Maltofer - instructions for use, dose, side effects, contraindications

Active substanceIron [III] hydroxide polymaltosateIron [III] hydroxide polymaltosate

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Dosage form: & nbspchewing tablets

Composition:

1 tablet contains:

active substance:

iron (III) hydroxide polymaltozate .................. 357.0 mg

in terms of iron ............................................... 100, 0mg

Excipients:

dextrates ................................................. ............... 232.0 mg

macrogol 6000 ................................................ ......... 37.0 mg

talcum purified ................................................ ... 21.0 mg

sodium cyclamate ................................................ ..... 9.0 mg

vanillin................................................. .................. 2.9 mg

cocoa powder ................................................ ........ 29.0 mg

chocolate flavors .................................... 0.6 mg

cellulose microcrystalline ....................... up to 730.0 mg

Description:Round, flat tablets of brown color with impregnations of white color, with a risk.

Pharmacotherapeutic group:The iron preparation

ATX: & nbsp

B.03.A.B Preparations of iron (trivalent) for oral administration

B.03.A.B.05 Iron hydroxide polymaltosate

Pharmacodynamics:

In iron (III), the polymethyltosate hydroxide multinucleated iron (III) hydroxide is surrounded from the outside by a number of covalently bound polymaltosate molecules, which gives a total average molecular weight of about 50 kDa. The structure of the multinucleated core of iron (III) hydroxide of polymaltose is similar to the structure of the core of the ferritin protein, the physiological depot of iron. Iron (III) hydroxide polymaltose is stable and under physiological conditions does not emit a large number of iron ions. Due to the size of the degree of diffusion of iron (III), the polymethyltosate hydroxide through the mucosa is approximately 40 times smaller compared to the complex of six aqueous iron (II). Iron from iron (III) hydroxide polymaltose is actively absorbed in the intestine.

The effectiveness of the preparation Maltofer® for normalizing the hemoglobin content and iron depot replacement has been demonstrated in numerous randomized controlled clinical trials using a placebo-controlled or active comparator in adults and children with different iron depot status.

Pharmacokinetics:

Suction

Iron from iron (III) hydroxide polymaltose is absorbed in accordance with the controlled mechanism. The increase in serum iron content after administration of the drug is not correlated with total iron absorption, measured as incorporation into hemoglobin (Hb). Studies with a labeled radioisotope of iron (III) hydroxide with polymaltozate revealed a strong correlation between the inclusion of iron in erythrocytes and the iron content throughout the body. The maximum activity of iron absorption from iron (III) hydroxide polymaltose is noted in the duodenum and small intestine. As in the case of other oral iron preparations, the relative absorption of iron from iron (III), the polymethyltosate hydroxide, defined as incorporation into hemoglobin, decreases with increasing doses of iron. In addition, a correlation was observed between the degree of iron deficiency (in particular serum ferritin concentration) and the relative amount of absorbed iron (i.e., the greater the iron deficiency, the better the relative absorption). In patients with anemia, absorption of iron from iron (III), polymethyltosate hydroxide, in contrast to iron salts, increased in the presence of food.

Distribution

The distribution of iron from iron (III) after the absorption of polymalthosate hydroxide was studied in a study using the technique of double isotopes (⁵⁵Fe and ⁵⁹Fe).

Biotransformation

The 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.

Excretion

Non-sucked iron is excreted by the intestine (with feces).

Indications:

Treatment of iron deficiency without anemia (latent iron deficiency) and treatment of clinically pronounced iron deficiency anemia.
Increased need for iron during pregnancy and during breastfeeding, blood donation, intensive growth, vegetarianism and the elderly.

Contraindications:

The established hypersensitivity to iron (III) hydroxide polymaltozate or to any auxiliary substance.
Iron overload (eg, hemosiderosis, hemochromatosis).
Impaired iron utilization (eg, lead anemia, sideroachrestic anemia, thalassemia).
Anemia not related to iron deficiency (eg, hemolytic anemia or megaloblastic anemia caused by a deficiency of vitamin B₁₂).
Children under 12 years of age (due to the need to prescribe small doses in this age group, it is recommended to use the preparation Maltofer®, drops for oral administration 50 mg / ml, or Maltofer®, syrup 10 mg / ml).

Pregnancy and lactation:

Pregnancy

To date, there have been no reports of serious adverse reactions after taking Maltofer® inside at therapeutic doses while treating anemia during pregnancy. The data obtained from animal studies did not indicate a risk to the fetus and mother. Data of clinical studies on the use of the preparation of Maltofer® in the first trimester of pregnancy are absent.

In studies conducted in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of the preparation Maltofer® on mothers and / or newborns were found. In this regard, adverse effects 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 that passes from iron (III) hydroxide polymaltose to breast milk is unknown.It is unlikely that the use of the drug Maltofer® by breast-feeding women can lead to undesirable effects in the child.

As a precaution, women of childbearing age and women during pregnancy and breastfeeding should take the drug Maltofer®only after consulting a doctor. It is recommended that the benefit / risk ratio be evaluated.

Dosing and Administration:

For oral administration.

The daily dose can be divided into several doses or taken at a time. Maltofer® should be taken during or immediately after meals. Maltofer®, chewable tablets of 100 mg, can be chewed or swallowed whole.

