Maltofer Foul
Maltofer Foul: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Maltofer Fol
ATX code: B03AD04
Active ingredient: iron (III) hydroxide polymaltosate + folic acid [ferric (III) hydroxide polymaltosate + folic acid]
Manufacturer: Vifor SA (Switzerland)
Description and photo update: 2018-23-10
Prices in pharmacies: from 620 rubles.
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Maltofer Fol is a combined antianemic drug, a hematopoietic stimulator.
Release form and composition
Maltofer Foul is produced in the form of chewable tablets: brown interspersed with white, flat, round, scored (10 pcs. In a blister, in a cardboard box 1 or 3 blisters).
1 tablet contains:
- active ingredients: iron (III) hydroxide polymaltose - 357 mg (which corresponds to iron in the amount of 100 mg); folic acid - 0.35 mg;
- additional components: macrogol 6000, dextrates, sodium cyclamate, purified talc, cocoa powder, vanillin, microcrystalline cellulose, chocolate flavor.
Pharmacological properties
Pharmacodynamics
Maltofer Fol is a combined remedy - a combination of iron and vitamin preparations.
The multinuclear iron (III) hydroxide contained in iron (III) polymaltose hydroxide is surrounded on the outside by a large number of covalently bound polymaltose molecules, resulting in a total average molecular weight of about 50 kDa. The structure of the multinucleated nucleus of iron (III) polymaltose hydroxide is similar to the structure of the ferritin protein nucleus (physiological iron depot). Iron (III) hydroxide polymaltose is stable and does not release a significant number of iron ions under physiological conditions. Due to its size, the degree of diffusion of this active substance of the drug through the mucous membrane is about 40 times lower in comparison with the complex of hexahydrate iron (II). Iron, which is part of the substance, is intensively absorbed in the intestines.
Folic acid (folate) belongs to the group of vitamins B. This substance is a precursor of tetrahydrofolate, a coenzyme of various metabolic processes, including the biosynthesis of nucleic acid components (purines and thymidylates); necessary for the production of nucleoproteins and the maintenance of normal erythropoiesis.
When carrying out the normalization of hemoglobin concentration and replenishment of iron stores, the effectiveness of Maltofer Fol was noted in numerous randomized controlled clinical trials in children and adults with varying degrees of iron content in the depot using placebo control or an active comparison drug.
Pharmacokinetics
The absorption of iron from the substance occurs according to a controlled mechanism. The increase in the level of serum iron after the use of the drug is not associated with the total absorption of this bioelement, defined as incorporation into hemoglobin (Hb). Studies carried out with radio-labeled iron (III) hydroxide polymaltose have shown a significant correlation between the level of iron in the whole body and its incorporation into red blood cells.
The maximum absorption of iron included in the preparation is observed in the small intestine and duodenum. Relative absorption, as with other oral iron preparations (defined as incorporation into Hb), decreases with increasing iron doses. In addition, there is a correlation between the relative volume of absorbed iron and the level of iron deficiency, in particular the serum ferritin content (the greater the iron deficiency, the higher the relative absorption). In the presence of anemia, the absorption of the bioelement from Maltofer Fol, in contrast to iron salts, improved with food intake. The distribution of iron from the preparation after absorption was studied in studies using double isotopes - 55 Fe and 59 Fe.
The absorption of folic acid takes place mainly in the small intestine and duodenum and at a dose of 0.35 mg reaches about 80%. The maximum concentration (C max) of folic acid in the blood is detected after 30-60 minutes. According to the research results, this substance is rapidly absorbed when taking a single dose of Maltofer Fol, while the C max of folates in plasma is observed 0.75 hours after administration and is equal to 11 ng / ml. Folic acid is characterized by active binding to blood plasma proteins, penetrates the blood-brain barrier, placenta and breast milk.
The absorbed iron binds to transferrin and then participates in the process of Hb production in the bone marrow or is deposited mainly in the liver, where it is bound to ferritin. Unabsorbed iron is excreted in the feces.
The metabolic transformation of folic acid occurs in the cells of the liver and small intestine, and in other organs. Then folates, combined with transport proteins, are distributed to all organs. Folic acid is excreted mainly by the kidneys and through the gastrointestinal tract (GIT).
Indications for use
According to the instructions, Maltofer Fol is recommended for the treatment of iron deficiency anemia, including during pregnancy and breastfeeding.
Contraindications
- violation of the mechanisms of iron utilization (including sideroachrestic anemia, lead anemia, thalassemia);
- excessive iron levels (including hemochromatosis, hemosiderosis);
- anemia not caused by iron deficiency (including hemolytic anemia or megaloblastic anemia caused by a lack of vitamin B 12);
- hypersensitivity to any of the constituents of Maltofer Foul.
It is not recommended to use the product for children under 12 years of age.
Instructions for the use of Maltofer Foul: method and dosage
Maltofer Foul is taken orally during or immediately after a meal, chewed or swallowed whole. The daily dose of the drug can be used in one dose or divided into several times.
The drug is taken 1-3 times a day, 1 tablet for 3-5 months until the normal Hb level is reached. Then it is recommended to continue taking it in a daily dose of 1 tablet for several more months to restore iron stores in the body.
In the treatment of iron deficiency anemia during pregnancy, Maltofer Fol should be taken 2-3 tablets per day (200-300 mg of iron and 0.7-1.05 mg of folic acid) until the Hb level normalizes. Then therapy is required to continue until the end of pregnancy (at least) in order to restore iron stores against the background of an increased need for this bioelement associated with pregnancy.
