TARDIFERON

Active material: Iron sulfate
When ATH: B03AA07
CCF: Antianemic drug
When CSF: 19.02.01.01
Manufacturer: PIERRE FABRE MEDICAMENT PRODUCTION (France)

Pharmaceutical form, composition and packaging

Pills long-acting, sugar-coated nearly white (white to light beige), smooth, flat surface.

Excipients: vitamin C, mukoproteoza (Anhydrous), potato starch, methacrylic acid and methacrylate copolymer (Eudragit S), magnesium trisilicate, triэtiltsitrat, povidone, magnesium stearate, Hydrogenated castor oil, talc.

The composition of the shell: talc, Titanium dioxide, rice starch, methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer (And Эудрагит), carnauba wax, sucrose.

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

Pharmacological properties

Farmakodinamika

Tardiferon - iron complex preparation of prolonged action. It contains ferrous sulfate, the use of which makes up for deficiency of iron in the body and stimulates hematopoiesis. High safety of the drug due to the presence in its composition mukoproteozy.
Mukoproteoza - natural mucopolysaccharide, protects the mucous membrane of the digestive tract from the irritative (irritant) the impact of iron ions, It contributes to sustained release of iron (for 5-6 hours), significantly improves tolerability. Vitamin C, providing an antioxidant effect, It increases the bioavailability of iron and promotes its absorption.

Pharmacokinetics

Absorbed in the duodenum and proximal small intestine. The maximum concentration of iron in serum is reached after approximately 7 h, and remained elevated for 24 h after dosing.

Testimony

Iron deficiency (hypochromic) anemia, prevention of iron deficiency anemia during pregnancy in case of impossibility of adequate supply of iron from food.

APPLICATIONS

Adults and children over the age of 7 years inside, with 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: children over the age of 7 years - 1 tablet per day (morning); for adults - 1-2 tablets a day (in the morning and in the evening).
Duration of treatment is determined by the severity of the clinical picture. After normalization of hemoglobin levels continue to receive over 1-3 months on 1 tablet in the morning before breakfast every day.
Monitoring the effectiveness of treatment (determining the level of hemoglobin, average globular blood volume, serum ferritin, serum iron and transferrin saturation) it is advisable to carry out only after 3 months of treatment.

Contraindications

Hypersensitivity to the active or other ingredients; iron overload (hemosiderosis, gemoxromatoz); other types of anemia,not associated with iron deficiency (gemoliticheskaya anemia, aplasticheskaya anemia, sideroahresticheskaya anemia, zhelezorefrakternaya anemia, anemia, lead poisoning, thalassemia, etc.); stenosis of the esophagus and / or other obstructive diseases of the digestive tract; intestinal diverticula, ileus, regular blood transfusions, the simultaneous use of parenteral forms of iron; Children under the age of 7 years.

SIDE EFFECTS

On the part of the digestive tract: epigastric pain, abdominal pain, nausea, vomiting, painting stool black, diarrhea or constipation, flatulence, darkening of the teeth.
In individuals with hypersensitivity allergic reactions of varying severity, skin rash, hives, dermahemia, itch, anaphylaxis.
Continued indiscriminate use can lead to constipation and hemosiderosis.

Cautions

It is necessary to take into account, that iron deficiency anemia, associated with inflammatory syndrome, resistant to treatment with iron.
It is necessary to establish the etiology of anemia.
Because the drug contains sucrose, He is contraindicated in fructose intolerance, malabsorption syndrome glucose / galactose or sucrase-isomaltase deficiency.
Castor oil, part of the drug, can cause disorders of the stomach, and diarrhea.
Using drugs can change the color to black stool, that may interfere with the diagnosis of chronic gastrointestinal bleeding. The test for occult blood in the stool can be a false positive.
Egg and milk, Black tea, coffee, bread, raw cereals, dairy products inhibit iron absorption. Oral iron supplements should not be taken for 1-2 hours after consuming the above mentioned foods. Do not take simultaneously with other drugs, containing iron. To use caution in patients with leukemia, chronic diseases of the liver and kidneys, inflammatory disease of the gastrointestinal tract, gastric ulcer and duodenal ulcer, bowel disease (enteritis, yazvennыy colitis, Crohn's disease). Possible worsening of rheumatoid arthritis. To prevent constipation drug washed down with plenty of fluids.
A systematic control of the serum iron and hemoglobin.
If necessary, about every 4 weeks following parameters were evaluated to determine the extent of iron deficiency, response to providing treatment and need for continued therapy: hemoglobin, the number of red blood cells, mean corpuscular volume (MCV), the mean value of hemoglobin in red blood cells (MCH), the number of reticulocytes, iron levels in the serum, transferrin. Determination of serum ferritin to evaluate the accumulation of iron; figure serum ferritin ≤15 mg / l means the absence of iron stores in the body.
The preparation contains sucrose, that should be considered when used in patients with diabetes mellitus.
Children. Do not use in children under the age of 7 years.
Pregnancy and breast-feeding.
Animal studies revealed no malformations in the offspring of mice and rats, treated preparations in pregnancy iron dose, in 1100 times the human therapeutic.
Adequate studies in humans have not performed, However, the analysis of the bibliographic data did not reveal data on developmental defects in children of women, take iron supplements during pregnancy.
Iron is excreted in breast milk in small amounts (about 0,25 mg / day).
During pregnancy and lactation Tardiferon be taken only after consultation with a doctor.
Ability to influence the reaction rate when driving and operating other machines. Not established.

