Iron III hydroxide polymaltozate

Brand Sandoz

In stock 507 Items

Available since: 2019-09-19

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Clinical Pharmacology

Ferrum Lek - antianemic drug.

The molecular mass of the complex is so high - about 50 kDa - that its diffusion through the mucous membrane of the gastrointestinal tract 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 in a structure similar to that of the natural iron compound, ferritin. Due to this similarity, the iron of this complex is absorbed only by active absorption. Iron-binding proteins located on the surface of the intestinal epithelium absorb iron (III) from the complex through a competitive exchange of ligands. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow, it is incorporated into the hemoglobin.

The iron (III) complex hydroxide of polymaltose does not possess the prooxidant properties inherent in the salts of iron (II).

Pharmacokinetics

Studies using the double isotope method (⁵⁵Fe and⁵⁹Fe) showed that iron absorption, as measured by the level of hemoglobin in the 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). Most iron is absorbed in the duodenum and jejunum.

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

Indications

For oral administration:

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

Composition

1 chewable tablet contains:
active substance: iron (III) hydroxide polymaltozate 400 mg, in terms of iron - 100 mg,
Excipients: macrogol 6000 - 37.0 mg; aspartame, 1.5 mg; chocolate flavoring - 0.6 mg; talc - 21.0 mg; dextrates - to obtain 730.0 mg.

Iron III hydroxide polymaltozate is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Ferrum Lek	Sandoz	Switzerland	pills
Maltofer	Vifor (International) Inc	Switzerland	pills
Ferrum Lek	Sandoz	Switzerland	syrup
Ferrum Lek	Sandoz	Switzerland	solution
Maltofer	Vifor (International) Inc	Switzerland	syrup
Maltofer	Vifor (International) Inc	Switzerland	drops

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Dosage and Administration

Inside, the pills can be chewed or swallowed whole. The drug is recommended to be taken during or immediately after a meal.
The daily dose can be divided into several doses.
Doses and duration of treatment depend on the degree of iron deficiency.
Latent iron deficiency
The duration of treatment is about 1-2 months,
Children over 12, adults and mothers who are breastfeeding
1 chewable tablet (100 mg) Ferrum Lek® per day.
Iron-deficiency anemia
Duration of treatment is about 3-5 months. After the hemoglobin concentration is normalized, the drug should be continued for a few more weeks to replenish the body's iron stores.
Children over 12, adults and mothers who are breastfeeding
1-3 chewable pills (100-300 mg) Ferrum Lek® per day.
Pregnant women
Latent iron deficiency and prevention of iron deficiency
1 chewable tablet (100 mg) Ferrum Lek® per day.
Iron-deficiency anemia
2-3 chewable pills (200-300 mg) Ferrum Lek® per day until hemoglobin concentration normalizes. After that, you should continue to take 1 chewable tablet per day, at least until the end of pregnancy to replenish iron stores in the body.

Daily doses of Ferrum Lek® pills for the prevention and treatment of iron deficiency in the body

	Iron-deficiency anemia	Latent iron deficiency	Prevention of iron deficiency
Children over 12, adults and nursing mothers	1-3 chewable pills (100-300 mg of iron)	1 chewable tablet (100 mg of iron)	—
Pregnant women	2-3 chewable pills (200-300 mg of iron)	1 chewable tablet (100 mg of iron)	1 chewable tablet (100 mg of iron)

Adverse reactions

The reported side effects were mostly mild and transient.

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

From the digestive tract: very rarely - abdominal pain, nausea, constipation, diarrhea, dyspepsia, vomiting, discoloration of feces (due to elimination of non-absorbed iron, has no clinical significance).

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

Use in children

It is possible to use according to indications and in doses that take into account the age of the patient. Children under the age of 12 years old due to the need to prescribe the drug in low doses are preferably used in the form of a syrup.

Drug interactions

Interaction with other drugs or food products has not been identified.

Simultaneous use with parenteral preparations of iron and other oral preparations of iron (III) hydromaldehyde is not recommended because of the pronounced inhibition of absorption of oral iron.

Pregnancy and Lactation

In the course of controlled studies with the use of the drug in the II and III trimesters of pregnancy, there was no adverse effect on the mother or fetus. No adverse effects on the fetus were detected when using the drug in the first trimester of pregnancy.

Special instructions

In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticulo-endothelial system, from which it is mobilized and utilized only after curing the underlying disease.
When using the preparation Ferrum Lek®, the stool may turn dark, which does not have any clinical significance. Ferrum Lek® does not affect the results of the test for hidden blood (selective for hemoglobin); thus, there is no need to suspend iron therapy.
Note for patients with diabetes mellitus: 1 Ferrum Lek® chewable tablet contains 0.04 bread units (HE).
Note for patients with phenylketonuria: Ferrum Lek® contains aspartame (E951), which is a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.

Influence on ability to steer vehicles, mechanisms

Ferrum Lek® does not affect the ability to drive a car and control mechanisms that require high concentration of attention.

Overdosage

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