Ferrum-Lek syrup 50 mg/5 ml. 100 ml.

Description

Ferrum-Lek Storage:

active substance: 5 ml of syrup (1 tablespoon) contain iron (III) 50 mg in the form of a complex of iron (III) hydroxide with polymaltose;

Excipients: sucrose, sorbitol solution (E 420), ethanol 96% (16.25 mg / 5 ml),

methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), cream essence, sodium hydroxide, purified water.

Ferrum-Lek Dosage form.

Syrup.

Basic physical and chemical properties: brown transparent solution.

Ferrum-Lek Pharmacotherapeutic group.

Antianemic drugs. Iron (III) preparations for oral use. ATX code B03A B05.

Pharmacological properties.

Pharmacodynamics.

The drug contains iron in the form of polymaltose complex of iron (III) hydroxide. This macromolecular complex is stable and does not emit iron in the form of free ions into the gastrointestinal tract. The structure of the drug is similar to the natural iron compound – ferritin. Due to this similarity, iron (III) enters the bloodstream from the intestine through active absorption. Absorbed iron binds to ferritin and is stored in the body, mainly in the liver. Later in the bone marrow, it is included in hemoglobin. The iron preparation has the form of a polymaltose complex of Fe3 + hydroxide. Externally, the multinuclear centers of Fe3 + hydroxide are surrounded by many non-covalently bound polymaltose molecules, forming a complex with a molecular weight of 50 kDa, which is so large that its diffusion through the mucous membranes of the intestinal mucosa is about 40 times lower than that of Fe2 + hexahydrate. to the composition of polymaltose complex of iron (III) hydroxide, does not show prooxidant properties inherent in simple salts of iron. The susceptibility to oxidation of very low density lipoproteins and low density lipoproteins is therefore reduced.

Pharmacokinetics.

A study using the dual isotope technique (55Fe and 59Fe) showed that the absorption of iron, measured by the level of erythrocyte hemoglobin, is inversely proportional to the dose of the drug administered (the higher the dose, the lower the absorption). There is a correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). The most active process of absorption occurs in the duodenum and small intestine. Absorbed iron is excreted in the feces. The excretion of iron, which occurs during exfoliation of the epithelium of the digestive tract and skin, as well as sweat, bile and urine, is only 1 mg per day. Women also need to consider iron loss during menstruation.

Clinical characteristics.

Indication.

Treatment of iron deficiency without anemia (latent iron deficiency) and iron deficiency anemia (clinically severe iron deficiency).

Iron deficiency and its degree should be confirmed by appropriate laboratory tests.

Contraindication.

There is hypersensitivity or intolerance to the active substance or any component of the drug; excessive iron content in the body (eg, hemochromatosis, hemosiderosis); disorder of iron excretion mechanisms (lead anemia, sideroahrestic anemia, thalassemia); anemia not due to iron deficiency (eg, hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency); esophageal stenosis and / or other obstructive diseases of the digestive tract; intestinal diverticulum, intestinal obstruction, regular blood transfusions; simultaneous use of parenteral forms of iron.

Interaction with other drugs and other types of interactions.

Studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine and paracenomal III) hydroxide.

In vitro studies showed no interaction with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soy flour. The results of the study indicate that the polymaltose complex of iron (III) hydroxide can be taken during or immediately after a meal.