Pharmacological properties of the drug Ferrum lek
Iron supplement. Contains iron Fe3+ in the form of a complex compound of iron (III) hydroxide with polymaltose (HPA). The iron in the polynuclear "core" is associated with a structure similar to serum ferritin. This macromolecular complex is stable and under physiological conditions does not release iron in the form of free ions. Therefore, when taken orally, iron, which is part of the GPC, enters the blood from the intestine only through active absorption. There is a correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). It is this property of the drug that explains the impossibility of poisoning with the drug even in the case of an overdose, unlike simple iron salts, the absorption of which occurs along a concentration gradient. Maximum absorption of iron after oral administration occurs in the duodenum and jejunum, and its absorption is not reduced by interaction with certain food components or with drugs containing a phenolic group (for example, tetracycline). Iron administered in the form of HPA is slowly absorbed and enters the blood serum, from where it quickly passes into iron-depositing tissues. Absorbed iron is stored bound to ferritin, mainly in the liver. Later in the bone marrow it is included in hemoglobin. In hemoglobin, iron is in divalent form, but it is Fe3+ (trivalent iron) that stimulates the formation of globin, which ultimately helps to increase hemoglobin levels. Since iron in the dosage form for oral administration is contained in non-ionized form, the drug does not have such side effects as irritation of the mucous membrane of the digestive tract, staining of tooth enamel, and the appearance of a metallic taste in the mouth. Chewable tablets and syrup are characterized by a high degree of safety and are well tolerated by patients. Comparative studies of the bioavailability of Ferrum Lek oral dosage forms using the radioisotope method, as well as comparative clinical trials, have proven that the absorption and bioavailability of iron in the form of iron (III) hydroxide complex with polyisomaltose is equivalent to the absorption and bioavailability of iron (II) salts.
Ferrum Lek Solution, ampoules, 50 pcs., 2 ml, 50 mg/ml, for injection
Directions for use and doses
The drug in solution form can only be administered intramuscularly. IV administration of the drug is not allowed! Before administering the first therapeutic dose, each patient should be given a test dose of 1/4-1/2 ampoule (25-50 mg of iron) for adults and 1/2 the daily dose for children. If there are no adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered. Doses of the drug Ferrum Lek are selected individually in accordance with the total iron deficiency, calculated using the following formula: Total iron deficiency (mg) = body weight (kg) × (calculated Hb level (g/l) - detected Hb (g/l)) × 0.24 + deposited iron (mg). For body weight up to 35 kg: calculated Hb level = 130 g/l, deposited iron = 15 mg/kg body weight. With a body weight of more than 35 kg: calculated Hb level = 150 g/l, deposited iron = 500 mg. Factor 0.24 = 0.0034 × 0.07 × 1000 (iron content in Hb = 0.34%, total blood volume = 7% of body weight, factor 1000 - conversion from g to mg). Calculation of the total number of ampoules of the drug based on the detected hemoglobin level and body weight Body weight (kg) Total number of ampoules at Hb level 60 g/l 75 g/l 90 g/l 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 total number of ampoules to be administered exceeds the maximum permissible daily dose, then the total number of ampoules should be divide by the required number of days. If hematological parameters do not improve 1-2 weeks after the start of treatment, the diagnosis should be clarified again. Calculation of the total dosage for replacement of iron due to blood loss With a known amount of lost blood, intramuscular administration of 200 mg of iron (2 ampoules) leads to an increase in hemoglobin equivalent to 1 blood unit (400 ml with a hemoglobin content of 150 g/l). Amount of iron to be replaced (mg) = number of blood units lost x 200 or number of ampoules required = number of blood units lost x 2 If the final hemoglobin level is known, the above formula is used, taking into account that the deposited iron does not need to be replaced. The amount of iron that needs to be replaced (mg) = body weight (kg) × (calculated Hb level (g/l) - detected Hb level (g/l)) x 0.24 Usual doses of Ferrum Lek Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules) depending on hemoglobin level; children - 3 mg/kg/day (0.06 ml/kg body weight/day). The maximum daily dose for adults is 200 mg (2 ampoules); for children - 7 mg/kg/day (0.14 ml/kg body weight/day). Rules for administering the drug The drug is administered deep intramuscularly alternately into the right and left buttocks. In order to reduce pain and avoid skin staining, the following rules should be followed: - the drug should be injected into the upper outer quadrant of the buttock using a needle 5-6 cm long; — before injection, after disinfection of the skin, the subcutaneous tissues should be moved down 2 cm to prevent subsequent leakage of the drug; - after administration of the drug, the subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 minute. Before using the solution for intramuscular injection, ampoules should be carefully inspected. Only ampoules containing a homogeneous solution without sediment should be used. The solution for intramuscular injection should be used immediately after opening the ampoule.
