Description
Pharmacological action
An agent for treating iron deficiency conditions. The multinuclear centers of iron (III) hydroxide are surrounded externally by a multitude of non-covalently bound sucrose molecules. As a result, a complex is formed whose molecular weight is approximately 43 kD therefore, its excretion by the kidneys in unchanged form is impossible. This complex is stable and does not emit iron ions under physiological conditions. Iron in this complex is associated with structures similar to natural ferritin.
Pharmacokinetics of
After a single iv injection in a dose containing 100 mg of iron, Cmax of iron, on average 538 Ојmol, is achieved 10 minutes after injection. Vd of the central chamber almost completely corresponds to the volume of serum – about 3 liters. Vd at equilibrium is approximately 8 L (which indicates a low distribution of iron in body fluids). Due to the low stability of sugar iron in comparison with transferrin, there is a competitive exchange of iron in favor of transferrin. As a result, about 31 mg of iron (III) is transferred in 24 hours. T1 / 2 – about 6 hours. In the first 4 hours, less than 5% of the total clearance of iron is excreted by the kidneys. After 24 hours, the serum iron level returns to its original (before administration) value, and approximately 75% of sucrose leaves the vascular bed.
Indications
Iron-deficient conditions: if rapid iron replenishment is necessary if oral iron preparations are intolerant or treatment regimen is not followed in the presence of active inflammatory bowel diseases, when oral iron preparations are ineffective.
Contraindications
Anemia not associated with iron deficiency signs of iron overload (hemosiderosis, hemochromatosis) impaired iron utilization I trimester of pregnancy hypersensitivity to the active substance.
Special instructions
Use with caution in patients with bronchial asthma, eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations in patients with low iron binding capacity of serum and / or folic acid deficiency in patients with liver failure, with acute or chronic infections , with an increased content of ferritin in serum due to the fact that parenteral administration of iron may have an adverse effect in the presence of a bacterial or viral infection.
Used only when the diagnosis of anemia is confirmed by appropriate laboratory data (for example, the results of determination of serum ferritin or hemoglobin and hematocrit levels, the number of red blood cells and their parameters – the average volume of the red blood cell, the average hemoglobin in the red blood cell).
IV iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life-threatening.
A higher incidence of unwanted adverse reactions (especially a decrease in blood pressure), which can also be severe, is associated with an increase in dose.
Composition
1 ml contains:
Active ingredient: iron III (in the form of hydroxide of the sucrose complex) – 20 mg,
Excipients: sodium hydroxide – up to pH 10.5-11.1, water d / and – up to 1 ml.
Dosage and administration
is administered only intravenously (slowly drip or stream) or into the venous section of the dialysis system. Not intended for i / m administration. The simultaneous administration of a full therapeutic dose is unacceptable.
A test dose must be given before the first therapeutic dose. If intolerance occurs during the observation period, the administration should be stopped immediately.
The dose is calculated individually in accordance with the general iron deficiency in the body according to a special formula.
Side effects
From the nervous system: very rarely – dizziness, headache, loss of consciousness, paresthesia.
From the cardiovascular system: very rarely – palpitations, tachycardia, decreased blood pressure, collaptoid states, a feeling of heat, flushing of the face.
On the part of the respiratory system: very rarely – bronchospasm, shortness of breath.
From the digestive system: very rarely – spilled abdominal pain, pain in the epigastric region, diarrhea, taste perversion, nausea, vomiting.
From the skin: very rarely – erythema, pruritus, rash, pigmentation disorders, excessive sweating.
From the musculoskeletal system: very rarely – arthralgia, back pain, swelling of the joints, myalgia, pain in the limbs.
Allergic reactions: very rarely – anaphylactoid reactions, swelling of the face, swelling of the larynx.
General reactions: very rarely – asthenia, chest pain, feeling of heaviness in the chest, weakness, peripheral edema, feeling of malaise, pallor, fever, chills.
Local reactions: very rarely – pain and swelling at the injection site.
active substance
The iron III hydroxide sucrose complex
Terms of delivery from
pharmacies Prescription
dosage form
infusion solution