This is anemia that occurs when there is insufficient supply of iron to the bone marrow, which leads to disruption of the normal production of red blood cells. IDA was first described by Lange in 1554, and iron preparations for its treatment were first used by Sydenham in 1600.
Iron deficiency is the most common reason anemia worldwide. IN European countries Iron deficiency is detected in approximately 15-25% of women and 2% of men. This prevalence of IDA is explained by the high frequency of blood loss and limited ability gastrointestinal tract to iron absorption.
The adult human body contains approximately 4 g of iron. Daily iron loss through feces, urine, sweat, skin cells and gastrointestinal mucosa is about 1 mg. Iron absorption occurs predominantly in duodenum and, to a lesser extent, in jejunum. The amount of iron and the possibility of its absorption in the gastrointestinal tract varies widely depending on the type of product. Meat and liver are better sources of iron than vegetables, fruits or eggs. The most actively absorbed iron is heme and inorganic iron. The average daily diet contains 10-15 mg of iron, of which only 5-10% is absorbed. Typically, no more than 3.5 mg of iron is absorbed into the gastrointestinal tract per day. In some conditions, such as iron deficiency or pregnancy, the proportion of iron absorbed may increase to 20-30%. but still the main part of dietary iron is not utilized. The daily requirement for iron depends mainly on gender and age, it is especially high during pregnancy, in adolescents and women of reproductive age. It is these categories that are most likely to develop iron deficiency due to additional loss or insufficient intake.
Causes:
The main cause of iron deficiency is chronic blood loss as a result of uterine and gastrointestinal bleeding. 1 ml of whole blood contains approximately 0.5 mg of iron. Therefore, despite increased iron absorption in such individuals, chronic loss of even small volumes of blood leads to iron deficiency. In women, iron deficiency often occurs due to menorrhagia or other gynecological pathologies. Normal iron loss through menstrual blood is about 20 mg per month. The increased need for iron in pregnant women consists of a 35% increase in the total number of red blood cells, transfer of iron to the fetus and blood loss during childbirth. In general, during pregnancy and childbirth, a woman’s body loses approximately 500-1000 mg of iron.
Impaired iron absorption is rarely the only cause of IDA. However (after which accelerated passage of food occurs), as well as severe gastrointestinal diseases (chronic, chronic atrophic gastritis) can participate in the formation of iron deficiency. It should be remembered that iron deficiency itself contributes to the development of chronic atrophic gastritis and duodenitis.
Often one patient simultaneously has several causes of iron deficiency.
The main causes of iron deficiency:
1. Chronic blood loss: menorrhagia, metrorrhagia:
- gastrointestinal bleeding (varicose veins of the esophagus, gastric and duodenal ulcers, gastritis, duodenitis, long-term use of anti-inflammatory drugs, tumors, hemangioma, helminthic infestations etc.);
- rare causes of blood loss (massive, hemoglobinuria, pulmonary hemosiderosis, etc.).
2. Increased need for iron: rapid growth; pregnancy, lactation.
3. Impaired absorption of iron:
- total gastrectomy;
- chronic and trophic gastritis, duodenitis, enteritis.
4. Inadequate intake of iron from food.
A rare cause of IDA may be impaired incorporation of transferrin-bound iron into erythroid cells due to a defect or absence of transferrin receptors. This pathology can be either congenital or acquired as a result of the appearance of antibodies to these receptors.
As deficiency develops, iron reserves in the body (ferritin, hemosiderin of RES macrophages) are completely depleted even before anemia develops, and so-called latent iron deficiency occurs. As the deficiency progresses, iron deficiency erythropoiesis occurs, and then anemia.
Symptoms:
Since iron deficiency usually develops gradually, its symptoms, especially in initial period, may be scarce. As the disease progresses, signs of the so-called sideropenic syndrome appear: muscle weakness, decreased performance and tolerance to physical activity, perversion of taste and smell (pica chlorotica ~ patients like the taste of chalk, lime, the smell of paint, gasoline, etc.), peculiar changes in the skin, nails, hair, mucous membranes (glossitis, angular, easily broken nails, etc.). These symptoms can also appear with normal hemoglobin levels, i.e. with latent iron deficiency.
A decrease in hemoglobin concentration is accompanied by the appearance of signs anemic syndrome. Many patients with IDA often have complaints related to the pathology of the gastrointestinal tract (usually atrophic with achlorhydria): pain, a feeling of heaviness in the epigastric region after eating, decreased appetite, etc.
Iron deficiency leads not only to the development of anemia, but also to non-hematological consequences (slower development of the fetus with severe iron deficiency in the mother, changes in the skin, nails and mucous membranes, impaired muscle function, decreased tolerance for heavy metal poisoning, changes in behavior, decreased motivation, intellectual abilities, etc.). Non-hematological manifestations of iron deficiency are more pronounced in children than in adults; restoration of iron stores usually leads to the disappearance of these phenomena.
Diagnostics:
Laboratory tests can identify all stages of the development of iron deficiency. Latent iron deficiency is characterized by a sharp decrease or absence of iron deposits in bone marrow macrophages, which are detected using special staining. The second sign of depletion of iron reserves in the body is a decrease in ferritin levels in the blood serum.
Iron deficiency erythropoiesis is accompanied by the appearance of moderate hypochromic microcytosis with normal hemoglobin concentration. The concentration of unsaturated transferrins increases, the content of saturated transferrins and iron in the blood serum decreases. The amount of free protoporphyrin in erythrocytes increases due to a lack of iron necessary for its conversion into heme.
IDA is characterized by a decrease in hemoglobin concentration, more pronounced hypochromia and microcytosis of erythrocytes, and the appearance of poikilocytosis. The reticulocyte count is normal or moderately decreased, but may increase after acute blood loss. Leukocyte formula usually does not change, the platelet count is normal or slightly increased. The concentration of iron and saturated transferrins is reduced, and the concentration of unsaturated transferrins is increased. Bone marrow cellularity is normal; moderate hyperplasia of the erythroid lineage may be observed. The number of sideroblasts is sharply reduced.
If the patient has already been treated with iron supplements or has undergone red blood cell transfusion, then microscopy of peripheral blood may reveal so-called dimorphic red blood cells, i.e., a combination of hypochromic microcytes and normal red blood cells. With a combination of iron deficiency and vitamin B, g Hypochromic microcytes and hyperchromic macrocytes can be detected simultaneously.
Differential diagnosis is carried out with other hypochromic microcytic anemias: thalassemia, sideroblastic anemia and anemia in chronic inflammatory and malignant diseases.
If diagnosing IDA usually does not present significant difficulties, then determining its cause is not always simple, and often requires the persistence of a doctor and a comprehensive examination of the patient. Special attention should be considered in elderly patients, in whom iron deficiency may be the first sign of malignancy. In adolescent girls and women of childbearing age, the main causes of iron deficiency are usually menorrhagia and recurrent pregnancies, although others should be excluded possible reasons. In postmenopausal men and women, the main cause of iron deficiency is bleeding from the gastrointestinal tract.
In all patients with IDA, a thorough examination of the gastrointestinal tract is required, with repeated examination of stool for hidden stool using fibrogastroduodenoscopy and sigmoidoscopy. Fluoroscopy of the esophagus and stomach, irrigoscopy, fibrocolonoscopy, ultrasound and computed tomography abdominal organs. If the stool test is occult blood indicates bleeding from the gastrointestinal tract, and these methods did not lead to identification of the source, vascular angiography may be performed abdominal cavity for exception . An accurate method of identification from the gastrointestinal tract is a test with radioactive chromium, in which the patient's red blood cells, after incubation with chromium, are reinfused into the patient, and then a radioactive assessment of the stool is performed within 5 days. Examination of the gastrointestinal tract allows you to simultaneously identify the causes of possible impaired iron absorption.
If uterine or gastrointestinal blood loss is not detected, then more rare sources of bleeding should be excluded. organs of the chest cavity allow one to suspect isolated pulmonary hemosiderosis. Repeated urine testing is carried out to detect hematururia, as well as hemosiderinuria caused by chronic intravascular hemolysis.
It should be emphasized once again that lack of iron in food and impaired absorption are rarely the only cause of iron deficiency.
Treatment:
Treatment of IDA includes treatment of the pathology that led to iron deficiency and the use of iron-containing drugs to restore iron reserves in the body. Detection and correction pathological conditions, which are the cause of iron deficiency, - essential elements complex treatment. Routine administration of iron-containing drugs to all patients with IDA is unacceptable, since it is not effective enough, is expensive and, more importantly, is often accompanied by diagnostic errors(non-detection of neoplasms, etc.).
The diet of patients with IDA should include meat products containing heme iron, which is absorbed better than from other products. It must be remembered that severe iron deficiency cannot be compensated for by diet alone.
