Iron sulfate + Serine + Folic acid - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Macro and microelements

Stimulators of hematopoiesis

Included in the formulation

Aktiferrin compositum

capsules inwards

Teva Pharmaceutical Enterprises Co., Ltd. Israel

АТХ:

B.03.A.E.10 Iron preparations in combination with other drugs

B.03.A.E. Iron preparations in combination with other drugs

Pharmacodynamics:

The preparation of iron. Iron is the most important microelement of the body. As coenzyme of cytochrome oxidase, catalase and peroxidase, as well as a constituent of hemoglobin, myoglobin and cytochromes, it is involved in a variety of metabolic processes, stimulates erythropoiesis.

Included in the preparation of α-amino acid serine promotes more efficient absorption of iron and its entry into the systemic bloodstream, which leads to a rapid restoration of the normal iron content in the body. This ensures a better tolerance of the drug and allows to reduce the necessary dose of iron.

Folic acid takes part in the synthesis of amino acids, nucleotides, nucleic acids; is necessary for normal erythropoiesis. During pregnancy, it performs a certain protective function in relation to the action of teratogenic factors.

The daily requirement for iron in adults is 1-2 mg, in pregnant women - 2-5 mg, in children under 7 years - 0.5-1.5 mg.On average, 10% is absorbed, therefore, in order to meet the need for iron, the intake dose should exceed the daily requirement by 10 times.

Pharmacokinetics:

After ingestion, the iron contained in the preparation is sufficiently absorbed from the digestive tract into the systemic circulation.

In the blood, iron binds to transferrin and in the trivalent form is transported to the sites of hemopoiesis and to specific depots. After binding of iron with apoferritin it is deposited in the liver, spleen and bone marrow in the form of ferritin. Iron penetrates the placental barrier, the minimum amounts are excreted in breast milk.

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 iron deficiency anemia with concomitant deficiency of folic acid; conditions, accompanied by an increased need for the body in these substances, especially in pregnancy.

ICD-10

XV.O20-O29.O25 Malnutrition in pregnancy

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

IV.E50-E64.E53.9 Insufficiency of B vitamins, unspecified

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

III.D50-D53.D50 Iron-deficiency anemia

Contraindications:

- hemolytic and aplastic anemia;

- hemosiderosis, hemochromatosis;

- Sideroachrestic anemia, anemia in lead poisoning, thalassemia;

- other types of anemia, not caused by iron deficiency in the body;

- Hypersensitivity to folic acid.

Carefully:

In patients with inflammation and ulcerative lesions of the gastrointestinal mucosa, the relationship between the benefits of treatment and the risk of exacerbations of gastrointestinal diseases should be evaluated against the background of iron therapy. The drug may cause an exacerbation of ulcerative and inflammatory bowel diseases.

Be wary appoint patients with hepatitis, liver failure, kidney failure. Hepatic or renal insufficiency increases the risk of cumulation of iron.

Pregnancy and lactation:

Use during pregnancy and during lactation is considered reasonable and safe.

Dosing and Administration:

Capsules of the drug are taken orally during a meal, without chewing and drinking with a sufficient amount of water.

If the physician does not prescribe a different dosage, then follow the instructions given below.

Daily dose: 1 capsule. Depending on the severity of the disease, the dose may be increased to 2-3 capsules per day.

After reaching the normal values of serum iron and hemoglobin, the drug is continued for at least 4 weeks.

Side effects:

The occurrence of side effects should be reported to the attending physician.

The drug is usually well tolerated by patients of any age. Only in some cases, especially at high dosages and with long-term treatment, there may be slight complaints from the digestive tract (flatulence, constipation, diarrhea). With a decrease in dose, these phenomena usually disappear.

Very rarely there can be reactions of hypersensitivity to folic acid: redness of the skin, spasms of bronchial muscles, nausea, irritability, excitability, sleep disorder with nightmares.

In patients with epilepsy, convulsive seizures may become more frequent.

In some cases, there may be a loss of appetite, a bitter taste in the mouth.

Overdose:

If you accidentally take especially large doses of the drug (all capsules from one package), there may be overdose phenomena.

Symptoms: abdominal pain, diarrhea, vomiting, cyanosis, confusion, symptoms of hyperventilation.

Treatment: before the specific therapy - the intake of milk, raw eggs. Specific therapy is carried out by the administration of deferoxamine inward and parenterally. In acute poisoning to bind iron, not yet absorbed from the gastrointestinal tract, give inside 5-10 g of the drug by dissolving the contents of 10-20 ampoules in drinking water. To remove the absorbed iron deferoxamine Enter intramuscularly for 1-2 g every 3-12 hours.

In severe cases, accompanied by the development of shock in patients, intravenous drip 1 g of the drug is administered and symptomatic therapy is performed.

Interaction:

Do not wash down with black tea, coffee, milk to avoid reducing the absorption of iron. In addition, a decrease in absorption may be due to solid food, bread, raw cereals, dairy products, eggs.

Simultaneous use of the drug and:

- antibiotics of the tetracycline series causes mutual impairment of absorption;

- antacids and colestyramine prevents the absorption of iron;

- oral contraceptives, anticonvulsants (phenytoin, primidon, barbiturates) and pyrimethamine leads to a decrease in folate levels in the blood;

- chloramphenicol interferes with the onset of the therapeutic effect of folic acid treatment;

- colchicine, neomycin, biguanides, paraaminosalicylic acid and ethyl alcohol interferes with the absorption of cyanocobalamin.

Special instructions:

When taking iron-containing preparations, it is possible to stain the feces in a dark (black) color, which has no clinical significance.

Instructions

Iron sulphate + Serine + Folic acid (Ferri sulfas + Serinum + Acidum folicum)