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Active ingredients
Iron sulfate
Release form
Drops
Composition
per 100 ml: Active substances: iron sulfate heptahydrate - 4.72 g, D, L-serine - 3.56 g; Excipients: ascorbic acid - 0.8 g, potassium sorbate - 0.1 g, sugar syrup invert (72.7% TS) - 15.18 g, ethanol 96% - 0.1563 g, cream flavor - 0.0125 g, raspberry flavor - 0.05 g, purified water - 83.4 g.
Pharmacological effect
The drug is iron. Iron is the most important trace element in the body. As a coenzyme of cytochrome oxidase, catalase and peroxidase, as well as an integral part of hemoglobin, myoglobin and cytochrome, it is involved in many metabolic processes, stimulates erythropoiesis .; Serin, which is a part of the preparation, promotes more efficient absorption of iron and its entry into the systemic circulation, which leads to a rapid restoration of the normal iron content in the body. This provides a better tolerability of the drug and reduces the required dose of iron.; The daily need for iron in adults is 1-2 mg, in pregnant women - 2-5 mg, in children under the age of 7 years - 0.5-1.5 mg. On average, 10% is absorbed, so to replenish the need for iron, the dose for ingestion should exceed the daily requirement by 10 times.
Pharmacokinetics
After ingestion, about 10-15% of ferrous iron is absorbed from the duodenal and jejunum. Iron absorption is also possible through the mechanism of passive diffusion. Iron absorption increases significantly with its deficiency and with increased erythropoiesis. In patients with low hemoglobin and depleted iron depot, absorption may increase to 50-60% and decrease with normalization of these indicators. Cmax of iron is reached in 2-4 hours after administration; Distribution; In the blood, iron binds to transferrin and in trivalent form is transported to hematopoiesis sites and to specific depots. After iron is bound to apoferritin, it is deposited in the liver, spleen, and bone marrow in the form of ferritin. Iron penetrates the placental barrier, the minimum amount excreted in breast milk.
Indications
- treatment of iron deficiency.
Contraindications
- hypersensitivity to the drug; - iron absorption disorders (sideroachrestrial anemia, lead anemia,thalassemia); - elevated levels of iron in the body (hemochromatosis, hemolytic anemia); - anemia not related to iron deficiency .; Care should be taken iron supplements with dietary products and additives containing iron salts (possible risk of overdose). In patients with inflammation and ulcerative lesions of the mucous membrane of the gastrointestinal tract, the ratio of the benefits of treatment and the risk of developing gastrointestinal exacerbations during iron therapy should be assessed .; It should not be prescribed to patients with hereditary intolerance to fructose or galactose, lactase deficiency, glucose-galactose malabsorption, sucrase-isomaltase deficiency.
Use during pregnancy and lactation
Use during pregnancy and lactation is possible if the potential benefit of therapy for the mother outweighs the possible risk to the fetus or infant.
Dosage and administration
Dosage regimen; The daily dose is set at the rate of 5 drops per 1 kg of body weight, the multiplicity of intake is 2-3 times / day; Breast children: the average dose is 10-15 drops 3 times / day; Preschool children: the average dose is 25-35 drops 3 times / day; School-age children: the average dose is 50 drops, 3 times a day; To open the bottle, press the cap down and simultaneously turn it in the direction of the arrow. After applying the medication, install the cap and tighten it tightly (prevents access for children). Iron deficiency can be approximately calculated by the formula: iron (mg) = body weight (kg) × 3.5 × (16 is the amount of hemoglobin (g%)); In order to enhance the response, iron therapy should be carried out for a long time and continued for at least 8 weeks; then, after normalization of hemoglobin, treatment should be continued for another 6-8 weeks to replenish the iron depot .; Control of laboratory parameters; If necessary, the degree of iron deficiency and the subsequent need for iron supplementation should be monitored every 4 weeks according to the following laboratory parameters: hemoglobin, erythrocytes, reticulocytes, serum iron, transferrin, average erythrocyte hemoglobin, average red blood cells.
