Gyno-Tardyferon film-coated tablets, prolonged action, 30 pieces

Pharmacodynamics. Gyno-Tardyferon is a complex iron preparation of prolonged action. The drug replenishes the deficiency of iron and folic acid in the body. Folic acid contributes to the normal course of pregnancy, prevents the development of spontaneous abortion, is necessary for erythropoiesis and the synthesis of nucleic acids. Folic acid deficiency can cause pathological development of the fetal spinal cord. The high safety of the drug is due to the presence of mucoproteose in its composition.

Mucoproteose is a natural mucopolysaccharide that protects the mucous membrane of the digestive tract from the irritating effect of iron ions, promotes the slow release of iron for 5-6 hours, which significantly increases the tolerability of the drug. Ascorbic acid, which has an antioxidant effect, increases the bioavailability of iron and promotes its absorption.

Pharmacokinetics. The drug is absorbed in the duodenum and proximal small intestine. Cmax of iron in blood plasma is reached after approximately 7 hours and remains elevated for 24 hours after taking the drug.

Prevention and treatment of folate and iron deficiency anemia, including during pregnancy when it is impossible to obtain an adequate amount of iron from food.

Inside, with a glass of water, before meals.

Adults and children over 7 years of age: prevention of iron deficiency anemia – 1 tablet per day on an empty stomach.

Treatment of iron deficiency anemia: children over 7 years old – 1 tablet (in the morning), adults – 1-2 tablets per day (in the morning and evening).

The duration of treatment is determined individually, depending on the severity of anemia. It is recommended to continue therapy for 1-3 months (at a dose of 1 tablet in the morning before breakfast) after normalization of hemoglobin levels.

Hypersensitivity to the active or other components of the drug. iron overload (hemosiderosis, hemochromatosis), other types of anemia not associated with iron deficiency (hemolytic anemia, aplastic anemia, sideroachrestic anemia, iron-refractory anemia; anemia in lead poisoning, thalassemia, etc.), esophageal stenosis and / or other obstructive diseases of the gastrointestinal tract; intestinal diverticulum, intestinal obstruction, regular blood transfusions, simultaneous use of parenteral forms of iron; children’s age up to 7 years.

Gastrointestinal: epigastric pain, abdominal pain, nausea, vomiting, black stools, diarrhea or constipation, flatulence, darkening of teeth.

In individuals with hypersensitivity, allergic reactions of varying severity may occur (skin rash, urticaria, skin hyperemia, itching, anaphylaxis, bronchospasm, hyperthermia).

Others: hot flashes, general weakness.

Prolonged unjustified use can lead to constipation and hemosiderosis.

It should be noted that iron deficiency anemia associated with inflammatory syndromes is resistant to treatment with iron preparations.

It is necessary to establish the etiology of anemia.

Since the drug contains sucrose, it is contraindicated in fructose intolerance, glucose/galactose malabsorption syndrome or sucrase-isomaltase deficiency.

Castor oil, which is part of the drug, can cause stomach upset and diarrhea.

When using the drug, the color of the stool may turn black, which may interfere with the diagnosis of chronic gastrointestinal bleeding. The test for occult blood in the stool may be falsely positive.

Eggs and milk, black tea, coffee, bread, raw cereals, dairy products inhibit iron absorption. Oral iron preparations should not be taken within 1-2 hours after consuming the above foods. Do not take simultaneously with other iron-containing drugs. Use with caution in patients with leukemia, chronic liver and kidney diseases, inflammatory diseases of the gastrointestinal tract, gastric and duodenal ulcers, intestinal diseases (enteritis, ulcerative colitis, Crohn’s disease). Exacerbation of rheumatoid arthritis is possible. To prevent constipation, the drug is washed down with sufficient fluid.

Systematic monitoring of serum iron and hemoglobin levels is necessary.

If necessary, the following parameters are assessed approximately every 4 weeks to determine the degree of iron deficiency, response to treatment, and the need for continued therapy: hemoglobin, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCH), reticulocyte count, plasma iron, and transferrin. Determination of plasma ferritin allows for the assessment of the level of stored iron; a plasma ferritin level of 15 μg/L indicates the absence of iron stores in the body.

With prolonged use, it is necessary to monitor vitamin B12 levels _.

The drug contains sucrose, which should be taken into account when used in patients with diabetes.

Children: Do not use in children under 7 years of age.

Pregnancy and lactation: Animal studies have not shown malformations in the offspring of mice and rats given iron supplements during pregnancy at a dose 1100 times the human therapeutic dose.

Adequate studies in humans have not been conducted, however, an analysis of bibliographic data did not reveal any data on malformations in children of women who took iron supplements during pregnancy.

Iron is excreted in breast milk in small amounts (about 0.25 mg/day).

During pregnancy and breastfeeding, Gyno-Tardyferon should be taken only after consulting a doctor.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms has not been established.

