Maltofer - instructions for use, analogs, reviews and release forms (solution, drops, syrup, chewable tablets FOL) of a drug for the treatment of iron and folic acid deficiency in adults, children and pregnancy. Compound. Maltofer - replenishing the deficiency

Maltofer is a drug for replenishing iron deficiency in iron deficiency anemia or replenishing hemoglobin reserves during periods of increased need.

Iron preparation in the form of a polymaltose complex of Fe3+ hydroxide. Active ingredient: Iron (III) hydroxide polymaltosate.

Maltofer contains a stable macromolecular complex and does not release iron in the form of free ions in the gastrointestinal tract. Due to this, it enters the blood from the intestines through active transport. Absorbed iron binds to ferritin and is stored in the body, mainly in the liver.

In addition to iron, the drug Maltofer FOL contains folic acid, which belongs to the B group of vitamins and is involved in the production of nucleic acids, purines, amino acids, and pyrimidines. Additionally stimulates erythropoiesis (the process of producing red blood cells).

Forms of release of the drug:

Oral solution: dark brown (5 ml in glass bottles, 10 bottles in a cardboard box);
Drops for oral administration: dark brown (30 ml in dark glass bottles with a dispenser, 1 bottle in a cardboard box);
Syrup: dark brown (150 ml in dark glass bottles, 1 bottle in a cardboard box complete with a measuring cap);
Chewable tablets: flat-cylindrical, scored, brown with white inclusions (10 pieces in blisters, 3 blisters in a cardboard box);
Solution for injection: brown (2 ml in colorless glass ampoules, 5 ampoules in a cardboard box).

Indications for use

What does Maltofer help with? According to the instructions, the drug is prescribed in the following cases:

Treatment of latent and severe iron deficiency (iron deficiency anemia);
Prevention of iron deficiency during pregnancy;
Prevention of iron and folic acid deficiency (including during pregnancy and lactation).

Injection:

Treatment of iron deficiency anemia in case of ineffectiveness or impossibility of taking oral iron-containing medications (including in patients with gastrointestinal diseases and those suffering from malabsorption syndrome).

Instructions for use Maltofer, dosage

The tablets should be taken orally after meals with clean water. The dosage and timing of treatment depend on the degree of iron deficiency. The daily dose can be divided into several doses or taken once (depending on tolerance).

To treat severe iron deficiency, take 1 Maltofer tablet 1 to 3 times a day for 3-5 months. After a course of use, the drug is continued until the level of iron in the body is restored - 1 tablet \ 1 time per day.

Dosage for pregnant women: 1 tablet \ 2 to 3 times a day, until hemoglobin stabilizes. Afterwards, you should drink 1 tablet \ 1 time per day until childbirth, in order to prevent iron deficiency and treat hidden iron deficiency.

Instructions for Maltofer drops and syrup

Drops and syrup are (mainly) used for children; adults are recommended to take tablets.

The dosage of Maltofer syrup and drops for children depends on the indications and the level of iron in the body. Do not exceed the dosage!

For iron deficiency anemia:

Premature babies: 1-2 drops of solution/kg;
Children under 1 year: 10-20 drops of solution or 2.5-5 ml of syrup;
Children 1-12 years old: 20-40 drops of solution or 5-10 ml of syrup;
Children from 12 years old: 40-120 drops of solution or 10-30 ml of syrup;
Adults (including nursing women): 40-120 drops of solution, 10-30 ml of syrup;
Pregnant women: 80-120 drops of solution, 20-30 ml of syrup.

For latent iron deficiency:

Children under 1 year: 15-25 mg of iron – 6-10 drops of solution;
Children 1-12 years old: 25-50 mg of iron - 10-20 drops of solution or 2.5-5 ml of syrup;
Children from 12 years old: 50-100 mg of iron - 20-40 drops of solution or 5-10 ml of syrup;
Adults (including nursing women): 50-100 mg of iron – 20-40 drops of solution, 5-10 ml of syrup;
Pregnant women: 100 mg of iron – 40 drops of solution, 10 ml of syrup.

For prevention purposes, the instructions for use recommend the following dosages of Maltofer:

Children under 1 year: 6-10 drops of solution;
Children 1-12 years old: 10-20 drops of solution or 2.5-5 ml of syrup;
Children from 12 years old: 20-40 drops of solution or 5-10 ml of syrup;
Adults (including nursing women): 20-40 drops of solution or 5-10 ml of syrup;
Pregnant women: 40 drops of solution, 10 ml of syrup.

special instructions

It is important to understand that treatment with iron supplements is quite long and takes at least 3 months - this is necessary so that the body’s iron levels are replenished and the necessary reserves are created. Thus, after complete normalization of the clinical blood picture, it is necessary to take the drug for another 1 month.

During the period of use of Maltofer, the instructions recommend refraining from drinking coffee and strong black tea. After taking the drug, it is not recommended to drink milk. These products lead to a decrease in iron absorption and a decrease in the therapeutic effect. Milk and coffee should be drunk no earlier than 3 hours after taking the drug.

Side effects

The instructions warn about the possibility of developing the following side effects when prescribing Maltofer:

nausea,
vomit,
pain in the epigastric region,
stool disorders.

Darkening of the stool may be observed - the symptom does not matter.

Contraindications

It is contraindicated to prescribe Maltofer in the following cases:

increased individual sensitivity to the components of the drug;
excess iron in the body (hemochromatosis, hemosiderosis);
anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by cyanocobalamin deficiency, aplastic anemia);
violation of iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia, cutaneous porphyria tarda).