Indications for use of the drug Ferrum lek
Orally prescribed for the prevention and treatment of iron deficiency conditions of various etiologies, including the prevention of iron deficiency in children, women of childbearing age (especially during pregnancy and breastfeeding), adults (especially vegetarians) and the elderly; treatment of iron deficiency anemia. Ferrum Lek for parenteral administration is indicated for the treatment of iron deficiency conditions that require rapid and reliable compensation of iron deficiency: severe posthemorrhagic anemia, impaired iron absorption, as well as when treatment of iron deficiency anemia with oral iron preparations is ineffective. Ferrum Lek is used in patients with clear indications for the drug, with mandatory determination of the level of ferritin in the blood plasma and the number of red blood cells in the peripheral blood. If iron malabsorption is suspected, an iron absorption test should be performed.
Ferrum-LEK, solution for intramuscular administration 50 mg/ml, ampoules 2 ml, 5 pcs.
Inside,
during or immediately after meals.
Ferrum Lek® chewable tablets can be chewed or swallowed whole.
The daily dose can be divided into several doses or taken at one time.
Ferrum Lek® syrup can be mixed with fruit or vegetable juices or added to baby food.
Doses and duration of treatment depend on the degree of iron deficiency.
The measuring spoon included in the package is used for precise dosing of Ferrum Lek® syrup.
Iron-deficiency anemia
Duration of treatment is about 3–5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under one year of age
: 2.5 ml (½ measuring spoon) - 5 ml (1 measuring spoon) Ferrum Lek® syrup per day.
Children aged 1 to 12 years
: 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
: 1–3 chewable tablets or 10–30 ml (2–6 scoops) Ferrum Lek® syrup.
Latent iron deficiency
The duration of treatment is about 1–2 months.
Children aged 1 to 12 years
: 2.5–5 ml (1/2–1 scoop) Ferrum Lek® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
: 1 table. or 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Pregnant women
Iron-deficiency anemia
: 2–3 chewable tablets per day or 20–30 ml (4–6 scoops) of Ferrum Lek® syrup until hemoglobin levels normalize. After this, you should continue to take 1 chewable tablet or 10 ml (2 scoops) of syrup per day, at least until the end of pregnancy to replenish iron stores in the body.
Latent iron deficiency and prevention of iron deficiency
: one chewable tablet or 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency in the body
| Patients | Form of the drug | Iron-deficiency anemia | Latent iron deficiency | Preventing iron deficiency |
| Children under 1 year | Syrup | 2.5–5 ml (25–50 mg iron) | — | — |
| Children 1–12 years old | Syrup | 5–10 ml (50–100 mg iron) | 2.5–5 ml (25–50 mg iron) | — |
| Children over 12 years old, adults, nursing mothers | Chewable tablets | 1–3 tables | 1 table | — |
| Syrup | 10–30 ml (100–300 mg iron) | 5–10 ml (50–100 mg iron) | — | |
| Pregnant women | Chewable tablets | 2–3 tables | 1 table | 1 table |
| Syrup | 20–30 ml (200–300 mg iron) | 10 ml (100 mg iron) | 5–10 ml (50–100 mg iron) |
(-) Due to the fact that this group of patients requires low doses of iron, it is not recommended to use tablets or syrup in these cases.
V/m
(only).
Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4–1/2 amp. Ferrum Lek® (25–50 mg iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose can be administered within 15 minutes.
Doses of Ferrum Lek® must be selected individually, in accordance with the general iron deficiency, which is calculated using the following formula:
Total iron deficiency = body weight (kg) × (calculated hemoglobin level (g/l) − actual hemoglobin level (g/l) × 0.24) + deposited iron (mg)
Body weight up to 35 kg: estimated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg
Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg
Factor 0.24 = 0.0034 × 0.07 × 1000
(Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g to mg).
