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

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

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Dosage form: & nbspsyrup

Composition:

1 ml of the preparation contains:

active substance:

iron (III) hydroxide polymaltosate .................. 35.7 mg

in terms of iron ............................................... 10, 0mg

Excipients:

sucrose ................................................. .................. 200.0 mg

solution of sorbitol 70% ......................................... 400.0 mg

methylparahydroxybenzoate 0.583 mg

propyl parahydroxybenzoate. 0.167 mg

ethanol 96% ............................................... ............... 3.25 mg

Cream flavor .......................................... 3.0 mg

sodium hydroxide, ............................................... ... to pH 5.0 to 7.0

purified water................................................ up to 1 ml

Description:

The solution is dark brown in color.

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, the degree of diffusion of iron (III) polymethyltosate hydroxide through the mucosa is approximately 40 times less than that of the iron-hexahedral complex (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 application of the drug does not correlate 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 ⁵⁹Ff).

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 (see section "Dosing and Administration"),
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 associated with iron deficiency (eg, hemolytic anemia or megaloblastic anemia,caused by a lack of vitamin B₁₂).
Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

Carefully:

Contains ethanol, so the drug is administered with caution to patients with liver disease, alcoholism, with craniocerebral trauma or with diseases of the brain.

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 showed no danger to the fetus and the 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.

The exact dose of the drug can be measured with a measuring cap attached to the preparation of Maltofer®, a syrup of 10 mg / ml.

Maltofer® can be mixed with fruit and vegetable juices, or with children's food, or non-alcoholic drinks. Light coloring of the mixture has no effect on either its taste or the effectiveness of the preparation.

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

Table of daily doses for children and adults according to age

Category patients	Treatment iron deficiency anemia	Treatment of iron deficiency without anemia	Increased need for iron
Children under 1 year old	2.5-5 ml (25-50 mg of iron)	_ * (15-25 mg of iron)	_*
Children from 1 to 12 years old	5-10 ml (50-100 mg of iron)	2.5-5 ml (25-50 mg of iron)	_*
Children over 12 years old	10-30 ml (100-300 mg of iron)	5-10 ml (50-100 mg of iron)	_*
Adults and women breastfeeding	10-30 ml (100-300 mg of iron)	5-10 ml (50-100 mg of iron)	5-10 ml (50-100 mg of iron)
Pregnant women	20-30 ml (200-300 mg of iron)	10 ml (100 mg of iron)	10 ml (100 mg of iron)

* Due to the need to prescribe very small doses for these indications, it is recommended to use the preparation Maltofer®, drops for oral administration of 50 mg / ml.

Treatment of iron deficiency anemia in children and adults

Treatment until the normal hemoglobin content is reached (Hb) takes about 3 to 5 months. After this, the treatment should be continued for 1-2 months at the dose described for the case of iron deficiency without anemia, in order to replenish iron stores.

Treatment of iron deficiency anemia during pregnancy

Treatment should continue until normal 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

Treatment takes approximately 1 to 2 months.

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 bodies	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

¹ Often 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

There were no additional undesirable drug reactions.

Deviations of laboratory indicators

No data available.

Overdose:

In the event 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 legal 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 polymaltose 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:

The daily dose of the drug contains ethanol in an amount of 0.008 g (dose 2.5 ml) to 0.1 g (a dose of 30 ml). When prescribing a drug for patients with diabetes, it should be noted that 1 ml of syrup 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.

Maltofer® contains sucrose, which can harm the teeth.

Auxiliary substances of sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate can cause allergic reactions (possibly, delayed type).

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:

Syrup 10 mg / ml.

Packaging:

To 75 ml or 150 ml in bottles of dark glass, closed with screwed covers of high-pressure polyethylene with the control of the first opening and a measuring cap, put on the lid.

One bottle with instructions for use is 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:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N011981 / 04

Date of registration:11.10.2011 / 20.02.2018

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®)