Treatment of iron deficiency is carried out mainly with oral iron-containing drugs, parenteral medicines use if available special indications. It should be noted that the use of iron-containing oral medications is effective in most patients, whose body is able to absorb a sufficient amount of pharmacological iron to correct the deficiency. Currently, a large number of drugs containing iron salts are produced (ferroplex, orferon, tardiferon, etc.). The most convenient and cheapest are preparations containing 200 mg of ferrous sulfate, i.e. 50 mg of elemental iron in one tablet (ferrocal, ferroplex). The usual dose for adults is 1-2 tablets. 3 times a day. An adult patient should receive at least 3 mg of elemental iron per kg of body weight per day, i.e. 200 mg per day. The usual dosage for children is 2-3 mg of elemental iron per kg of body weight per day.
The effectiveness of preparations containing ferrous lactate, succinate or fumarate does not exceed the effectiveness of tablets containing ferrous sulfate or gluconate. The combination of iron salts and vitamins in one preparation, with the exception of the combination of iron and folic acid during pregnancy, as a rule, does not increase iron absorption. Although this effect can be achieved with large doses ascorbic acids s, adverse events that arise make it inappropriate therapeutic use such a combination. The effectiveness of slow-acting (retard) drugs is usually lower than that of conventional drugs, since they enter the lower intestine, where iron is not absorbed, but it may be higher than that of fast-acting drugs. active drugs taken with food.
It is not recommended to take a break of less than 6 hours between taking tablets, since for several hours after using the drug, duodenal enterocytes are refractory to iron absorption. Maximum absorption of iron occurs when taking the tablets on an empty stomach; taking it during or after meals reduces it by 50-60%. Do not take iron-containing medications with tea or coffee, which inhibit iron absorption.
Most adverse events when using iron-containing drugs are associated with gastrointestinal irritation. At the same time, adverse events associated with irritation of the lower gastrointestinal tract (moderate constipation, diarrhea) usually do not depend on the dose of the drug, while the severity of irritation of the upper gastrointestinal tract (nausea, discomfort, pain in the epigastric region) is determined by the dose. Adverse effects are less common in children, although in them the use of iron-containing liquid mixtures may lead to temporary darkening of the teeth. To avoid this, you should give the drug to the root of the tongue, take the medicine with liquid and brush your teeth more often.
If there are severe adverse events associated with irritation of the upper gastrointestinal tract, you can take the drug after meals or reduce single dose. If adverse effects persist, you can prescribe drugs containing smaller amounts of iron, for example, in the composition of ferrous gluconate (37 mg of elemental iron per tablet). If in this case the adverse effects do not stop, then you should switch to slow-acting drugs.
Improvement in the well-being of patients usually begins on the 4-6th day of adequate therapy, on the 10-11th day the number of reticulocytes increases, on the 16th-18th day the hemoglobin concentration begins to increase, microcytosis and hypochromia gradually disappear. The average rate of increase in hemoglobin concentration with adequate therapy is 20 g/l over 3 weeks. After 1 -1.5 months successful treatment With iron supplements, their dose can be reduced.
The main reasons for the lack of the expected effect when using iron-containing drugs are presented below. It should be emphasized that main reason The ineffectiveness of such treatment is ongoing bleeding, so identifying the source and stopping the bleeding is the key to successful therapy.
The main reasons for the ineffectiveness of treatment for iron deficiency anemia: ongoing blood loss; inappropriate use of medications:
- incorrect diagnosis (anemia in chronic diseases, sideroblastic anemia);
- combined deficiency (iron and vitamin B12 or folic acid);
- taking slow-acting medications containing iron: impaired absorption of iron supplements (rare).
It is important to remember that in order to restore iron reserves in the body in case of severe deficiency, the duration of taking iron-containing drugs should be at least 4-6 months or at least 3 months after normalization of hemoglobin levels in peripheral blood. The use of oral iron supplements does not lead to iron overload, since absorption is sharply reduced when iron stores are restored.
Prophylactic use of oral iron-containing drugs is indicated during pregnancy, patients receiving regular iron, and blood donors. For premature babies, the use of nutritional mixtures containing iron salts is recommended.
Patients with IDA rarely need the use of parenteral drugs containing iron (ferrum-lek, imferon, ferkoven, etc.), since they usually respond quickly to treatment with oral drugs. Moreover, adequate therapy with oral medications is usually well tolerated even by patients with gastrointestinal pathology ( peptic ulcer, ulcerative, etc.). The main indications for their use are the need to quickly compensate for iron deficiency (significant blood loss, upcoming surgery, etc.), severe side effects of oral medications or impaired iron absorption due to damage small intestine. Parenteral administration of iron supplements may be accompanied by severe side effects and may also lead to excessive accumulation of iron in the body. Parenteral iron preparations do not differ from oral preparations in the rate of normalization of hematological parameters, although the rate of restoration of iron reserves in the body when using parenteral preparations is much higher. In any case, the use of parenteral iron supplements can be recommended only if the doctor is convinced that treatment with oral medications is ineffective or intolerable.
Iron preparations for parenteral use are usually administered intravenously or intramuscularly, with the intravenous route of administration being preferred. They contain from 20 to 50 mg of elemental iron per ml. The total dose of the drug is calculated using the formula:
Iron dose (mg) = (Hemoglobin deficiency (g/l)) / 1000 (Circulating blood volume) x 3.4.
The volume of circulating blood in adults is approximately 7% of body weight. To restore iron stores, 500 mg is usually added to the calculated dose. Before starting therapy, 0.5 ml of the drug is administered to exclude anaphylactic reaction. If there are no signs of anaphylaxis within 1 hour, then the drug is administered so that the total dose is 100 mg. After this, 100 mg is administered daily until the total dose of the drug is reached. All injections are given slowly (1 ml per minute).
An alternative method is to immediately intravenous administration the entire total dose of iron. The drug is dissolved in 0.9% sodium chloride solution so that its concentration is less than 5%. The infusion is started at a rate of 10 drops per minute; if there are no adverse events within 10 minutes, the rate of administration is increased so that total duration infusion was 4-6 hours.
The most severe side effect of parenteral iron supplements is an anaphylactic reaction, which can occur with both intravenous and intramuscular administration. Although such reactions occur relatively rarely, the use of parenteral iron supplements should only be carried out in medical institutions equipped to provide emergency care in full. Other undesirable effects include facial flushing, increased body temperature, urticarial rash, and phlebitis (if the drug is administered too quickly). Drugs should not get under the skin. The use of parenteral iron preparations can lead to activation of rheumatoid.
Red blood cell transfusions are performed only in cases of severe IDA, accompanied by severe signs of circulatory failure, or upcoming surgical treatment.
Registration number: P N011981/02-050413
Tradename: Maltofer®
International generic name or group name:
Dosage form: solution for intramuscular injection
Compound
1 ml of the drug contains:
active substance:
iron(III) hydroxide polymaltosate 141 - 182 mg
equivalent to 50 mg iron content
Excipients:
sodium hydroxide/hydrochloric acid to pH 5.2 - 6.5
water for injection up to 1 ml
Description: The solution is brown.
Pharmacotherapeutic group: iron preparation.
ATX code: B03AS01
Pharmacological properties
Pharmacodynamics
After intramuscular administration, iron released from the active component, iron(III) polymaltose hydroxide, is absorbed mainly by the liver. It is then incorporated into hemoglobin, myoglobin and iron-containing enzymes, and is also stored in the body as ferritin. The response in blood parameters is no faster with parenteral iron than with oral iron salts in patients in whom they are effective. Like other iron supplements. Maltofer® has no effect on erythropoiesis and is ineffective for anemia not associated with iron deficiency.
Pharmacokinetics
After intramuscular administration, the complex enters the bloodstream through lymphatic system. The maximum concentration of iron in the blood plasma is achieved approximately 24 hours after injection. From the blood plasma, the macromolecular complex enters the reticuloendothelial system, where it is split into components, polynuclear iron hydroxide and polymaltose (metabolized by oxidation). The slow release of iron is the reason why it is well tolerated. In the bloodstream, iron binds to transferrin, in tissues it is stored as part of ferritin, in the bone marrow it is included in hemoglobin and participates in the process of erythropoiesis. Only small amounts of iron are excreted from the body.
In small quantities, the unchanged complex can pass through the placental barrier, and small amounts of it enter the breast milk. Iron bound to transferrin can cross the placental barrier and, as part of lactoferrin, enters breast milk in small quantities.
Data on the pharmacokinetics of the drug in patients iron deficiency anemia No.
It is well known that iron absorption depends on the severity of iron deficiency anemia. It is intense in the case of low hemoglobin and decreases as hemoglobin normalizes.
The degree of iron utilization cannot be higher than the iron-binding capacity of transport proteins.
The effect of renal and liver failure on pharmacological properties Iron(III) hydroxide polymaltosate is not known. The toxicity of the drug is very low. LD50 determined for white mice with intravenous administration of the drug Maltofer® was >2500 mg of iron per kilogram of body weight, which is 100 times lower than for simple salts gland.
Indications for use
Iron deficiency anemia with ineffectiveness or impossibility of taking iron supplements orally (including in patients with diseases of the gastrointestinal tract (GIT) and malabsorption syndrome).
The drug is administered intramuscularly only in cases of iron deficiency confirmed by appropriate studies (for example, by measuring serum ferritin, hemoglobin (Hb), hematocrit or red blood cell count, as well as their parameters - average red blood cell volume, average Hb content in red blood cells or average Hb concentration in red blood cells).
