Maltofer instructions for using drops for pregnant women. Maltofer: use of drops, instructions for use, side effects, composition. Maltofer side effects

1 ml of the drug contains iron (III) hydroxide polymaltosate 35.7 mg, which corresponds to an iron content of 10 mg

Release form:

Syrup for oral administration 150 ml in a dark glass bottle complete with a measuring cap in a cardboard box.

Pharmachologic effect:

Antianemic drug.

In iron(III) hydroxide polymaltosate, polynuclear iron(III) hydroxide is externally surrounded by multiple covalently linked polymaltosate molecules, resulting in an overall average molecular weight of approximately 50 kDa. The structure of the active substance of the drug Maltofer is similar to the structure of the core protein ferritin - a physiological iron depot. Iron (III) hydroxide polymaltosate is stable and does not release large amounts of iron ions under physiological conditions. Due to its size, the degree of diffusion of iron(III) hydroxide polymaltosate through the mucosa is approximately 40 times less compared to iron(II) hexahydrate complex. Iron, which is part of the iron (III) complex polymaltosate hydroxide, is actively absorbed in the intestine.

The effectiveness of Maltofer in normalizing hemoglobin levels and replenishing iron depots has been demonstrated in numerous randomized controlled clinical trials using placebo control or an active comparator drug conducted in adults and children with different iron depot status.

Indications for use:

• treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia);
• prevention of iron deficiency during pregnancy, lactation, as well as in blood donors, in children and adolescents during periods of intensive growth, in vegetarians and the elderly.

Directions for use and dosage:

The drug is taken orally during or immediately after meals. The daily dose can be divided into several doses or taken at a time.

Drops and syrup can be mixed with fruit, vegetable juices or soft drinks, baby food or infant formula. Slight coloring of the mixture does not affect either its taste or the effectiveness of the drug.

The exact dose of Maltofer syrup can be measured using the measuring cap supplied with the drug.

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

Contraindications:

• excess iron (for example, hemosiderosis and hemochromatosis);
• impaired iron utilization (for example, lead anemia, sideroachrestic anemia, thalassemia);
• anemia not associated with iron deficiency (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency);
• sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (Maltofer drops for oral administration and Maltofer syrup);
• known hypersensitivity to iron (III) hydroxide polymaltose or to any excipient.

Special instructions:

The dosage form and concentration of Maltofer drops for oral administration and Maltofer syrup are suitable for taking the recommended dose in the age group of children under 12 years of age.

Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can be taken only after the underlying cause of the disease has been eliminated, the benefit-risk ratio of treatment should be determined.

The daily dose of the drug Maltofer syrup contains ethanol in an amount from 0.008 g (dose 2.5 ml) to 0.1 g (dose 30 ml).

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

Syrup and oral drops contain sucrose, which can harm teeth.

During treatment with Maltofer, dark coloration of the stool may be observed, but this has no clinical significance.

The excipients sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which are part of the drug Maltofer in the form of syrup and drops for oral administration, can cause allergic reactions (possibly of a delayed type).

Storage conditions:

In original packaging, in protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children.

Name:

Maltofer

Pharmacological
action:

The drug Maltofer contains iron in the form of a polymaltose complex of iron (III) 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(III) enters the bloodstream from the intestine 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 (III) 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 solution for oral administration does not stain teeth.

Indications for
application:

For the treatment of patients suffering from iron deficiency anemia, as well as latent iron deficiency;
- can be prescribed by the attending physician to prevent iron deficiency in patients at risk, including elderly patients, women during pregnancy, patients on a strict diet, as well as in children and adolescents during periods of active growth.

Mode of application:

Drops and oral solution
The drug is intended for oral use. The required dose of the drug can be dissolved in a small amount of juice or other non-alcoholic drinks. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient.

Syrup
The drug is intended for oral use. The required dose of the drug is measured using a measuring cap. Before use, the drug can be dissolved in a small amount of juice or other non-alcoholic drinks. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient.

Chewable tablets
The drug is intended for oral use. The tablets are swallowed whole or chewed with a small amount of liquid. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient.

