloric acid.

Ferrum Lek indications for use

• Treatment of all forms of iron deficiency conditions that require rapid iron replenishment, including the following:
• severe iron deficiency due to blood loss;
• impaired absorption of iron in the intestine;
• conditions for which treatment with oral iron preparations is ineffective or impracticable.

Ferrum Lek contraindications

• hypersensitivity to the components of the drug;
• excess iron in the body (hemochromatosis, hemosiderosis);
• anemia not associated with iron deficiency (for example, hemolytic anemia);
• violation of the mechanisms of “utilization” of iron (lead anemia, sideroachrestic
• anemia, thalassemia);
• first trimester of pregnancy;
• Osler-Rendu-Weber syndrome;
• infectious diseases kidney in acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis.
• With caution
• bronchial asthma, allergic eczema or other atopic allergies;
• chronic polyarthritis;
• cardiovascular failure;
• low iron binding capacity and/or deficiency folic acid;
• childhood up to 4 months.
• Use during pregnancy and lactation
• The drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters
• and during breastfeeding The use of the drug is possible only if
• expected benefit d

Ferrum Lek dosage

• 50 mg/ml

Ferrum Lek side effects

• From the outside immune system
• Anaphylactoid reactions, including shortness of breath, urticaria, rash, itching, nausea and trembling, acute severe anaphylactoid reactions (difficulty breathing, circulatory collapse) with fatal. It is also possible to develop delayed reactions (arthralgia, myalgia, fever).
• From the nervous system
• Loss of consciousness, convulsions, dizziness, headache, paresthesia, taste perversion.
• From the cardiovascular system
• Arrhythmia, tachycardia, palpitations, marked decrease/increase in blood pressure.
• From the respiratory system
• Bronchospasm, shortness of breath.
• From the digestive system
• Dyspeptic symptoms (including nausea, vomiting), abdominal pain, diarrhea.
• From the skin and subcutaneous tissue
• Itching, urticaria, rash, Quincke's edema, increased sweating.
• From the musculoskeletal and connective tissue side
• Cramps, myalgia, joint pain.
• From the genitourinary system
• Chromaturia (change in urine color).
• General and administration site disorders
• Chills, flushing of the face, chest pain, enlargement lymph nodes, increased body temperature, increased fatigue. Together intramuscular injection(usually due to violation of the drug administration technique) - skin staining, bleeding, formation of sterile abscesses, tissue necrosis or atrophy, pain.

Drug interactions

Should not be used concomitantly with oral iron-containing medications. Simultaneous use ACE inhibitors may cause increased systemic effects of parenteral iron preparations.

Overdose

Overdose can lead to acute iron overload and hemosiderosis. Treatment is symptomatic; As an antidote, deferoxamine is administered intravenously slowly (15 mg/kg/hour), depending on the severity of the overdose, but not more than 80 mg/kg per day. Hemodialysis is ineffective

Storage conditions

• store at room temperature 15-25 degrees
• keep away from children

Information provided

The issue of low hemoglobin in pregnant women is always very acute. First of all, anemia is quite dangerous condition(both during pregnancy and during childbirth). Secondly, it is quite difficult to maintain hemoglobin level: it tends to decrease (sometimes very sharply and strongly) constantly, up to last day term. Thirdly, raising hemoglobin during pregnancy even a little is not a task for their lungs. Because even while taking iron-containing medications, its level may continue to decline.

In order for the amount of hemoglobin to begin to increase during anemia in a pregnant woman, it is not enough to overeat apples and buckwheat. Without special drugs It is almost impossible to make up for its deficiency. AND to the expectant mother She will probably have to try more than one remedy until she finds exactly “hers.”

Today we will “try” Ferrum lek.

Ferrum Lek during pregnancy: instructions for use

It is unlikely that you will have a question about whether it is possible for pregnant women to take Ferrum Lek, because this particular drug is not only very often prescribed to them by local gynecologists and therapists, but is also given out free of charge to antenatal clinic. That’s why many women know (or have at least heard) about this drug and have taken it. Let's say right away that (if you believe the instructions) this medicine passed successfully clinical trials on pregnant women, that is, no dangerous effects from its use were identified among this category of patients.

As the name implies, the product is designed to replenish the lack of iron in the body (due to various reasons) and prevent it if taken prophylactically.

Ferrum Lek is a preparation of ferric iron (who doesn’t know: unlike divalent analogues, which are better absorbed and are considered more effective, trivalent ones are easier to tolerate and have fewer side effects).