Contraindications
The use of Maltofer® is contraindicated if:
observed increased sensitivity to the components of the drug;
anemia not associated with iron deficiency ( hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency);
disorders of erythropoiesis, bone marrow hypoplasia;
there are signs of iron overload (hemosiderosis, hemochromatosis) or a violation of the process of its utilization (sideroachrestic anemia, thalassemia, lead anemia, late porphyria of the skin);
Osler-Rendu-Weber syndrome, chronic polyarthritis, bronchial asthma, infectious diseases kidney in acute stage; uncontrolled hyperparathyroidism, decompensated liver cirrhosis, infectious hepatitis;
I trimester of pregnancy;
use for intravenous use;
childhood up to 4 months (experience with the drug is limited).
Carefully: impaired renal and/or liver function.
Doses and method of administration
Intramuscularly.
Before the first administration of the initial dose of the drug Maltofer®, it is necessary to conduct a test: the drug is administered intramuscularly - adults are administered from 1/4 to 1/2 doses of the drug (from 25 to 50 mg of iron (0.5-1 ml)), with 4 months - half the daily dose. If there are no adverse reactions within 15 minutes after administration, the remainder of the initial dose of the drug can be administered.
Dose calculation
The dose of the drug is calculated individually and adapted in accordance with the general iron deficiency according to the following formula:
Total iron deficiency (mg) = body weight (kg) x ( normal level Hb - patient's Hb level) (g/l) x 0.24* + iron reserves (mg).
For a patient with a body weight of up to 34 kg: normal Hb level = 130 g/l, which corresponds to iron reserves = 15 mg/kg body weight.
For a patient with a body weight over 34 kg: normal Hb level = 150 g/l, which corresponds to iron reserves = 500 mg.
* Factor 0.24 = 0.0034 x 0.07 x 1000 (iron content in hemoglobin = 0.34% / blood volume ≈ 7% of body weight / factor 1000 = conversion from g to mg)
Total number of ampoules to administer = Total iron deficiency (mg) / 100 mg
If required dose exceeds maximum daily dose, the administration of the drug should be fractional.
Standard dose
Adults: 1 ampoule daily (2.0 ml = 100 mg iron)
Children from 4 months: dosage is determined depending on body weight.
Maximum permissible daily doses
Children weighing up to 5 kg: 1/4 ampoule (0.5 ml = 25 mg iron)
Children weighing 5 to 10 kg: 1/2 ampoule (1.0 ml = 50 mg iron)
Children weighing from 10 to 45 kg: 1 ampoule (2.0 ml = 100 mg iron)
Adults: 2 ampoules (4.0 ml = 200 mg iron)
If there is no response from hematological parameters after 1-2 weeks (eg, an increase in Hb levels of approximately 0.1 g/dL per day), the initial diagnosis should be reconsidered. The total dose of the drug per course of treatment should not exceed the calculated number of ampoules.
Injection technique (see pictures)
Injection technique is critical. As a result of improper administration of the drug, there may be painful sensations and coloring of the skin at the injection site. The ventrogluteal injection technique described below is recommended instead of the generally accepted one - into the upper outer quadrant of the gluteus maximus muscle.
1) The length of the needle should be at least 5-6 cm. The lumen of the needle should not be too wide. For children, as well as for adults with low body weight, the needles should be shorter and thinner.
2) The injection site is determined as follows (see Figure 1): along the line of the spinal column at a level corresponding to the lumbar-iliac joint, fix point A. If the patient is lying on the right side, place middle finger left hand at point A. Move the index finger away from the middle finger so that it is under the line of the iliac crest at point B. A triangle located between proximal phalanges, average and index fingers is the injection site (see Figure 2).
3) Instruments are disinfected using the usual method. Before inserting the needle, move the skin approximately 2 cm (see Figure 3) in order to properly close the puncture channel after removing the needle. This prevents the injected solution from penetrating the subcutaneous tissue and staining the skin.
4) Place the needle vertically in relation to the surface of the skin, at a large angle to the point iliac joint than to the point of the hip joint (see Figure 4).
5) After injection, slowly remove the needle and press your finger against the area of skin adjacent to the injection site for about one minute.
6) After the injection, the patient needs to move.
Opening ampoules with a dot and a notch
The pictures below illustrate the method of opening ampoules with a dot and a notch. 
special instructions
Maltofer® should be prescribed only to those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data (for example, the results of determining serum ferritin or hemoglobin and hematocrit, the number of erythrocytes and their parameters - the average volume of an erythrocyte, the average hemoglobin in an erythrocyte or the average hemoglobin concentration in an erythrocyte) .
Before use, ampoules should be inspected for sediment and damage.
Only ampoules without sediment or damage can be used.
After opening the ampoule, Maltofer® should be administered immediately.
Maltofer® should not be mixed with other medications.
Parenteral iron supplements can cause allergic and anaphylactic reactions. In case of moderate allergic reactions, antihistamines should be prescribed; If a severe anaphylactic reaction develops, immediate administration of epinephrine (adrenaline) is necessary. Cardiopulmonary resuscitation must be available.
Caution should be exercised when administering the drug to patients with allergies, as well as liver and kidney failure.
Side effects that occur in patients with cardiovascular diseases can aggravate the course of the underlying disease.
Sick bronchial asthma or having low serum iron-binding capacity and/or folic acid deficiency belong to the group high risk development of allergic or anaphylactic reactions.
Administration to children under 4 months of age is not recommended due to lack of experience.
In children, parenteral iron supplements can negatively affect the course of the infectious process.
Side effect
In rare cases, the following may occur: arthralgia, increased lymph nodes, fever, headache, dyspepsia (nausea, vomiting).
Very rarely, allergic or anaphylactic reactions may develop.
Local reactions (if the drug is administered incorrectly): skin coloring, pain at the injection site, inflammation.
Overdose
To date, no cases of iron overdose have been reported.
When Maltofer® is administered in high doses, the complex cannot be removed by hemodialysis due to its high molecular weight. Periodic monitoring of serum ferritin may help in the timely recognition of progressive iron accumulation.
Overdose can cause acute iron overload, which manifests itself as symptoms of hemosiderosis. In case of overdose, it is recommended to use symptomatic agents and, if necessary, iron-binding substances (chelates), for example IV deferoxamine.
Interaction with other drugs
Like all other parenteral iron preparations, Maltofer® should not be used simultaneously with iron-containing preparations for oral administration, since absorption of the latter from the gastrointestinal tract is reduced. Therefore, treatment with iron-containing oral preparations should begin no earlier than 1 week after the last injection of Maltofer®.
Concomitant use of angiotensin-converting enzyme (ACE) inhibitors (for example, enalapril) may increase the systemic effects of parenteral iron supplements.
Use during pregnancy and breastfeeding
Clinical data on the use of the drug in pregnant women is currently insufficient. Animal studies have not examined the reproductive toxicity of the drug. During pregnancy, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus and/or child.
In small quantities, unchanged iron from the polymaltose complex can pass into breast milk. If it is necessary to use the drug during lactation, breast-feeding needs to stop.
The use of the drug in the first trimester of pregnancy is contraindicated.
Impact on the ability to drive vehicles and machinery
Effect on ability to drive vehicles and the mechanisms have not been studied.
Release form
Solution for intramuscular administration 50 mg/ml.
2 ml of the drug in colorless, transparent glass ampoules (type I according to the European Pharmacopoeia), having a notch and technical color marks in the form of a rim and a dot on the neck of the ampoule.
5 ampoules in polyvinyl chloride strip packaging.
1 or 20 blister packs along with instructions for medical use in a cardboard box.
Totema. A complex preparation containing iron gluconate, copper gluconate and manganese gluconate. Provides direct entry into the body of reduced divalent iron and trace elements. Used for the treatment and prevention of iron deficiency anemia, including in pregnant women and premature infants. The drug is available in the form of an oral solution in ampoules, which ensures faster absorption and better tolerability. Before use, the contents of the ampoule should be dissolved in water with or without sugar or in any other drink that does not contain alcohol. It is advisable to take the drug before meals. From side effects may be noted gastrointestinal disorders. Black stool should be considered normal.
Iron supplement: Pharma-med Lady's formula iron plus
Pharma-med lady's iron plus formula. This is a highly effective formula; containing vitamins, minerals and medicinal herbs, intended for the treatment and prevention of iron deficiency anemia. The drug contains ferrous sulfate and hematopoiesis stimulants such as vitamin B12 and folic acid. Medicinal plants that make up the natural basis of the drug (alfalfa, hydrangea root, yucca root, aralia root, red capsicum) also actively help stimulate hematopoiesis and increase the bioavailability of iron. Recommended for the treatment and prevention of iron deficiency anemia, including in pregnant women, as a second-order therapy for anemia of other etiologies, with heavy and unsteady periods (especially in adolescence), after blood loss, in postoperative period, with vegetarian diets. Take 1 tablet daily with food.
