Ferrum Lek, 50 mg/ml 2 ml 50 pcs

Ferrum Lek is an anti-anemic drug.

Pharmacodynamics

Tablets. Syrup. 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.

The solution for intramuscular administration. The drug contains trivalent iron in the form of iron trivalent hydroxide complex with dextran. The iron contained in the preparation quickly compensates the lack of this element in organism (in particular, in iron deficiency anemia), restores the content of hemoglobin. Gradual reduction of both clinical symptoms (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory indices of iron deficiency is observed during treatment with the preparation.

Pharmacokinetics

The tablets. Syrup. 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 must be taken into account.

The solution for intramuscular administration. After intramuscular administration of the drug iron enters the bloodstream rapidly: 15% of the dose – after 15 minutes, 44% – after 30 minutes. The biological T_1/2 is 3-4 days. Iron in complex with transferrin is transported to body cells, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The complex of iron (III) hydroxide with dextran is large enough and therefore is not excreted through the kidneys.

Indications

severe iron deficiency due to blood loss;
impaired absorption of iron in the intestines;
conditions for which treatment with oral iron preparations is ineffective or impracticable.

Pharmacological effect

Ferrum Lek is an antianemic drug.

Pharmacodynamics

Pills. Syrup. 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.

Solution for intramuscular administration. The drug contains ferric iron in the form of a complex of ferric hydroxide with dextran. Iron, which is part of the drug, quickly replenishes the lack of this element in the body (in particular, in case of iron deficiency anemia), restores hemoglobin content. When treated with the drug, there is a gradual decrease in both clinical symptoms (weakness, fatigue, dizziness, tachycardia, soreness and dry skin) and laboratory indicators of iron deficiency.

Pharmacokinetics

Pills. Syrup. 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.

Solution for intramuscular administration. After intramuscular administration of the drug, iron quickly enters the bloodstream: 15% of the dose after 15 minutes, 44% after 30 minutes. Biological T1/2 is 3–4 days. Iron, in combination with transferrin, is transported to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The complex of iron (III) hydroxide with dextran is large enough and therefore is not excreted through the kidneys.

Special instructions

The drug should be used only in a hospital setting.

When prescribing Ferrum Lek®, laboratory tests are required: a general clinical blood test and determination of serum ferritin levels; it is necessary to exclude impaired iron absorption.

Treatment with oral forms of iron-containing drugs should begin no earlier than 5 days after the last injection of Ferrum Lek®.

The contents of the ampoules should not be mixed with other drugs.

Active ingredient

Iron III hydroxide dextran

Composition

Active ingredient:

iron (III) hydroxide polyisomaltose;

Excipients:

sodium hydroxide,

hydrochloric acid (concentrated),

water d/i.

Pregnancy

Parenteral administration of the drug is contraindicated in the first trimester of pregnancy.

In the second and third trimesters of pregnancy and during breastfeeding, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Contraindications

I trimester of pregnancy;
Osler-Rendu-Weber syndrome;
infectious kidney diseases in the acute stage;
uncontrolled hyperparathyroidism;
decompensated cirrhosis of the liver;
infectious hepatitis.
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).

With caution: diabetes mellitus (for syrup); bronchial asthma; chronic polyarthritis; cardiovascular failure; low iron binding capacity and/or folic acid deficiency; children’s age (up to 4 months – for solution for intramuscular administration).

Side Effects

From the digestive system: nausea, vomiting.

From the side of the central nervous system: headache, dizziness.

Local reactions: if the drug is administered incorrectly, it is possible that the skin may become stained, soreness and an inflammatory reaction may occur at the injection site.

Other: arterial hypotension, arthralgia, enlarged lymph nodes, fever, malaise; extremely rarely – allergic or anaphylactic reactions.

Interaction

Ferrum Lek® for intramuscular injection should not be used simultaneously with iron preparations for oral administration.

The simultaneous use of Ferrum Lek® with ACE inhibitors may increase the systemic effects of parenteral iron preparations.

Overdose

Symptoms: An overdose of iron supplements can lead to acute iron overload and hemosiderosis.

Treatment: symptomatic therapy. 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

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

5 years.

Manufacturer

Lek d.d., Slovenia