So, the drug is widely prescribed to pregnant women with anemia and other patients who require increased iron levels in the body. The medicine is available in three pharmacological forms:

• Chewable tablets: Contraindicated for children under 12 years of age. During pregnancy, they can be used in any trimester according to the regimen prescribed by the doctor.
• Syrup: This form is intended primarily for children. But often pregnant women who cannot dissolve or swallow pills also resort to it. At diabetes mellitus syrup is practically not prescribed due to its sucrose content.
• Solution for injection: used for conditions when an acute lack of iron is detected and its rapid compensation is required. In this case, the injections are administered intramuscularly in a hospital setting with mandatory supervision laboratory parameters blood. In the first trimester of pregnancy, such injection therapy is not carried out; in the second and third trimester - only if absolutely necessary.

How to take Ferrum Lek during pregnancy: method of application and dosage

Most often, doctors prescribe chewable tablets. The therapeutic daily dose of medication for anemia in expectant mothers should not exceed 3 tablets (or 30 ml of syrup), which should be chewed, but you can simply swallow it with liquid. The medicine is taken during or after meals. In most cases, pregnant women are prescribed the drug for 2-3 months. Only after this period (or at least 1 month) can you check whether Ferrum Lek is effective in a particular case or not. If necessary, iron intake continues. If hemoglobin and red blood cells in the blood have increased, then it is possible to switch to a preventive dosage - 1 tablet (or 10 ml of syrup) per day.

All daily norm Medicines can be divided into several doses or taken once. Like any other iron-containing medications, this one (to increase absorption) must be combined with taking medications or foods/drinks containing vitamin C. For example, you can wash down the medicine with orange or pomegranate juice. In addition, iron will be poorly absorbed if the body lacks B vitamins (in particular folic acid) or has reduced secretion gastric juice. Therefore, iron supplementation is usually combined with other medications.

It is also necessary to know what iron-containing preparations should not be combined with. This is, in particular, tannin (found in coffee, cocoa, chocolate, strong tea), calcium (found in many mineral complexes, as well as products - cottage cheese, milk, cheese, yogurt), phosphorus (fish, seafood), phytin (legumes, rice, wheat bran).

If your doctor has prescribed Ferrum Lek for you, be sure to check with him whether it can be combined with other medications (that you are currently taking).

Ferrum Lek during pregnancy: side effects

You should carefully study the composition of the prescribed form of medication to ensure there is no allergy to any of its components. So, syrup, for example, contains alcohol, sugar, aromatic additives (as in tablets), and other excipients. Ferrum Lek syrup and chewable tablets are not prescribed for excess iron in the body, for anemia of a different nature (not iron deficiency), or for impaired excretion of iron from the body. For a number of conditions, the drug is prescribed with caution and under the supervision of a physician.

Pharmacologists claim that Ferrum Lek is well tolerated and absorbed, but still some side effects can sometimes occur (as an individual reaction of the body to the substance). These include stool disorders (diarrhea or constipation), nausea and vomiting, heartburn and abdominal pain, a feeling of heaviness in the stomach, change in the color of stool, and occasionally - skin reactions in the form of a rash or itching.

Since excess iron is excreted from the body along with feces, then black stool during pregnancy while taking the drug is an absolutely natural, normal and harmless phenomenon. By the way, about 1 mg of Ferrum Lek iron is excreted from the body along with urine, sweat, bile and epithelial cells.

The positive thing is that, unlike many other iron-containing pharmaceutical products it does not lead to darkening of the teeth. Although…

Who drank Ferrum Lek during pregnancy: reviews

There are isolated reviews that teeth turn yellow or darken as a result of this treatment. However, this is not the most unpleasant thing side effect. Contrary to assurances that adverse reactions As a result of taking Ferrum Lek, they occur infrequently; such phenomena cannot be called rare either. Pregnant women often complain of nausea, heartburn, severe vomiting, diarrhea, difficulties with bowel movements (and the stool becomes dry, hard, rocky) and other discomfort. The worst thing is that there is no positive effect from taking the drug: the hemoglobin level remains the same low, and often even decreases even further. Doctors do not deny that Ferrum Lek is often ineffective, but they still praise the drug for its good tolerability.

The fact that not everyone likes the taste of the tablets and sticks strongly to the teeth when chewed is no longer such a problem (after all, they can simply be swallowed).

At the same time, one cannot help but say that there are also positive reviews. Ferrum Lek helps some pregnant women and does not cause any problems in them. adverse reactions from the body. And some even like the taste.

Obviously, Ferrum Lek during pregnancy is not suitable for everyone. Like any other drug similar action. Therefore, women believe that they still need to find “their” drug: one that will be well tolerated and will show therapeutic effect, that is, it will increase the level of hemoglobin in the blood. But at the same time, it is desirable, they note, that the treatment of anemia is prescribed not by a therapist, but by a hematologist.