Iron supplement: Fenyuls
Fenyuls. The drug is available in the form of capsules containing a strictly calculated amount of microdialysis granules. Each granule is created using a special technology that allows iron and vitamins to maintain a stable concentration in the blood and provide long action and, at the same time, prevent the risk of overdose. The gradual release of iron from the capsule eliminates local irritation of the mucous membrane of the digestive tract, manifested by abdominal pain, metallic taste, darkening of teeth and gums, nausea, belching, and stool upset. Each capsule contains the optimal amount of easily digestible divalent elemental iron (45 mg), vitamins B1, B2, B5, nicotinamide, ascorbic acid. The complex of vitamins restores the impaired metabolism of carbohydrates, proteins and fats. The optimal dose of iron for a single dose, as well as vitamin C, reduces the risk of developing the prooxidant effect of iron. Fenyuls is recommended for hidden iron deficiency, iron deficiency anemia, women during pregnancy and breastfeeding, during the menstrual cycle, with intense physical activity, hypo- and vitamin deficiencies of group B. From side effects In case of individual intolerance, dyspeptic disorders and allergic reactions may occur.
Iron supplement: Ferroglobin B12
Ferroglobin B12. A complex of vitamins and microelements to normalize the hematopoietic system and well-being. Contains in special liquid form iron, zinc, B vitamins, including B12, folic acid, lysine, vitamin C for better absorption of iron. Recommended for children over 1 year of age, adolescents, women before and during pregnancy, people of any age after injury, illness or surgery, vegetarians and athletes. Available in 200 ml bottles in the form of syrup, which has a delicate orange flavor, is prepared on the basis of honey and malt, and does not contain preservatives or alcohol. It is well absorbed, has a gentle effect on the digestive tract, and does not cause dyspepsia. Ideal for children and adults who have difficulty swallowing tablets and capsules.
Iron preparation: Ferro-foil
Ferro foil. A combined preparation containing ferrous sulfate (the divalent form of iron ion) with ascorbic acid, vitamin B12 and Folic acid. This combination ensures good absorption of iron ions (vitamin C helps maintain iron in a divalent state, folic acid increases its absorption by 2-3 times). Due to the rapid synthesis of hemoglobin (vitamin B12 and folic acid have a stimulating effect), rapid elimination of the clinical signs of iron deficiency anemia is achieved. The enteric coating and rapeseed oil contained in the capsule can reduce the number of unwanted dyspeptic symptoms.
Iron supplement: Heferol
Heferol. An antianemic drug containing iron fumarate - 350 mg (including iron - 115 mg) in one capsule. Encapsulated dosage form the drug provides a uniform gradual release of iron into gastrointestinal tract, and also avoids direct contact of iron with the gastric mucosa, which reduces the risk of irritation. Heferol effectively replenishes iron deficiency during bleeding (including hypermenorrhea and metrorrhagia), during pregnancy and lactation, intensive growth and puberty, with insufficient intake of iron into the body from food. There is no information on use in children under 12 years of age. Take 1 capsule 1 time per day. Taking 1 capsule daily provides a therapeutic dose of elemental iron. The drug should be taken 30 minutes before meals. The course of treatment averages from 6 to 12 weeks. The drug should be continued for some time after normalization of hemoglobin levels.
Vitamins for anemia
At low blood pressure We can recommend the Activanad-N dragee, which contains, along with vitamins C, B1, B2, PP, a light activating dose of caffeine. To stimulate hematopoiesis (including after blood loss), multivitamins containing increased doses of iron and vitamins C, B1, B2, PP, folic acid, which are involved in enhancing iron absorption and hemoglobin synthesis, can be recommended. These drugs primarily include Fefolvit; Fesovit, which is close to it, does not contain folic acid, and Fenyuls, in addition, contains lower doses of iron. A drug such as Ferrofolik 500 contains a dose of iron 3 times greater than in other drugs, as well as therapeutic doses of folic and ascorbic acids, which determines the indications for use - only iron deficiency anemia. A high dose of iron has an irritating effect on the gastric mucosa, which impairs the tolerability of the drug and may lead to its withdrawal. A milder effect, associated with a slightly smaller dose of iron, is characteristic of Irrovit capsules (contain, along with iron, ascorbic, folic acid and vitamin B12) and Irradian dragees (does not contain folic acid, the dose of vitamin B12 is increased 3 times). Since the last two drugs contain therapeutic doses of cyanocobalamin, they can be used not only for iron deficiency, but also for B12 deficiency anemia.
According to medical literature, ferric iron is absorbed better than divalent iron (note by the site author).
Preparations containing Iron (Ferrum, abbreviated to Fe in the table):
| Common forms of ferric iron release | |||
|---|---|---|---|
| Release form | Pack, pcs. | Price, r | |
| Maltofer; Switzerland, Vifor; polymaltosate hydroxide | tablets 100mgFe | 30 | 260-380 |
| syrup 10 mgFe/ml - bottle 150 ml | 1 | 230-355 | |
| r/r for oral administration 50 mgFe/ml - 30 ml bottle | 1 | 220-320 | |
| r/r d/i 100 mg Fe in 2 ml | 5 | 800-1.230 | |
| Maltofer Fol; Switzerland, Vifor; polymaltosate hydroxide + folic acid 0.35 mg | Chew the tablets. 100mgFe | 30 | 450-820 |
| Ferrum Lek; Slovenia, Lek; polymaltosate hydroxide | syrup 10 mgFe/ml - bottle 100 ml | 1 | 130-170 |
| Chew the tablets. 100mgFe | 30 | 250-360 | |
| 50 | 415-600 | ||
| 90 | 680-890 | ||
| r/r d/i i/m 100 mg Fe in 2 ml | 5 | 860-1.450 | |
| 50 | 8.150-11.400 | ||
| Ferlatum; Italy, Italfarmaco; protein succinylate | 10 | 735-1.060 | |
| 20 | 760-1.360 | ||
| Ferlatum Fol; Italy, Italfarmaco; protein succinylate + folic acid 0.2 mg | r/r for oral administration 40 mgFe in vial. 15ml | 10 | 580-1.030 |
| Biofer; India, MicroLabs; polymaltosate hydroxide + folic acid 0.35 mg | Chew the tablets. 100mgFe | 30 | 280-400 |
| Venofer; Switzerland, Vifor; hydroxide-sucrose complex | r/r d/i i/v 100 mg Fe in 5 ml | 5 | 2.300-3.120 |
| Likferr 100; Greece, Sotex; hydroxide-sucrose complex | r/r d/i i/v 100 mgFe in 5 ml | 5 | 1.600-3.130 |
| Common ferrous iron preparations | |||
| Name, manufacturer, composition | Release form | Pack, pcs. | Price, r |
| Aktiferrin; Germany, Merkle; sulfate | capsules 34.5 mg Fe + serine 129 mg | 20 | 110-270 |
| 50 | 250-500 | ||
| drops (in 1 ml - 9.5 mg Fe + serine 35 mg) in a 30 ml bottle | 1 | 245-510 | |
| syrup (5 ml - 34 mg Fe + serine 130 mg) in a 100 ml bottle | 1 | 185-370 | |
| Sorbifer Durules; Hungary, Egis; sulfate + VitS 60 mg | tablets 100mgFe | 30 | 310-600 |
| 50 | 415-760 | ||
| Tardiferon; France, Pierre Fabre; sulfate | tablets 80mgFe | 30 | 180-320 |
| Tothema; France, Innoterra; in 1 ampoule - 50 mgFe in the form of gluconate + manganese 1.33 mg + copper 0.7 mg | r/r for oral administration in ampoules 10ml | 20 | 360-780 |
| Fenules; India, Ranbaxy; sulfate + Vit C 50 mg + riboflavin 2 mg + nicotinamide 2 mg + pyridoxine 1 mg + pantothenic acid 2.5 mg | caps 45mgFe | 10 | 80-260 |
| 30 | 180-375 | ||
| Ferretab comp.; Austria, Lannacher; fumarate + folic acid 0.5 mg | capsules prolongir action 50 mgFe | 30 | 240-550 |
| Ferro-Folgamma; Germany, Scherer; sulfate + vitB12 0.01 mg + folic acid 5 mg | capsules 37 mgFe | 20 | 250-480 |
| 50 | 530-920 | ||
| Hematogen, various, ferrous sulfate + food grade albumin | different | up to 40r | |
| Rare and discontinued ferric iron preparations | |||
| Name, manufacturer, composition | Release form | Pack, pcs. | Price, r |
| Argeferr; Argentina, Rivero; hydroxide-sucrose complex | r/r d/i i/v 100 mgFe in 5 ml | 5 | 3.030-4.320 |
| CosmoFer; Denmark, PharmaCosmos; dextran hydroxide | r/r d/i/m injections of 100 mg Fe in 2 ml | 5 | 3.350-4.550 |
| FerMed; Germany, Medice; hydroxide-sucrose complex | r/r d/i i.v. 20 mgFe/ml 5 ml | 5 | 2.600-3.000 |
| Fenyuls Complex(Fenules Complex); India, Ranbaxy; polymaltosate hydroxide | syrup 50 mg Fe in 1 ml fl. 150ml | 1 | No |
| Rare and discontinued ferrous iron preparations | |||
| Name, manufacturer, composition | Release form | Pack, pcs. | Price, r |
| Hemophere prolongatum(Hemofer prolongatum); Poland, Glaxo Wellcome; sulfate | dragee 106 mgFe | 30 | No |
| Gyno-Tardiferon(Gyno-Tardyferon); France, Pierre Fabre; sulfate + folic acid 0.35 mg | tablets 80mgFe | 30 | No |
| Ferrogradumet; England, Abbott; sulfate | tablets 105mgFe | 30 | No |
| Ferroplex; Hungary, Teva; sulfate + VitS 30 mg | Fe50mg tablets | 100 | No |
Maltofer - official instructions for use. The drug is a prescription, the information is intended only for healthcare professionals!
