Ferrum Lek, 50 mg/ml 2 ml 50 pcs

Ferrum Lek is an anti-anemic drug.

Pharmacodynamics

Tablets. Syrup. The molecular mass of the complex is so large – about 50 kDa – that its diffusion through the gastrointestinal mucosa is 40 times slower than that of divalent iron. The complex is stable and does not release iron ions under physiological conditions. The iron in the multinuclear active zones of the complex is bound in a structure similar to that of the natural iron compound, ferritin. Because of this similarity, the iron of this complex is absorbed only by active absorption. The iron-binding proteins on the surface of the intestinal epithelium absorb iron (III) from the complex through competitive ligand exchange. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow it is incorporated into hemoglobin.

The iron (III) complex polymaltose hydroxide does not have the pro-oxidant properties of iron (II) salts.

The solution for intramuscular administration. The drug contains trivalent iron in the form of iron trivalent hydroxide complex with dextran. The iron contained in the preparation quickly compensates the lack of this element in organism (in particular, in iron deficiency anemia), restores the content of hemoglobin. Gradual reduction of both clinical symptoms (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory indices of iron deficiency is observed during treatment with the preparation.

Pharmacokinetics

The tablets. Syrup. Double isotope studies (⁵⁵Fe and ⁵⁹Fe) have shown that iron absorption, as measured by hemoglobin levels in erythrocytes, is inversely proportional to the dose taken (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). The greatest degree of iron absorption is in the duodenum and jejunum.

The remaining (unabsorbed) iron is excreted in the feces. Its excretion with the exfoliating cells of the gastrointestinal epithelium and skin, as well as with sweat, bile and urine is approximately 1 mg of iron per day. In women during menstruation there is an additional loss of iron, which must be taken into account.

The solution for intramuscular administration. After intramuscular administration of the drug iron enters the bloodstream rapidly: 15% of the dose – after 15 minutes, 44% – after 30 minutes. The biological T_1/2 is 3-4 days. Iron in complex with transferrin is transported to body cells, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The complex of iron (III) hydroxide with dextran is large enough and therefore is not excreted through the kidneys.

Indications

Dizziness, Prevention of iron deficiency, Bleeding, Weakness and fatigue, Pale skin, Anemia

• Severe iron deficiency due to blood loss;
• disordered absorption of iron in the intestine;
• circumstances in which treatment with oral iron preparations is ineffective or not feasible.

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Composition

Active substance:

Iron (III) hydroxide polyisomaltosate;

Auxiliary substances:

Sodium hydroxide,

Hydrochloric acid (concentrated),

water d/i.

How to take, the dosage

The drug in the form of a solution can only be administered in m/m. The drug is not to be administered intravenously!

Before administering the first therapeutic dose, each patient should receive a test dose of 1/4-1/2 ampoule (25-50 mg of iron) for adults and 1/2 of the daily dose for children. If there are no adverse reactions within 15 minutes after administration, administer the remainder of the initial daily dose.

The doses of Ferrum Lek^® are adjusted individually according to the total iron deficiency calculated according to the following formula:

Total iron deficiency (mg) = body weight (kg) × (calculated Hb level (g/L) – detected Hb (g/L) × 0.24 + deposited iron (mg).

With body weight up to 35 kg: calculated Hb level = 130 g/l, deposited iron = 15 mg/kg body weight.

For body weight over 35 kg: calculated Hb = 150 g/l, deposited iron = 500 mg.

Factor 0.24 = 0.0034 × 0.07 × 1000 (Hb iron content = 0.34%, total blood volume = 7% of body weight, factor 1000 – conversion from g to mg).

Calculating the total number of vials of the drug based on the hemoglobin level detected and body weight

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If the total number of ampoules to be administered exceeds the maximum allowable daily dose, the total number of ampoules should be divided by the required number of days. If haematological parameters do not improve 1-2 weeks after the start of treatment, the diagnosis should be clarified again.

Calculating the total dosage to compensate for iron due to blood loss

If the amount of blood lost is known, the administration of 200 mg of iron (2 ampoules) in an ampoule will result in an increase in hemoglobin equivalent to 1 blood unit (400 ml with 150 g/l hemoglobin content).

The amount of iron to be replenished (mg) = number of blood units lost x 200 or number of ampoules needed = number of blood units lost x 2

If the final hemoglobin level is known, the above formula is used, taking into account that the iron deposited does not need to be replenished.

The amount of iron to be replenished (mg) = body weight (kg) × (estimated Hb level (g/L) – detected Hb level (g/L)) x 0.24

Common doses of Ferrum Lek^®

Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules) depending on hemoglobin levels; 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).

Principles of administration

The drug is injected deeply into the right and left buttocks alternately in a deep, intravenous fashion.

In order to decrease pain and avoid staining of the skin, the following rules must 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 disinfecting the skin, the subcutaneous tissues should be moved down 2 cm to prevent subsequent leakage of the drug;

After the injection, 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 I / M injections, the ampoules should be carefully inspected. Only ampoules containing a homogeneous solution without precipitate should be used. The solution for i/m injection should be used immediately after opening the ampoule.

Interaction

Ferrum Lek ^® for intravenous injection should not be used simultaneously with iron preparations for oral administration.

The concomitant use of the drug Ferrum Lek ^® with ACE inhibitors may increase the systemic effects of parenteral iron drugs.

Special Instructions

The drug should only be used in a hospital setting.

When prescribing Ferrum Lek^® it is necessary to perform laboratory tests: general clinical blood test and determination of serum ferritin levels; iron absorption disorders must be excluded.

The treatment with oral forms of iron-containing drugs should not be started earlier than 5 days after the last injection of Ferrum Lek^®.

The contents of the ampoules should not be mixed with other drugs.

Contraindications

• Pregnancy first trimester;
• Osler-Randu-Weber syndrome;
• infectious kidney disease in the acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis.
• high sensitivity to the components of the drug;
• excess iron in the body (hemochromatosis, hemosiderosis);
• Impaired iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia);
• anemias not related to iron deficiency (e.g. hemolytic, megaloblastic, caused by cyanocobalamin deficiency).

With caution: diabetes mellitus (for syrup); bronchial asthma; chronic polyarthritis; cardiovascular insufficiency; low iron binding capacity and/or folic acid deficiency; childhood age (under 4 months – for solution for intramuscular administration).

Side effects

Digestive system disorders: nausea, vomiting.

CNS disorders: headache, dizziness.

Local reactions: in case of improper technique of drug administration – skin staining, soreness and inflammatory reaction at the injection site are possible.

Others: arterial hypotension, arthralgia, increased lymph nodes, fever, malaise; extremely rare – allergic or anaphylactic reactions.

Overdose

Symptoms: overdose of iron preparations can lead to acute iron overload and hemosiderosis.

Treatment: symptomatic therapy. As an antidote, deferoxamine is administered slowly (15 mg/kg/h) by IV, depending on the severity of the overdose, but no more than 80 mg/kg/day. Hemodialysis is ineffective.

Pregnancy use

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 benefits to the mother exceed the potential risk to the fetus or infant.