Additionally, for a solution for intramuscular administration:

Randu-Weber-Osler disease;
chronic polyarthritis;
infectious kidney diseases in the acute stage;
uncontrolled hyperparathyroidism;
decompensated cirrhosis of the liver;
infectious hepatitis;
early childhood (up to 4 months);
pregnancy (first trimester).

Patients with allergies, liver and kidney failure should take the drug with caution.

Suffering from bronchial asthma, patients with low serum iron-binding capacity and/or folic acid deficiency are at risk of developing allergic or anaphylactic reactions.

Before using the solution for intramuscular administration, ampoules should be inspected for sediment and damage. Ampoules with sediment and damage should not be used.

Overdose

The likelihood of an overdose when taking the drug orally is low. Clinical studies have confirmed that even with 2000 mg of iron per 1 kg of human weight, death is unlikely. In case of overdose, increased side effects are likely.

The likelihood of an overdose increases with intramuscular administration of the drug. Acute iron overload may occur and symptoms of hemosiderosis will appear.

Treatment is symptomatic, taking chelates (deferoxamine intravenously).

Analogues of Maltofer, price in pharmacies

If necessary, you can replace Maltofer with an analogue for therapeutic action - these are preparations containing iron:

Globigen,
Ferumbo,
Ferinject,
Profer,

Matches by ATX code:

Sorbitrim,
Fer-Rompharm,
Ferrum Lek.

When choosing analogues, it is important to understand that the instructions for use of Maltofer, price and reviews do not apply to drugs with similar effects. It is important to consult a doctor and not change the drug yourself.

Price in pharmacies in Moscow and Russia: Maltofer drops 50 mg/ml 30 ml - from 255 to 311 rubles, cost of syrup 10 mg/ml 150 ml - from 282 to 369 rubles, price of Maltofer chewable tablets 100 mg 30 pcs. – from 301 to 370 rubles, according to 702 pharmacies.

Store in a place protected from light and out of reach of children at a temperature not exceeding +25°C.

Dispensing conditions from pharmacies are by prescription.

Maltofer is an antianemic drug used for iron deficiency.

Release form and composition

The following dosage forms of Maltofer are produced:

Chewable tablets: flat, brown with white spots, round, scored (in blisters of 10 pcs.; 1 or 3 blisters in a cardboard pack);
Drops for oral administration: dark brown liquid (in dark glass bottles with a dispenser of 10 or 30 ml, 1 bottle in a cardboard pack; in polymer containers with a dispenser of 10 or 30 ml, 1 container in a cardboard pack);
Syrup: dark brown substance (in dark glass bottles of 75 or 150 ml with a measuring cap included; 1 set in a cardboard pack);
Oral solution: dark brown liquid (in glass bottles of 5 ml; 10 bottles in a cardboard pack);
Solution for intramuscular administration: brown liquid (in 2 ml clear glass ampoules; 5 ampoules in a cardboard pack).

One chewable tablet contains:

Active ingredient: iron (III) hydroxide polymaltosate – 375 mg;
Auxiliary components: microcrystalline cellulose, purified talc, dexrates, chocolate flavor, macrogol 6000, vanillin, cocoa powder, sodium cyclamate.

20 ml of drops for oral administration contains:

Active ingredient: iron (III) hydroxide polymaltosate – 178.6 mg;
Auxiliary components: sodium hydroxide, sucrose, cream flavor, sodium methyl parahydroxybenzoate, purified water, sodium propyl parahydroxybenzoate.

1 ml of syrup contains:

Active ingredient: iron (III) hydroxide polymaltosate – 35.7 mg;
Auxiliary components: methyl parahydroxybenzoate, purified water, cream flavor, sorbitol solution 70%, sodium hydroxide, ethanol 96%, propyl parahydroxybenzoate, sucrose.

1 ml of oral solution contains:

Active ingredient: iron (III) hydroxide polymaltosate – 71.4 mg;
Auxiliary components: sodium methyl parahydroxybenzoate, sorbitol solution 70%, sodium hydroxide, purified water, sodium propyl parahydroxybenzoate, sucrose, cream flavor.

1 ml of solution for intramuscular administration contains:

Active ingredient: iron (III) hydroxide polymaltosate – 50 mg;
Auxiliary components: water for injection, hydrochloric acid/sodium hydroxide.

Indications for use

Chewable tablets, syrup, drops and oral solution: treatment of clinically significant and latent iron deficiency (LDI); prevention of iron deficiency in patients of childbearing age, during pregnancy and breastfeeding, in children, adolescents and adults (for example, vegetarians and elderly patients);
Solution for intramuscular administration: treatment of iron deficiency in cases of ineffectiveness, insufficient effectiveness or impossibility of taking oral forms of the drug, for example, with malabsorption, in patients who refuse to regularly and long-term use of oral iron supplements, in patients suffering from diseases of the gastrointestinal tract (GIT) ), iron supplements for oral administration in which may worsen the disease.

Maltofer in the form of a solution for intramuscular administration is prescribed only when the state of iron deficiency is confirmed by necessary studies (for example, when determining the level of hemoglobin, serum ferritin, the number of red blood cells or hematocrit, as well as their parameters - the average content and/or the average concentration of hemoglobin in an erythrocyte, the average erythrocyte volume).

Contraindications

Excess iron (for example, hemochromatosis and hemosiderosis);
Impaired iron utilization (for example, sideroachrestic or lead anemia);
Non-iron deficiency anemia (for example, hemolytic or megaloblastic anemia caused by a lack of vitamin B 12);
Hypersensitivity to the components of the drug.

Additional contraindications to the use of the solution for intramuscular administration are:

Decompensated cirrhosis of the liver;
Bronchial asthma;
Infectious hepatitis;
Uncontrolled hyperparathyroidism;
Infectious kidney diseases in the acute stage;
Chronic polyarthritis;
Osler-Rendu-Weber syndrome;
Pregnancy (1st trimester).

