Tardiferon® [Iron sulfate]

Pharmacological properties

Tardiferon is a complex drug of prolonged action iron. contains ferrous sulfate, the use of which compensates for the deficiency of iron in the body and stimulates hematopoiesis. high safety of the drug is due to the presence of mucoproteoses in its composition.

Mucoproteosis is a natural mucopolysaccharide that protects the mucous membrane of the digestive tract from the irritant (irritating) effects of iron ions, and contributes to the delayed release of iron (within 5-6 hours), which significantly improves tolerance to the drug. Ascorbic acid, having an antioxidant effect, increases the bioavailability of iron and promotes its absorption.

Pharmacokinetics It is absorbed in the duodenum and proximal small intestine. C_max iron in blood plasma is reached after about 7 hours and remains elevated for 24 hours after taking the drug.

Indications

Iron deficiency (hypochromic) anemia, prophylaxis of iron deficiency anemia during pregnancy if adequate intake of iron with food is not possible.

Application

In adults and children over the age of 7 years, inside, drink a glass of water before eating.

Prevention of iron deficiency anemia (in particular during pregnancy): 1 tablet per day on an empty stomach.

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

The duration of treatment is determined by the severity of the clinical picture. After normalizing the level of hemoglobin, administration is continued for 1-3 months, 1 tablet in the morning before breakfast daily.

Monitoring the effectiveness of therapy (determining the level of hemoglobin, average globular blood volume, plasma ferritin, plasma iron and transferrin saturation) is advisable only after 3 months of treatment.

Contraindications

Hypersensitivity to active or other components of the drug; excess iron (hemosiderosis, hemochromatosis); other types of anemia that are not associated with iron deficiency (hemolytic anemia, aplastic anemia, siderohrestical anemia, iron-refractory anemia, lead poisoning anemia, thalassemia, etc.); esophageal stenosis and / or other obstructive gastrointestinal diseases; intestinal diverticulum, intestinal obstruction, regular blood transfusion, the simultaneous use of parenteral forms of iron; children under the age of 7 years.

Side effects

From the digestive tract: epigastric pain, abdominal pain, nausea, vomiting, stool black, diarrhea or constipation, flatulence, darkening of the teeth.

Persons with hypersensitivity may experience allergic reactions of varying severity, skin rash, urticaria, skin hyperemia, itching, anaphylaxis.

Prolonged unreasonable use can lead to constipation and hemosiderosis.

special instructions

It should be borne in mind 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 preparation contains sucrose, it is contraindicated in case of fructose intolerance, glucose / galactose malabsorption syndrome or sucrose-isomaltase deficiency.

Castor oil, which is part of the drug, can cause disturbances in the stomach, as well as diarrhea.

When using the drug, the color of feces may change to black, which may interfere with the diagnosis of chronic gastrointestinal bleeding. A test for occult blood in the stool can be false positive.

Eggs and milk, black tea, coffee, bread, raw cereals, dairy products inhibit the absorption of iron. Oral iron preparations should not be taken within 1-2 hours after eating the above foods.Do not take simultaneously with other medicines containing iron. It is used 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, Crohns disease). Possible exacerbation of rheumatoid arthritis. To prevent constipation, the drug is washed down with a sufficient amount of liquid.

Systematic monitoring of iron and hemoglobin in the blood plasma is necessary.

If necessary, approximately every 4 weeks, the following parameters are evaluated to determine the degree of iron deficiency, the response to treatment and the need to continue therapy: hemoglobin, red blood cell count, average red blood cell volume (MCV), average erythrocyte hemoglobin content (MCH), reticulocyte count, plasma iron level, transferrin. Determination of ferritin in blood plasma allows you to evaluate the accumulated iron; an indicator of plasma ferritin of 15 μg / l means the absence of iron stores in the body.

The drug contains sucrose, which should be considered when used in patients with diabetes mellitus.

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

During pregnancy and breastfeeding. Animal studies did not reveal malformations in the offspring of mice and rats who received iron preparations during pregnancy at a dose 1100 times higher than the therapeutic for humans.