Antianemic drug
pharmachologic effect
Iron supplement. Contains iron in the form of polymaltose iron(III) hydroxide complex. This macromolecular complex is stable and does not release iron in the form of free ions in the gastrointestinal tract. Structure active substance Maltofer® is similar to the natural iron compound ferritin. Due to this similarity, iron (III) moves from the intestine into the blood through active transport. Absorbed iron binds to ferritin and is deposited in the body, mainly in the liver. Then, in the bone marrow it is included in hemoglobin.
Iron, which is part of the polymaltose complex of iron (III) hydroxide, does not have pro-oxidant properties, unlike simple iron salts.
There is a correlation between the severity of iron deficiency and the level of its absorption (the greater the severity of iron deficiency, the better the absorption). Most active process absorption occurs in the duodenum and small intestine.
Pharmacokinetics
Data on the pharmacokinetics of the drug Maltofer® are not provided.
Indications for use of the drug MALTOFER®
- treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia);
- prevention of iron deficiency during pregnancy, lactation, in women of childbearing age, children, adolescents, adults (for example, vegetarians and the elderly).
Dosage regimen for tablets, drops and syrup for oral administration:
The drug is taken orally during or immediately after meals.
Drops and syrup can be mixed with fruit, vegetable juices or soft drinks. Chewable tablets can be chewed or swallowed whole.
The daily dose of the drug depends on the degree of iron deficiency (table):
| Category of patients | Form of the drug | Iron-deficiency anemia | Latent iron deficiency | Prevention |
| Premature babies | Drops | 1-2 drops/kg for 3-5 months | — | — |
| Children under 1 year | Drops | 10-20 drops | 6-10 drops | 6-10 drops |
| Children under 1 year | Syrup | 2.5-5 ml | * | * |
| Children under 1 year | Iron content | (25-50 mg) | (15-25 mg) | (15-25 mg) |
| Children from 1 year to 12 years | Drops | 20-40 drops | 10-20 drops | 10-20 drops |
| Children from 1 year to 12 years | Syrup | 5-10 ml | 2.5-5 ml | 2.5-5 ml |
| Children from 1 year to 12 years | Iron content | (50-100 mg) | (25-50 mg) | (25-50 mg) |
| Children over 12 years old | Drops | 40-120 drops | 20-40 drops | 20-40 drops |
| Children over 12 years old | Syrup | 10-30 ml | 5-10 ml | 5-10 ml |
| Children over 12 years old | Iron content | (100-300 mg) | (50-100 mg) | (50-100 mg) |
| Drops | 40-120 drops | 20-40 drops | 20-40 drops | |
| Adults (including nursing women) | Syrup | 10-30 ml | 5-10 ml | 5-10 ml |
| Adults (including nursing women) | Pills | 1-3 tablets | 1 tablet | ** |
| Adults (including nursing women) | Iron content | (100-300 mg) | (50-100 mg) | (50-100 mg) |
| Pregnant women | Drops | 80-120 drops | 40 drops | 40 drops |
| Pregnant women | Syrup | 20-30 ml | 10 ml | 10 ml |
| Pregnant women | Pills | 2-3 tablets | 1 tablet | 1 tablet |
| Pregnant women | Iron content | (200-300 mg) | (100 mg) | (100 mg) |
* Due to the need to prescribe very small doses for these indications, it is recommended to use Maltofer® drops for oral administration.
** Due to the need to prescribe small doses for these indications, it is recommended to use the drug Maltofer® drops for oral administration or Maltofer® syrup.
The duration of treatment for clinically pronounced iron deficiency (iron deficiency anemia) is 3-5 months, until hemoglobin levels normalize. After this, the drug should be continued at the dose intended for treatment latent deficiency iron for several more months, and for pregnant women, at least until childbirth to restore iron reserves.
The duration of treatment for latent iron deficiency is 1-2 months.
In the case of clinically pronounced iron deficiency, normalization of hemoglobin levels and replenishment of iron reserves occurs only 2-3 months after the start of treatment.
Dosage regimen for 5 ml bottles:
Maltofer oral solution in single-dose vials is intended for oral administration.
The daily dose can be taken all at once during or immediately after meals.
The drinking solution can be mixed with fruit and vegetable juices or soft drinks. The weak color of the drink does not change its taste and does not reduce the effectiveness of the drug.
The daily dose of the drug depends on the degree of iron deficiency.
Children over 12 years of age, adults and nursing mothers:
Treatment of clinically significant iron deficiency (iron deficiency anemia): 1 bottle 1-3 times a day for 3-5 months until blood hemoglobin levels normalize. After this, taking the drug should be continued for several more months in order to restore iron reserves in the body at a dosage of 1 bottle per day.
For the treatment of latent iron deficiency and for the prevention of iron deficiency: 1 bottle per day for 1-2 months.
Pregnant women:
Treatment of clinically significant iron deficiency (iron deficiency anemia): 1 bottle 2-3 times a day for 3-5 months until blood hemoglobin levels normalize. After this, the drug should be continued at a dosage of 1 bottle per day, at least until delivery to restore iron reserves.
For the treatment of latent deficiency: 1 bottle per day for 1-2 months.
In the case of clinically pronounced iron deficiency, normalization of hemoglobin levels occurs only 2-3 months after the start of treatment.
Dosage regimen for the injection form of the drug:
The drug is administered intramuscularly.
Before the first administration of a therapeutic dose, it is necessary to conduct an intramuscular test: adults are administered from 1/4 to 1/2 of the dose of the drug (from 25 to 50 mg of iron), children - half the daily dose. In the absence of adverse reactions, the remainder of the initial dose of the drug can be administered within 15 minutes after administration.
During the injection, it is necessary to ensure the availability of funds to provide emergency assistance in the event of anaphylactic shock.
The dose of the drug is calculated individually and adapted in accordance with the general iron deficiency using the following formula:
Total iron deficiency (mg) = body weight (kg) × (normal Hb level - patient's Hb level) (g/l) × 0.24* + iron reserves (mg)
With body weight less than 35 kg: normal Hb = 130 g/l, which corresponds to deposited iron = 15 mg/kg body weight
With a body weight of more than 35 kg: normal Hb level = 150 g/l, which corresponds to deposited iron = 500 mg
* Factor 0.24 = 0.0034×0.07×1000 (iron content in hemoglobin = 0.34% / blood volume = 7% of body weight / factor 1000 = conversion from g to mg)
Total number of ampoules to be administered = total iron deficiency (mg)/100 mg.
Table for calculating the total (total per course of treatment) number of ampoules for administration:
| Body weight (kg) | Нb 60 g/l | Нb 75 g/l | Нb 90 g/l | Нb 105 g/l |
| 5 | 1.5 | 1.5 | 1.5 | 1 |
| 10 | 3 | 3 | 2.5 | 2 |
| 15 | 5 | 4.5 | 3.5 | 3 |
| 20 | 6.5 | 5.5 | 5 | 4 |
| 25 | 8 | 7 | 6 | 5.5 |
| 30 | 9.5 | 8.5 | 7.5 | 6.5 |
| 35 | 12.5 | 11.5 | 10 | 9 |
| 40 | 13.5 | 12 | 11 | 9.5 |
| 45 | 15 | 13 | 11.5 | 10 |
| 50 | 16 | 14 | 12 | 10.5 |
| 55 | 17 | 15 | 13 | 11 |
| 60 | 18 | 16 | 13.5 | 11.5 |
| 65 | 19 | 16.5 | 14.5 | 12 |
| 70 | 20 | 17.5 | 15 | 12.5 |
| 75 | 21 | 18.5 | 16 | 13 |
| 80 | 22.5 | 19.5 | 16.5 | 13.5 |
| 85 | 23.5 | 20.5 | 17 | 14 |
| 90 | 24.5 | 21.5 | 18 | 14.5 |
If the required dose exceeds the maximum daily dose, then the drug should be administered in fractional doses.
Adults are prescribed 1 ampoule daily (2.0 ml = 100 mg of iron).
For children, the dose is determined depending on body weight.
Maximum permissible daily doses:
Children weighing up to 6 kg - 1/4 ampoule (0.5 ml = 25 mg iron)
Children weighing from 5 to 10 kg - 1/2 ampoule (1.0 ml = 50 mg iron)
Adults - 2 ampoules (4.0 ml = 200 mg iron)
If there is no therapeutic response from hematologic parameters after 1–2 weeks (eg, an increase in Hb levels of approximately 0.1 g/dL per day), then the initial diagnosis should be reconsidered. The total dose of the drug per course of treatment should not exceed the calculated number of ampoules.