The solution cannot be administered intravenously. It should be used with caution in patients with allergies, renal or liver failure.

Directions for use and dosage

The daily dose of syrup, chewable tablets, drops or oral solution is taken all at once during or immediately after a meal.

Using the measuring cap included with the syrup, you can calculate the exact dose of the drug.

Chewable tablets can be swallowed whole; syrup, drops or oral solution - mix with soft drinks, vegetable or fruit juices. The weak color of the drink does not affect the effectiveness or taste of Maltofer.

Daily dose of the drug depending on the category/age of patients and the degree of iron deficiency:

Premature babies: the dose for iron deficiency anemia (IDA) is determined based on the calculation - 1-2 drops per 1 kg of body weight, for 3-5 months;
Children under 1 year: IDA – 10-20 drops, 2.5-5 ml of syrup; LID and prevention of conditions (IDA and LID) – 6-10 drops;
Children from 1 year to 12 years: IDA – 20-40 drops or 5-10 ml of syrup; LDH and prevention of conditions – 10-20 drops or 2.5-5 ml of syrup;
Children over 12 years old: IDA – 40-120 drops or 10-30 ml of syrup; LDH and prevention of conditions – 20-40 drops or 5-10 ml of syrup;
Adults (including nursing women): IDA – 40-120 drops, 10-30 ml syrup, 1-3 chewable tablets, 1-3 bottles of oral solution; LJ – 20-40 drops, 5-10 ml syrup, 1 chewable tablet, 1 bottle of oral solution; prevention – 20-40 drops or 5-10 ml of syrup;
Pregnant women: IDA – 80-120 drops, 20-30 ml of syrup, 2-3 chewable tablets or 2-3 bottles of oral solution; LDH and prevention of conditions – 40 drops, 10 ml syrup, 1 chewable tablet or 1 bottle of oral solution.

The duration of therapy for clinically significant iron deficiency (IDA) is 3-5 months until hemoglobin levels normalize. Next, Maltofer is continued at the dosage used to treat LID for several more months; during pregnancy, it should be continued at least until delivery (to restore iron reserves).

The duration of LID therapy is 1-2 months. In case of clinically pronounced iron deficiency, replenishment of microelement reserves and normalization of hemoglobin levels occurs only after 2-3 months after starting the drug.

Before the first administration of a therapeutic dose of a solution for intramuscular administration, an intramuscular test is performed: children are administered half the daily dose, adults - from 1/4 to 1/2 dose (25-50 mg of iron). If there are no side effects within 15 minutes after administration, the remainder of the initial dose of Maltofer can be administered. It is important to have resources to help with the development of anaphylactic shock.

The dose of the drug for intramuscular administration is determined individually and adapted in accordance with the general iron deficiency using the formula: general iron deficiency (mg) = body weight (kg) × (normal hemoglobin level - patient hemoglobin level) (g/l) × 0.24 * + iron reserves (mg);

If body weight< 35 кг: нормальный гемоглобин (Hb) составляет 130 г/л, что соответствует железу запасов – 15 мг/кг;

If body weight > 35 kg: normal Hb level is 150 g/l, which corresponds to iron reserves - 500 mg;

*Coefficient 0.24 = 0.0034×0.07×1000 (iron content in Hb – 0.34%×blood volume – 7% of body weight×coefficient 1000 – conversion from g to mg).

Total number of ampoules with solution for intramuscular administration = total iron deficiency (mg)/100 mg.

The total number of ampoules depending on the patient’s body weight and hemoglobin level – Hb 60 g/l/Hb 75 g/l/Hb 90 g/l/Hb 105 g/l:

5 kg: 1.5/ 1.5/1.5/1;
10 kg: 3/3/2.5/2;
15 kg: 5/4.5/3.5/3;
15 kg: 6.5/4.5/3.5/3;
20 kg: 6.5/5.5/5/4;
25 kg: 8/7/6/5.5;
30 kg: 9.5/8.5/7.5/6.5;
35 kg: 12.5/11.5/10/9;
40 kg: 13.5/12/11/9.5;
45 kg: 15/13/11.5/10;
50 kg: 16/14/12/10.5;
55 kg: 17/15/13/11;
60 kg: 18/16/13.5/11.5;
65 kg: 19/16.5/14.5/12;
70 kg: 20/17.5/15/12.5;
75 kg: 21/18.5/16/13;
80 kg: 22.5/19.5/16.5/13.5;
85 kg: 23.5/20.5/17/14;
90 kg: 24.5/21.5/18/14.5.

If the required dose exceeds the maximum daily dose, the drug should be administered in fractions.

Dosage regimen depending on the patient’s age:

Adults: 1 ampoule daily (2 ml – 100 mg iron);
Children: the dosage is determined depending on the weight of the child.

Maximum permissible daily doses:

Adults: 2 ampoules (4 ml – 200 mg iron);
Children weighing less than 5 kg: 1/4 ampoule (0.5 ml - 25 mg iron);
Children weighing from 5 to 10 kg: 1/2 ampoule (1 ml - 50 mg iron).

If there is no response from hematological parameters after 7-14 days of therapy (for example, the Hb level increases by approximately 100 mg/dL per day), it is recommended to reconsider the initial diagnosis.

The total dose of Maltofer per course of therapy should not exceed the calculated number of ampoules.

The technique of administering the drug is of decisive importance. If the injection is performed incorrectly, pain and staining of the skin at the injection site may occur. The solution should be administered using the ventrogluteal injection technique instead of the conventional one. The needle should be at least 5-6 cm long, its clearance should not be too wide. For adults with low body weight and children, shorter and thinner needles should be used.