With simultaneous use, iron salts reduce the absorption of tetracycline, DNA gyrase inhibitors (for example, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), diphosphonates, penicillamine, levodopa, carbidopa and methyldopa, penicillin, sulfasalazine. Iron salts reduce the absorption of thyroxine, zinc. Iron absorption is reduced when taken simultaneously with cholestyramine, antacids (containing aluminum, magnesium, calcium, bismuth), as well as food supplements containing calcium and magnesium. Vitamin C and citric acid promote iron absorption. With simultaneous use of iron salts with nonsteroidal anti-inflammatory drugs, the irritating effect of iron on the mucous membrane of the gastrointestinal tract may increase. Iron absorption may be slowed down with simultaneous intravenous administration of chloramphenicol. Tardiferon should not be taken within 2-3 hours after using one of the above-mentioned drugs. If possible, it is necessary to monitor the effectiveness of the simultaneous use of drugs using medical or laboratory diagnostic methods. Antibiotics of the tetracycline group, as well as penicillin, form complex compounds with iron sulfate, which reduce the absorption of iron and antibiotics. Glucocorticoids can stimulate erythropoiesis. Simultaneous use of vitamin E can reduce the pharmacological effect of iron in the child’s body. Simultaneous use of iron salts and allopurinol should be avoided.

The absorption of folic acid is reduced when taken simultaneously with analgesics, anticonvulsants, antacids, cholestyramine, sulfonamides, antibiotics, cytostatics (methotrexate), trimethoprim. When used simultaneously with chloramphenicol, neomycin, polymyxins, tetracyclines, the absorption of folic acid is reduced. When used simultaneously, folic acid reduces the effects of primidone, PAS, sulfasalazine, hormonal oral contraceptives, chloramphenicol, phenytoin, increasing its metabolism.

When following the recommended doses of Gyno-Tardyferon, the risk of excessive iron accumulation is low. If the recommended doses are exceeded, overdose symptoms are possible.

Symptoms. Acute iron overdose may manifest as nausea and vomiting, and in severe cases may lead to collapse and death. The lethal dose of elemental iron is considered to be 180-300 mg/kg body weight. However, for some patients, a dose of elemental iron of 30 mg/kg may be toxic.

Symptoms of acute iron poisoning may occur within 10-60 minutes or after several hours. Possible abdominal pain, epigastric pain, nausea, diarrhea with green stools and later tarry, melena, vomiting with or without blood, drowsiness, weakness, pale skin, cold sticky sweat, acrocyanosis, cyanosis, thready pulse, lethargy, decreased blood pressure, palpitations, fatigue, shock and coma, confusion, symptoms of hyperventilation, hyperthermia, paresthesia, necrosis of the gastrointestinal mucosa, convulsions.

After about 4-6 hours, a period of apparent well-being usually sets in. Further, after 12-48 hours, severe shock may develop, accompanied by Cheyne-Stokes respiration, oliguria, toxic liver failure, and coagulopathy.

Due to the possible toxic effects of overdose, the patient should be given immediate medical attention. The delayed release of iron may slow its absorption and thus prolong the period for providing assistance. In case of accidental ingestion of a larger number of tablets, the patient should consume raw eggs and milk, which will lead to the formation of insoluble iron compounds in the gastrointestinal tract and will promote its elimination from the body. The taken tablets can be removed from the stomach, causing the patient to vomit.

Specific therapy. Vomiting should be checked for the presence of Gyno-Tardyferon tablets. If there are not enough tablets, gastric lavage with 0.9% sodium chloride solution or 1% aqueous sodium carbonate solution should be performed and a laxative should be used. An X-ray examination of the abdominal cavity should be performed to determine the number of remaining tablets. If the methods used to remove the tablets do not give the desired result, surgical intervention may be required.

The best method of assessing the severity of the condition is to determine the plasma iron content and the total plasma iron-binding capacity. If the plasma iron level exceeds the total iron-binding capacity, there is a possibility of systemic poisoning.

Deferoxamine may be necessary. Deferoxamine chelation therapy should be used if:

• a potentially lethal dose was taken (180-300 mg/kg and above);
• iron concentration in blood plasma 400-500 mg/dl;
• the concentration of iron in the blood plasma exceeds the upper limit of normal and/or if the patient has severe symptoms of iron intoxication – coma, shock.

In acute poisoning, 5-10 g of the drug is used orally to bind iron not absorbed in the gastrointestinal tract (the contents of 10-20 ampoules are dissolved in drinking water). To eliminate absorbed iron, deferoxamine is administered i.m. at 1-2 g every 3-12 hours. In severe cases, accompanied by the development of shock, i.v. drip administration of 1 g of the drug and symptomatic therapy are used.

Young children are at particularly high risk of acute iron intoxication; life-threatening intoxication is possible with ingestion of 1 g of ferrous sulfate.

If necessary, treat shock and acidosis.

Peritoneal dialysis or hemodialysis is used for oliguria/anuria.

At a temperature not exceeding 25 °C.