Iron (III) hydroxide polymaltozane
Active ingredient: Iron (III) hydroxide polymaltozate (Ferric (III) hydroxide polymaltosate) Active ingredient concentration (mg): Iron (III) polymaltoxate hydroxide equivalent to 100 mg of iron, as well as dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin , cocoa powder, chocolate flavor, and microcrystalline cellulose.
The drug is iron. In iron (III) hydroxide polymaltozate, multicore iron (III) hydroxide is surrounded on the outside by a multitude of covalently bound polymaltozate molecules, which provides a total average molecular weight of approximately 50 kDa. The structure of the active substance of the drug Maltofer is similar to the structure of the ferritin protein core - a physiological depot of iron. Iron (III) hydroxide polymaltozate is stable and under physiological conditions does not emit a large amount of iron ions. Due to the size, the degree of diffusion of iron (III) hydroxide of polymaltozate through the mucous membrane is approximately 40 times less as compared with the complex of hexahydron iron (II). Iron, a component of the iron (III) complex hydroxide polymaltozate, is actively absorbed in the intestine. The effectiveness of Maltofer to normalize hemoglobin and replenish iron depots has been demonstrated in numerous randomized controlled clinical trials using placebo control or an active reference drug, conducted in adults and children with different iron depot status.
Absorption Iron (III) iron hydroxide of polymaltozate is absorbed in accordance with a controlled mechanism. The increase in serum iron after administration of the drug does not correlate with the total absorption of iron, measured as incorporation into hemoglobin (Hb). Studies with a labeled radioisotope of iron (III) hydroxide polymaltozate revealed a strong correlation between the inclusion of iron in red blood cells and the iron content in the whole body. The maximum activity of iron absorption from iron (III) hydroxyl polymaltozate is noted in the duodenal and small intestine. As in the case of other oral preparations of iron, the relative absorption of iron from iron (III) hydroxyl polymaltozate, defined as incorporation into hemoglobin, decreases with increasing doses of iron.In addition, a correlation was observed between the severity of iron deficiency (in particular, serum ferritin concentration) and the relative amount of iron absorbed (that is, the more pronounced the iron deficiency, the better the relative absorption). In patients with anemia, iron absorption from iron (III) polymaltose hydroxide, in contrast to iron salts, increased in the presence of food. Distribution Iron distribution from iron (III) polymaltose hydroxide after absorption was studied in a study using double isotope techniques (55Fe and 59Fe). Metabolism Absorbed iron binds to transferrin and is used to synthesize hemoglobin in the bone marrow or is stored mainly in the liver, where it binds to ferritin.
Treatment of latent (LAD) and clinically pronounced iron deficiency (iron deficiency anemia - IDA), Prevention of iron deficiency during pregnancy, lactation, during the childbearing period in women, in children, in adolescence, in adults (for example, vegetarians and the elderly ).
Iron overload (for example, hemo-siderosis and hemochromatosis) Disruption of iron utilization (for example, lead anemia, sideroachrestic anemia) Non-iron deficiency anemia (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B deficiency 12)
Do not exceed the recommended dose. With caution, Maltofer syrup should be prescribed to patients with liver diseases, alcoholism, with a head injury or with brain diseases, since The product contains ethanol.
Use during pregnancy and lactation
Pregnancy Up to now, there have been no reports of serious adverse reactions after taking the drug Maltofer orally in therapeutic doses for the treatment of anemia during pregnancy. The data obtained from animal studies have shown no danger to the fetus and mother. Data from clinical studies on the use of the drug Maltofer in the first trimester of pregnancy are not available. In studies conducted in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of the drug Maltofer in relation to mothers and / or newborns were detected.In this regard, the adverse effect on the fetus when using the drug Maltofer is unlikely. Breastfeeding period Breast milk of a woman contains iron associated with lactoferrin. The amount of iron transferring from iron (III) hydroxide of polymaltozate into breast milk is unknown. It is unlikely that the use of the drug Maltofer women breastfeeding, can lead to undesirable effects in the child. As a precautionary measure for women of childbearing age, women during pregnancy and during breastfeeding should take the drug Maltofer only after consulting a doctor. It is recommended to assess the balance of benefits and risks.
Dosage and administration
Chewable pills can be chewed or swallowed whole. Weak color of the drink does not change its taste and does not reduce the effectiveness of the drug. The daily dose of the drug depends on the degree of iron deficiency (see table of daily dosages). The duration of treatment of latent iron deficiency is 1-2 months. In the case of clinically severe iron deficiency, the normalization of hemoglobin and replenishment of iron stores occurs only 2-3 months after the start of treatment.
Very rarely (greater than or equal to 0.001% and less than 0.01%) there may be signs of irritation of the gastrointestinal tract, such as a feeling of fullness, pressure in the epigastric region, nausea, constipation or diarrhea. Perhaps dark staining of the stool, due to the release of non-absorbed iron (has no clinical significance).
In case of an overdose of the drug Maltofer, iron overload or intoxication is unlikely due to the low toxicity of iron (III) polymaltozate hydroxide and controlled iron uptake. No cases of unintentional poisoning with fatalities were reported.
Interaction with other drugs
The interaction of iron (III) hydroxyl polymaltozate with tetracycline and aluminum hydroxide was studied. No significant decrease in tetracycline absorption was observed. Plasma tetracycline concentration did not fall below the effective level. Iron absorption from iron (III) hydroxide of polymaltozate did not decrease under the influence of aluminum hydroxide or tetracycline.Thus, iron (III) hydroxyl polymaltozate can be used simultaneously with tetracycline and other phenolic compounds, as well as with aluminum hydroxide. In studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate combinations with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol, and aurafina were not found to interact with iron (III) hydroxide polymaltozate. Iron (III) hydroxides of polymaltozate 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. These results indicate that iron (III) hydroxide polymaltozate can be taken during or immediately after a meal. Taking the drug does not affect the results of the hidden blood (with the selective determination of hemoglobin), so there is no need to interrupt the treatment. It is necessary to avoid simultaneous the use of iron preparations for parenteral administration and ingestion, since the absorption of ingested iron slows down.
Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can be taken only after the main cause of the disease has been eliminated, the balance between the benefit and the risk of treatment should be determined. The daily dose of Maltofer syrup contains ethanol in an amount of 0.008 g (dose 2.5 ml) to 0.1 g (dose 30 ml). diabetes should take into account that 1 ml of drops for oral administration contains 0.01 XE, 1 ml of syrup - 0.04 XE, 1 chewable tablet - 0.04 XE. Syrup and drops for oral administration contain sucrose, which can harm the teeth. During treatment with Maltofer, from dark fecal staining is noted, however, it has no clinical significance. Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate adjuvants that are part of Maltofer in the form of syrup and drops for oral administration can cause allergic reactions (possibly of a delayed type). Use in pediatricsOperate Maltofer chewable pills in children under the age of 12 years.Dosage form and concentration of Maltofer drops for oral administration and Maltofer syrup are better suited for receiving the recommended dose in this age group. Effect on ability to drive vehicles and control mechanisms There are no data. It is unlikely that the drug Maltofer affects the ability to drive vehicles and mechanisms.