The line of the spine at the level of the lumboiliac joint is fixed as point A. If the patient lies on the right side, the middle finger of the left hand must be placed at point A;
The index finger should be set back from the middle finger so that it is under the iliac crest line at point B;
The triangle, which is located between the index and middle fingers, as well as the proximal phalanges, is the injection site.

Before injection, instruments should be disinfected as usual. Before inserting the needle, it is necessary to move the skin approximately 2 cm - this will tightly close the puncture channel after the needle is removed, which will prevent staining of the skin and penetration of the injected drug into the subcutaneous tissue.

The needle should be positioned vertically in relation to the skin surface - the angle to the point of the iliac joint should be greater than to the point of the femoral joint. Upon completion of the solution administration, the needle should be removed, while holding the area of skin adjacent to the injection site for 5 minutes. The patient needs to move around immediately after the procedure.

Side effects

When using Maltofer in the form of a solution for intramuscular administration, adverse reactions from certain systems and organs may occur:

Digestive system: rarely – vomiting, nausea;
Body as a whole: rarely – headache, swollen lymph nodes, malaise, joint pain, fever; very rarely - anaphylactic or allergic responses;
Local reactions: change in skin color, pain and inflammation at the injection site (if the solution administration technique is violated).

When taking chewable tablets, syrup, drops or oral solution, adverse reactions from the digestive system are observed: possible - dark coloring of the stool (due to the release of unabsorbed iron); very rarely - symptoms of gastrointestinal irritation (nausea, diarrhea, constipation, feeling of fullness, pressure in the epigastric region).

special instructions

For diabetes mellitus, it should be taken into account that one chewable tablet and one ml of syrup contain 0.04 XE (bread units), one ml of drops - 0.01 XE.

Iron preparations administered parenterally can cause anaphylactic and allergic reactions. In case of moderate allergic responses, it is recommended to use antihistamines; If a severe anaphylactic reaction develops, immediately administer epinephrine/adrenaline. It is important to have cardiopulmonary resuscitation available during administration.

The course of the underlying disease can be aggravated by side effects that occur in patients with pathologies of the cardiovascular system.

Patients at high risk of developing anaphylactic or allergic reactions include patients with bronchial asthma, folic acid deficiency and/or low serum iron-binding capacity.

Before using the solution for intramuscular administration, it is recommended to inspect the ampoules for sediment or damage. Only ampoules that do not contain sediment and are not damaged should be used. The solution should be administered immediately after opening the ampoule; it cannot be mixed with other therapeutic drugs.

Parenteral administration of the drug in children may have a negative effect on the course of the infectious process.

Drug interactions

Maltofer injection solution cannot be used in combination with iron preparations for oral use (their absorption from the gastrointestinal tract is reduced). In this regard, it is recommended to begin therapy with oral iron preparations no earlier than 7 days after the last administration of the solution.

When taken simultaneously with angiotensin-converting enzyme inhibitors (for example, enalapril), systemic adverse reactions that occur when using the injection solution may increase.

Terms and conditions of storage

Store at temperatures up to 25 ° C in a dry place, protected from light. Keep away from children.

Best before date:

Chewable tablets, solution for intramuscular administration, solution and drops for oral administration – 5 years;
Syrup – 3 years.

Maltofer ®

International nonproprietary name

Dosage form

Chewable tablets 100 mg

Compound

One tablet contains

active substance - iron (III ) polymaltose hydroxide 357.0 mg

(equivalent to 100 mg iron),

Excipients: dextrates, macrogol 6000, talc, sodium cyclamate, microcrystalline cellulose, vanillin, what powder, chocolate flavor

Description

The tablets are round, flat, brown-white, speckled, with a score line on one side.

Pharmacotherapeutic group

Hematopoiesis stimulants. Iron supplements. Ferric iron preparations for oral administration. Iron polyisomaltosate.

ATX code B03AB05

Pharmacological properties

Pharmacokinetics

Suction

Iron from iron(III) hydroxide polymaltose complex (ZHK) is absorbed through a controlled mechanism. The increase in serum iron levels after taking the drug does not correlate with the rate of total iron absorption, measured by the level of its inclusion in Hb. Studies using radiolabeled FA have shown a good correlation between the percentage of iron uptake into red blood cells (incorporation into Hb) and absorption, measured as body iron content. Maximum absorption of iron from the gastrointestinal tract occurs in the duodenum and jejunum. As with other oral iron preparations, the relative absorption of iron from the gall bladder, measured as its incorporation into Hb, decreased with increasing iron dose. A correlation has also been observed between the degree of iron deficiency (i.e., serum ferritin level) and the relative amount of iron absorbed (i.e., the greater the iron deficiency, the better the relative absorption). It was shown that, in contrast to iron salts, the absorption of iron from the bile duct was increased when the drug was taken with food in patients with anemia.

Distribution

The distribution of iron from the LPC after absorption was shown during the study and using the double isotope method (55Fe and 59Fe).

Biotransformation

After absorption, iron from the gallbladder is used in the bone marrow for the synthesis of Hb or stored by binding to ferritin, mainly in the liver.

Removal

Unabsorbed iron is excreted in the feces.

Pharmacodynamics

Mechanism of action

Polynuclear iron(III) hydroxide centers are surrounded by non-covalently bound polymaltose molecules, forming a complex with a total molecular weight of about 50 kDa. The multinuclear centers of the GC have a structure similar to ferritin, a physiological iron storage protein. Iron(III)-hydroxide polymaltose is a stable complex that does not release large amounts of iron under physiological conditions. This molecule is so large that its diffusion across the intestinal mucosal membrane is approximately 40 times less than that of a hexameric iron(II) compound. Iron from the digestive tract is absorbed in the intestine by active transport.

