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

active substance:
iron (III) hydroxide polymaltosate	71.4 mg
is equivalent to the content of iron	20 mg
Excipients:
sucrose	100.0 mg
sorbitol solution 70%	200.0 mg
sodium methyl parahydroxybenzoate	1.54 mg
sodium propyl parahydroxybenzoate	0.17 mg
cream flavors	3.0 mg
sodium hydroxide	to pH 4.5 - 7.0
purified water	up to 1 ml

One bottle (5 ml) contains 100 mg of iron.

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:

Preparations of Maltofer® contain iron in the form of iron (III) polymethyltosate hydroxide. This macromolecular complex is stable and does not release large amounts of iron in the form of free ions in the gastrointestinal tract. The structure of the core of the complex is similar to the natural iron compound - ferritin. Due to this similarity, Fe³⁺ from the intestine enters the blood only by active absorption, which explains the impossibility of an overdose (and intoxication) by the drug in contrast to simple iron salts, the absorption of which occurs along the concentration gradient.

Iron (III) hydroxide polymaltozate is iron dextrin, unlike Fe (II) hydroxide polyisomaltozate - iron dextran, does not contain dextrans, which makes it more likely that anaphylactic reactions will develop. Outside the multinucleated centers of hydroxide Fe³⁺ are surrounded by many non-covalently bound polymaltose molecules, forming a complex with a total molecular mass of 50,000.Yes, which is so great that its diffusion through the membranes of the intestinal mucosa is approximately 40 times less than that of Fe hexahydrate²⁺.

The absorbed iron is deposited in a ferritin-related form, mainly in the liver. Later, iron is included in the hemoglobin in the bone marrow. Iron, which is part of iron (III) of polymethyltosate hydroxide, does not possess pro-oxidant properties, unlike simple iron salts, which leads to a decrease in the oxidation of LDL and VLDL.

Rapidly replenishes iron deficiency in the body, stimulates erythropoiesis, restores hemoglobin.

Maltofer® does not stain tooth enamel.

Pharmacokinetics:

The iron contained in the preparation of Maltofer® comes from the intestine to the blood via active transport. The degree of absorption after oral administration depends on the degree of iron deficiency (the greater the deficit, the higher the absorption) and the dose of the drug (the higher the dose, the worse the absorption). The most active absorption process occurs in the duodenum and jejunum. The non-sucked part of Fe³⁺is excreted with caloric masses.

Indications:

Treatment of latent (LJ) and clinically pronounced iron deficiency (iron deficiency anemia - IDA).
Increased need for iron due to pregnancy, lactation, blood donation, intensive growth, vegetarianism and the elderly.

Contraindications:

Hypersensitivity to any of the components of the drug
Iron overload (eg, hemosiderosis and hemochromatosis)
Impaired iron utilization (eg, lead anemia, sideroblastic anemia)
Non-iron-deficiency anemia (eg, hemolytic anemia or megaloblastic anemia caused by a deficiency of vitamin B12)
Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption, since the drug contains sucrose and sorbitol.
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 or Maltofer® syrup).

Pregnancy and lactation:

In controlled studies in pregnant women after the first trimester of pregnancy, there was no undesirable effect of the drug on the mother and fetus. There is no evidence of an undesirable effect of the drug on the fetus during the first trimester of pregnancy.

In small quantities, unaltered iron from the polymaltose complex can penetrate into breast milk, but the occurrence of undesirable effects in breast-fed infants is unlikely.

Dosing and Administration:

Inside.

The daily dose can be taken all at once. The drug should be taken during or immediately after meals.

The oral solution can be mixed with fruit and vegetable juices or with soft drinks. At the same time, the taste of drinks does not change and the effectiveness of the drug does not decrease.

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

Table of daily doses:

Category of patients

IDA

Increased need for iron

Adults,

lactating women

1-3 bottles

(100-300 mg of iron)

1 bottle

(50-100 mg of iron)

Pregnant

women

2-3 bottles

(200-300 mg of iron)

1 bottle

(100 mg of iron)

1 bottle

(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 oral administration or Maltofer® syrup.

The duration of treatment for clinically significant iron deficiency (iron deficiency anemia) is 3-5 months before the normalization of the hemoglobin content.After that, the drug should be taken at a dose to treat latent iron deficiency for several more months, and for pregnant women, at least until the birth to restore iron stores.

The duration of treatment of latent iron deficiency is 1-2 months.

In the case of clinically severe iron deficiency, the normalization of the hemoglobin content and the replenishment of iron stores occur 2-3 months after the start of treatment.

Side effects:

Very rarely (greater than or equal to 0.001% and less than 0.01%) gastrointestinal irritation symptoms may occur, such as overflow sensation, epigastric pressure, nausea, constipation, or diarrhea.

Perhaps the dark staining of the stool, caused by the release of not absorbed iron (a clinical value does not matter).

Overdose:

To date, in cases of drug overdose, neither toxicity nor signs of iron overload have been reported.

Interaction:

Interaction with other drugs has not been identified.

Special instructions:When prescribing a patient with diabetes, it should be noted that 1 bottle contains 0.11 bread units.

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

Does not affect.

Form release / dosage:

Solution for oral administration 20 mg / ml.

Packaging:

5 ml in bottles of transparent glass of hydrolytic class III, sealed with stretchable polyethylene caps. For 10 vials along with the instructions for use 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:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N011981 / 05

Date of registration:05.10.2011

Expiration Date:Unlimited

Date of cancellation:2017-07-19

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

Manufacturer: & nbsp

GEYMONAT Italy

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp28.03.2018

Illustrated instructions

Instructions

Maltofer® (Maltofer®)