Recommended the dose of the drug does not depend on the dosage form, the attending physician independently selects the dosage form of the drug.
Premature infants with iron deficiency anemia are usually prescribed 2.5-5 mg of the drug/kg body weight once a day.
Children under 1 year of age for iron deficiency anemia, 25-50 mg of the drug is usually prescribed 1 time per day, for latent iron deficiency and for the prevention of iron deficiency, 15-25 mg of the drug 1 time per day.
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.
Children aged 1 to 12 years for iron deficiency anemia, 50-100 mg of the drug is usually prescribed 1 time per day, for latent iron deficiency and for the prevention of iron deficiency, 25-50 mg of the drug 1 time per day.
Adults and teenagers over 12 years of age, as well as for women during lactation with iron deficiency anemia, they are usually prescribed 100-300 mg of the drug once a day, with latent iron deficiency and for the prevention of iron deficiency, 50-100 mg of the drug once a day.
Women during pregnancy for iron deficiency anemia, 200-300 mg of the drug is usually prescribed 1 time per day, for latent iron deficiency and for the prevention of iron deficiency, 100 mg of the drug 1 time per day.
The duration of treatment for iron deficiency anemia is usually 5-7 months.
Pregnant women with iron deficiency anemia are recommended to take the drug before childbirth in order to restore iron reserves.
The duration of treatment for latent iron deficiency is usually 1-2 months.

Side effects:

The drug is usually well tolerated by patients, but some patients experienced nausea, vomiting, stool disorders and epigastric pain when using the drug.
When taking the drug, patients also experience darkening of the stool, which has no clinical significance.

Contraindications:

Increased individual sensitivity to the components of the drug;
- not prescribed to patients with hemosiderosis and hemochromatosis, as well as to patients suffering from impaired iron excretion, including sideroachrestic anemia, thalassemia and anemia caused by lead poisoning;
- not used for the treatment of patients with hemolytic and megaloblastic anemia.

When using the drug for the treatment of patients suffering from diabetes, it should be taken into account that 1 ml of drops for oral use contains 0.01 bread units, 1 ml of syrup and 1 chewable tablet - 0.04 bread units, 5 ml of oral solution - 0.11 bread units units.

Interaction
other medicinal
by other means:

Without features.

Pregnancy:

In controlled studies in pregnant women after the first trimester of pregnancy, no undesirable effects of the drug on the mother and fetus were noted.
There is no evidence of undesirable effects of the drug on the fetus during the first trimester of pregnancy.

Overdose:

To date, in cases of drug overdose, neither intoxication nor signs of iron overload have been reported.

Release form:

Oral drops Maltofer 10 ml or 30 ml in dark glass bottles and in bottles made of polymer materials, 1 bottle with a dropper cap and a protective cap in a cardboard package.
Syrup Maltofer 75 ml or 150 ml in dark glass bottles, 1 bottle complete with a measuring cap in a cardboard box.
Chewable tablets Maltofer 10 pieces in a blister pack, 3 blister packs in a cardboard box.
Oral solution Maltofer 5 ml in glass bottles, 10 bottles in cardboard packaging.
Chewable tablets MAltofer Foul p about 10 pieces in a blister pack, 3 blister packs in a cardboard box.

Storage conditions:

At a temperature not higher than plus 25°C in a place protected from light and out of reach of children.
The shelf life of the drug in the form of chewable tablets, drops for oral use and solution for oral use is 5 years.
The shelf life of the drug in syrup form is 3 years.

1 ml of Maltofer in the form of drops for oral use contains:
- active ingredient: iron (III) hydroxide polymaltosate (in terms of iron) – 50 mg.
1 ml contains 20 drops, 1 drop contains:
- active ingredient: iron (III) hydroxide polymaltosate (in terms of iron) – 2.5 mg; - excipients, including sucrose.

5 ml of Maltofer in syrup form contain:
- active ingredient: iron (III) hydroxide polymaltosate (in terms of iron) – 50 mg;
- excipients, including sucrose, sorbitol and ethyl alcohol.

1 chewable tablet drug Maltofer contains:

- excipients, including vanillin and cocoa powder.

5 ml of Maltofer in the form of an oral solution contain:
- active ingredient: iron (III) hydroxide polymaltosate (in terms of iron) – 100 mg;
- excipients, including sucrose and sorbitol.