Side effects
- nervous system: infrequently - headache;
- skin and subcutaneous tissues: infrequently - rash (including exanthema), itching;
- digestive system: very often - a change in the color of feces (during studies, it was noted in 23% of patients; has no clinical significance); often - dyspepsia, nausea, diarrhea; infrequently - abdominal pain, constipation, vomiting, discoloration of tooth enamel (observed in 0.6% of patients).
In extremely rare cases, allergic reactions to folic acid may occur.
Overdose
Since iron (III) hydroxide of polymaltosate has a low toxicity and controlled capture of iron, intoxication or excessive intake of the latter in case of an overdose of Maltofer Foul is unlikely. There are no reports of fatal accidental poisoning.
There is evidence of bloating, nausea, flatulence and undesirable effects from the nervous system, such as sleep disturbances, changes in mental state, hyperactivity, irritability, when taking an excess dose of folic acid.
special instructions
Anemia can be caused by diseases of an infectious etiology or malignant neoplasms. In view of the fact that iron preparations can be used only after the root cause of the disease has been eliminated, the ratio of benefits and risks of taking them should be taken into account.
Folic acid, which is part of Maltofer Fol, can mask vitamin B 12 deficiency.
1 tablet of the drug contains 0.04 bread units (XE). It is believed that in patients with diabetes, taking the drug should not affect the body's daily need for insulin.
Influence on the ability to drive vehicles and complex mechanisms
No data provided. There is no reason to assume that Maltofer Fall is capable of negatively affecting the ability to drive complex mechanisms and vehicles.
Application during pregnancy and lactation
There are no results of clinical studies on the use of the drug in the first trimester of pregnancy. Until now, there have been no cases of serious disorders after oral administration of therapeutic doses of Maltofer Foul in the treatment of anemia during pregnancy. The data obtained from animal studies did not confirm the existence of a threat to the fetus and mother. Studies conducted in pregnant women after the completion of the first trimester also did not demonstrate any adverse drug reactions in relation to the health of mothers and newborns.
Women's breast milk contains iron associated with lactoferrin. The amount of iron that passes from the drug into breast milk is unknown.
Due to the above, the adverse effect of the drug when used during pregnancy / lactation on the fetus / child is unlikely.
As a precautionary measure, Maltofer Fol is recommended for women of reproductive age, for women during pregnancy and lactation only after consulting a specialist.
Pediatric use
Treatment with the drug is not recommended for children under 12 years of age.
Drug interactions
The intake of iron (III) hydroxide of polymaltose can be combined with the use of aluminum hydroxide, tetracycline and other phenolic compounds.
It is required to avoid the combined use of iron-containing preparations for oral administration and parenteral administration, since the absorption of ingested iron in this case slows down.
Animal studies did not reveal the interaction of iron (III) hydroxide polymaltosate with sulfasalazine, acetylsalicylic acid, calcium acetate and calcium phosphate in combination with vitamin D 3, calcium carbonate, magnesium aspartate, bromazepam, methyldopa, D-penicillamine, auranofin, paracetamol …
The interaction of iron (III) hydroxide polymaltose was also not observed with the following food components: oxalic acid, tannin, phytic acid, choline and choline salts, sodium alginate, soy flour, soybean oil and vitamins D 3, A and E. These results are confirmation that iron (III) hydroxide polymaltose can be used during a meal or immediately after its completion.
Taking Maltofer Foul does not affect the results of occult blood detection (with selective determination in the hemoglobin sample), therefore, there is no need to interrupt therapy.
During treatment with folic acid, it is possible to increase the metabolism of phenytoin, this can cause a decrease in the content of the latter in the blood serum, especially in the presence of folate deficiency. Although this interaction reaction is not clinically significant, in some patients, the frequency of seizures may still increase. Patients receiving anticonvulsants (including phenytoin) should consult a doctor before starting therapy with drugs containing folic acid.
It has been established that the combined use of folic acid and chloramphenicol in the presence of folate deficiency can cause a weakening of the hematopoietic properties of folic acid as a result of the antagonistic effect of chloramphenicol. Despite the fact that the mechanism and significance of the interaction are unclear, if necessary, this combination is recommended to carefully monitor the hematopoietic effect of folic acid.
Analogs
Analogues of Maltofer Foul are: Ferretab Comp, Aktiferrin, Orofer, Gino-Tardiferon.
Terms and conditions of storage
Store in a place protected from light and out of reach of children, at temperatures below 25 ° C.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription
Reviews about Maltofer Foul
Reviews of Maltofer Foul are mostly good. Patients taking the drug note its effectiveness in treating anemia, a pleasant chocolate taste, and a convenient form of release. According to reviews, adverse reactions during administration are rare, which is especially important when using the drug during pregnancy.
The disadvantages of the funds include a fairly high price and the need for a long course of treatment.
Price for Maltofer Foul in pharmacies
The price of Maltofer Fol (30 tablets per pack) can range from 507-630 rubles.
Maltofer Fall: prices in online pharmacies
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Drug name Price Pharmacy |
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Maltofer Fol 100 mg + 0.35 mg chewable tablets 30 pcs. RUB 620 Buy |
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Maltofer FOL chewable tablets. 30 pcs. 735 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
