Ferrum lek, solution 50mg/ml 2ml ampoules 50pcs

Composition

Active ingredient:

iron (III) hydroxide polyisomaltosate;

Auxiliary substances:

sodium hydroxide,

hydrochloric acid (concentrated),

d/i water.

Pharmacological action

Ferrum Lek is an antianemic drug.

Pharmacodynamics

Pills. Syrup. The molecular weight 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 of the multicore active zones of the complex is bound together in a structure similar to that of the natural iron compound ferritin. Due to this similarity, the iron of this complex is absorbed only by active absorption. Iron-binding proteins located 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.

Iron (III) Complex polymaltose hydroxide does not have the pro-oxidant properties inherent in iron (II) salts.

Solution for intramuscular use. The preparation contains ferric iron in the form of a complex of ferric hydroxide with dextran. Iron, which is part of the drug, quickly makes up for the lack of this element in the body (in particular, in iron-deficient anemia), restores the content of hemoglobin. When treated with the drug, there is a gradual decrease in both clinical symptoms (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory indicators of iron deficiency.

Pharmacokinetics

Pills. Syrup. Studies using the double isotope method (55Fe and 59Fe) showed that iron absorption, measured by the level of hemoglobin in red blood cells, 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). Most iron is absorbed in the duodenum and jejunum.

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

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

Indications

• severe iron deficiency due to blood loss;
• impaired absorption of iron in the intestine;
• conditions in which treatment with iron preparations for oral use is ineffective or impracticable.

Use during pregnancy and lactation

Parenteral use 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 exceeds the potential risk to the fetus or infant.

Contraindications

• First trimester of pregnancy;
• Osler-Randu-Weber syndrome;
• acute infectious kidney diseases;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis.
• hypersensitivity to the components of the drug;
• excess iron in the body (hemochromatosis, hemosiderosis);
• violation of the mechanisms of iron utilization (lead anemia, sideroachrestic anemia, thalassemia);
• anemia not associated with iron deficiency (for example, hemolytic, megaloblastic, caused by a lack of cyanocobalamin).

With caution:  diabetes mellitus (for syrup); bronchial asthma; chronic polyarthritis; cardiovascular insufficiency; low ability to bind iron and / or folic acid deficiency; children’s age (up to 4 months — for intramuscular solution).

Side effects

From the digestive system:  nausea, vomiting.

From the central nervous system:  headache, dizziness.

Local reactions:  if the drug is administered incorrectly, it is possible to cause skin staining, soreness and an inflammatory reaction at the injection site.

Other services:  hypotension, arthralgia, enlarged lymph nodes, fever, malaise; extremely rare – allergic or anaphylactic reactions.

Interaction

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

Concomitant use of Ferrum Lek with ACE inhibitors may increase the systemic effects of parenteral iron preparations.

How to take, course of use and dosage

The drug in the form of a solution can only be administered intravenously. Intravenous use of the drug is not allowed!

Before the first therapeutic dose, each patient should be given a test dose of 1/4-1/2 ampoule (25-50 mg of iron) for an adult and 1/2 daily dose for children. In the absence of adverse reactions within 15 minutes after use, the remainder of the initial daily dose is administered.

Doses of Ferrum Lek® are selected individually in accordance with the total iron deficiency calculated using the following formula: :

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

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

If the body weight is 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

If the total number of ampoules to be administered exceeds the maximum allowable daily dose, then the total number of ampoules should be divided by the required number of days. If the 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 iron replacement due to blood loss

With a known amount of blood lost, intramuscular use 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 required number of ampoules = number of blood units lost x 2

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

Amount of iron to be replaced (mg) = body weight (kg) × (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 level of hemoglobin; 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 of body weight/day).

Rules for drug use

The drug is administered deep in / m alternately in the right and left buttocks.

In order to reduce pain and avoid skin staining, you should follow the following rules::

— the drug should be injected into the upper outer quadrant of the buttock using a needle with a length of 5-6 cm—

– before injection, after disinfection of the skin, the subcutaneous tissues should be moved down 2 cm to prevent subsequent leakage of the drug—

– after use of the drug, the subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 min.

Before applying the solution for intravenous injection, the ampoules should be carefully examined. Only ampoules containing a homogeneous solution without sediment should be used. The solution for intravenous injection should be used immediately after opening the ampoule.

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/h), depending on the severity of overdose, but not more than 80 mg/kg/day. Hemodialysis is ineffective.

Special instructions

The drug should only be used in a hospital setting.

When prescribing Ferrum Lek®, laboratory tests must be performed: a general clinical blood test and determination of serum ferritin levels; it is necessary to exclude a violation of iron absorption.

Treatment with oral forms of iron-containing drugs should begin no earlier than 5 days after the last injection of Ferrum Lek®.

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

Form of production

Solution for intravenous use.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Do not freeze it.

Shelf

life is 5 years.

Active ingredient

Iron III hydroxide dextran

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Nursing mothers as prescribed by a doctor, Pregnant women in the second and third trimester as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Prevention of Iron Deficiency, Bleeding, Anemia