Ferrum Lek, 100 mg 30 pcs.

Ferrum Lek is an anti-anemic drug.

Pharmacodynamics

The molecular mass of the complex is so large – about 50 kDa – that its diffusion through the gastrointestinal mucosa is 40 times slower than that of divalent iron. The complex is stable and does not release iron ions under physiological conditions. The iron in the multinuclear active zones of the complex is bound in a structure similar to that of the natural iron compound, ferritin. Because of this similarity, the iron of this complex is absorbed only by active absorption. The iron-binding proteins on the surface of the intestinal epithelium absorb iron (III) from the complex through competitive ligand exchange. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow it is incorporated into hemoglobin.

The iron (III) complex polymaltose hydroxide does not have the pro-oxidant properties of iron (II) salts.

Pharmacokinetics

Double isotope studies (55Fe and 59Fe) have shown that iron absorption, as measured by hemoglobin levels in erythrocytes, is inversely proportional to the dose taken (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). The greatest degree of iron absorption is in the duodenum and jejunum.

The remaining (unabsorbed) iron is excreted in the feces. Its excretion with the exfoliating cells of the gastrointestinal epithelium and skin, as well as with sweat, bile and urine is approximately 1 mg of iron per day. In women during menstruation there is an additional loss of iron, which should be taken into account.

Indications

treatment of latent iron deficiency;
treatment of iron deficiency anemia;
prevention of iron deficiency during pregnancy.

Pharmacological effect

Ferrum Lek is an antianemic drug.

Pharmacodynamics

The molecular mass of the complex is so large – about 50 kDa – that its diffusion through the gastrointestinal mucosa is 40 times slower than the diffusion of ferrous iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multinuclear active zones of the complex is bound into a structure similar to the structure of the natural iron compound – ferritin. Due to this similarity, the iron of this complex is absorbed only through active absorption. Iron-binding proteins located on the surface of the intestinal epithelium absorb iron (III) from the complex through competitive ligand exchange. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow it is incorporated into hemoglobin.

Iron (III) complex polymaltose hydroxide does not have the pro-oxidant properties inherent in iron (II) salts.

Pharmacokinetics

Studies using the dual isotope method (55Fe and 59Fe) have shown that iron absorption, as measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). Iron is absorbed to the greatest extent in the duodenum and jejunum.

The remaining (unabsorbed) iron is excreted in the feces. Its excretion with exfoliating epithelial cells of the gastrointestinal tract and skin, as well as with sweat, bile and urine is approximately 1 mg of iron per day. Women experience additional iron loss during menstruation, which must be taken into account.

Special instructions

For children under 12 years of age, due to the need to prescribe low doses of the drug, it is preferable to prescribe Ferrum Lek in syrup form.

Neither chewable tablets nor Ferrum Lekne syrup cause staining of tooth enamel.

In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the underlying disease has been cured.

When using the drug Ferrum Lek, the stool may turn dark in color, which does not have any clinical significance. Taking iron supplements does not affect the results of the test for hidden bleeding (selective for hemoglobin).

Notice for diabetics: 1 chewable tablet contains 0.04 XE.

Notice to patients with phenylketonuria: Ferrum Lek contains aspartame (E951), a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. The drug does not affect the ability to concentrate.

Active ingredient

Iron III hydroxide polymaltosate

Composition

1 chewable tablet contains:

Active ingredient:

iron (in the form of iron (III) hydroxide polymaltosate) 100 mg;

Excipients:

chocolate essence,

aspartame (E951),

talc,

macrogol 6000,

dextrates

Pregnancy

During controlled studies in pregnant women (II, III trimesters of pregnancy), no negative effects on the body of the mother and fetus were noted.

No harmful effects on the fetus were detected when taking the drugs in the first trimester of pregnancy.

Contraindications

hypersensitivity to the components of the drug;
excess iron in the body (hemochromatosis, hemosiderosis);
violation of iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia);
anemia not associated with iron deficiency (for example, hemolytic, megaloblastic, caused by a lack of cyanocobalamin).
children’s age up to 12 years.

With caution: bronchial asthma; chronic polyarthritis; cardiovascular failure; low ability to bind iron and/or folic acid deficiency.

Side Effects

The side effects reported were mostly mild and transient.

According to WHO, adverse reactions are classified according to their frequency as follows: very often (≥1/10), often (≥1/100,

From the gastrointestinal tract: very rarely – pain in the abdomen, nausea, constipation, diarrhea, dyspepsia, vomiting, change in the color of feces (due to the excretion of unabsorbed iron, has no clinical significance).

From the skin and subcutaneous tissue: very rarely – urticaria, rash, itching of the skin.

Interaction

No interaction with other drugs or food products has been identified.

Concomitant use of polymaltosate hydroxide with parenteral iron preparations and other oral iron (III) preparations is not recommended due to the pronounced inhibition of the absorption of orally administered iron.

Overdose

Symptoms: in case of an overdose of Ferrum Lek syrup or chewable tablets, there were no signs of intoxication or excess iron in the body, because iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Treatment: symptomatic; As an antidote, deferoxamine is administered intravenously slowly (15 mg/kg/hour), depending on the severity of the overdose, but not more than 80 mg/kg/day. Hemodialysis is ineffective.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

3 years.

Manufacturer

Lek d.d., Slovenia