The daily dose of the drug depends on the degree of iron deficiency (see table of daily doses).

Table of daily doses

Category patients	Treatment iron deficiency anemia	Treatment of iron deficiency without anemia	Increased demand for gland
Children over 12 years of age, adults, lactating women	1 -3 tablets (100-300 mg of iron)	1 tablet (50-100 mg of iron)	*
Pregnant women	2-3 tablets (200-300 mg of iron)	1 tablet (100 mg of iron)	1 tablet (100 mg of iron)

* Due to the need to prescribe small doses for these indications, it is recommended to use the preparation Maltofer®, drops for ingestion of 50 mg / ml, or Maltofer®,syrup 10 mg / ml.

Treatment of iron deficiency anemia in children older than 12 years and adults

From 100 to 300 mg of iron (1-3 tablets) per day for 3-5 months before the normalization of hemoglobin (Hb). After this, treatment should be continued for several weeks at the dose described for iron deficiency without anemia, in order to replenish iron stores.

Treatment of iron deficiency anemia during pregnancy

From 200 to 300 mg of iron (2-3 tablets) per day until the normal content of hemoglobin (Hb). After this treatment should be continued at least until the end of pregnancy in a dose described for the case of iron deficiency without anemia, in order to replenish iron stores and meet the increased requirements for iron in connection with pregnancy.

Treatment and prevention of iron deficiency without anemia in children over 12 years of age and adults

For 100 mg (1 tablet) per day for 1 -2 months. If a smaller dose is required for prevention, you can use the preparations Maltofer®, drops for ingestion 50 mg / ml, or Maltofer®, syrup 10 mg / ml.

Use in children

Maltofer®, 100 mg chewable tablets, are contraindicated for children aged 12 years and under.The dosage form and concentration of the preparations Maltofer®, drops for ingestion 50 mg / ml, and Maltofer®, syrup 10 mg / ml, are better suited for taking the recommended dose in this age group.

Side effects:

The safety and tolerability of the drug Maltofer® has been evaluated in a variety of clinical studies. The main undesirable drug reactions (NLR), noted in these studies, occurred in the following three classes of systems and organs.

Undesirable drug reactions observed in clinical trials

Classes and systems of organs	Very frequent (≥1/10)	Frequent (≥1/100, <1/10)	Infrequent (≥1/1000, <1/100)
Disturbances from the nervous system	-	-	Headache
Disorders from the gastrointestinal tract	Stool color change¹	Diarrhea, nausea, indigestion	Vomiting, constipation, abdominal pain, discoloration of tooth enamel²
Disturbances from the skin and subcutaneous tissues			Rash³, itching

¹Often recorded as an undesirable phenomenon (in 23% of patients), this is a well-known NLR for oral iron preparations.

² An adverse event was reported in 0.6% of patients, and this is a well-known NLR for oral iron preparations.

³ Including exanthema.

Spontaneous post-marketing reports of adverse drug reactions

No additional unwanted drug reaction was noted.

Deviations of laboratory indicators

No data available.

Overdose:

In the case of an overdose of Maltofer®, iron overload or intoxication is unlikely, due to the low toxicity of iron (III), polymethyltosate hydroxide and controlled iron uptake. No cases of unintentional poisoning with a lethal outcome were reported.

Interaction:

Interactions of iron (III) hydroxide of polymaltosate with tetracycline or aluminum hydroxide have been studied. There was no significant decrease in tetracycline absorption. The concentration of tetracycline in the blood plasma did not drop below the effective level. Absorption of iron from iron (III) hydroxide polymaltozate did not decrease under the influence of aluminum hydroxide or tetracycline. Thus, iron (III) hydroxide polymaltosate 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 in combination with vitamin D₃, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol, and auranofina, no interactions with iron (III) hydroxide polymaltosate were observed.

Also, no interaction of iron (III) hydroxide of polymaltosate 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 soybean flour. These results indicate that iron (III) hydroxide polymaltose can be taken during or immediately after ingestion.

The administration of the drug does not affect the results of the detection of hidden blood (with a selective determination of hemoglobin), therefore, it is not necessary to interrupt treatment. It is necessary to avoid the simultaneous use of parenteral and oral iron preparations, since the absorption of iron taken orally slows down.

Special instructions:

It is assumed that taking Maltofer® should not have an effect on the daily insulin requirement in patients with diabetes mellitus. 1 chewable tablet contains 0.04 bread units.

Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can only be taken after the root cause of the disease has been eliminated, the relationship between benefit and risk of treatment should be determined.

During treatment with the preparation Maltofer®, dark staining of the stool can be noted, however this has no clinical significance.

Effect on the ability to drive transp. cf. and fur:

No data available. It is unlikely that the preparation of Maltofer® influences the ability to drive vehicles and mechanisms.

Form release / dosage:

Tablets chewing 100 mg.

Packaging:

For 10 tablets in blisters of aluminum foil, laminated with polyethylene.

For 1 or 3 blisters, together with the instructions, they are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011981 / 03

Date of registration:11.10.2011

Expiration Date:Unlimited

The owner of the registration certificate:Vifor (International) Inc.Vifor (International) Inc. Switzerland

Manufacturer: & nbsp

VIFOR, S.A. Switzerland

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp28.03.2018

Illustrated instructions

Instructions

Maltofer® (Maltofer®)