Maltofer is a drug used to replenish iron deficiency.

Release form and composition

Maltofer is produced in the following dosage forms:

• 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).

The composition of 1 ml of oral solution includes:

• Active substance: iron – 20 mg (in the form of iron (III) hydroxide polymaltosate);
• Auxiliary components: sucrose, 70% sorbitol solution, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, cream flavor, sodium hydroxide, purified water.

The composition of 1 ml (20 drops) drops for oral administration includes:

• Excipients: sucrose, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, cream flavor, sodium hydroxide, purified water.

1 ml of syrup contains:

• Active substance: iron – 10 mg (in the form of iron (III) hydroxide polymaltosate);
• Excipients: sucrose, 70% sorbitol solution, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, 96% ethanol, cream flavor, sodium hydroxide, purified water.

1 chewable tablet contains:

• Active substance: iron – 103 mg (in the form of iron (III) hydroxide polymaltose);
• Auxiliary components: dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor, microcrystalline cellulose.

The composition of 1 ml of solution for injection includes:

• Active substance: iron – 50 mg (in the form of iron (III) hydroxide polymaltosate);
• Auxiliary components: sodium hydroxide/hydrochloric acid, water for injection.

Indications for use

Maltofer in oral dosage forms (solution and drops for oral administration, chewable tablets, syrup) is prescribed for the following conditions/diseases:

• Latent and clinically pronounced iron deficiency (treatment);
• Iron deficiency in lactating and pregnant women, children and adolescents, adults (for example, the elderly and vegetarians), women of childbearing age (prevention).

Maltofer in the form of an injection solution is used in the treatment of iron deficiency in cases where it is impossible to take iron-containing drugs orally, as well as their ineffectiveness or lack of effectiveness in case of malabsorption, in patients who do not agree to regularly and long-term use of oral iron supplements and in patients with gastrointestinal disorders tract (for example, with ulcerative colitis), in which an exacerbation of the disease may occur when taking iron supplements orally.

Maltofer for injection is prescribed only in cases of iron deficiency confirmed by research (for example, determination of the level of hemoglobin, serum ferritin, number of red blood cells or hematocrit, as well as their parameters - the average content of hemoglobin in an erythrocyte, the average volume of an erythrocyte).

Contraindications

• Excess iron (hemosiderosis, hemochromatosis);
• Anemia not associated with iron deficiency (for example, impaired erythropoiesis, hemolytic anemia caused by a lack of vitamin B12 in the body, megaloblastic anemia, bone marrow hypoplasia);
• Impaired iron utilization (eg, thalassemia, sideroachrestic anemia, cutaneous porphyria tarda, lead anemia);
• Hypersensitivity to the components of the drug.

Additional contraindications to the use of Maltofer in the form of an injection solution are:

• Infectious hepatitis;
• Osler-Rendu-Weber syndrome;
• Chronic polyarthritis;
• Uncontrolled hyperparathyroidism;
• Infectious kidney diseases (in acute cases);
• Bronchial asthma;
• Decompensated cirrhosis of the liver;
• Intravenous administration;
• First trimester of pregnancy.

When taking the drug orally, due to the need to prescribe smaller doses, Maltofer is recommended for premature children in the form of drops, for children under 12 years old - in the form of syrup.

The drug in the form of an injection solution is not recommended for use in children under 4 months of age (due to the lack of data on the safety and effectiveness of its use in this category of patients).

Directions for use and dosage

Maltofer in the form of solution, drops, chewable tablets and syrup is taken orally during or immediately after meals.

Before taking the drops, solution and syrup can be mixed with soft drinks or vegetable or fruit juices. Chewable tablets can be swallowed whole or chewed.

The daily dose of the drug is determined by the degree of iron deficiency.

For iron deficiency anemia, the drug is prescribed in the following dosages:

• Premature babies: 1-2 drops of solution/kg;
• Children under 1 year: 25-50 mg of iron - 10-20 drops of solution or 2.5-5 ml of syrup;
• Children 1-12 years old: 50-100 mg of iron - 20-40 drops of solution or 5-10 ml of syrup;
• Children from 12 years old: 100-300 mg of iron – 40-120 drops of solution or 10-30 ml of syrup;
• Adults (including nursing women): 100-300 mg of iron – 40-120 drops of solution, 10-30 ml of syrup or 1-3 chewable tablets;
• Pregnant women: 200-300 mg of iron - 80-120 drops of solution, 20-30 ml of syrup or 2-3 chewable tablets.