Injection technique
Injection technique is critical. As a result of incorrect administration of the drug, pain and staining of the skin at the injection site may occur. The ventrogluteal injection technique described below is recommended instead of the generally accepted one (in the upper outer quadrant of the gluteus maximus muscle).
The length of the needle should be at least 5-6 cm. The lumen of the needle should not be wide. For children, as well as for adults with low body weight, the needles should be shorter and thinner.
Instruments are disinfected using the usual method.
Before inserting the needle, you should move the skin about 2 cm in order to properly close the puncture channel after removing the needle. This prevents the injected solution from penetrating the subcutaneous tissue and staining the skin.
Place the needle vertically in relation to the surface of the skin, at a greater angle to the point of the iliac joint than to the point of the femoral joint.
After the injection, slowly remove the needle and press the area of skin adjacent to the injection site with your finger for about 5 minutes.
After the injection, the patient needs to move.
Side effect
From the outside digestive system: very rare (≥ 0.001%< 0.01%) - симптомы раздражения ЖКТ, такие как ощущение переполнения, давления в эпигастральной области, тошнота, запор или диарея; возможно темное окрашивание стула, обусловленное выделением невсосавшегося железа (clinical significance does not have).
Contraindications to the use of oral forms of the drug MALTOFER®
- excess iron (for example, hemosiderosis and hemochromatosis);
- impaired iron utilization (for example, lead anemia, sideroachrestic anemia);
- non-iron deficiency anemias (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).
Contraindications to the use of the injection form of the drug MALTOFER®
- anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency, disorders of erythropoiesis, bone marrow hypoplasia);
- excess iron (i.e. hemochromatosis, hemosiderosis);
- impaired iron utilization (for example, sideroachrestic anemia, thalassemia, lead anemia, cutaneous porphyria tarda);
- Osler-Rendu-Weber syndrome;
- chronic polyarthritis;
- bronchial asthma;
- infectious kidney diseases in the acute stage;
- uncontrolled hyperparathyroidism;
- decompensated cirrhosis of the liver;
- infectious hepatitis;
- I trimester of pregnancy;
- intravenous administration;
Use of the drug MALTOFER® during pregnancy and breastfeeding
In controlled studies in pregnant women after the first trimester of pregnancy, no undesirable effects of the drug on the mother and fetus were noted. There is no data on the undesirable effect of the drug on the fetus in the first trimester of pregnancy.
special instructions
When prescribing the drug to patients diabetes mellitus It should be taken into account that 1 ml of drops for oral administration contains 0.01 XE, 1 ml of syrup - 0.04 XE, 1 chewable tablet - 0.04 XE.
Maltofer® does not stain tooth enamel.
Overdose
To date, neither intoxication nor signs of iron overload have been reported in cases of drug overdose.
Drug interactions
No interactions with other drugs have been identified.
Conditions for dispensing from pharmacies
Storage conditions and periods
List B. The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C. The shelf life of oral drops and chewable tablets is 5 years; syrup - 3 years.
Sorbifer Durules - official instructions for use. The drug is a prescription, the information is intended only for healthcare professionals!
Clinical and pharmacological group:
Antianemic drug
pharmachologic effect
Antianemic drug. Iron is an essential component of the body, necessary for the formation of hemoglobin and the occurrence of oxidative processes in living tissues.
Durules technology provides a gradual release of the active ingredient (iron ions) over a long period of time. The plastic matrix of Sorbifer Durules tablets is completely inert in digestive juice, but completely disintegrates when exposed to intestinal peristalsis when the active ingredient is completely released.
Ascorbic acid helps improve iron absorption.
Pharmacokinetics
Suction
Durules is a technology that ensures a gradual release of the active substance (iron ions), a uniform supply medicinal product. Taking 100 mg 2 times a day provides 30% greater absorption of iron from Sorbifer Durules compared to conventional iron preparations.
Absorption and bioavailability of iron are high. Iron is absorbed primarily in the duodenum and proximal jejunum.
Distribution
Plasma protein binding - 90% or more. Deposited in the form of ferritin or hemosiderin in hepatocytes and cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in muscles.
Removal
T1/2 is 6 hours.
Indications for use of the drug SORBIFER DURULES
- Iron-deficiency anemia;
- iron deficiency;
- prevention of iron deficiency anemia during pregnancy, lactation, and in blood donors.
Dosage regimen
I take the drug orally. Film-coated tablets should not be split or chewed. The tablet should be swallowed whole and washed down with at least half a glass of liquid.
Adults and adolescents are prescribed 1 tablet 1-2 times a day. If necessary, for patients with iron deficiency anemia, the dose can be increased to 3-4 tablets per day in 2 doses (morning and evening) for 3-4 months (until the iron depot in the body is replenished).
During pregnancy and lactation, for the purpose of prevention, 1 tablet per day is prescribed; For treatment, 1 tablet is prescribed 2 times a day (morning and evening).
Treatment should be continued until the optimal hemoglobin level is achieved. To further replenish the depot, you may need to continue taking the drug for another 2 months.
Side effect
From the digestive system: nausea, vomiting, abdominal pain, diarrhea, constipation (the frequency of these side effects may increase with increasing dose from 100 mg to 400 mg); rarely (<1/100) - язвенное поражение пищевода, стеноз пищевода.
Allergic reactions: rare (<1/100) - зуд, сыпь.
From the side of the central nervous system: rarely (<1/100) - головная боль, головокружение.
Other: rarely (<1/100) - гипертермия кожи, слабость.
Contraindications to the use of the drug SORBIFER DURULES
- esophageal stenosis and/or other obstructive changes in the digestive tract;
- increased iron content in the body (hemosiderosis, hemochromatosis);
- impaired iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia);
- children under 12 years of age (due to lack of clinical data);
- hypersensitivity to the components of the drug.
The drug should be used with caution in case of gastric and duodenal ulcers, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).
Use of the drug SORBIFER DURULES during pregnancy and breastfeeding
It is possible to use the drug Sorbifer Durules during pregnancy and lactation according to indications.
special instructions
When using the drug, darkening of the stool is possible, which has no clinical significance.
Overdose
Symptoms: abdominal pain, vomiting and diarrhea mixed with blood, fatigue or weakness, hyperthermia, paresthesia, pale skin, cold clammy sweat, acidosis, weak pulse, decreased blood pressure, palpitations. In case of severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma may appear after 6-12 hours.
Treatment: in case of overdose, consult a doctor immediately. It is necessary to rinse the stomach, inside a raw egg, milk (to bind iron ions in the gastrointestinal tract); deferoxamine is administered. Symptomatic therapy.
Drug interactions
Sorbifer Durules may reduce the absorption of concomitantly administered enoxacin, clodronate, grepafloxacin, levodopa, levofloxacin, methyldopa, penicillamine, tetracyclines and thyroid hormones.
The simultaneous use of Sorbifer Durules and antacid preparations containing aluminum hydroxide and magnesium carbonate may reduce the absorption of iron. The maximum possible time interval should be maintained between taking Sorbifer Durules and any of these drugs. The recommended minimum time interval between doses is 2 hours, except when taking tetracyclines, when the minimum interval should be 3 hours.
Sorbifer Durules should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature of 15° to 25°C. Shelf life - 3 years.
Owners of patent RU 2478964:
The invention relates to the field of medicine. The individual course dose (A) of elemental iron (mg) is calculated using the formula: A=0.34M(HbN-HbB)+DFe, where A is the course dose, mg; , M is the patient’s body weight, kg, HbN is the target hemoglobin value in g/l for men, taken as 160 g/l, HbB is the hemoglobin content in the patient’s blood, the actual hemoglobin level in g/l, DFe is the content of deposited iron in mg is normal. The method allows you to quickly and accurately calculate an individual course dose of elemental iron for patients with coronary heart disease with concomitant iron deficiency. 3 tab., 2 pr.
The invention relates to medicine, cardiology and can be used to determine the course dose of elemental iron in men with coronary heart disease (CHD) and concomitant iron deficiency.
Anemic syndrome in coronary artery disease enhances the clinical symptoms of coronary insufficiency. Clinical observations indicate that with limited coronary reserve, ischemic, chronic myocardial dysfunction (systole-diastolic) can form even against the background of a normal volume of coronary blood flow at rest.
Patients with coronary artery disease and iron deficiency anemia (IDA) have less compensatory capabilities of the erythrocyte unit aimed at eliminating myocardial ischemia, which is clinically manifested by a greater frequency and duration of ischemic attacks. It is impossible to use iron supplements without making sure that its content in the blood serum is reduced and iron deficiency anemia is present. Iron overload is considered a very significant factor contributing to the progression of atherosclerosis and increasing the risk of myocardial infarction. Calculation of the daily and course dose of the drug must be made taking into account the severity of the anemic syndrome, visceral lesions, and serum iron levels.
