Iron (III) hydroxide polimaltozat + Folic Acid - instructions for use, dosage, adverse effects, contraindications

Clinical and pharmacological group: & nbsp

Stimulators of hematopoiesis

Macro and microelements

Included in the formulation

Lickferr-Folly

capsules inwards

FarmSirma Soteks, ZAO Russia

Maltofer® Foul

pills inwards

Vifor (International) Inc. Switzerland

АТХ:

B.03.A.D. Preparations of iron in combination with folic acid

Pharmacodynamics:

Combined drug, stimulates erythropoiesis in iron deficiency anemia.

Fe³⁺ is in the form of a complex hydroxide of the polymaltose complex, which consists of a central lattice formed by Fe³⁺ and surrounded by a large number of polymaltose molecules; has no prooxidant properties, reduces oxidation of low density lipoproteins and very low density lipoproteins. Contains 100 mg of Fe³⁺.

Folic acid - a vitamin B group, stimulates erythropoiesis, participates in the synthesis of amino acids, nucleic acids, purines, pyrimidines, in the exchange of choline.

Pharmacokinetics:

Iron. Absorption is proportional to the degree of deficiency (with a deficit of 10-30%, in the absence of a deficit - 5-15%). Depends on the intake of food (it is better to take an empty stomach, in the presence of hydrochloric acid in the stomach). Distribution: bone marrow (transferrin-iron complex). Depot (ferritin, hemosiderin): hepatocytes, reticuloendothelial system, muscle tissue (insignificant amount).Communication with plasma proteins 90% or more (significantly - with hemoglobin, to a lesser extent - with myoglobin, transferrin, ferritin, hemosiderin, enzymes). Half-life (iron sulfate alone) - 6 hours. There is no physiological elimination system; there is a risk of cumulation. Physiological losses: epidermis, hair, nails, feces, sweat, breast milk, menstrual blood, urine - 1,1-1,4 mg per day; in healthy men and women in postmenopause - 1 mg per day, in healthy women of the reproductive period - 1.5-2 mg per day.

Folic acid. The connection with plasma proteins is high. Deposited and biotransformed in the liver (active form - tetrahydrofolic acid). C_max - 30-60 minutes. Eliminated by the kidneys (unchanged species, metabolites). Removed by hemodialysis.

Indications:

Treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia);

Prevention of iron deficiency and folic acid (including before, during and after pregnancy, during lactation).

ICD-10

III.D50-D53.D50 Iron-deficiency anemia

IV.E50-E64.E53 Insufficiency of other B vitamins

IV.E50-E64.E61.1 Insufficiency of iron

XV.O95-O99.O99.0 Anemia complicating pregnancy, childbirth and the puerperium

Contraindications:

- Iron overload (hemochromatosis, hemosiderosis);

- violation of iron utilization (lead anemia, sideroblastic anemia, thalassemia);

- nezhelezodefitsitnye anemia (hemolytic anemia, or megaloblastic anemia caused by lack of vitamin B₁₂);

- Hypersensitivity to the components of the drug.

Carefully:

One tablet contains 0.04-0.06 bread units that must be considered when administered to patients with diabetes.

Pregnancy and lactation:

In controlled studies in pregnant women in II and III trimester of pregnancy was not observed undesirable effect of the drug to the mother and fetus. There is no evidence of an undesirable effect of the drug on the fetus in the first trimester of pregnancy.

In small quantities of iron from unmodified polymaltose complex is excreted in breast milk, but the occurrence of undesirable effects in breast-fed children is unlikely.

Dosing and Administration:

The drug is taken inwards, during or immediately after a meal. Tablets can be chewed or swallowed whole.

The dose of the drug and the duration of therapy depend on the severity of iron deficiency. The daily dose of the drug can be taken 1 time per day.

Treatment of iron deficiency anemia: 1 tablet 1-3 times a day for 3-5 months before the normalization of the hemoglobin level in the blood. After this, the drug should be continued for several more months in order to restore iron stores in the body - 1 tablet a day.

Pregnant women the drug should be taken 1 tablet 2-3 times a day before the normalization of hemoglobin. Then the therapy should be continued at a dose of 1 tablet per day, at least until the birth to restore iron stores. The duration of therapy should be at least 2 months.

With iron deficiency anemia, the normalization of the hemoglobin level and the replenishment of iron stores occurs 2-3 months after the start of treatment.

For the treatment of latent iron deficiency and the prevention of iron deficiency and folic acid in pregnancy, the drug is prescribed 1 tablet per day. The duration of treatment of latent iron deficiency is 1-2 months.

Side effects:

Side effects of iron intake. Irritation, cramps and abdominal pain. Contact irritation (pain in the throat, chest), especially when swallowing, irritation in the areas of ulcerative lesions (with prolonged passage of the drug through the gastrointestinal tract). Nausea, vomiting, diarrhea.

With prolonged admission: nausea, vomiting, constipation, diarrhea, darkening of the urine (dose-dependent effect), staining of the enamel of the teeth, heartburn.

Adverse effects of folic acid supplementation. Bronchospasm, allergic reactions, erythema, fever, general malaise, rash, itching, gastrointestinal disorders.

Overdose:

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

Interaction:

Antacids and tetracycline antibiotics reduce absorption.

Special instructions:

Perhaps the dark staining of the stool, due to the release of iron that has not yet absorbed (of clinical importance).

Instructions

Iron (III) hydroxide polymaltosate + Folic acid (Ferri (III) hydroxydum polymaltosatum + Acidum folicum)