Example
Patient body weight: 70 kg
Real hemoglobin concentration: 80 g/l
Total iron deficiency = (150 − 80) × 0.24 + 500 = 1700 mg iron
Total number of Ferrum Lek® ampoules to be administered = Total iron deficiency (mg) / 100 mg
Calculation of the total number of Ferrum Lek® ampoules that must be administered, based on the actual hemoglobin concentration and body weight
| Body weight, kg | Total number of Ferrum Lek® ampoules for administration | |||
| Hb 60 g/l | Hb 75 g/l | Hb 90 g/l | Hb 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 of Ferrum Lek® exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days).
If hematological parameters do not change 1–2 weeks after the start of treatment, the diagnosis should be clarified.
Calculation of the total dose for iron replacement due to blood loss
The required amount of the drug to compensate for post-hemorrhagic iron deficiency is calculated using the following formula.
If the amount of blood lost is known: administration of 200 mg IM (2 amps of Ferrum Lek®) leads to an increase in hemoglobin levels, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).
Iron to be replaced (mg) = number of blood units lost × 200 or required number of Ferrum Lek® ampoules = number of blood units lost × 2.
If the final hemoglobin level is known, the following formula must be used, taking into account that deposited iron does not need to be replaced.
Iron to be replaced (mg) = body weight (kg) × (estimated hemoglobin level (g/L) − actual hemoglobin level (g/L) × 0.24.
A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1.5 ampoules of Ferrum Lek®.
Standard doses
Children: 0.06 ml/kg/day (3 mg iron/kg/day).
Adults: 1–2 amp. Ferrum Lek® (100–200 mg iron), depending on the hemoglobin level.
Maximum daily doses
Children: 0.14 ml/kg/day (7 mg iron/kg/day).
Adults: 4 ml (2 amps) per day.
Use of the drug Ferrum lek
The dose and duration of taking the drug depend on the severity of iron deficiency. Tablets and syrup for the treatment of iron deficiency conditions are prescribed in the usual daily dose: adults and children over 12 years of age in the absence of clinical signs of anemia - 10 ml of syrup or 1 tablet per day, in the presence of clinical signs of anemia - 30 ml of syrup per day or 1 tablet 3 times a day; children aged 1–12 years - at the rate of 3 mg of iron per 1 kg of body weight per day or 5–10 ml of syrup per day; it is recommended that syrup be prescribed to infants in an initial dose of 10 drops per day, gradually increasing the dose to 5 ml (1 teaspoon of syrup) per day. A teaspoon of syrup contains 100 drops. Women during pregnancy or breastfeeding are prescribed 20–30 ml of syrup or 1–3 tablets per day.
Patients | Treatment of iron deficiency | Prevention of iron deficiency | ||
Pills | Syrup | Pills | Syrup | |
| Children under 1 year of age | 2.5–5 ml/day | — | — | |
| Children aged 1–12 years | 5–10 ml/day | — | — | |
| Adults and children over 12 years old | 1–3 tablets per day | 10–30 ml/day | — | — |
| Women during pregnancy and breastfeeding | 1–3 tablets per day | 20–30 ml/day | 1 tablet per day | 5–10 ml/day |
The duration of use of chewable tablets or Ferrum Lek syrup is at least 3 months after normalization of the peripheral blood composition to restore the iron depot in the body (course of treatment is 6 months). To prevent iron deficiency conditions, the usual dose for pregnant and breastfeeding women is 5–10 ml of syrup or 1 tablet per day. Solution for IM administration IV administration of the solution is contraindicated! Before administering the first therapeutic dose of the drug, its tolerability is determined by administering a test dose - 1/4–1/2 from an ampoule of Ferrum Lek (which corresponds to 25–50 mg of iron) for adults and half the daily dose for children. If no undesirable effects develop over the next 15 minutes, administer the remainder of the initial daily dose. 1 ) first, calculate the total iron deficiency (TID) (mg): TID = TI + ID, where TI is iron included in hemoglobin, mg: TI is = MT (CZG - AIG) 0.24, where MT body weight (kg); CZH - target hemoglobin value, g/l (for body weight up to 35 kg - 130 g/l, for body weight more than 35 kg - 150 g/l); AUC —actual hemoglobin level, g/l; coefficient 0.24 = 0.0034 • 0.07 • 1000, where 0.34% is the iron content in hemoglobin; 7% - total blood volume as a percentage of body weight; 1000 is the conversion factor from grams to milligrams; ID - deposited iron, mg (for body weight up to 35 kg - 15 mg per 1 kg of body weight, for body weight more than 35 kg - 500 mg); 2) calculate the total number of ampoules per course of treatment (OCA): OKA = OCA: 100, where 100 is the iron content in 1 ampoule, mg. Calculation example: body weight = 70 kg; actual hemoglobin level = 80 g/l; iron included in hemoglobin - 70 • 0.24 • (150 – 80) = 1200 mg of iron; deposited iron - 500 mg of iron; general iron deficiency - 1200 + 500 = 1700 mg of iron; the total number of ampoules per course of treatment is 1700: 100 = 17. Table for calculating the total number of ampoules for one patient per course of treatment.
