Contraindications
- there is hypersensitivity or intolerance to the active substance or any component of the drug;
- excess iron content in the body (for example, hemochromatosis, hemosiderosis);
- disorder of iron excretion mechanisms (lead anemia, sideroachrestic anemia, thalassemia);
- anemia not caused by iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency);
- esophageal stenosis and/or other obstructive diseases of the digestive tract; intestinal diverticulum, intestinal obstruction, regular blood transfusions;
- simultaneous use of parenteral forms of iron.
Maltofer Fol chewable tablets No. 10x3
Name
Maltofer Fol tab. chewable in blister pack No. 10x3
Main active ingredient
Gland
iii
polymaltosate hydroxide + folic acid
Release form
tablet
Pharmacodynamics
Mechanism of action The polymaltose complex of iron (III) hydroxide is a multinuclear iron (III) hydroxide center surrounded by non-covalently bound polymaltose molecules with a total average molecular weight of about 50 kDa. The polynuclear iron (III) centers of polymaltosate hydroxide are similar in structure to the natural iron storage protein ferritin. This macromolecular complex is stable and does not release large amounts of iron under physiological conditions. Due to its large size, the degree of diffusion of iron (III) hydroxide polymaltosate through the mucosal membrane is approximately 40 times lower than the degree of diffusion of iron (II) hexaaqua complex. Iron (III) hydroxide polymaltosate comes from the intestine by active transport. Folic acid belongs to the B vitamins. It is a precursor of tetrahydrofolate, a coenzyme involved in various metabolic processes, including the biosynthesis of purines and nucleic acid thymidylates; it is also necessary for the synthesis of nucleoproteins and maintaining normal levels of erythropoiesis. Pharmacodynamic effects Absorbed iron binds to transferrin and is used for the synthesis of hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin.
Pharmacokinetics
Absorption Absorption of iron (III) hydroxide polymaltose occurs through a controlled mechanism. The increase in serum iron levels after taking the complex does not correlate with the total absorption of iron, assessed by its inclusion in Hb. Studies using radiolabeled iron(III) hydroxide polymaltose have shown a clear correlation between the percentage of iron absorption by red blood cells (incorporation in Hb) and absorption in terms of the whole body. The most active absorption of the polymaltose complex of iron (III) hydroxide occurs in the duodenum and jejunum. As with other oral iron preparations, the relative extent of iron absorption from iron(III) polymaltose hydroxide, assessed by its incorporation into Hb, decreased with increasing iron doses. There was also a correlation between the degree of iron deficiency (i.e., serum ferritin level) and the amount of iron absorbed (i.e., the greater the iron deficiency, the better the absorption). When using the drug Maltofer® Fol, the degree of absorption is about 10%. It has been shown that in patients with anemia, the absorption of iron from the polymaltose complex of iron (III) hydroxide, in contrast to iron salts, increases in the presence of food. Folic acid is mainly absorbed in the small intestine, mainly in the duodenum and jejunum. After taking 0.35 mg of folic acid, 80% of its absorption can be expected. Distribution The distribution of iron following absorption of iron(III) hydroxide polymaltose has been demonstrated in a study using the dual isotope technique (55Fe and 59Fe). The maximum concentration of folic acid in the blood plasma is achieved after 30-60 minutes. A single-dose study of Maltofer® Fol chewable tablets (100 mg iron, 0.35 mg folic acid) in 12 healthy volunteers demonstrated rapid absorption of folic acid, with a maximum folate concentration of 11 ng/ml achieved at 0.75 hours after dosing doses. Biotransformation Iron (III) hydroxide polymaltosate after absorption is used for the synthesis of hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin. Folic acid is metabolized in the cells of the intestines and liver, as well as in other organs. The resulting folates bind to transport proteins and distribute throughout all organs. Excretion Unabsorbed iron is excreted in the feces. Folic acid is excreted by the kidneys and also through the digestive tract. Pharmacokinetics in special populations Renal, hepatic and cardiac failure. No data available.
Indications for use
Treatment and prevention of latent (hidden) iron deficiency and iron deficiency anemia (clinically pronounced iron deficiency) with an increased need for folic acid during pregnancy and breastfeeding. Iron deficiency and its severity must be established and confirmed by appropriate laboratory tests.
Directions for use and doses
For oral administration. Treatment of iron deficiency anemia and replenishment of the increased need for folic acid: 1 chewable tablet 2-3 times a day (from 200 mg of iron and 0.70 mg of folic acid to 300 mg of iron and 1.05 mg of folic acid) until hemoglobin levels are normalized. After normalization of hemoglobin: 1 chewable tablet daily throughout pregnancy to build up iron reserves. Treatment and prevention of latent iron deficiency and replenishment of the increased need for folic acid: 1 chewable tablet (100 mg of iron and 0.35 mg of folic acid) per day. The daily dose should be taken all at once or divided into several doses. Maltofer® Fol should be taken during or immediately after meals. Chewable tablets can also be swallowed whole or chewed. If you forget to take Maltofer® Fol on time, continue taking the drug as usual. Do not take a double dose to make up for a separate missed dose. Renal failure No studies have been conducted in patients with renal failure. No data available. Hepatic impairment No studies have been conducted in patients with hepatic impairment. No data available.
