FERRUM CHAT (Chewable Tablets, Syrup)

Active material: gland [III] hydroxide polimaltozat
When ATH: B03AB
CCF: Antianemic drug
ICD-10 codes (testimony): D50, E61.1, O99.0
When CSF: 19.02.01.01
Manufacturer: LEK d.d. (Slovenia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Chewable Tablets dark brown, interspersed with a light brown color, round, flat, chamfered.

1 tab.
gland [III] hydroxide polimaltozat400 mg,
based on iron100 mg

Excipients: macrogol 6000, Aspartame, chocolate flavor, talc, dekstratы.

10 PC. – strips (3) – packs cardboard.

Syrup clear, Brown color.

5 ml
gland (III) hydroxide polimaltozat200 mg,
based on iron50 mg

Excipients: sucrose, sorbitol (solution), metilparagidroksiʙenzoat, propilparagidroksibenzoat, ethanol, cream flavor, Sodium hydroxide, water.

100 ml – vials of dark glass (1) complete with measuring spoon – packs cardboard.

 

Pharmacological action

Antianemic drug. The drug Ferrum Lek® iron is in the form of complex compounds of iron (III) hydroxide with polymaltose.

The molecular weight of the complex – about 50 kDa, therefore diffusion through the gastrointestinal mucosa in 40 times slower, than the diffusion of ferrous. The complex is stable under physiological conditions and does not release iron ions. Iron cores of multi-core complex is connected to the structure, similar to the structure of natural compounds of iron – ferritina. Due to the similarity of the iron complex is absorbed only by active absorption. Iron-binding proteins, located on the surface of the intestinal epithelium, absorb iron (III) from the complex by a competitive ligand exchange. Absorb iron mainly deposited in the liver, where it binds to the ferritin. Later, the bone marrow is included in the hemoglobin. The iron complex (III) hydroxide with polymaltose not have pro-oxidant properties, inherent iron salts (II).

 

Pharmacokinetics

Studies using the method of double isotope (55Fe and 59Fe) shown, that the absorption of iron, measured by the level of hemoglobin in erythrocytes, inversely proportional to the dose (The higher dose of, the lower the absorbance). There is a statistically negative correlation between the degree of iron deficiency and the amount of absorbed iron (The more iron deficiency, better absorption). In most iron is absorbed in the duodenum and jejunum. Remaining (unabsorbed) iron excreted in the feces. His urinary epithelial cells exfoliate the skin and gastrointestinal tract, and then with, bile and urine is approximately 1 mg iron / day. In women during menstruation there is an additional loss of iron, that must be taken into account.

 

Testimony

- Treatment of latent iron deficiency;

- The treatment of iron deficiency anemia;

- Prevention of iron deficiency in pregnancy.

 

Dosage regimen

The drug is recommended to be taken during or immediately after a meal. Chewable tablets can be chewed or swallowed whole. The daily dose can be divided into several stages or take over 1 time.

Syrup can be mixed with fruit or vegetable juices or added to infant formula. Package insert scoop used for precise dosing syrup.

Dose and duration of treatment depends on the degree of iron deficiency.

At iron deficiency anemia the duration of treatment is about 3-5 Months. After normalization of hemoglobin level should continue taking the drug for a few more weeks, to replenish iron stores in the body.

Children under 1 year appointed 2.5-5 ml (1/2-1 scoop) syrup / day.

Children aged 1 to 12 years – 5-10 ml (1-2 measuring spoons) syrup / day.

Children over 12 years, adults and mothers, breastfeeding, – 1-3 tab. chewing or 10-30 ml (2-6 scoops) syrup / day.

Pregnant women appoint 2-3 tab. Chewable or 20-30 ml (4-6 scoops) syrup to the normalization of hemoglobin levels. After that you should continue to take 1 tab. chewing or 10 ml (2 measuring spoons) syrup / day, at least, until the end of pregnancy to replenish iron stores in the body.

At latent iron deficiency the duration of treatment is about 1-2 Months.

Children aged 1 to 12 years – 2.5-5 ml (1/2-1 scoop) syrup / day.

Children over 12 years, adults and mothers, breastfeeding, – 1 tab. chewing or 5-10 ml (1-2 measuring spoons) syrup / day.

Pregnant women appoint 1 tab. chewing or 5-10 ml (1-2 measuring spoons) syrup / day.

Daily doses of the drug Ferrum Lek® for the prevention and treatment of iron deficiency in

AgeZhelezodefitsitnaya anemiaLatent iron deficiencyPrevention of iron deficiency
Children up 1 year2.5-5 ml syrup (25-50 Iron mg)**
Children (1-12 years)5-10 ml (50-100 Iron mg)2.5-5 ml (25-50 Iron mg)*
Children (>12 years), adults and nursing mothers1-3 tab. Chewable or 10-30 ml syrup (100-300 Iron mg)1 tab. chewing or 5-10 ml syrup (50-100 Iron mg)*
Pregnant2-3 tab. Chewable or 20-30 ml syrup (200-300 Iron mg)1 tab. chewing or 10 ml syrup (100 Iron mg)1 tab. chewing or 5-10 ml syrup (50-100 Iron mg)

* – because, that for this group of patients with low doses of iron are necessary, not recommended in these cases, appoint a drug in the form of tablets or syrup.

 

Side effect

From the digestive system: rarely – feeling of weight, sensation of fullness and epigastric pressure, nausea, constipation, diarrhea. Before the drug is marked staining of stool in a dark color, due to breeding nevsosavsheysya iron and has no clinical significance.

Celebrating the side effects were generally mild and transient.

 

Contraindications

- An excessive content of iron in the body (eg, gemoxromatoz);

- Utilization of iron disorders (eg, anemia, caused by lead poisoning, sideroahresticheskaya anemia);

- Anemia, not associated with iron deficiency (eg, hemolytic anemia, megaloblastnaya anemia, caused by lack of cyanocobalamin);

- Hypersensitivity to the drug.

 

Pregnancy and lactation

In controlled studies of the drug when used in II and III trimester of pregnancy has not noted the negative impact on the mother or fetus. There were no adverse effects on the fetus when using the drug in the I trimester of pregnancy.

 

Cautions

Chewable tablets and syrup do not cause staining of tooth enamel.

In the appointment of Ferrum Lek® patients with diabetes should be considered, what 1 tab. chewing and 1 ml syrup contains 0.04 HE.

In cases of anemia, caused by an infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the treatment of the underlying disease.

The drug has no effect on the results of fecal occult blood (selectively on the hemoglobin).

Use in Pediatrics

Children under 12 years the need prescribing low doses is preferably used in the form of a syrup.

Effects on ability to drive vehicles and management mechanisms

No effect on the ability to concentrate.

 

Overdose

In cases of overdose Ferrum Lek® for oral administration so far has not been described symptoms or signs of intoxication Excessive intake of iron in the body, since iron of the active ingredient is present in free form in the gastrointestinal tract and is not absorbed by passive diffusion.

 

Drug Interactions

There was no interaction with other drugs or with food.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 5 years. Do not use after the expiry date, on the package.

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