Body weight, kg | Total number of Ferrum Lek ampoules per course of treatment | |||
Hb = 60 g/l | Hb = 75 g/l | Hb = 90 g/l | Hb =150 g/l | |
| 5 | 1,5 | 1,5 | 1,5 | 1,0 |
| 10 | 3,0 | 3,0 | 2,5 | 2,0 |
| 15 | 5,0 | 4,5 | 3,5 | 3,0 |
| 20 | 6,5 | 5,5 | 5,0 | 4,0 |
| 25 | 8,0 | 7,0 | 6,0 | 5,5 |
| 30 | 9,5 | 8,5 | 7,5 | 6,5 |
| 35 | 12,5 | 11,5 | 10,0 | 9,0 |
| 40 | 13,5 | 12,0 | 11,0 | 9,5 |
| 45 | 15,0 | 13,0 | 11,5 | 10,0 |
| 50 | 16,0 | 14,0 | 12,0 | 10,5 |
| 55 | 17,0 | 15,0 | 13,0 | 11,0 |
| 60 | 18,0 | 16,0 | 13,5 | 11,5 |
| 65 | 19,0 | 16,5 | 14,5 | 12,0 |
| 70 | 20,0 | 17,5 | 15,0 | 12,5 |
| 75 | 21,0 | 18,5 | 16,0 | 13,0 |
| 80 | 22,5 | 19,5 | 16,5 | 13,5 |
| 85 | 23,5 | 20,5 | 17,0 | 14,0 |
| 90 | 24,5 | 21,5 | 18,0 | 14,5 |
If the total number of Ferrum Lek ampoules exceeds the maximum daily dose, it is necessary to divide the administration of the drug into several doses. If after 1–2 weeks of therapy there is no normalization of blood counts, it is necessary to reconsider the established diagnosis. Calculation of the total dose of Ferrum Lek for intramuscular injection to replenish iron losses due to blood loss. The required number of ampoules is calculated using the following formulas:
- If the amount of blood lost is known, the administration of 200 mg of iron IM (2 ampoules) causes an increase in hemoglobin levels by 1 unit of blood (400 ml 150 g/l hemoglobin content). Required amount of iron (mg) = number of blood units lost • 200 or required number of Ferrum Lek ampoules = number of blood units lost • 2.
- If a reduced hemoglobin level is known , use the formula for calculation, assuming that there is no need to replenish stored iron: required amount of iron (mg) = body weight (kg) • (target hemoglobin value [g/l] - actual hemoglobin level [g/l ]) • 0.24. For patients weighing 60 kg with a hemoglobin deficiency of 10 g/l, the required amount of iron is 150 mg or 1.5 ampoules of Ferrum Lek.
