Iron deficiency in patients who cannot be prescribed oral iron medications or if they are ineffective in such cases: intolerance to oral iron preparations; the presence of inflammatory diseases of the gastrointestinal tract (for example, ulcerative colitis), which can be aggravated by oral iron therapy; iron-deficient conditions that are resistant to therapy, when the control of these conditions with oral iron preparations is insufficient.
Feroxid solution Storage
active substance: iron (III) hydroxide sucrose complex;
1 ml of solution contains iron (III) hydroxide sucrose complex equivalent to iron (III) 20 mg;
Excipients: sodium hydroxide, water for injections.
Feroxid solution Dosage form
Solution for injection.
Basic physical and chemical properties: colloidal solution from brown to red-brown color.
Feroxid solution Pharmacotherapeutic group
Antianemic drugs. Iron preparations. Code ATX B0ZA C.
The active component of iron sucrose consists of multinuclear centers of iron (III) hydroxide surrounded on the outside by a large number of non-covalently bound sucrose molecules. The weight of the complex is the average molecular weight (mV), which is approximately 43 kD, which is quite high and does not allow its excretion by the kidneys. The multinuclear iron center has a structure similar to the structure of the ferritin center, which is a physiological iron-containing protein. The complex was developed to provide controlled digestible iron for iron transport and storage of proteins in the body (transferrin and ferritin, respectively).
After intravenous administration, the multinuclear iron center of the complex is captured mainly by the reticuloendothelial system of the liver, spleen and bone marrow. In the second stage, iron is used to synthesize hemoglobin, myoglobin and other iron-containing enzymes or stored in the liver as ferritin.
Distribution. Evaluation of the ferrokinetics of iron hydroxide sucrose complex, labeled 59Fe and 52Fe, was performed in 6 patients with anemia and chronic renal failure. For the first 6-8 hours, 52Fe is absorbed by the liver, spleen, and bone marrow. Radioactive uptake of iron occurs in macrophages of the reticuloendothelial system of the spleen.
After intravenous administration to healthy volunteers of a single dose of the drug containing 100 mg of iron, the maximum concentration of iron was observed 10 minutes after administration and reached an average value of 538 mmol / l. The volume of distribution of the central chamber corresponded well to the volume of plasma (approximately 3 liters).
Metabolism. After injection, sucrose is almost completely broken down and the multinucleated iron center is captured mainly by the reticuloendothelial system of the liver, spleen and bone marrow.
Within 4 weeks after the introduction of iron absorption by erythrocytes ranges from 68 to 97%.
Breeding. The weight of the iron sucrose complex corresponds to the average molecular weight (mV), which is approximately 43 kD. The weight of the complex is large enough to avoid excretion by the kidneys. Renal excretion of iron during the first 4 hours after injection of 100 mg of iron was less than 5% of the dose. After 24 hours, the total serum iron concentration decreased to baseline (before administration), and renal excretion of sucrose was approximately 75% of the administered dose.
Pharmacokinetics in certain groups of patients. It is still unknown whether renal and hepatic failure affect the pharmacological properties of iron (III) sucrose complex hydroxide (see section “Special warnings and precautions for use”).
Iron deficiency in patients who cannot be prescribed oral iron supplements or in case of their ineffectiveness in the following cases:
intolerance to oral iron supplements;
the presence of inflammatory diseases of the gastrointestinal tract (eg ulcerative colitis), which may be exacerbated by therapy with oral iron supplements;
iron-deficient conditions resistant to therapy, in the case when the control of these conditions by oral iron supplements is insufficient.
Non-iron deficiency anemia (eg haemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency, erythropoiesis disorders, bone marrow hypoplasia, anemia caused by lead poisoning);
diseases accompanied by iron oversaturation (hemosiderosis, hemochromatosis) or hereditary disorders of iron utilization (eg sideroachrestic anemia, cutaneous porphyria, thalassemia);
hypersensitivity to the active substance or other components of the drug;
I trimester of pregnancy.
Interaction with other medicinal products and other forms of interaction
Ferroxide is indicated for patients who cannot be prescribed oral iron supplements or if they are ineffective. Like other iron preparations for parenteral use, Feroxide should not be used concomitantly with iron-containing oral agents, as the absorption of iron administered orally is reduced. Therefore, treatment with oral iron should be started no earlier than 5 days after the last injection of Feroxide.