In patients with coronary artery disease with anemia, normalization of iron metabolism and erythron levels has a bradycardic, cardioprotective, and anti-ischemic effect. Heart rate decreases (R=0.23; p=0.0001). The therapeutic effect of oral iron intake appears gradually. Patients experience minimal side effects at individually calculated doses. Complaints do not require discontinuation of the iron supplement, and patients receive the full course of therapy. Patients receive 1 tablet per day, which reduces polypharmacy and toxic effects. Initially, clinical improvement is noted, and only after some time does the hemoglobin level normalize. The first positive clinical sign that appears during treatment with iron supplements is the disappearance or reduction of muscle weakness. The latter is due to the fact that iron is part of the enzymes involved in the contraction of myofibrils. From day 4, the hemoglobin content increases, reaching normal values by day 21. All patients showed a decrease in the general symptoms of anemia, the number of episodes of myocardial ischemia, and the average magnitude of ST segment depression decreased. After normalization of red blood counts and iron metabolism, the duration of ischemic episodes decreased significantly. Pathogenetically based treatment is the administration of iron supplements. The total amount of blood in the body of an adult is on average 6-8% of body weight, which corresponds to 5 to 6 liters of blood, and in men - from 7 to 10. Every day, this amount of blood passes through the heart more than 1000 times. A normal red blood cell contains approximately 30 pg of hemoglobin, which contains 0.34% iron. Normally, about 7-10% of iron administered orally is absorbed, with depletion of its reserves (prelatent and latent iron deficiency) - up to 17%, and with iron deficiency anemia - up to 25%. The maximum amount of iron incorporated into erythroblasts and used for hemoglobin synthesis is about 25-30 mg per day. Increasing the daily dose above 200 mg (in terms of elemental iron) significantly increases the frequency and severity of adverse reactions. The threshold for iron toxicity for humans is 200 mg/day. In this regard, it is most advisable to prescribe 100-200 mg of iron per day. Such daily doses fully satisfy the body's need for iron to restore the amount of hemoglobin. WHO (1990) recommends prescribing iron supplements at a rate of 3 mg/kg per day until hemoglobin levels are restored, and then using iron supplements for at least 2 months at 1-2 mg kg/day to replenish iron reserves in the body. There are known methods for determining course doses for parenteral administration of elemental iron; methods for determining course non-toxic doses for oral administration are not described in the known literature. The administration of parenteral forms of elemental iron has strict indications and cannot be used in patients with mild forms, and especially those with iron deficiency. Many works provide examples of correction of iron deficiency using an individual formula without taking into account the gender of the patient; average values of standards for patients are taken instead of target values. Thus, in the works of A.M. Shilov, intravenous administration of iron supplements was proposed for mild anemia, which is a contraindication. Determination of the dose in mg of the drug ferofolgamma was 375.2 mg, and ferrous sulfate in 1 capsule contained 35 mg, i.e. the patient had to take 10 tablets per day. There are also recommended average doses for anemia without indicating the severity, concomitant pathology, or gender of the patient. For patients with coronary artery disease, this is essential, since an excess of iron in the body is toxic to the myocardium. All these effects are realized by individually determining the course dose of elemental iron for oral administration and using average therapeutic doses with minimal side effects for mild anemia for the correction and prevention of latent iron deficiency. Individually determined course doses do not cause toxic effects on the myocardium and lead to normalization of erythron, serum iron and ferritin levels.
Known sources of information do not contain methods for determining individual course doses, in particular for men.
A new technical challenge is to expand the arsenal of methods for determining the individual course dose for men with coronary heart disease in combination with mild iron deficiency anemia or latent iron deficiency, and to reduce the number of complications by increasing the accuracy of the method.
To solve the problem in the method of determining the course dose of elemental iron in men with coronary heart disease (CHD) and concomitant iron deficiency, capillary blood hemoglobin, body weight and serum iron are determined, and if there is a decrease in serum iron from the norm for men, an individual calculation is carried out course dose (A) of elemental iron (mg) according to the formula:
A=0.34M(HbN-HbB)+DFe,
A - course dose, mg;
Coefficient 0.34=0.0034*0.1*1000,
where 0.0034 is the iron content in hemoglobin,
0.1 - total blood volume as a percentage of body weight in men,
1000=gram to milligram conversion factor
M is the patient’s body weight, kg,
HbN - target hemoglobin value in g/l for men, taken as 160 g/l,
The method is carried out as follows: in men with coronary heart disease (CHD) and concomitant iron deficiency, capillary blood hemoglobin, body weight are determined, and in case of unstable ischemic heart disease, serum iron is determined and if there is a decrease in serum iron from the norm for men, an individual course dose is calculated (A ) elemental iron (mg) according to the formula:
A=0.34M(HbN-HbB)+DFe,
A - course dose, mg;
Coefficient 0.34=0.0034*0.1*1000,
where 0.0034 is the iron content in hemoglobin,
0.1 - total blood volume as a percentage of body weight in men,
1000=gram to milligram conversion factor
M is the patient’s body weight, kg,
HbN - target hemoglobin value in g/l for men, taken as 160 g/l,
The proposed method is based on the results of analysis of clinical observation data.
The study involved 98 male miners working in coal mining who were undergoing hospital treatment. The average age was 51±7.9 years. Depending on the initial level of hemoglobin and iron, the patients were divided into 4 groups: Group 1 (control) consisted of 18 patients with coronary artery disease without anemia, the average age of those examined was 46.09 ± 7.06 years, percentiles were 25% - 37, 0 years; 75% - 59 years old; Group 2 included 28 patients with coronary artery disease without myocardial infarction in combination with IDA, the average age of those examined was 51.0±6.1 years, percentile - 25% - 48.0 years; 75% - 53.5 years; Group 3 - patients with coronary artery disease with previous myocardial infarction in combination with IDA - 23 examined, average age 50.0±6.4 years, percentiles - 25% - 47.0 years, 75% - 55.0 years; The 4th group consisted of 29 patients with ischemic heart disease and sideropenia (latent form of iron deficiency anemia), the average age of those examined was 52.0±4.6 years, percentile - 25% - 49.0 years; 75% - 55.0 years. The composition of patients in the groups is identical in gender and age. Clinical, morphofunctional manifestations, changes in laboratory parameters and tolerability of therapy were compared in patients with coronary artery disease with concomitant IDA of mild severity before and after correction of the anemic syndrome, who were treated in the therapeutic department of the Central City Hospital of Anzhero-Sudzhensk. Diagnosis of coronary artery disease was carried out in accordance with the recommendations of the All-Russian Scientific Committee. Anemia was diagnosed, according to the WHO classification, when the hemoglobin level in men was below 130 g/l and erythrocytes less than 4.5x10 12 /l. Iron deficiency has been associated with nutritional factors. Patients with severe concomitant diseases and operations, bleeding, anemia of non-iron deficiency, and patients with angina pectoris of functional class VI were excluded from the study. All patients underwent a clinical analysis of capillary blood with determination of the number of red blood cells, hemoglobin concentration (Hb), hematocrit level, erythrocyte indices: mean erythrocyte volume (MCV), mean hemoglobin content in an erythrocyte (MCH), mean hemoglobin concentration in an erythrocyte (MCHC) on hematology analyzer "HEMOLUX 19" using original consumables. Quantitative determination of serum iron (SI), total iron-binding capacity of serum (TIBC), coefficient of transferrin saturation with iron (TIS) in blood serum was carried out on a biochemical analyzer "Stat Fax 3300" (USA) using reagent kits for clinical biochemistry produced by "Vital Diagnostics" . Determination of ferritin was carried out on an enzyme immunoassay analyzer “Stat Fax 2100” (USA), using the diagnostic test system “Ferritin-ELISA-Best” produced by JSC “Vector-Best”. ECG registration for calculating values was carried out synchronously in 12 standard leads (V=50 mm/s), in a supine position, after 10 minutes at rest on a digital 3-channel device “Fukuda” (Japan). Left ventricular myocardial hypertrophy was determined according to the Socolowa-Lyon criteria. 24-hour Holter ECG monitoring (SM ECG) was carried out in a hospital setting using the Ar MaSoft N. Novgorod 2000-2004 Safe Haert System 24h version 2.02 system. Signal recording and processing were carried out in accordance with the recommendations of the Working Group of the European Society of Cardiology and the North American Society of Stimulation and Electrophysiology (1996). The work used a modified M. Ryan (1975) system of gradations of ventricular extrasystole according to B. Lown and M. Wolf (1971), based on data from daily ECG monitoring. The structural and functional state of the heart was studied using an Aloka-2000 echo chamber with a 3.5 MHz phase-electronic sensor. Ultrasound examination in B- and Doppler modes was performed in the left lateral decubitus position according to the generally accepted technique proposed in 1980 by the American Association of Echocardiography (ASE). Anemia was treated with oral iron sulfate (Sorbifer-Durules, Egis, Hungary), containing 100 mg of elemental iron and 60 mg of ascorbic acid per tablet, 1 tablet 1 time per day 30 minutes before meals, following nutritional recommendations . The study is prospective. Statistical data processing was carried out using the STATISTICA 6.1 software package (Stat Software, USA), license agreement BXXROO6BO92218FAN11. Parameters by group are represented by the median (Me) and percentile interval 25%-75% (Q1:Q2), mean value (M) and error of the mean value (m). To compare groups and study relationships, nonparametric methods were used (Mann-Whitney, Wilcoxon tests, Spearman correlations). The threshold level of statistical significance was accepted at the value of the p test<0,05.