The usual dose of Ferrum Lek for intramuscular administration : Children: 0.6 ml of the drug per 1 kg of body weight per day (3 mg of iron per 1 kg of body weight per day). Adults and elderly patients: contents of 1-2 ampoules of Ferrum Lek (100-200 mg iron) depending on the hemoglobin level. Maximum daily dose of Ferrum Lek for intramuscular administration Children: 0.14 ml of the drug per 1 kg of body weight per day (7 mg of iron per 1 kg of body weight per day). Adults: 4 ml of the drug (contents of 2 ampoules) Ferrum Lek. Ferrum Lek for intramuscular injection is administered every other day, deep intramuscularly, alternately into the left and right gluteal muscles. Before use, carefully check the ampoule visually. It is allowed to use only a transparent solution that does not contain sediment. If sediment appears and after the expiration date indicated on the package, the ampoule is not suitable for use. The ampoule is opened immediately before injection. The IM injection is performed slowly to avoid pain and staining of the skin, into the upper outer quadrant of the buttock with a needle 5–6 cm long. Before the injection, wipe the skin with alcohol, pull it to the side by 2 cm so that after removing the needle the injection channel is covered with skin to prevent fluid from leaking into the subcutaneous fat. During injection, the pulled skin is gradually released; after the injection, the injection site is pressed for 1 minute.
Ferrum Lek for intramuscular administration
Release form, composition and packaging
The solution for intramuscular administration is brown, opaque, with virtually no visible particles.
1 ml. iron [III] hydroxide polyisomaltose 50 mg.
1 amp. iron [III] hydroxide polyisomaltose 100 mg.
Excipients: sodium hydroxide, hydrochloric acid (concentrated), water for injection.
Clinical and pharmacological group: Antianemic drug.
pharmachologic effect
Antianemic drug.
In the preparation, iron is in the form of a complex compound of iron (III) hydroxide with polyisomaltose. This macromolecular complex is stable and does not release iron in the form of free ions. The complex is similar in structure to the natural iron compound ferritin.
Iron (III) hydroxide polyisomaltose complex does not have the pro-oxidant properties that are inherent in iron (II) salts. Iron, which is part of the drug, quickly compensates for the lack of this element in the body (including in iron deficiency anemia), restores the level of hemoglobin (Hb).
When using the drug, there is a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, dry skin) and laboratory symptoms of iron deficiency.
Pharmacokinetics
Suction
After intramuscular administration of the drug, iron quickly enters the bloodstream: 15% of the dose - after 15 minutes, 44% of the dose - after 30 minutes.
Iron, in combination with transferrin, is transported to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes.
Removal
T1/2 - 3-4 The complex of iron (III) hydroxide with polyisomaltose is large enough and therefore is not excreted through the kidneys; the compound is stable and does not release iron ions under physiological conditions.
Indications
Treatment of all iron deficiency conditions requiring rapid replenishment:
- severe iron deficiency due to blood loss;
- impaired absorption of iron in the intestines;
- conditions for which treatment with oral iron preparations is ineffective or impracticable.
Dosage regimen
The drug in solution form can only be administered intramuscularly. IV administration of the drug is not allowed!
Before administering the first therapeutic dose, the patient should be given a test dose of 1/4-1/2 ampoule (25-50 mg of iron) for adults and 1/2 the daily dose for children. If there are no adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered.
Doses of the drug Ferrum Lek are selected individually in accordance with the general iron deficiency, calculated using the following formula:
Total iron deficiency (mg) = body weight (kg) x (calculated Hb level (g/l) - detected Hb (g/l)) x 0.24 + deposited iron (mg).
For body weight up to 35 kg: calculated Hb level = 130 g/l, deposited iron = 15 mg/kg body weight.
With a body weight of more than 35 kg: calculated Hb level = 150 g/l, deposited iron = 500 mg.
Calculation of the total dosage for iron replacement due to blood loss
With a known amount of lost blood, intramuscular administration of 200 mg of iron (2 ampoules) leads to an increase in hemoglobin equivalent to 1 blood unit (400 ml with a hemoglobin content of 150 g/l).
Amount of iron to be replaced (mg) = number of blood units lost x 200 or number of ampoules required = number of blood units lost x 2
When the hemoglobin level is known, the above formula is used, taking into account the fact that the deposited iron does not need to be replenished.
Amount of iron to be replaced (mg) = body weight (kg) x (estimated Hb level (g/l) - detected Hb level (g/l)) x 0.24
Usual doses of Ferrum Lek
Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules) depending on the hemoglobin level; children - 3 mg/kg/(0.06 ml/kg body weight/day).
The maximum daily dose for adults is 200 mg (2 ampoules); for children - 7 mg/kg/(0.14 ml/kg body weight/day).
Rules for administering the drug
The drug is administered every other day deep intramuscularly alternately into the right and left buttocks.