Pharmacodynamic effects

Once absorbed, iron binds to transferrin and is used for hemoglobin synthesis in the bone marrow or stored primarily in the liver, where it binds to ferritin.

Clinical efficacy and safety

The effectiveness of the drug Maltofer® in normalizing Hb levels and replenishing iron stores has been demonstrated in numerous randomized placebo-controlled or drug-comparison clinical studies conducted in adult patients and children with different iron levels in the body. These studies involved 3,800 patients, approximately 2,300 of whom received Maltofer® .

Indications for use

Maltofer ® used to treat iron deficiency conditions in the following cases:

treatment of iron deficiency without anemia and iron deficiency anemia (IDA)

prevention of iron deficiency

prevention of iron deficiency during pregnancy

Directions for use and doses

The daily dose can be divided into several doses or taken once. The drug Maltofer® Take during meals or immediately after.

Maltofer tablets® Chewable tablets can be chewed or swallowed whole.

Treatment of iron deficiency anemia in children over 12 years of age and adult patients:

100 - 300 mg of iron (1 - 3 tablets) daily for 3 - 5 months until hemoglobin (Hb) levels normalize. After this, the drug must be continued to be taken for several weeks at the dosage used for iron deficiency without anemia in order to replenish iron reserves in the body.

Treatment of iron deficiency anemia during pregnancy:

200 - 300 mg of iron (2 - 3 tablets) daily until Hb levels normalize. After this, the drug must be continued until the end of pregnancy at the dosage used for iron deficiency without anemia in order to replenish iron reserves in the body and meet the increased need for iron during pregnancy.

Treatment and prevention of iron deficiency without anemia in children over 12 years of age and adult patients:

100 mg (1 tablet) daily for 1 - 2 months. If it is necessary to use a lower dose for preventive purposes, you can use the drug Maltofer® in syrup form.

Side effects

Often (>1/10)

change in stool color

Often (≥1/100,<1/10)

indigestion

Infrequently (≥1/1000, <1/100)

abdominal pain

discoloration of tooth enamel

rash, itching

headache

Contraindications

known hypersensitivity to iron(III)-hydroxide polymaltose complex (IPC) or any of the excipients listed in section "Composition"

Iron overload, such as hemochromatosis, hemosiderosis

iron absorption disorders such as lead poisoning anemia, sideroblastic anemia, thalassemia

anemia not caused by iron deficiency, such as hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency

Drug interactions

The interaction of ZPA (with or without folic acid) with tetracycline or aluminum hydroxide was studied in 3 human studies. There was no significant decrease in tetracycline absorption. Tetracycline plasma concentrations did not fall below the efficacy level. When using aluminum hydroxide or tetracycline, the absorption of iron from the iron was not reduced. Iron (III) hydroxide is a polymaltose complex, therefore, can be used simultaneously with tetracycline and other phenolic compounds, as well as aluminum hydroxide.

Similarly, no interactions were observed with food ingredients such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean flour in studies invitro using ZhPC. These results confirm that GPC can be taken during or immediately after a meal.

There is no deterioration in the results of the hemoccult test to detect occult blood (selective for Hb), therefore, there is no need to interrupt treatment.

special instructions

The presence of infectious diseases or a tumor process can cause anemia. It is recommended to evaluate the benefit/risk ratio, since iron can begin to be absorbed only after treatment of the underlying disease.

While using the drug Maltofer® There may be a change in the color of the stool to a darker color, but this phenomenon has no clinical significance.

Application of Maltofer® does not affect daily insulin control in patients with diabetes.

One chewable tablet Maltofer® contains 0.04 bread units.

Use in pediatrics

The drug Maltofer® Chewable tablets are not recommended for use in children under 12 years of age. For this age group it is recommended to take Maltofer® in the form of syrup or drops.

Pregnancy

There are no clinical trial data regarding the use of the drug Maltofer® in pregnant women in the first trimester. To date, there have been no reports of serious adverse reactions after taking Maltofer.® in therapeutic doses for the treatment of anemia during pregnancy. Animal data do not provide evidence of risk to mother or fetus

Studies involving pregnant women after the first trimester have not revealed any undesirable effects from taking Maltofer® for the mother and/or newborn. Therefore, it is unlikely that the use of Maltofer® will have a negative effect on the fetus.

Lactation period

Breast milk usually contains iron bound to lactoferrin. The amount of iron transferred from the gallbladder to breast milk is unknown. It is unlikely that the use of Maltofer® in women during breastfeeding will have undesirable effects on the baby.

As a precautionary measure, women of childbearing age, as well as during pregnancy and breastfeeding, should take the drug Maltofer® only after consulting a doctor. It is recommended to evaluate the benefit/risk ratio.

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

No data available.

Overdose

It is unlikely that cases of overdose, iron oversaturation or intoxication will occur when using the drug Maltofer® due to the low toxicity of gallstones and controlled iron intake. No accidental poisoning episodes or deaths were reported.

Release form and packaging

10 tablets are placed in a blister pack made of aluminum foil.

In this article you can read the instructions for use of the drug Maltofer. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Maltofer in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Maltofer in the presence of existing structural analogues. Use for the treatment of iron and folic acid deficiency in adults, children, as well as during pregnancy and lactation. Composition of the drug.

