LOFFER [Iron hydroxide polymaltose complex] 50 mg/5 ml Oral syrup

instructions for the medical use of the medicinal product

LOFFER

Tradename

Loffer, Лоффер

International non-proprietary name or generic name

Iron hydroxide polymaltose complex, Железа гидроксид полимальтозный комплекс.

Dosage form

Syrup for oral administration.

Ingredients for 5 ml of syrup:

active substance: iron (III) hydroxide polymaltose complex 161.29 mg equivalent to elemental iron 50 mg;

excipients: sodium methylparaben, sodium propylparaben, glycerin, sorbitol, sucrose, anhydrous citric acid, caramel flavor, purified water.

Pharmacotherapeutic group

Antianemic agents. Iron-based agents.

АТХ code: В03АВ05

Pharmacological properties

Pharmacodynamics

Anemia treatment. The polynuclear centers of Fe3+ hydroxide are externally surrounded by many non-covalently bound molecules of polymaltose, forming a complex with a total molecular weight of 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 by active absorption, which explains the impossibility of overdose (and intoxication), unlike simple iron salts, the absorption of which occurs along the concentration gradient.

The absorbed iron is deposited in a form bound to ferritin, mainly in the liver. Later, in the bone marrow, it is included in hemoglobin. Iron, which is part of the Fe3+ hydroxide polymaltose complex, does not have prooxidant 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, 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 on the dose of the drug (the higher the dose, the worse the absorption). The time to reach Cmax is 24 hours. In the RES, the complex is broken down into iron (III) hydroxide and polymaltose (metabolized by oxidation). In the bloodstream, iron binds to transferrin, is deposited in tissues as part of ferritin, and is included in hemoglobin in the bone marrow and used in the process of erythropoiesis. It is absorbed mainly in the duodenum and small intestine. The unabsorbed portion is excreted in the feces.

Indications for use

- prevention and treatment of latent iron deficiency (in adults, infants and young children);

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

- iron deficiency anemia (in adults, infants and young children).

Contraindications

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

- in patients with impaired iron utilization mechanisms (sideroachrestic anemia, lead anemia, thalassemia);

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

- hypersensitivity to the active substance or any excipient of the drug.

Method of administration and dosage

Orally. The drug is best taken during or immediately after meals. The dose should be measured using the supplied dosing syringe. The daily dose can be taken once or in several doses. The drug can be mixed with fruit or vegetable juices or added to baby food.

Dosage

Children, adults and breastfeeding mothers:

Prevention and treatment of latent iron deficiency:

Children (1-12 years): 2.5 - 5 ml (25 to 50 mg iron) per day.

Children over 12 years, adults and breastfeeding mothers: 5 - 10 ml (50 to 100 mg iron) per day.

The duration of treatment is about 1-2 months.

Iron deficiency anemia:

The duration of treatment is about 3-5 months, until the hemoglobin level is normalized. After this, treatment should be continued for several more weeks to replenish iron reserves.

Children under 1 year: the initial dose of syrup is 2.5 ml (25 mg iron) per day. Then the dose should be gradually increased to 5 ml (50 mg iron) per day.

Children (1-12 years): 5-10 ml (50 to 100 mg iron) per day

Children over 12 years, adults and breastfeeding mothers: 10-30 ml (100 to 300 mg iron) per day.

Pregnant women: The dosage regimen and duration of treatment depend on the degree of iron deficiency.

Prevention and treatment of latent iron deficiency:

5 - 10 ml (50 to 100 mg iron) per day.

Iron deficiency anemia:

20-30 ml (200 to 300 mg of iron) per day until normal hemoglobin levels are achieved. Then 10 ml (100 mg of iron) per day, at least until the end of pregnancy, to replenish iron stores.

Daily doses of the drug Loffer, syrup for the treatment and prevention of iron deficiency.

*- considering the too small doses used for these indications, it is recommended to use the drug Loffer drops for oral administration, solution.

Special instructions and precautions

Before using the drug, it is recommended to consult a doctor.

It is necessary to continue taking iron preparations even after the hemoglobin level has returned to normal.

It is prescribed with caution in case of liver and/or kidney failure, bronchial asthma, cardiovascular and allergic diseases.

The drug contains sucrose. Patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency should not take the drug.

The drug may cause dark stool. This symptom has no clinical significance.

Iron deficiency and the degree of iron ion deficiency must be confirmed by laboratory methods.

Influence on the ability to drive vehicles and mechanisms

Loffer does not affect the ability to drive a car or operate machinery.

Use during pregnancy and breastfeeding

During pregnancy and lactation, the use of the drug does not have a harmful effect on the body.

The drug Loffer can be used during pregnancy and breastfeeding only after consultation with a doctor.

Side effect

The drug is generally well tolerated. The following side effects are possible: nausea, constipation, diarrhea, abdominal pain, feeling of fullness in the stomach.

Dark coloration of feces observed during drug administration is not of significant clinical significance.

The drug does not cause staining of tooth enamel.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction with other medicinal products

No interaction studies have been conducted. Given that iron is in the form of a complex compound, interactions with food components (phytates, oxalates, tannin) and concomitantly taken medications (antacids, tetracyclines) are unlikely. Taking the drug does not affect the results of the occult blood test.

Overdose

In cases of overdose, no signs of intoxication or signs of elevated iron levels in the body have been described to date, since iron ions from the iron (III) hydroxide polymaltose complex in the gastrointestinal tract are not in free form and are not absorbed by passive diffusion.

Storage conditions

Store at temperatures below 25°C. Keep out of reach of children.

Shelf life

2 years. Do not use after the expiration date stated on the package.

Vacation conditions

Dispensed by prescription.

Release form

100 ml of the preparation in PET bottles with a screw cap. 1 bottle and a dosing syringe together with instructions for use in a cardboard box.