For latent iron deficiency, Maltofer is prescribed:

• Adults (including nursing women): 50-100 mg of iron – 20-40 drops of solution, 5-10 ml of syrup or 1 chewable tablet;

For prophylaxis, the drug is prescribed in the following dosages:

• 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 or 5-10 ml of syrup;
• Pregnant women: 100 mg of iron - 40 drops of solution, 10 ml of syrup or 1 chewable tablet.

The daily dose of Maltofer in the form of an oral solution can be taken all at once. When treating iron deficiency anemia, adults, children over 12 years of age and nursing mothers are prescribed 1 bottle 1-3 times a day, pregnant women - 2-3 times a day. To prevent iron deficiency and treat latent iron deficiency, adults (including nursing and pregnant women) and children over 12 years of age should take 1 bottle per day.

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

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

With clinically significant iron deficiency, replenishment of the necessary iron reserves and restoration of hemoglobin levels usually occurs within 2-3 months from the start of treatment.

Maltofer injection solution is administered intramuscularly.

Before the first use of the drug, a test should be carried out: adults are given 1/4-1/2 of the daily dose, children over 4 months – 1/2 of the daily dose. The remaining solution can be administered if no adverse reactions were noted within 15 minutes.

When performing an injection, it is necessary to ensure the availability of the funds necessary to provide assistance in the event of anaphylactic shock.

The dose of Maltofer is calculated individually using the following formula and adjusted according to the general iron deficiency: total iron deficiency (mg) = body weight (kg) × (normal Hb level - patient Hb level) (g/l) × 0.24 + iron reserves (mg).

With body weight less than 35 kg: normal Hb = 130 g/l (deposited iron = 15 mg/kg body weight).

With a body weight of more than 35 kg: normal Hb level = 150 g/l (deposited iron = 500 mg).

If the required dose is higher than the maximum daily dose, the administration of Maltofer should be fractional.

Adults are prescribed 1 ampoule daily; for children over 4 months, the dose is determined based on body weight.

The maximum permissible daily doses are (1 ml = 50 mg iron = 1/2 ampoule):

• Children up to 6 kg: 0.5 ml;
• Children 5-10 kg: 1 ml;
• Children 10-45 kg: 2 ml;
• Adults: 4 ml.

If there is no therapeutic response from hematological parameters after 7-14 days, the initial diagnosis should be reconsidered. The total dose of Maltofer per treatment course should not exceed the calculated number of ampoules.

The injection technique is important. Due to incorrect administration of the solution, pain and staining of the skin at the injection site may occur. Maltofer is injected into the upper outer quadrant of the gluteus maximus muscle. The lumen of the needle should be narrow, the length should be at least 5-6 cm. For adults with low weight and children, the needles should be thinner and shorter. After the injection, the patient should move around.

Side effects

When taking oral forms of Maltofer, it is very rarely possible to develop disorders of the digestive system, manifested as symptoms of irritation of the gastrointestinal tract (a feeling of fullness, pressure in the epigastric region, nausea, diarrhea or constipation). Also, during therapy, dark coloration of the stool is possible (this symptom is due to the release of unabsorbed iron and has no clinical significance).

When using Maltofer in the form of an injection solution, the following side effects may develop:

• Digestive system: rarely - vomiting, nausea (these side effects can be relieved with symptomatic therapy);
• Local reactions: pain, inflammation and staining of the skin at the injection site (if the technique of administering the drug is violated);
• Body as a whole: rarely - headaches, swollen lymph nodes, joint pain, malaise, fever; very rarely - anaphylactic or allergic reactions.

special instructions

When prescribing Maltofer orally to patients with diabetes mellitus, it should be taken into account that 1 ml of oral drops contains 0.01 XE (bread units), 1 ml of syrup - 0.04 XE, 1 bottle of oral solution - 0.11 XE, 1 chewable tablet – 0.04 XE.

Maltofer does not stain tooth enamel.