Maltofer- contains iron in the form of a polymaltose complex of iron hydroxide. This macromolecular complex is stable and does not release iron in the form of free ions in the gastrointestinal tract. The structure of Maltofer is similar to the natural iron compound ferritin. Due to this similarity, iron moves from the intestines into the blood through active transport. Absorbed iron binds to ferritin and is stored in the body, mainly in the liver. Then, in the bone marrow it is included in hemoglobin. Iron, which is part of the polymaltose complex of iron hydroxide, does not have pro-oxidant properties, unlike simple iron salts. There is a correlation between the severity of iron deficiency and the level of its absorption (the greater the severity of iron deficiency, the better the absorption). The most active absorption process occurs in the duodenum and small intestine.

Maltofer does not stain teeth.

Compound

Iron (in the form of iron (3) hydroxide polymaltose) + excipients.

Iron (in the form of iron (3) hydroxide polymaltosate) + Folic acid + excipients (Maltofer FOL).

Indications

treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia);
prevention of iron deficiency during pregnancy;
prevention of iron and folic acid deficiency (including before, during and after pregnancy, during lactation).

Release forms

Oral solution.

Drops, syrup (ideal children's form of the drug).

Chewable tablets (Maltofer FOL).

Instructions for use and dosage regimen

Solution

Maltofer oral solution in single-dose vials is intended for oral administration.

The daily dose can be taken all at once during or immediately after meals.

The drinking solution can be mixed with fruit and vegetable juices or soft drinks. The weak color of the drink does not change its taste and does not reduce the effectiveness of the drug.

Children over 12 years of age, adults and nursing mothers:

Treatment of clinically significant iron deficiency (iron deficiency anemia): 1 bottle 1-3 times a day for 3-5 months until blood hemoglobin levels normalize. After this, taking the drug should be continued for several more months in order to restore iron reserves in the body at a dosage of 1 bottle per day.

For the treatment of latent iron deficiency and for the prevention of iron deficiency: 1 bottle per day for 1-2 months.

Pregnant women:

Treatment of clinically significant iron deficiency (iron deficiency anemia): 1 bottle 2-3 times a day for 3-5 months until blood hemoglobin levels normalize. After this, the drug should be continued at a dosage of 1 bottle per day, at least until delivery to restore iron reserves.

For the treatment of latent deficiency: 1 bottle per day for 1-2 months.

In the case of clinically pronounced iron deficiency, normalization of hemoglobin levels occurs only 2-3 months after the start of treatment.

Drops or syrup

The drug is taken orally during or immediately after meals.

Drops and syrup can be mixed with fruit, vegetable juices or soft drinks. Chewable tablets can be chewed or swallowed whole.

The daily dose of the drug depends on the degree of iron deficiency.

Chewable tablets

The drug is taken orally, during or immediately after meals. The tablets can be chewed or swallowed whole.

The dose of the drug and duration of therapy depend on the severity of iron deficiency. The daily dose of the drug can be taken 1 time per day.

Treatment of clinically pronounced iron deficiency (iron deficiency anemia): 1 tablet 1-3 times a day for 3-5 months until blood hemoglobin levels normalize. After this, taking the drug should be continued for several more months in order to restore iron reserves in the body - 1 tablet per day.

Pregnant women should take the drug 1 tablet 2-3 times a day until hemoglobin normalizes. Then therapy should be continued at a dose of 1 tablet per day, at least until delivery to restore iron reserves.

For the treatment of latent iron deficiency and the prevention of iron and folic acid deficiency, the drug is prescribed 1 tablet per day.

The duration of treatment for clinically significant iron deficiency (iron deficiency anemia) is 3-5 months until hemoglobin levels normalize. After this, the drug should be continued at a dose to treat latent iron deficiency for several more months, and for pregnant women, at least until childbirth to restore iron reserves.

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

In the case of clinically pronounced iron deficiency, normalization of hemoglobin levels and replenishment of iron reserves occurs only 2-3 months after the start of treatment.

Side effect

signs of gastrointestinal irritation (including a feeling of fullness, pressure in the epigastric region, nausea, constipation or diarrhea);
dark coloration of the stool (black stool), due to the release of unabsorbed iron (has no clinical significance);
allergic reactions to iron and folic acid (for Maltofer FOL).

Contraindications

excess iron (for example, hemosiderosis and hemochromatosis);
impaired iron utilization (lead anemia, sideroachrestic anemia, thalassemia);
non-iron deficiency anemia (hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).

Use during pregnancy and breastfeeding

In controlled studies in pregnant women in the 2nd and 3rd trimesters of pregnancy, no undesirable effects of the drug on the mother and fetus were observed. There is no data on the undesirable effect of the drug on the fetus in the 1st trimester of pregnancy

Use in children

Due to the need to prescribe smaller doses, it is recommended to use the drug Maltofer drops in premature infants, and Maltofer syrup in children under 12 years of age (including infants).

special instructions

1 tablet of Maltofer Fol contains 0.04 XE, which must be taken into account when prescribing to patients with diabetes.

Drug interactions

No interactions with other drugs have been identified.

Analogues of the drug Maltofer

Structural analogues of the active substance and other drugs for the treatment of iron deficiency conditions:

Actiferrin compositum;
Aloe syrup with iron;
Biovital elixir;
Biofer;
Venofer;
Vitrum Superstress;
Vitrum Circus;
Hemofer;
Gyno Tardiferon;
Polymaltose iron;
Likferr 100;
Maltofer Fall;
Multi tabs Active;
Pikovit Complex;
Sorbifer Durules;
Merz special dragee;
Stress formula with iron;
Supradin Kids Junior;
Tardiferon;
Totema;
Fenyuls Complex;
Ferlatum;
Ferri;
Ferrinate;
Ferro Folgamma;
Ferrogrademet;
Ferronal;
Ferrum Lek;
Heferol;
Enfamil Premium 2;
Enfamil with iron.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Iron preparation in the form of a polymaltose complex of Fe3+ hydroxide. On the outside, the multinuclear Fe3+ hydroxide centers are surrounded by many non-covalently bound polymaltose molecules, forming a complex with a total mol. weighing 50 thousand Daltons, which is so large that its diffusion through the membranes of the intestinal mucosa is approximately 40 times less than that of Fe2+ hexahydrate.