Patients included in the studies more often had angina pectoris of the second grade of functional class (FC), which amounted to 69 (70%) patients. 23 (23.5%) patients had stable angina of functional class III, and 6 (6.1%) had functional class I. When assessing the severity of FC of stable angina, it turned out that in the group of patients with anemic syndrome they had a more severe course of the disease and they had angina FC III 2 times more often (p = 0.00001). 19.6% of patients had more than seven angina attacks per week - they experienced angina episodes daily. There were no significant differences in glycemia. Of the concomitant diseases, 16 (17.8%) were diagnosed with chronic obstructive pulmonary disease (stages 1-2), and 48 (42.8%) miners were diagnosed with mild vibration disease. The occurrence of angina attacks and their frequency in groups 1 (control) and 2, 3 were the same. Statistically significant changes consisted of a longer duration of angina attacks in patients with anemia and with predominant physical activity (p = 0.001 and p = 0.003, respectively). Nitroglycerin intake was the same in all groups, where the differences were not statistically significant. In the 6-minute walking test (WWT) there was also no difference between the comparison groups. Anemia in groups 2 and 3 was of mild iron deficiency; group 4 was characterized by a decrease in plasma ferritin and iron levels. In the study groups, there was no connection between the indicators of red blood, iron metabolism and the age of the patients. In all patients with anemia, compared with the control group, dystrophic changes in the myocardium were noted, characterized by a decrease in the voltage of the QRS complex, mainly in standard leads, and changes in the final part of the ventricular ST-T complex in the form of a horizontal decrease in ST in standard leads, V1-3, V5 -6 to 2.4±1.2 mm (p=0.000002) in group 2, 2.5±0.61 (p<0,0001) в 3-й группе и 1,8±0,4 (р=0,001) в 4-й группе. Гипертрофия левого желудочка (ГЛЖ) была у 50 больных с анемией. При CM-ЭКГ нарушения ритма сердца выявлялись во всех группах. Оценка связи эктопической активности миокарда с изучаемыми показателями выявила, что снижение гемоглобина и ферритина крови сопровождается увеличением желудочковой эктопической активности. У 40,2% пациентов отмечались нарушения ритма: неспецифические внутрижелудочковые блокады, атриовентрикулярная блокада 1 степени, предсердные и желудочковые экстрасистолы. У больных 3-й группы наблюдалось более значимое увеличение количества желудочковых экстрасистол. ИММЛЖ был больше у больных 2-й, 3-й и 4-й групп по сравнению с контрольной группой (р=0,00001) табл.1. Обнаружена прямая слабая корреляция ММЛЖ с концентрацией железа в плазме крови (R=0,21; р=0,005), и обратная слабая корреляционная связь с ферритином крови (R=-0,19; р=0,05) в группах по сравнению с контрольной. Отношение Е/А у пациентов 2-й, 3-й и 4-й групп ниже, чем в группе контроля (р=0,0035). В результате приема препарата железа в течение трех недель и соблюдения пищевого регламента у всех пациентов нормализовались показатели эритрона и обмена железа (табл.1).
We associate the regression of clinical manifestations of IHD with this circumstance. The clinical dynamics of the course of IHD were positive both in terms of symptoms characteristic of IHD and anemic syndrome. Heart rate decreased. Undoubtedly, anemic syndrome in coronary artery disease increases the clinical symptoms of coronary insufficiency. It is likely that patients with coronary artery disease and iron deficiency anemia have less compensatory capabilities of the erythrocyte unit aimed at eliminating myocardial ischemia, which is clinically manifested by a higher frequency of ischemic attacks. Thus, after normalization of red blood parameters and iron metabolism, the number of angina attacks decreased by 10-15 times compared to group 1. The nature of angina pectoris has changed - attacks that previously occurred at rest have disappeared, and the number of attacks during physical activity has decreased significantly. The need for patients to use short-acting nitrates (nitroglycerin), used to relieve attacks, has decreased by approximately 30 times. The duration of anginal excesses in groups 2, 3 and 4 decreased tenfold. The patients' walking distance in TSH increased (p=0.00004) Table 1. The positive dynamics of this indicator reflects both effective therapy for anemic syndrome and manifestations of coronary artery disease (before relief of anemia, 36% of patients stopped the test due to an attack of angina). After correction of anemia, this reason for the decrease in the distance walked was not recorded. The therapeutic effect of oral iron intake appeared gradually. Patients experienced minimal side effects at individually calculated doses (Table 2).
These complaints did not require discontinuation of the iron supplement, and the patients received the full course of therapy. Initially, clinical improvement was noted, and only after some time did the hemoglobin level normalize. The first positive clinical sign that appeared during treatment with iron preparations was the disappearance or reduction of muscle weakness. The latter is due to the fact that iron is part of the enzymes involved in the contraction of myofibrils. On the 3rd day, the first signs of reticulocytosis appeared, reaching a peak on the 5-10th day from the start of ferrotherapy. From day 4, the hemoglobin content increased, reaching normal values by day 21. The results of the study show that after a course of treatment with iron supplements, all patients experienced a decrease in the general symptoms of anemia, the number of episodes of myocardial ischemia, and the average magnitude of ST segment depression decreased. After normalization of red blood counts and iron metabolism, the duration of ischemic episodes decreased significantly. Against the background of normalization of erythron and serum iron levels, there was a significant increase in LV ejection fraction in groups of patients with anemia.
Example 1. Sick man Z., 34 years old, working, suffering from coronary artery disease and concomitant mild iron deficiency anemia
The course dose was determined according to the proposed method. The examination revealed a body weight of 83 kg, a general blood test for hemoglobin of 110 g/l, and serum iron of 7.2 mmol/l.
Let's create the formula: A=0.34*83(160-110)+500; A=1911 mg - elemental iron. Each annotation for an iron-containing preparation indicates the amount of active iron in the tablet and the recommended average therapeutic dose. We use table 3 indicating the amount of elemental iron, from which you can select a drug and calculate the number of tablets and doses per day.
The number of days (N) of taking the course dose was calculated using the formula: N=A/D, where A is the course dose, mg; D is the amount of elemental iron in an iron-containing preparation, mg.
For example, to determine the course dose of the drug “Sorbifer-durulis”, where 1 tablet contains 100 mg of active iron sulfate, calculate the number of days of taking 100 mg per day (average non-toxic dose) = 1911 mg/100 mg = 19 days
Patient I., 56 years old, working, suffers from ischemic heart disease and concomitant latent iron deficiency.
The course dose of the drug “Ferrum-lek” was calculated.
The examination revealed a body weight of 93 kg, a general blood test showed hemoglobin was 135 g/l, serum iron was 8.2 mmol/l.
According to the formula: A=0.34*93(160-135)+500; A=1291 mg determine the dose of elemental iron. 1 tablet of the drug “Ferrum-lek” contains 100 mg of active iron, we get N=1291 mg/100 mg=13 days.
The proposed method for determining the course dose of iron-containing drugs in the treatment of men with coronary artery disease with mild iron deficiency or latent iron deficiency is advisable to use in the work of cardiology, therapeutic and cardiac surgery departments. In this way, correction of iron deficiency states in patients is carried out, taking into account the targeted effect of energy-supplying and other anti-ischemic agents on the transport of oxygen to the ischemic myocardium due to the effect on the affinity of hemoglobin for oxygen.
Bibliography
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Application
1) Table 1. Effect of anemia correction on various indicators (M±m)
2) Table 2. Course doses of elemental iron and side effects
3) Table 3. Amount of elemental iron in the preparation
| table 2 | |||
| index | IHD (angina) in combination with anemia (n=28) | IHD (myocardial infarction) in combination with anemia (n=23) | IHD and sideropenia (n=29) |
| Course dose of elemental iron (mg) M±SD | 1247.7±186.5 | 1501.7±0.5 | 1000±0.38 |
| Duration of treatment (days) M±SD | 12.8±2.1 | 15.5±2.5 | 10.0±0.1 |
| Fever (n, %) | - | - | - |
| Skin itching (n, %) | - | 1 (4,3) | - |
| Skin hyperemia (n, %) | 1 (3,6) | - | - |
| Arrhythmias (n, %) | - | - | - |
| Arthralgia (n, %) | - | - | - |
| Hematuria (n, %) | - | - | - |
| Allergic dermatitis (n, %) | - | - | - |
| Anaphylactic shock (n, %) | - | - | - |
| Metallic taste in the mouth (n, %) | 2 (7,2) | 2 (8,6) | 3 (10,3) |
| Darkening of teeth, gums (n, %) | - | - | - |
| Nausea, vomiting (n, %) | 1 (3,6) | - | - |
| Decreased appetite (n, %) | 1 (3,6) | - | - |
| Diarrhea (n, %) | - | - | - |
| Pain in the lumbar region (n, %) | - | - | - |
| Hemosiderosis (n, %) | - | - | - |