In order to reduce fighting sensations and avoid skin staining, the following rules should be followed:
- the drug should be injected into the upper outer quadrant of the buttock using a needle 5-6 cm long;
- before injection, after disinfection of the skin, the subcutaneous tissues should be moved down 2 cm to prevent subsequent leakage of the drug;
- after administration of the drug, the subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 minute.
Before using the solution for intramuscular injection, ampoules should be carefully inspected. Only ampoules containing a homogeneous solution without sediment should be used. The solution for intramuscular injection should be used immediately after opening the ampoule.
Side effect
From the digestive system: nausea, vomiting.
From the side of the central nervous system: headache, dizziness.
Local reactions: if the drug is administered incorrectly, it is possible to stain the skin, develop pain and an inflammatory reaction at the injection site.
Other: arterial hypotension, arthralgia, enlarged lymph nodes, increased temperature; extremely rarely - allergic or anaphylactic reactions.
Contraindications
- excess iron content in the body (hemosiderosis, hemochromatosis);
- violations of the mechanisms of inclusion of iron in hemoglobin (anemia caused by lead poisoning, sideroachrestic anemia, thalassemia);
- anemia not associated with iron deficiency;
- Osler-Rendu-Weber syndrome;
- infectious kidney diseases in the acute stage;
- uncontrolled hyperparathyroidism;
- decompensated cirrhosis of the liver;
- infectious hepatitis;
- I trimester of pregnancy;
- hypersensitivity to the components of the drug.
The drug should be used with caution in case of bronchial asthma, chronic polyarthritis, cardiovascular failure, low ability to bind iron and/or folic acid deficiency, in pediatric patients under 4 months.
Pregnancy and lactation
Parenteral administration of the drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy and during breastfeeding, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Use for liver dysfunction
The use of the drug is contraindicated in cases of decompensated liver cirrhosis and infectious hepatitis.
Use for renal impairment
The use of the drug is contraindicated for infectious kidney diseases in the acute stage.
special instructions
The drug should be used only in a hospital setting.
When prescribing Ferrum Lek, laboratory tests are required: a general clinical blood test and determination of serum ferritin levels; it is necessary to exclude impaired iron absorption.
Treatment with oral forms of iron-containing drugs should begin no earlier than 5 days after the last injection of Ferrum Lek. Ferrum Lek is intended for intramuscular administration only. It is necessary to insert deeply into the gluteal muscle (a needle 5-6 cm long), as well as shifting the tissue when inserting the needle and squeezing the tissue after removing the needle; injected in turn into the right and left gluteal muscles.
The opened ampoule should be used immediately.
The contents of the ampoules should not be mixed with other drugs.
The use of ampoules in which sediment has formed as a result of improper storage of the drug is unacceptable.
Overdose
Symptoms: An overdose of iron supplements can lead to acute iron overload and hemosiderosis.
Treatment: symptomatic therapy. As an antidote, deferoxamine is administered intravenously slowly (15 mg/kg/hour), depending on the severity of the overdose, but not more than 80 mg/kg. Hemodialysis is ineffective.
Contraindications to the use of the drug Ferrum lek
Hypersensitivity to the drug , anemia not caused by iron deficiency, including hemolytic; hypersensitivity to any of the components of the drug; excess iron in the body (hemochromatosis, hemosiderosis); disorders of hemoglobin synthesis (anemia caused by lead poisoning, sideroblastic anemia), thalassemia; severe hemostasis disorders (hemophilia); oral administration is not advisable when there is a decrease in the concentration of iron in the blood serum and anemia caused by a chronic inflammatory process or neoplasm.
Ferrum Lek for injection solution d/i/m 100mg/2ml amp 2ml N5x1 Lek d.d.