This macromolecular complex is stable, does not release iron in the form of free ions, and is similar in structure to the natural compound of iron and ferritin. Due to this similarity, Fe3+ ions from the intestine enter the blood only through active absorption, which explains the impossibility of overdose (and intoxication) with the drug, unlike simple iron salts, the absorption of which occurs along a concentration gradient.

Absorbed iron is deposited bound to ferritin, mainly in the liver. Later, in the bone marrow it is included in Hb. Iron, which is part of the Fe3+-hydroxide polymaltose complex, does not have pro-oxidant properties (which are inherent in simple Fe2+ salts), which leads to a decrease in the oxidation of LDL and VLDL.

Quickly replenishes iron deficiency in the body, stimulates erythropoiesis, and restores hemoglobin.

Pharmacokinetics

The degree of absorption after oral administration depends on the degree of iron deficiency (the greater the deficiency, the higher the absorption) and the dose of the drug (the higher the dose, the worse the absorption). Absorbed predominantly in the duodenum and small intestine. The unabsorbed part is excreted in the feces.

After intramuscular administration, it enters the bloodstream through the lymphatic system. The time to reach Cmax is 24 hours. In the reticuloendothelial system, the complex is split into iron (III) hydroxide and polymaltose (metabolized by oxidation). In the bloodstream, iron binds to transferrin, in tissues it is deposited as part of ferritin, in the bone marrow it is included in hemoglobin and is used in the process of erythropoiesis.

Indications for use of the drug

For oral administration:

- treatment of iron deficiency anemia of various origins and latent iron deficiency in infants and young children;

- increased need for iron (pregnancy, lactation, donation, period of intensive growth, vegetarianism, old age).

Injection:

- treatment of iron deficiency anemia in case of ineffectiveness or impossibility of taking oral iron-containing medications (including in patients with gastrointestinal diseases and those suffering from malabsorption syndrome).

Dosage regimen

Inside, during or immediately after meals. The dosage and timing of treatment depend on the degree of iron deficiency. The daily dose can be divided into several doses or taken once.

Pills: should be chewed or swallowed whole during or after meals. The daily dose can be taken at one time. Treatment of clinically significant deficiency: 1 tablet. 1-3 times a day for 3-5 months until hemoglobin normalizes. Then the intake should be continued for several more months in order to restore iron reserves in the body (1 tablet per day). Pregnant women: 1 tablet. 2-3 times/day until hemoglobin normalizes, followed by 1 tablet/day until delivery. For the treatment of latent iron deficiency and for the prevention of iron deficiency - 1 tablet/day.

Drops It is permissible to mix with fruit and vegetable juices or with artificial nutritional mixtures without fear of reducing the activity of the drug. 1 ml (20 drops) contains 176.5 mg of iron (III) hydroxide polymaltose complex (50 mg of elemental iron), 1 drop. equal to 2.5 mg of elemental iron. Doses for the treatment of clinically significant iron deficiency: premature infants - 1-2 drops/kg daily for 3-5 months; children under 1 year - 10-20 drops/day; 1-12 years - 20-40 drops/day; children over 12 years old and adults - 40-120 drops/day; pregnant women - 80-120 drops/day. Duration of treatment - at least 2 months. In the case of clinically pronounced iron deficiency, normalization of hemoglobin is achieved only 2-3 months after the start of treatment. To restore internal iron reserves, administration in prophylactic doses should be continued for several months. Doses for the treatment of latent iron deficiency: children under 1 year - 6-10 drops/day; 1-12 years - 10-20 drops/day; children over 12 years old and adults - 20-40 drops/day; pregnant women - 40 drops/day. Prevention of iron deficiency: children under 1 year - 2-4 drops/day; 1-12 years - 4-6 drops/day; children over 12 years old and adults - 4-6 drops/day; pregnant women - 6 drops/day.

Syrup contains 10 mg of iron (III) per ml. Doses for the treatment of clinically pronounced iron deficiency: children under 1 year - 2.5-5 ml/day (25-50 mg iron); 1-12 years - 5-10 ml/day; children over 12 years old, adults and lactating women - 10-30 ml/day; pregnant women - 20-30 ml/day. Doses for the treatment of latent iron deficiency: children from 1 to 12 years - 2.5-5 ml/day; children over 12 years old, adults and lactating women - 5-10 ml/day; pregnant women - 10 ml/day. Prevention of iron deficiency: pregnant women - 5-10 ml/day.

Solution for intramuscular administration

Before the first administration of a therapeutic dose, it is necessary to conduct an intramuscular test: adults are administered from? before? doses of the drug (from 25 to 50 mg of iron), for children - half the daily dose. If there are no adverse reactions within 15 minutes after administration, the remainder of the initial dose of the drug can be administered. Treatments should be available to assist with the development of anaphylactic shock.

Dose calculation: The dose of the drug is calculated individually and adapted in accordance with the general iron deficiency according to the following formula:

Total iron deficiency (mg) = body weight (kg) x (normal Hb level – patient’s Hb level) (g/l) x 0.24 * + iron reserves (mg)

At body weight less than 35 kg: normal Hb = 130 g/l, which corresponds to iron reserves = 15 mg/kg body weight

At body weight above 35 kg: normal Hb level = 150 g/l, which corresponds to iron reserves = 500 mg

* Factor 0.24 = 0.0034 x 0.07 x 1000 (iron content in hemoglobin = 0.34% / blood volume? 7% of body weight / factor 1000 = conversion from g to mg)

If the required dose exceeds the maximum daily dose, the drug should be administered in fractional doses.