Pregnant women with experience advise all expectant mothers, in addition to taking iron-deficiency medications, to be sure to drink enough fluids, walk a lot fresh air- all this together helps to overcome anemia and improve blood test results. But beet juice, which (as many believe) helps increase hemoglobin levels, it is better not to consume: firstly, you need to be able to do it correctly (otherwise the drink has a powerful toxic effect on the body); secondly, beet juice (doctors say) can remove iron from the body, that is, reduce hemoglobin. And against the background of pregnancy and anemia, this can be doubly dangerous.

Especially for - Ekaterina Vlasenko

Name:

Ferrum Lek

Pharmacological
action:

Tablets, syrup.
Pharmacodynamics.
The drug contains iron Fe3+ in the form of a complex compound of iron (III) hydroxide with polymaltose. This macromolecular complex is stable and does not release iron in the form of free ions in the gastrointestinal tract.
The structure of the complex is similar to the structure of ferritin. Due to this, iron (III) from this complex is absorbed through the process of active absorption.
Absorbed iron mainly accumulates in the liver in combination with ferritin, then in bone marrow it is incorporated into hemoglobin. The iron preparation has the form of a polymaltose hydroxide complex Fe3+.
The externally polynuclear Fe3+ hydroxide sites are surrounded by many non-covalently bound polymaltose molecules, forming a 50 kDa complex that is so large that its diffusion across intestinal mucosal membranes is approximately 40 times lower than that of Fe2+ hexahydrate.
Iron, which is part of the polymaltose complex of iron (III) hydroxide, does not exhibit the pro-oxidant properties inherent in simple salts gland.
The sensitivity of VLDL and LDL to oxidative factors is therefore reduced.

Pharmacokinetics.
A study using the double isotope technique (55Fe and 59Fe) showed that iron absorption, as measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (the higher the dose, the less absorption).
There is a correlation between the degree of iron deficiency and the amount of iron that is absorbed (the higher the iron deficiency, the better the absorption).
Active process absorption occurs in the duodenum and small intestine.
Unabsorbed iron is excreted in the feces.
The amount of iron that is excreted from the body along with exfoliated epithelial cells of the digestive tract and skin, as well as with sweat, bile and urine, is approximately 1 mg/day.
For women, iron loss through menstrual blood should also be taken into account.

Solution for intramuscular administration
Pharmacodynamics.
Iron is an important component of hemoglobin, myoglobin and some other enzymes.
Its main role is the transfer of electrons, oxygen molecules and oxidative metabolism during tissue growth and proliferation.
As an integral part of enzymes, iron is a catalyst for oxidation, hydroxylation and other vital important processes metabolism.
Iron deficiency is formed when there is insufficient intake of iron from food, a violation of its absorption in digestive tract, as well as with an increased need for it (increased growth, pregnancy) and as a result of blood loss.
In blood plasma, iron is transported by β-globulin transferrin, which is synthesized in the liver. Each transferrin molecule binds to two iron atoms.
In combination with transferrin, iron is transported into the body's cells, where it is reversibly bound to ferritin and used for the synthesis of hemoglobin, myoglobin and some enzymes.
After parenteral administration complex of iron (III) hydroxide with dextran, the hemoglobin level increases faster than after the administration of iron (II) salts orally, despite the absence of dependence of the kinetics of iron incorporation on the route of its administration.
The size of the complex of iron (III) hydroxide with dextran is quite large, so its excretion by the kidneys is impossible.
This complex is stable and under physiological conditions there is no release of iron in the form of ions.

Pharmacokinetics.
After intramuscular injection, the complex of iron (III) hydroxide with dextran is absorbed mainly through lymphatic system and diffuses into the blood after approximately 3 days.
No data are available regarding bioavailability, but it is known that a fairly large portion of the complex is not absorbed from muscle tissue for long period. T½ of iron (III) hydroxide complex with dextran - 3–4 days.
The macromolecular dextran complex enters the reticuloendothelial system, where it breaks down into the iron-containing component and dextran.
The iron then binds to ferritin or hemosiderin and, to a lesser extent, to transferrin and is used to synthesize hemoglobin.
Dextran is metabolized or excreted. The amount of iron excreted is insignificant.

Indications for
application:

Tablets, syrup:
- treatment of latent iron deficiency; treatment of iron deficiency anemia (severe iron deficiency);
- prevention of iron deficiency during pregnancy, breastfeeding, in women reproductive age, in children, adolescents, adults (for example, vegetarians and the elderly).
Solution for injection: therapy of iron deficiency conditions when treatment with iron preparations for oral administration is ineffective or impossible.