Parenteral iron supplements can cause anaphylactic and allergic reactions. Patients at increased risk of developing such reactions include patients with bronchial asthma or patients with low serum iron-binding capacity and/or folic acid deficiency.

For moderately severe allergic reactions, antihistamines should be prescribed. If a severe anaphylactic reaction occurs, epinephrine (adrenaline) should be administered immediately. When administering Maltofer, the availability of funds for cardiopulmonary resuscitation should be ensured.

Parenteral use of Maltofer in children may have a negative effect on the course of the infectious process.

Side effects that develop in patients with cardiovascular disorders can aggravate the course of the underlying disease.

Before using Maltofer, ampoules should be inspected for damage and the presence of sediment. The solution for injection should be administered immediately after opening the ampoule.

Maltofer for injection should not be mixed with other medications.

Drug interactions

The injection solution should not be used simultaneously with oral iron preparations, since this reduces the absorption of the latter from the gastrointestinal tract. It is recommended to start taking oral iron supplements no earlier than 7 days after the last injection.

Increased systemic effects of Maltofer in the form of an injection solution can be caused by simultaneous use with angiotensin-converting enzyme inhibitors (for example, with enalapril).

Terms and conditions of storage

Store in a place protected from light, out of reach of children at temperatures up to 25 °C.

Best before date:

• Solution and drops for oral administration, chewable tablets, solution for injection – 5 years;
• Syrup – 3 years.

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Content

To eliminate the lack of iron in the blood, doctors prescribe Maltofer - the instructions for use of the drug indicate its effect on the stomach and brain. The medication is available in several convenient formats and is prescribed to adults and children for special indications. You should carefully read the instructions for use of the medicine to cope with the disease.

Iron supplement Maltofer

The pharmacological classification of drugs classifies the iron preparation Maltofer as antianemic. This means that the drug counteracts the lack of hemoglobin in the blood serum and replenishes iron deficiency. The active ingredient of the composition is iron hydroxide polymaltosate; the instructions indicate the amount of the component in terms of pure iron.

Composition and release form

Maltofer is available in five convenient formats for oral administration: chewable tablets, syrup, drops, solution and injections for intramuscular administration. Detailed composition of each medicine:

Pharmacodynamics and pharmacokinetics

Ferric hydroxide contains the metal in the form of polymaltose hydroxide. Its structure is similar to the structure of the core protein ferritin, which is a physiological iron depot in the human body. Once inside, the substance is incorporated into hemoglobin and red blood cells, binds to transferrin, participates in the synthesis of hemoglobin in the bone marrow and liver for connection with ferritin, and in choline metabolism. Maximum absorption activity is observed in the duodenum and small intestine. The remains are excreted in the feces.

With intramuscular injections of a solution, iron polymaltosate hydroxide enters the bloodstream through the lymphatic system. Due to the slow release of iron, it is well tolerated. In the liver, the active drug enters the structure of hemoglobin, myoglobin, enzymes, and is used in the process of erythropoiesis. The substance reaches its maximum concentration within 24 hours.

Indications for use

The instructions for use of Maltofer highlight the following indications for use by patients:

• treatment of iron deficiency without anemia (latent deficiency), symptomatic iron deficiency anemia;
• increased need for iron (pregnancy, lactation, blood donation, intensive growth, vegetarianism, old age);
• Iron solution is used when it is impossible to take oral iron supplements or diseases of the gastrointestinal tract.

Directions for use and dosage

Each package of the drug contains Maltofer instructions, which determine the method of use of the drugs and their dosage. Oral medications are taken during or after meals, the daily dose is divided into several doses or taken once. The dosage is indicated in the table:

The course of Maltofer for adults and children depends on the degree of iron deficiency; it is indicated in the instructions for use:

• iron deficiency anemia – 3-5 months, then therapy lasts 1-2 at a reduced dose to replenish microelement reserves;
• anemia during pregnancy - until hemoglobin stabilizes, after which treatment should be continued at a minimum dose;
• prevention of iron deficiency without signs of anemia – 1-2 months.

Maltofer drops

According to the instructions, the drops are allowed to be combined with fruit or vegetable juices, soft drinks, infant formula, and dairy products. The products are slightly colored, which does not affect the taste of the food or the effectiveness of the drug. To accurately measure the dose, the bottle should be held vertically. If the liquid does not flow out immediately, lightly tap the bottom until it appears. Do not shake the container.