Standard dosage: Adults: 1 ampoule daily (2.0 ml = 100 mg iron). Children: the dosage is determined depending on body weight.

Maximum permissible daily doses: Children weighing up to 6 kg: ? ampoules (0.5 ml = 25 mg iron). Children weighing from 5 to 10 kg: ? ampoules (1.0 ml = 50 mg iron). Adults: 2 ampoules (4.0 ml = 200 mg iron).

If there is no response from hematological parameters after 1-2 weeks (eg, an increase in Hb levels of approximately 0.1 g/dL per day), the initial diagnosis should be reconsidered. The total dose of the drug per course of treatment should not exceed the calculated number of ampoules.

Side effect

Oral dosage forms: dyspepsia (feeling of fullness and pressure in the epigastric region, nausea, constipation or diarrhea), dark color of stool (due to the excretion of unabsorbed iron and has no clinical significance).

Solution for intramuscular administration: in rare cases - arthralgia, swollen lymph nodes, fever, headache, malaise, dyspepsia (nausea, vomiting); extremely rarely - allergic reactions. Local reactions (if the injection technique is incorrect): skin coloring, pain, inflammation.

Contraindications to the use of the drug

- hypersensitivity;

- excess iron in the body (hemochromatosis, hemosiderosis);

- anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by a lack of cyanocobalamin, aplastic anemia);

- violation of iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia, cutaneous porphyria tarda).

For IM solution only (optional):

- Randu-Weber-Osler disease;

— chronic polyarthritis;

— infectious kidney diseases in the acute stage;

- uncontrolled hyperparathyroidism;

— decompensated cirrhosis of the liver;

— infectious hepatitis;

— early childhood (up to 4 months);

- pregnancy (first trimester).

Use of the drug during pregnancy and lactation

The solution for intramuscular administration is contraindicated for use in the first trimester of pregnancy.

Solution for injection: Experimental reproduction studies and controlled studies in pregnant women have not been conducted. In small quantities, unchanged iron from the polymaltose complex can pass into breast milk, but adverse effects are unlikely to occur in breast-fed infants.

No negative effects on the fetus have been established when oral forms are prescribed during pregnancy (including in the first trimester).

Use for liver dysfunction

Caution should be exercised when administering the drug intramuscularly to patients with liver failure.

Use for renal impairment

Caution should be exercised when administering the drug intramuscularly to patients with renal failure.

special instructions

When prescribing the drug to patients with diabetes, it should be taken into account that 1 ml of syrup contains 0.04 XE, and 1 ml of drops - 0.01 XE.

Taking iron supplements should be continued even after hemoglobin normalization.

Does not stain tooth enamel.

Parenteral iron supplements can cause allergic and anaphylactic reactions. In case of moderate allergic reactions, antihistamines should be prescribed; If a severe anaphylactic reaction develops, immediate administration of adrenaline is necessary. Cardiopulmonary resuscitation must be available. Caution should be exercised when administering the drug to patients with allergies, as well as liver and kidney failure. Side effects that occur in patients with cardiovascular diseases can aggravate the course of the underlying disease. Patients with bronchial asthma or those with low serum iron-binding capacity and/or folic acid deficiency are at high risk of developing allergic or anaphylactic reactions. Administration to children under 4 months of age is not recommended due to lack of experience. In children, parenteral iron supplements can negatively affect the course of the infectious process.

Solution for injection is intended for intramuscular administration only.. Injection technique is important. As a result of incorrect administration of the drug, pain and staining of the skin at the injection site may occur. The ventrogluteal injection technique is recommended instead of the generally accepted one - into the upper outer quadrant of the gluteus maximus muscle.

1) The length of the needle must be at least 5-6 cm. The lumen of the needle should not be too wide. For children, as well as for adults with low body weight, the needles should be shorter and thinner.

2) In accordance with Hochstetter recommendations, the injection site is determined as follows: point A is fixed along the line of the spinal column at a level corresponding to the lumbar-iliac joint. If the patient is lying on the right side, the middle finger of the left hand is placed at point A. The index finger is left behind from the middle one so that it is under the line of the iliac crest at point B. The triangle located between the proximal phalanges, middle and index fingers is the injection site.

3) Instruments are disinfected using the usual method.

4) Before inserting the needle, move the skin about 2 cm in order to properly close the puncture channel after removing the needle. This prevents the injected solution from penetrating the subcutaneous tissue and staining the skin.

5) Place the needle vertically in relation to the surface of the skin, at a greater angle to the point of the iliac joint than to the point of the femoral joint.

6) After the injection, slowly remove the needle and press the area of skin adjacent to the injection site with your finger for about 5 minutes.

7) After the injection, the patient needs to move.

Only undamaged ampoules can be used. If a precipitate forms, the solution is unsuitable for use. After opening the ampoule, the solution should be administered immediately.

Overdose

When the solution is administered for intramuscular administration in too high doses, the complex cannot be removed from the body by hemodialysis due to its high molecular weight. Periodic monitoring of serum ferritin levels may help in timely recognition of progressive iron accumulation.

Overdose can cause acute iron overload, which manifests itself as symptoms of hemosiderosis. In case of overdose, it is recommended to use symptomatic agents and, if necessary, iron-binding substances (chelates), for example IV deferoxamine.

Drug interactions

Oral forms: No interactions with other drugs were detected.

Injection: ACE inhibitors enhance systemic effects. Should not be used simultaneously with oral iron-containing drugs (iron absorption from the gastrointestinal tract is reduced).