Directions for use:

The drug is recommended take during or immediately after meals.
Chewable tablets Can be chewed or swallowed whole. The daily dose can be divided into several doses or taken at once.
Doses and duration of treatment depend on the degree of iron deficiency.
Syrup Can be mixed with fruit or vegetable juices or added to baby food. The measuring spoon included in the package is used for precise dosing of syrup.
For iron deficiency anemia, the duration of treatment is about 3-5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under 1 year of age are prescribed 2.5-5 ml (1/2-1 scoop) of syrup/day.
Children aged 1 to 12 years - 5-10 ml (1-2 scoops) of syrup/day.
Children over 12 years old, adults and mothers breastfeeding - 1-3 tablets. chewing or 10-30 ml (2-6 scoops) syrup/day.
Pregnant women are prescribed 2-3 tablets. chewing or 20-30 ml (4-6 scoops) of syrup until hemoglobin levels normalize. After this, you should continue to take 1 tablet. chewable or 10 ml (2 scoops) syrup/day, at least until the end of pregnancy to replenish iron reserves in the body.
For latent iron deficiency, the duration of treatment is about 1-2 months.
Children aged 1 to 12 years - 2.5-5 ml (1/2-1 scoop) of syrup/day.
Children over 12 years old, adults and mothers breastfeeding - 1 tablet. chewing or 5-10 ml (1-2 scoops) syrup/day.
Pregnant women are prescribed 1 tablet. chewable or 5-10 ml (1-2 scoops) syrup/day.

Ferrum Lek solution
Injected only intramuscularly! Before administering the first therapeutic dose of the solution, the tolerability of the drug is determined by administering a test dose to the patient, which is ¼–½ ampoule (25–50 mg of iron) for adults and half the daily dose for children. If side effects no, within 15 minutes after administration, the remainder of the initial daily dose of the drug can be administered.

If the total number of Ferrum Lek ampoules exceeds the maximum daily dose, it is necessary to divide the administration of the drug into several times. If after 1–2 weeks of therapy there is no normalization of hematological parameters, it is necessary to reconsider the established diagnosis.

Calculation of the total dose of Ferrum Lek to replenish iron loss due to blood loss:
1. If the amount of lost blood is known: when 200 mg of iron is administered intramuscularly (2 ampoules), the hemoglobin level increases by 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).
Total quantity iron (mg) that the patient should receive = units of blood lost ⋅ 200
The total number of Ferrum Lek ampoules that the patient should receive = number of blood units lost ⋅ 2.
2. If a reduced hemoglobin level is known
Use the formula below for calculation, assuming that there is no need to replenish deposited iron.
Total amount of iron (mg) that the patient should receive = body weight (kg) ⋅ (target hemoglobin [g/L] - actual hemoglobin level [g/L]) ⋅ 0.24.
For patients weighing 60 kg with a hemoglobin deficiency of 10 g/l required quantity iron is 150 mg or 1.5 ampoules of Ferrum Lek.
Typically, Ferrum Lek is injected every other day deep into the upper outer quadrant of the gluteal muscle - alternately into the left and right.
To avoid pain and staining of the skin, it is important to carry out the IM injection properly, using a 5-6 cm long needle. Before injection, it is necessary to disinfect the skin, pull the subcutaneous tissue down 2 cm to reduce the spreading of the injected solution. After administering the drug, it is necessary to press the injection site for 1 minute.
Children are given 0.06 ml of the drug per 1 kg of body weight per day (3 mg iron/kg per day).
Adults and elderly patients: 1–2 ampoules of the drug (100–200 mg of iron) per day.

Maximum daily doses:
children: 0.14 ml of the drug per 1 kg of body weight (7 mg iron/kg);
adults: 4 ml (200 mg or 2 ampoules) of the drug.
Ampoules containing homogeneous solution without sediment. The solution should be used immediately after opening the ampoule.

Side effects:

In most cases, side effects are mild and temporary.
Very in rare cases may arise gastrointestinal disorders(abdominal pain, feeling of fullness, flatulence, nausea, vomiting, constipation or diarrhea).
Dark coloration of stool caused by iron supplementation is not clinically significant.
From the immune system: very rarely - anaphylaxis, urticaria, rash, exanthema, itching.
Other: When taken orally, there are isolated cases of staining of tooth enamel in children.
With intramuscular injection rarely possible arterial hypotension, joint pain, swollen lymph glands, fever, headache, dizziness, gastrointestinal disorders (nausea, vomiting). Allergic and anaphylactic reactions are very rarely possible, especially in patients with asthma, as well as in patients with a reduced ability to bind iron and/or folic acid deficiency.
If the drug is administered incorrectly, inflammation at the injection site and hematoma may occur.