Injection

According to the instructions, the solution is administered intramuscularly. Before administration, doctors conduct a test - adults are administered from a quarter to half the dose (25-50 mg / 0.5-1 ml), children from four months - half the daily maximum. If no adverse reactions appear within 15 minutes, the remaining portion is administered. The approximate adult dosage is one ampoule daily. Maximum daily doses depend on body weight:

• up to 6 kg – ¼ ampoule;
• 5-10 kg – ½ piece;
• 10-45 kg – 1 ampoule;
• adults – 2 pcs.

The instructions for using the solution indicate the injection technique, because incorrect injection can cause pain and staining of the skin:

• the upper outer quadrant of the gluteus maximus muscle is used for insertion;
• the needle should have a narrow opening; for children, thin short needles are chosen;
• the needles are disinfected, the skin is moved about 2 cm to close the puncture channel;
• the needle is positioned vertically in relation to the skin;
• after the injection, the needle is slowly removed, and the area of ​​skin near the injection site is pressed with your finger for five minutes;
• After administering the solution, patients are advised to move.

Oral solution

According to the instructions, the solution is taken orally during or after meals in a dose depending on the degree of iron deficiency. The duration of treatment for symptomatic iron deficiency is 3-5 months, plus after that therapy continues at a reduced dosage. For latent deficiency, the solution is taken for 1-2 months. Replenishment of iron deficiency is observed after 2-3 months from the start of treatment.

Maltofer tablets

According to the instructions, from the age of 12 years, chewable Maltosphere tablets are allowed to be taken orally. According to the instructions, they are chewed or swallowed whole. In the second option, do this during or after a meal, drinking a glass of clean boiled water at room temperature. The dosage of use depends on the severity of iron deficiency and should not exceed the daily maximum. The course of treatment is determined by the doctor.

Maltofer syrup

According to the instructions, Maltofer syrup can be mixed with vegetable and fruit juices, soft drinks, infant formula or other foods. As a result of mixing, the food is colored, but does not change in taste. The effectiveness of the drug also does not suffer. To accurately measure the dose of syrup, use the measuring cap that comes with the bottle.

special instructions

When studying the instructions for use of Maltofer, you should pay attention to the special instructions section:

• if anemia occurs due to infectious diseases or malignant neoplasms, iron should be taken after eliminating the cause;
• the daily dose of syrup contains 0.008-0.1 g of ethanol;
• 1 ml of Maltofer drops contains 0.01 bread units (XE), a chewable tablet - 0.04 XE, 1 ml of syrup - 0.04 XE, patients with diabetes mellitus should know this;
• syrup and drops contain sucrose, which can harm teeth;
• during therapy with Maltofer, stool turns dark;
• it is unlikely that Maltofer can cause a slowdown in psychomotor reactions;
• if an allergy to the parenteral solution occurs, antihistamines are prescribed; if an anaphylactic reaction develops, epinephrine is administered;
• preparations containing iron are used with caution in patients with renal failure and liver diseases.

During pregnancy

The instructions for use of Maltofer state that to date there are no reports of adverse reactions when taking the drug during pregnancy. According to animal studies, the medication does not cause danger to the fetus and mother after the end of the first trimester. There is no information about the effect of the drug in the first trimester of pregnancy.

According to reviews, during breastfeeding the medicine is prescribed only after consultation with a doctor and assessment of the potential risk and expected benefit for the child and mother. The active component of the composition passes into breast milk, its amount has not been studied. Theoretically, the use of the drug by women who are breastfeeding will not cause negative reactions for the baby.

Maltofer for children

According to the instructions for use, Maltofer in the form of drops can be prescribed for the treatment of anemia in premature infants. Syrup and solution for oral use are prescribed from the age of one year, chewable tablets - from the age of 12. The solution for parenteral use is indicated only for adults. It is optimal to choose syrup and drops for the treatment of iron deficiency anemia and normalization of the child’s hemoglobin.