Adequate studies in humans have not been carried out, however, when analyzing bibliographic data, no information was found on developmental defects in children of women who took iron preparations during pregnancy.

Iron is excreted in breast milk in an insignificant amount (about 0.25 mg / day).

During pregnancy and lactation, Tardiferon should be taken only after consulting a doctor.

The ability to influence the reaction rate when driving vehicles and working with other mechanisms. Not installed.

Interactions

With the simultaneous use of iron salts, the absorption of tetracycline, dna gyrase inhibitors (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), diphosphonate, penicillamine, levodopa, carbidopa and methyldopa, penicillin, sulfasalazine is reduced. iron salts reduce the absorption of thyroxine, zinc. iron absorption decreases with simultaneous administration with colestyramine, antacids (containing aluminum, magnesium, calcium, bismuth), as well as nutritional supplements containing calcium and magnesium. Vitamin C and Citric Acid promote iron absorption. with the simultaneous use of iron salts with NSAIDs, the irritating effect of iron on the gastrointestinal mucosa may increase. absorption of iron can slow down with simultaneous iv administration of chloramphenicol. Tardiferon should not be taken within 2-3 hours after using one of the above 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 that reduce the absorption of iron and antibiotics. glucocorticoids can stimulate erythropoiesis. the simultaneous use of vitamin e can reduce the pharmacological effect of iron in the body of the child. simultaneous use of iron salts and allopurinol should be avoided.

Overdose

Subject to the recommended doses of tardiferon, the risk of excessive cumulation of iron is low. if the recommended doses are exceeded, overdose may occur.

Symptoms An acute overdose of iron can be manifested by nausea and vomiting, in severe cases, it can lead to the development of collapse and death. A 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 can occur within 10-60 minutes or after a few hours. Possible abdominal pain, pain in the epigastric region, nausea, diarrhea with green stools and later tarry, melena, vomiting with / without blood impurities, drowsiness, weakness, pallor of the skin, cold clammy sweat, acrocyanosis, cyanosis, filamentous 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 remission usually begins. Later, after 12–48 hours, severe shock may develop, accompanied by Cheyne – Stokes breathing, oliguria, toxic liver failure, and coagulopathy.

In connection with the possible toxic effects of an overdose, the patient must immediately receive medical attention. Slow release of iron can slow its absorption, and thereby lengthens the period to assist. If more tablets are accidentally taken, the patient should consume raw eggs and milk, which will lead to the formation of insoluble iron compounds in the digestive tract and will contribute to its elimination from the body. Taken tablets can be removed from the stomach, causing the patient to vomit.

Specific therapy. Vomit must be checked for the presence of Tardiferon tablets. If the number of tablets is insufficient, gastric lavage should be performed with 0.9% sodium chloride solution or 1% aqueous sodium carbonate solution and a laxative should be used. It is necessary to conduct an x-ray examination of the abdominal organs to determine the number of remaining tablets. If the pill removal methods used do not give the desired result, surgery may be necessary.

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

The use of deferoxamine may be necessary. Chelation with deferoxamine should be given if:

• a potentially lethal dose was taken (180-300 mg / kg body weight or higher);
• the concentration of iron in blood plasma is higher than 400-500 mg / dl;
• the concentration of iron in the blood plasma exceeds the total iron binding capacity and / or if the patient has severe symptoms of iron intoxication - coma, shock.

In acute poisoning, 5–10 g of the drug is used inside to bind iron that is not absorbed in the digestive tract (the contents of 10–20 ampoules are dissolved in drinking water). To eliminate the absorbed iron, deferoxamine is administered IM in 1-2 g every 3-12 hours. In severe cases, accompanied by the development of shock, 1 g of the drug is injected intravenously and symptomatic therapy.

In young children, the risk of acute iron intoxication is particularly high; life-threatening intoxication is possible when taking 1 g of iron sulfate.

If necessary, treat shock and acidosis.

For oliguria / anuria, peritoneal dialysis or hemodialysis is used.

Storage conditions

At a temperature not exceeding 25 ° C.