Ferrum Lek solution is intended for intramuscular administration only. The drug should be administered only in a hospital setting, by specially trained personnel who can recognize the signs of incipient anaphylactic shock, in conditions of availability of resuscitation facilities and the possibility of carrying out a complex of anti-shock measures. The patient should be observed for at least 30 minutes after each injection. Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4-1/2 ampoule of Ferrum Lek (25 - 50 mg of iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose should be administered within 15 minutes. The dose of Ferrum Lek must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula: General iron deficiency [mg] = body weight (kg) x (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l )) x 0.24* + deposited iron (mg). Body weight up to 35 kg: calculated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight. Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg. *Factor 0.24 = 0.0034 x 0.07 x 1000: (Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g/L to mg/L). If the required dose of Ferrum Lek exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days). If 1-2 weeks after the start of treatment the hematological parameters do not change, an additional examination should be carried out to clarify the diagnosis. If the amount of blood lost is known: administration of 200 mg intramuscularly (2 ampoules of Ferrum Lek) leads to an increase in hemoglobin concentration, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l). Iron to be replaced (mg) = number of units of blood lost x 200 or Number of ampoules of Ferrum Lek required = number of units of blood lost x 2. If the final hemoglobin level is known: use the following formula, taking into account that deposited iron does not need to be replaced. Iron to be replaced (mg) = body weight (kg) x (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L)) x 0.24. Standard doses. Children: 0.06 ml/kg body weight/day (3 mg iron/kg/day). Adults: 1 - 2 ampoules of Ferrum Lek (100 - 200 mg of iron), depending on the hemoglobin content. Maximum daily doses. Children: 0.14 ml/kg body weight per day (7 mg iron/kg/day). Adults: 4 ml (2 ampoules of Ferrum Lek) per day.
Side effects of Ferrum Lek
Usually well tolerated, side effects are mostly transient and mild. Gastrointestinal disorders such as a feeling of heaviness and fullness in the stomach, distension in the epigastric region, nausea, constipation or diarrhea are very rarely observed. Dark coloration of stool caused by iron supplementation is not clinically significant. With intramuscular administration, arterial hypotension, arthralgia, swollen lymph nodes, fever, headache, dizziness, and infiltrate at the injection site rarely occur; very rarely - anaphylactic and anaphylactoid reactions.
Special instructions for the use of the drug Ferrum Lek
1 tablet contains 0.04 XE, 1 ml of syrup - 0.04 XE. Each Ferrum Lek tablet contains 1.5 mg of aspartame (a precursor to phenylalanine), and may therefore have an adverse effect on patients with phenylketonuria. In controlled trials, the use of the drug in the second and third trimester of pregnancy did not have a negative effect on the fetus. Iron is released into breast milk in the form of a complex with lactoferrin, only a small amount of iron from the complex of iron (III) hydroxide with polymaltose passes into breast milk in ionized form, so the occurrence of side effects in an infant when the mother takes Ferrum Lek is unlikely. Parenteral administration of iron preparations can cause the development of allergic reactions. For an allergic reaction of moderate severity, the administration of antihistamines is recommended. If an anaphylactic reaction develops, immediate administration of epinephrine is indicated. The risk of developing anaphylaxis is quite high in patients with asthma, Crohn's disease, polyarthritis, reduced iron binding capacity and/or folic acid deficiency.
FERRUM-LEK CHEWABLE TAB 100MG N50
Inside,
during or immediately after meals.
Ferrum Lek® chewable tablets can be chewed or swallowed whole.
The daily dose can be divided into several doses or taken at one time.
Ferrum Lek® syrup can be mixed with fruit or vegetable juices or added to baby food.
Doses and duration of treatment depend on the degree of iron deficiency.
The measuring spoon included in the package is used for precise dosing of Ferrum Lek® syrup.
Iron-deficiency anemia
Duration of treatment is about 3–5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under one year of age
: 2.5 ml (? measuring spoon) - 5 ml (1 measuring spoon) Ferrum Lek® syrup per day.
Children aged 1 to 12 years
: 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
: 1–3 chewable tablets or 10–30 ml (2–6 scoops) Ferrum Lek® syrup.
Latent iron deficiency
The duration of treatment is about 1–2 months.
Children aged 1 to 12 years
: 2.5–5 ml (1/2–1 scoop) Ferrum Lek® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
: 1 table. or 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Pregnant women
Iron-deficiency anemia
: 2–3 chewable tablets per day or 20–30 ml (4–6 scoops) of Ferrum Lek® syrup until hemoglobin levels normalize. After this, you should continue to take 1 chewable tablet or 10 ml (2 scoops) of syrup per day, at least until the end of pregnancy to replenish iron stores in the body.