Drug interactions

The instructions for use indicate that Maltofer in drops, syrup, tablets and solution can interact with other medications:

• does not reduce the absorption of tetracycline, aluminum hydroxide, is compatible with phenolic compounds;
• does not interact with acetylsalicylic acid, vitamin D3, Bromazepam, magnesium aspartate;
• the effectiveness of the drug is not affected by food components;
• It is not recommended to combine treatment with parenteral and oral drugs.

Side effects

The instructions for use of Maltofer indicate the presence of possible side effects while taking the drug:

• headaches, diarrhea, nausea, dyspepsia;
• constipation, vomiting, abdominal pain, darkening of enamel;
• rash, itching on the skin, exanthema, allergic reactions;
• darkening of the skin at the injection site;
• no deviations in laboratory parameters were found.

Overdose

According to the instructions for use, it is unlikely that an overdose of Maltofer or iron intoxication will occur. This is due to the low toxicity of the microelement and the controllability of iron capture by polymaltose hydroxide. There are no reported cases of overdose or unintentional poisoning of patients with fatal outcome.

Contraindications

The instructions indicate contraindications for which the use of Maltofer tablets, drops, solution and syrup is prohibited:

• hypersensitivity to the components of the drug;
• iron overload, hemosiderosis, hemochromatosis;
• impaired iron utilization, lead or sideroachrestic anemia, thalassemia;
• hemolytic, megaloblastic anemia (not associated with iron deficiency);
• deficiency of sucrase, isomaltase, fructose intolerance.

Terms of sale and storage

All forms of the drug can be purchased with a prescription. The drugs are stored away from sunlight, children at temperatures up to 25 degrees. The shelf life for drops and syrup is three years, for tablets and solution – five years.

Analogs

On the shelves of Russian pharmacies you can find direct or indirect analogues of Maltfer. The direct ones are completely identical in composition and have the same active ingredient. Indirect ones coincide in their therapeutic effects. You can choose from the following drugs in syrup or drop format:

• Ferumbo;
• Ferrum Lek;
• Hemojet;
• Globigen;
• Profer;
• Hematocrine.

Maltofer price

You can buy Maltofer via the Internet or a pharmacy, having received a prescription from your doctor in advance. The cost of drugs depends on the chosen form of release, volume, and trade markup. Approximate prices for Moscow and St. Petersburg are listed below.

INN: Iron (III) hydroxide polymaltosate

Manufacturer: Vifor SA

Anatomical-therapeutic-chemical classification: Ferric oxide polymaltose complexes

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 021554

Registration period: 14.08.2015 - 14.08.2020

Instructions

Tradename

Maltofer®

International nonproprietary name

Dosage form

Film-coated tablets 100 mg

Compound

One tablet contains

active substance- iron (III) hydroxide polymaltose 357.0 mg

(equivalent to 100 mg iron),

Excipients: macrogol 6000, microcrystalline cellulose, crospovidone, magnesium stearate,

composition of the film shell - dye Opadry ОY-S-36413 burgundy*.

*Dye composition: hydroxypropyl methylcellulose, hydroxypropylcellulose, polyethylene glycol 6000, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).

Description

The tablets are round, biconvex, film-coated, brownish-burgundy in color.

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 (IPC) 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 Maltofer® in normalizing Hb levels and replenishing iron stores has been demonstrated in numerous randomized, placebo-controlled or comparison-controlled 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® is 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. Maltofer® tablets are taken orally during meals or immediately after, swallowing 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.

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 the "Composition" section

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 in vitro 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

Anemia can be caused by infections or tumors. Since iron can only begin to be absorbed after treatment of the underlying disease, it is recommended to evaluate the benefit/risk ratio.

During treatment with the drug Maltofer®, a change in the color of the stool to a darker color may be observed, but this phenomenon has no clinical significance.

Use in pediatrics

Maltofer® film-coated 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 data from clinical studies regarding the use of Maltofer® in pregnant women in the first trimester. To date, there have been no reports of serious adverse reactions occurring after taking Maltofer® in therapeutic doses for the treatment of anemia during pregnancy. Therefore, it is unlikely that the use of Maltofer® can cause harm to the health of the mother and/or 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 child.

As a precaution, women of childbearing age, as well as during pregnancy and breastfeeding, should take 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 the glandular complex and controlled intake of iron. No accidental poisoning episodes or deaths were reported.

Release form and packaging