INTERACTION

With simultaneous use of iron salts reduce the absorption of tetracycline, inhibitors of DNA gyrase (eg ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), difosfonata, penicillamina, levodopa, carbidopa and methyldopa, penicillina, sulfasalazine. Iron salts reduce the absorption of thyroxine, Zinc. Iron absorption is reduced when taken with cholestyramine, antaцidami (containing aluminum, magnesium, calcium, vysmut), and nutritional supplements, containing calcium and magnesium. Vitamin C and citric acid promote iron absorption. With simultaneous use of iron salts with NSAIDs may intensify the irritant effect of iron on the gastrointestinal mucosa. Iron absorption can be slowed down at the same time / in the introduction of chloramphenicol. Tardiferon not be taken for 2-3 hours after the application of one of the above preparations. If possible, it is necessary to monitor the effectiveness of simultaneous use of drugs by medical or laboratory diagnostic methods. Antibiotics tetracycline, and penicillin sulfate iron form complexes, reduces the absorption of iron and antibiotics. Glucocorticoids can stimulate erythropoiesis. The simultaneous use of vitamin e may reduce the pharmacological action of iron in the body of the child. Avoid the simultaneous application of iron salts and allopurinol.

Overdose

While respecting the recommended doses Tardiferona excess risk cumulation iron low. If you exceed the recommended dosages are possible symptoms of overdose.
Symptoms. Acute overdose of iron can be manifested by nausea and vomiting, in severe cases, can lead to the development of collapse and death. Lethal dose of elemental iron believe 180-300 mg/kg body weight. However, for some patients the dose of elemental iron 30 mg / kg can be toxic.
Symptoms of acute iron poisoning may occur for 10-60 minutes or a few hours. There may be pain in the abdomen, epigastric pain, nausea, diarrhea with Chair of green and the degtepodobnym, ground, vomiting with or without blood, drowsiness, weakness, pale skin, cold clammy sweat, acrocyanosis, cyanosis, thready pulse, lethargy, decrease in blood pressure, heartbeat, fatiguability, shock and coma, confusion, symptoms of hyperventilation, hyperthermia, paraesthesia, necrosis of the gastrointestinal mucosa, convulsions.
Approximately 4-6 hours is usually a period of remission. In the future, through 12-48 hours may develop severe shock, accompanied by Cheyne - Stokes, oliguria, toxic liver failure and coagulopathy.
The possible toxic effects of overdose, the patient should immediately provide medical assistance. Slow release of iron can slow its absorption and thereby extends the period to help. If you accidentally receive a larger number of pills a patient should eat raw eggs and milk, that will lead to the formation of insoluble compounds of iron in the blood and will contribute to its elimination from the body. Accepted tablets can be deduced from the stomach, causing the patient vomit.
Specific therapy. Vomited to check mass availability of tablets Tardiferona. If insufficient quantities of tablets should conduct gastric lavage 0,9% p-rum sodium chloride or 1% Water district rum sodium carbonate and apply a laxative. It is necessary to carry out fluoroscopic examination of the abdominal cavity to establish the number of remaining tablets. If you used the pills removal methods have not yielded the desired result, you may need surgery.
The best way to assess the severity of the condition is the determination of iron content in plasma and total železosvâzyvaûŝej ability of blood serum. If the level of iron in the blood plasma iron binding capacity exceeds the total, there is a possibility of systemic poisoning.
You might need to use program. Deferoxamine chelation therapy should be, if:
– It adopted a potentially lethal dose (180-300 Mg / kg body weight or higher);
– serum iron concentration above 400-500 mg/dl;
– serum iron concentration exceeds the total iron binding capacity and/or if the patient has severe symptoms of intoxication iron-coma, shock.
In acute poisoning to link does not absorbirovavšegosâ in the stomach of iron, applied inside 5-10 grams of the drug (the contents of the 10-20 ampoules dissolved in drinking water). For elimination of absorbirovavšegosâ iron Deferoxamine give/m to 1-2 g every 3-12 h. In severe cases,, accompanied by the development of shock, used in/in drip introduction 1 g and symptomatic therapy.
In young children the risk of acute intoxication with iron is particularly high; life threatening intoxication is possible at the reception 1 g iron sulfate.
If necessary, conduct treatment of shock and acidosis.
If oliguria / anuria used peritoneal dialysis or hemodialysis.

STORAGE CONDITIONS

When temperature is not above 25 ° C.