Maltofer foul chewable pills 100mg 0.35mg N30
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Active ingredients
Iron (III) hydroxide polymaltozane
Release form
Pills
Composition
Iron (III) hydroxide polymaltozate 357 mg, folic acid 0.35 mg, dextrates - 232 mg, macrogol 6000 - 37 mg, purified talc - 21 mg, sodium cyclamate - 9 mg, vanillin - 2.9 mg, cocoa powder - 29 mg, chocolate flavor - 0.6 mg, microcrystalline cellulose - up to 730 mg.
Pharmacological effect
The preparation of iron + vitamin. In iron (III) hydroxide of polymaltozate, multicore iron (III) hydroxide is surrounded on the outside by a multitude of covalently bound molecules of polymaltozate, which provides a total average molecular weight of approximately 50 kDa. The structure of the active substance of the drug Maltofer; The foul is similar to the core structure of ferritin protein - 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 from iron (III) hydroxide of polymaltozate is actively absorbed in the intestine. Folic acid (folate) belongs to the group of vitamins B. It is a precursor of tetrahydrofolate, which is a coenzyme of various metabolic processes, including biosynthesis of purines and nucleic acid thymidylates; it is necessary for the synthesis of nucleoproteins and for the maintenance of normal erythropoiesis. The effectiveness of the drug Maltofer; A foul for the normalization of hemoglobin and iron supplementation was demonstrated in numerous randomized controlled clinical trials using placebo control or an active comparator drug conducted in adults and children with different iron depot status.
Pharmacokinetics
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) hydroxyl polymaltozate revealed a strong correlation between the inclusion of iron in red blood cells and the iron content of 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. Folic acid is absorbed in the gastrointestinal tract, mainly in the duodenum and small intestine. When taking folic acid in a dose of 0.35 mg, the absorption is about 80%. Distribution The distribution of iron from iron (III) polymaltose hydroxide after absorption was studied in a study using double isotopes (55Fe and 59Fe) .Cmax of folic acid in the blood is reached in 30-60 min A single dose study in 12 healthy women showed that folic acid is from Maltofer; Foul, chewable pills (100 mg of iron, 0.35 mg of folic acid) are rapidly absorbed, and Cmax of plasma folates, equal to 11 ng / ml, is reached 0.75 hours after taking the drug. Folic acid is intensively bound to plasma proteins and penetrates through BBB , placental barrier, is excreted in breast milk. MetabolismSuced 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. Folic acid is metabolized in cells eteka small intestine and liver, as well as in other organs. After that, folates associated with transport proteins are distributed to all organs. Excretion Non-absorbed iron is excreted in feces. Excretion of folic acid occurs mainly through the kidneys, as well as through the digestive tract. Folic acid is derived through hemodialysis.
Indications
- iron deficiency anemia (including during pregnancy and during breastfeeding).
Contraindications
- established hypersensitivity to iron (III) hydroxide polymaltozate, folic acid, or to any excipient; - iron overload (hemochromatosis, hemosiderosis); (hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).
Precautionary measures
Keep out of the reach of children.
Use during pregnancy and lactation
Pregnancy Data from clinical studies on the use of the drug Maltofer; Foul in the first trimester of pregnancy are absent. To date, no serious adverse reactions have been reported after taking Maltofer; Oral foul in therapeutic doses in the treatment of anemia during pregnancy. The data obtained in animal studies showed no danger to the fetus and mother. In studies conducted in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of the Maltofer preparation were detected; Foul against mothers and / or newborns. In this regard, the adverse effect on the fetus when using the drug Maltofer; Foul 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; Foul breastfeeding women can lead to undesirable effects on the baby. As a precautionary measure for women of childbearing age, women during pregnancy and during breastfeeding should take the drug Maltofer; Foul only after consulting a doctor.
Dosage and administration
The drug is taken orally during or immediately after a meal. Tablets can be chewed or swallowed whole. The daily dose of the drug can be divided into several doses or taken at once. Treatment of iron deficiency anemia outside of pregnancyPo 1 tab. 1-3 times / day for 3-5 months to achieve normal hemoglobin (Hb). After that, the drug should be continued for 1 tablet / day for a few more months in order to restore iron stores in the body. Treatment of iron deficiency anemia in pregnancy 2 to 3 tab.(from 200 mg of iron and 0.70 mg of folic acid to 300 mg of iron and 1.05 mg of folic acid) / day until normal hemoglobin (Hb) content is reached. After this, treatment should be continued at least until the end of pregnancy, taking 1 tab. (100 mg of iron and 0.35 mg of folic acid) / day, in order to replenish iron stores and meet the increased need for iron due to pregnancy.
Side effects
The main undesirable drug reactions noted in these studies occurred in the following three classes of systems and organs. The adverse drug reactions observed in clinical studies were from the nervous system: not often - headache. From the digestive system: very often - discoloration of feces1; often - diarrhea, nausea, dyspepsia; infrequently - vomiting, constipation, abdominal pain, discoloration of tooth enamel2. On the side of the skin and subcutaneous tissues: infrequently - rash3, pruritus.1. Often recorded as an adverse event (in 23% of patients), this is a well-known undesirable drug reaction to oral preparations of iron. Registered as an undesirable phenomenon in 0.6% of patients, this is a well-known undesirable drug reaction to iron preparations for oral administration. Including exanthema. Spontaneous post-marketing reports of undesirable drug reactions In very rare cases (≥0.001% and less than 0.01%), allergic reactions to folic acid are possible.
Overdose
In case of an overdose of the drug Maltofer Foul, an iron overload or intoxication is unlikely, due to the low toxicity of iron (III) polymaltoxate hydroxide and controlled iron uptake. No cases of unintentional poisoning with a fatal outcome have been reported. There are reports that an excess dose of folic acid can cause disorders of the central nervous system (in particular, changes in mental state, sleep disturbances, irritability and hyperactivity), nausea, bloating and flatulence.
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 aurafin were not found to interact with iron ((III) hydroxide polymaltozate. Also, no interaction was noted 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. 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 selective determination of hemoglobin), so there is no need to interrupt the treatment. Qdim avoid the simultaneous use of iron preparations for parenteral administration and oral administration because the absorption of iron, ingestable, zamedlyaetsya.Lechenie folic acid may enhance metabolism of phenytoin that results in a decrease in the serum phenytoin concentration, especially in patients with folate deficiency. Although this interaction is not clinically significant, some patients may experience an increase in the incidence of convulsive seizures. Patients receiving phenytoin or other anticonvulsant drugs should consult a doctor before starting to take a drug containing folic acid. It has been found that the simultaneous use of chloramphenicol and folic acid in patients with folate deficiency can lead to a weakening of the hematopoietic response to folic acid due to antagonism of folic acid. chloramphenicol. Although the significance and mechanism of interaction is unclear, in patients receiving both drugs at the same time, the hematological response to treatment with folic acid should be closely monitored.
special instructions
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. It is assumed that taking the drug Maltofer Foul should not affect the daily need for insulin in diabetic patients. 1 chewable tablet contains 0.04 XE. Maltofer Foul preparation contains folic acid, which can lead to masking of vitamin B12 deficiency. During treatment with Maltofer; Foul dark fecal staining may occur, however, this has no clinical significance. Effects on the ability to drive vehicles and control mechanisms. There are no data available. It is unlikely that the drug Maltofer Fall has an impact on the ability to drive vehicles and mechanisms.