Side effects
Allergic reactions: rarely (> 1/10 000 and <1/1000) - skin manifestations .; On the part of the digestive system: very rarely (<1/10 000) - constipation, diarrhea, abdominal pain, nausea, vomiting.When taking iron-containing drugs it is possible to stain feces in a dark (black) color, which has no clinical significance .; Gastrointestinal disorders can be prevented by gradually increasing the dose at the beginning of treatment or by lowering the dose during treatment.
Overdose
Children have a high risk of intoxication with iron preparations; life-threatening conditions can occur when taking 1 g of iron sulfate. Therefore, iron preparations should be kept out of the reach of children .; Symptoms: in case of accidental use of the drug in very high doses, weakness, fatigue, paresthesia, pale skin, cold sticky sweat, decreased blood pressure, palpitations, acrocyanosis, abdominal pain, diarrhea mixed with blood, cyanosis, confusion, weak pulse, hyperthermia , lethargy, convulsive seizures, hyperventilation symptoms, coma. Signs of peripheral vascular collapse appear within 30 minutes after ingestion; metabolic acidosis, convulsions, fever, leukocytosis, coma - within 12-24 hours; acute renal and hepatic necrosis - in 2-4 days .; Treatment: before carrying out specific therapy, measures should be taken to remove the not yet absorbed drug from the stomach (gastric lavage), give the patient to drink milk, a raw egg. Specific therapy is carried out by the prescription of deferoxamine (desferal) orally and parenterally. For acute poisoning to bind iron, not yet absorbed from the gastrointestinal tract, 5-10 g deferoxamine is administered orally (dissolve the contents of 10-20 ampoules in drinking water). To remove absorbed iron, deferoxamine is injected intramuscularly slowly, for children - 15 mg / h, for adults - 5 mg / kg / h (up to 80 mg / kg / day); in case of mild poisoning, i / m children take 1 g every 4-6 hours, adults 50 mg / kg (up to 4 g / day). In severe cases, accompanied by the development of shock, injected into / in a drip in a dose of 1 g and spend symptomatic therapy. Fatal outcome is mainly caused by late anti-shock therapy .; Hemodialysis is not effective for the removal of iron, but can be used to accelerate the elimination of the iron-deferoxamine complex, and can also be administered in oligo- and anuria. Peritoneal dialysis is possible; In the course of treatment with iron preparations, systematic control of the level of serum iron and other indicators of blood serum is necessary .; For severe intoxication, unitiol (sodium dimercaptopropanesulfonate) is administered parenterally. Because of the possibility of formation of neurotoxic complexes, unitiol should be used with caution.
Interaction with other drugs
Specific antidote deferoxamine (desferal) .; With the simultaneous use of iron salts reduce the absorption of drugs such as tetracyclines, gyrase inhibitors (for example, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa .; In patients receiving levothyroxine sodium replacement therapy, iron salts reduce its absorption .; High-dose iron preparations reduce renal absorption of zinc preparations (the latter are recommended to be taken 2 hours after taking iron preparations) .; Iron absorption decreases with simultaneous administration of Kolestiramine, antacids (containing aluminum, magnesium, calcium, bismuth) and additives containing calcium and magnesium .; The simultaneous use of iron salts and NSAIDs can enhance the damaging effect of iron on the gastrointestinal mucosa .; In children with simultaneous use of iron reduces the effectiveness of vitamin E .; All of the above means is recommended to take 3-4 hours before or after taking Aktiferrin. If necessary, the simultaneous appointment of drugs should be systematic clinical and laboratory monitoring .; Tea, coffee, plant foods containing iron chelating substances (such as phosphates, phytates, oxalates), milk, eggs reduce iron absorption .; Ascorbic acid and citric acid increase iron absorption. Ethanol increases iron absorption and the risk of toxic complications.
special instructions
Hepatic or renal failure increases the risk of iron cumulation .; The drug may cause exacerbation of ulcerative and inflammatory bowel disease .; When using the drug may persistent darkening of the teeth .; Impact on the ability to drive motor vehicles and control mechanisms; Not identified.