Contraindications:

Tablets, syrup, d/in solution.: individual hypersensitivity to any component of the drug; excess iron in the body (for example, hemochromatosis, hemosiderosis), impaired incorporation of iron into hemoglobin (for example, anemia caused by lead poisoning, sideroachrestic anemia, thalassemia), anemia not caused by iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency).
Tablets, syrup: esophageal stenosis and/or other obstructive gastrointestinal diseases; intestinal diverticulum, intestinal obstruction, regular blood transfusions; simultaneous use of parenteral forms of iron.
Solution for injection.: severe violations hemostasis (hemophilia), first trimester of pregnancy.

If anemia is caused by an infection or tumor, the iron that is introduced into the body accumulates in the reticuloendothelial system and begins to be used by the body only after the underlying disease has been cured.
Parenteral administration Iron supplements can cause allergic reactions. At allergic reaction medium degree introduction recommended antihistamines.
If an anaphylactic reaction develops, immediate administration of epinephrine is indicated. The risk of developing anaphylaxis is quite high in patients with asthma, Crohn's disease, polyarthritis, reduced iron binding capacity and/or folic acid deficiency.

Use in pediatrics
For children under 12 years of age, due to the need to prescribe the drug in low doses, it is preferable to use it in syrup form.
The ability to influence the speed of reaction during control vehicles or working with other mechanisms - no data available.

Interaction with
other medicinal
by other means:

Ferrum Lek's interactions with others so far medicines not noted.
Due to the fact that iron is part of a complex compound, ionic interactions with food components - phytin, oxalates, tannin - and medications (tetracycline, antacids) are unlikely.
The drug does not affect the results of the test for the presence of occult blood (selectively for hemoglobin), so there is no need to stop treatment for the test.
Do not mix the solution for intramuscular administration with other medications; Like other iron preparations for parenteral use, Ferrum Lek is not prescribed simultaneously with iron preparations for oral administration.
Interval between parenteral use drug and initiation of oral dosage forms iron should be at least 5 days.

Pregnancy:

Study of the impact on reproductive function in animals showed no harmful effects on the fetus.
During controlled studies with the participation of pregnant women (II and III trimester of pregnancy), no negative effect on the organisms of the mother and newborn was detected.
There is no evidence of danger to the fetus when taking the drug in the first trimester of pregnancy. Iron is released into breast milk, in which it is contained in a complex with lactoferrin. Only a small part of the iron from the complex of iron (III) hydroxide with polymaltose passes into breast milk, so the occurrence of side effects in a breastfed baby when the mother takes Ferrum Lek tablets is unlikely.
During pregnancy and breastfeeding, Ferrum Lek tablets should be taken take only after consulting a doctor.

Overdose:

Symptoms: with an overdose of iron (III) hydroxide complex preparations with polymaltose, signs of poisoning and iron overload were not observed, which is due to the lack of free iron in the gastrointestinal tract, as well as the fact that iron in this form is not transported in the body using the mechanism of passive diffusion, but by active transport, and the degree of iron absorption from the hydroxide-polymaltose complex directly depends on the severity of iron deficiency.
Treatment: therapy is symptomatic. A specific antidote for iron is the chelating agent deferoxamine (iron binding chelating agent) 1 g IV (maximum 15 mg/kg/h).

Release form:

Chewable tablets (100 mg) Ferrum lek dark brown, interspersed with light brown, round, flat, chamfered, 30 or 50 pcs.
Syrup (100 mg) Ferrum lek transparent, brown in dark glass bottles complete with a measuring spoon.
Solution for intramuscular administration (100 mg/2ml) Ferrum lek brown, opaque, practically without visible particles in ampoules of 5 or 50 pcs.

Storage conditions:

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
The shelf life of chewable tablets is 5 years, syrup - 3 years.
Do not use after expiration date.

1 tablet Ferrum lek contains:
- active substance: iron (III) hydroxide polymaltosate - 400 mg, in terms of iron - 100 mg;
- excipients: macrogol 6000, aspartame, chocolate flavor, talc, dextrates.

5 ml Ferrum lek syrup contain:
- active ingredient: iron (III) hydroxide polymaltosate - 200 mg, in terms of iron - 50 mg;
- excipients: sucrose, sorbitol (solution), methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, cream flavor, sodium hydroxide, water.

1 ampoule of solution for IM administration Ferrum Lek contains:
- active ingredient: iron (III) hydroxide polyisomaltose 50 mg - 100 mg;
- excipients: sodium hydroxide, hydrochloric acid (concentrated), water for injection.