Latent iron deficiency and prevention of iron deficiency
: one chewable tablet or 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency in the body
| Patients | Form of the drug | Iron-deficiency anemia | Latent iron deficiency | Preventing iron deficiency |
| Children under 1 year | Syrup | 2.5–5 ml (25–50 mg iron) | — | — |
| Children 1–12 years old | Syrup | 5–10 ml (50–100 mg iron) | 2.5–5 ml (25–50 mg iron) | — |
| Children over 12 years old, adults, nursing mothers | Chewable tablets | 1–3 tables | 1 table | — |
| Syrup | 10–30 ml (100–300 mg iron) | 5–10 ml (50–100 mg iron) | — | |
| Pregnant women | Chewable tablets | 2–3 tables | 1 table | 1 table |
| Syrup | 20–30 ml (200–300 mg iron) | 10 ml (100 mg iron) | 5–10 ml (50–100 mg iron) |
(-) Due to the fact that this group of patients requires low doses of iron, it is not recommended to use tablets or syrup in these cases.
V/m
(only).
Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4–1/2 amp. Ferrum Lek® (25–50 mg iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose can be administered within 15 minutes.
Doses of Ferrum Lek® must be selected individually, in accordance with the general iron deficiency, which is calculated using the following formula:
Total iron deficiency = body weight (kg) ? (calculated hemoglobin level (g/l) ? actual hemoglobin level (g/l) ? 0.24) + deposited iron (mg)
Body weight up to 35 kg: estimated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg
Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg
Factor 0.24 = 0.0034? 0.07? 1000
(Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g to mg).
Example
Patient body weight: 70 kg
Real hemoglobin concentration: 80 g/l
Total iron deficiency = (150 × 80) ? 0.24 + 500 = 1700 mg iron
Total number of Ferrum Lek® ampoules to be administered = Total iron deficiency (mg) / 100 mg
Calculation of the total number of Ferrum Lek® ampoules that must be administered, based on the actual hemoglobin concentration and body weight
| Body weight, kg | Total number of Ferrum Lek® ampoules for administration | |||
| Hb 60 g/l | Hb 75 g/l | Hb 90 g/l | Hb 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 of Ferrum Lek® exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days).
If hematological parameters do not change 1–2 weeks after the start of treatment, the diagnosis should be clarified.
Calculation of the total dose for iron replacement due to blood loss
The required amount of the drug to compensate for post-hemorrhagic iron deficiency is calculated using the following formula.
If the amount of blood lost is known: administration of 200 mg IM (2 amps of Ferrum Lek®) leads to an increase in hemoglobin levels, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).
Iron to be replaced (mg) = number of units of blood lost ? 200 or the required number of Ferrum Lek® ampoules = number of lost units of blood? 2.
If the final hemoglobin level is known, the following formula must be used, taking into account that deposited iron does not need to be replaced.
Iron to be replaced (mg) = body weight (kg) ? (calculated hemoglobin level (g/l) ? actual hemoglobin level (g/l) ? 0.24.
A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1.5 ampoules of Ferrum Lek®.
Standard doses
Children: 0.06 ml/kg/day (3 mg iron/kg/day).
Adults: 1–2 amp. Ferrum Lek® (100–200 mg iron), depending on the hemoglobin level.
Maximum daily doses
Children: 0.14 ml/kg/day (7 mg iron/kg/day).
Adults: 4 ml (2 amps) per day.
Interactions of the drug Ferrum lek
Do not mix the solution for intramuscular administration with other medications; Like other iron preparations for parenteral use, Ferrum Lek is not prescribed simultaneously with iron preparations for oral administration. The interval between parenteral use of the drug and the start of use of oral dosage forms of iron should be at least 5 days. Since iron is included in the drug in the form of a complex of iron (III) hydroxide with polymaltose, when taken in the form of chewable tablets or syrup, it does not form insoluble chelate compounds with components of food products (phytin, oxalates, tannin) or medicines (tetracyclines, antacids ).
Ferrum lek overdose, symptoms and treatment
With parenteral administration, hemosiderosis may develop. Incorrect diagnosis of anemia as iron deficiency can lead to iron overdose. In case of an overdose of tablets or syrup, symptoms of acute poisoning can develop in extremely rare cases, since iron from HPA is absorbed not through passive diffusion, but through active transport, and the degree of absorption of iron from HPA directly depends on the severity of iron deficiency. Treatment is symptomatic; a specific iron antidote is the chelating agent deferoxamine.