Use during pregnancy and lactation
Pregnancy To date, there have been no reports of the development of serious adverse reactions when taking the drug Maltofer® Fol in recommended therapeutic doses for the treatment of anemia during pregnancy. Animal studies have not shown any risk to mother or fetus. There are no clinical trial data on the use of this drug in the first trimester of pregnancy. In clinical studies of taking the drug Maltofer® Fol in the second and third trimesters of pregnancy, no undesirable effects of the drug on the body of the mother and/or newborns were noted. Thus, the presence of a negative effect of the drug Maltofer® Fola on fetal health seems unlikely. Breastfeeding Breast milk normally contains iron bound to lactoferrin. It is unknown how much iron(III) hydroxide polymaltosate passes into breast milk. It is unlikely that taking Maltofer® Fol by nursing women can cause undesirable effects in infants. As a precautionary measure, for women of childbearing age and women during pregnancy or breastfeeding, the use of Maltofer® is recommended only after consultation with a doctor to assess the benefit/risk ratio.
Precautionary measures
Anemia should always be treated under medical supervision. If there is no effect (hemoglobin level has not increased by approximately 20-30 g/l after 3 weeks), the treatment plan should be reconsidered. Caution should be exercised when prescribing the drug to patients who have received multiple blood transfusions, since red blood cells carry iron, which can cause iron oversaturation. During treatment with Maltofer® Fol, stool may become dark in color and has no clinical significance. The drug Maltofer® Fol contains folic acid and can mask the symptoms of vitamin B12 deficiency. Infections or tumors can cause anemia. Since iron can only be used if the underlying disease is controlled, a benefit/risk assessment is recommended in these situations. It is expected that taking Maltofer® Fol will not affect the insulin administration regimen in patients with diabetes mellitus. One chewable tablet contains 0.03 bread units.
Interaction with other drugs
The interaction of iron (III) hydroxide polymaltose with tetracycline and aluminum hydroxide was studied in clinical studies. There was no significant decrease in tetracycline absorption. The concentration of tetracycline in the blood plasma did not fall below the level providing the required effectiveness. Aluminum hydroxide and tetracycline did not reduce the absorption of iron(III) polymaltose hydroxide in human studies. Therefore, iron (III) hydroxide polymaltosate can be taken simultaneously with tetracycline or other phenolic substances, as well as aluminum hydroxide. Studies in rats have shown no interactions with tetracycline, aluminum hydroxide, acetylsalicylate, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin . There were also no in-vitro interactions with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and its salts, vitamin A, vitamin D3, vitamin E, soybean oil and soybean flour. These results indicate that Maltofer® Fol can be taken with or immediately after meals. The drug does not affect the results of the test for the presence of occult blood (selective hemoglobin test), so there is no need to stop treatment for the test. Concomitant parenteral and oral administration of iron should be avoided as this significantly reduces the absorption of oral iron. Treatment with folic acid may increase the metabolism of phenytoin, leading to a decrease in its serum concentration, especially in patients with folic acid deficiency. Although this phenomenon is usually not clinically significant, the frequency of seizures may increase in some patients. Patients taking phenytoin or any other anticonvulsants should consult their physician before starting folic acid treatment. It has been reported that the combined use of folic acid with chloramphenicol in patients with folate deficiency may have an antagonistic effect on the hematopoietic response to folic acid. Although the significance and mechanism of this interaction remain unclear, the hematologic response to folic acid treatment in patients taking both drugs should be closely monitored.
Contraindications
A history of hypersensitivity to iron (III) hydroxide polymaltose, folic acid or any of the excipients; iron overload (eg, hemochromatosis or hemosiderosis); disorders of iron utilization (anemia associated with lead poisoning, sideroachrestic anemia, thalassemia), anemia not associated with iron deficiency (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).
Compound
One tablet contains: active ingredients: 100 mg of iron in the form of iron (III), polymaltosate hydroxide (357 mg) and 0.35 mg of folic acid; excipients: dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor and microcrystalline cellulose.
Overdose
In case of an overdose of iron (III) hydroxide polymaltose, signs of poisoning and iron overload are unlikely, due to the low toxicity of the drug and controlled absorption of iron. There are no reports of accidental fatal poisonings. When using too high doses of folic acid, changes in the central nervous system (changes in mental state, disturbances in sleep and wakefulness, increased irritability, hyperactivity), nausea and flatulence may develop.
Side effect
The safety and tolerability of iron(III) hydroxide polymaltosate (with and without folic acid) has been evaluated in numerous clinical trials and published reports. The frequency of adverse reactions is assessed based on the following classification: often (?1/100,
Storage conditions
In a place protected from light at a temperature not exceeding 25°C. Keep away from children.
Note!
Description of the drug Maltofer FOL table. chewing No. 30 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
