Ferrum Lek solution for injections 100 mg/2 ml. ampoules 2 ml. №5

Description

Ferrum Lek №5 Storage
active substance: iron (III) in the form of a complex of iron (III) hydroxide with dextran;

1 ampoule (2 ml of solution) contains iron (III) 100 mg in the form of a complex of iron (III) hydroxide with dextran;

Excipients: sodium hydroxide, concentrated hydrochloric acid, water for injections.

Ferrum Lek №5 Dosage form
Solution for injection.

Main physical and chemical properties: opaque brown solution.

Ferrum Lek №5 Pharmacotherapeutic group
Antianemic drugs. Trivalent iron preparations for parenteral use. ATX code B0ZA C06.

Pharmacological properties

Pharmacodynamics.

Ferrum Lek solution for injection contains iron in the form of a complex of iron (III) hydroxide with dextran, which is analogous to the physiological form of iron in the body – ferritin (protein hydroxide-iron-phosphate complex). Serum ferritin levels peak approximately 7–9 days after intravenous administration of a dose of Ferrum Lek and slowly return to baseline after approximately 3 weeks. Bone marrow studies of iron stores after long-term therapy with iron (III) hydroxide complex with dextran may be inaccurate because residual iron complex with dextran may accumulate in reticuloendothelial cells.

Pharmacokinetics.

After intramuscular injection, the complex of iron (III) hydroxide with dextran is absorbed mainly through the lymphatic system and diffuses into the blood after about 3 days. There are no data on bioavailability, but it is known that a large part of the complex is not absorbed from muscle tissue for a long time. The half-life of the complex of iron (III) hydroxide with dextran is 3-4 days.

The macromolecular dextran complex enters the reticuloendothelial system, where it breaks down into iron-containing component and dextran. Iron then binds to ferritin or hemosiderin and to a lesser extent to transferrin and is used to synthesize hemoglobin. Dextran is metabolized or excreted. The amount of iron excreted is insignificant. Iron is not easily excreted from the body, and its accumulation can be toxic. Due to the size of the complex of iron (III) hydroxide with dextran, it is not excreted by the kidneys. A small amount of iron is excreted in the urine and feces.

Indication
Treatment of iron deficiency conditions with ineffectiveness or impossibility of treatment with iron supplements for oral administration.

Contraindication
Hypersensitivity to the active substance or to any other component of the drug;
anemia not associated with iron deficiency;
excess iron in the body (eg, hemochromatosis, hemosiderosis);
impaired incorporation of iron into hemoglobin (eg, anemia caused by lead poisoning, sideroblastic anemia);
severe hemostasis (hemophilia) due to possible hematomas;
in cases of known severe hypersensitivity to other parenteral forms of iron supplements;
I trimester of pregnancy (see section “Use during pregnancy or breastfeeding”).
Interaction with other medicinal products and other forms of interaction
Like other parenteral iron supplements, Ferrum Lek should not be used concomitantly with oral iron supplements, as this may reduce the absorption of orally administered iron. Therefore, treatment with oral iron should be started no earlier than 5 days after the last injection of iron.

The effectiveness of parenteral iron drugs is increased by their simultaneous use with ACE inhibitors.