Iron (III) hydroxide sucrose complex - instructions for use, dose, side effects, contraindications

A remedy for iron deficiency disorders. The multinuclear centers of iron (III) hydroxide are surrounded from the outside by a multitude of non-covalently bound sucrose molecules. As a result, a complex is formed, the molecular mass of which is approximately 43 kD, as a result of which its excretion in the unchanged form is impossible.This complex is stable and does not release iron ions under physiological conditions. Iron in this complex is associated with structures similar to natural ferritin.

Pharmacokinetics:

After a single intravenous administration in a dose containing 100 mg of iron, C_max iron (an average of 538 μmol) is reached 10 minutes after the injection. V_dThe central chamber almost completely corresponds to the volume of the serum - about 3 liters. V_din the equilibrium state is approximately 8 liters (indicating a low distribution of iron in the liquid media of the body). Due to the low stability of iron, sugar compared with transferrin, there is a competitive exchange of iron in favor of transferrin. As a result, about 31 mg of iron (III) is transferred within 24 hours. The half-life is about 6 hours. In the first 4 hours, less than 5% of the total clearance is excreted by the kidneys. After 24 hours, the serum iron level returns to its original (before administration) value, and about 75% sucrose leaves the vascular bed.

Indications:

Iron deficiency: if fast iron is needed; with intolerance of oral iron preparations or non-adherence to the treatment regimen; in the presence of active inflammatory bowel disease, when oral iron preparations are ineffective.

ICD-10

III.D60-D64.D63.0 * Anemia in neoplasm (C00-D48 +)

III.D60-D64.D62 Acute posthemorrhagic anemia

III.D50-D53.D50 Iron-deficiency anemia

IV.E50-E64.E61.1 Insufficiency of iron

Contraindications:

Anemia not related to iron deficiency; signs of iron overload (hemosiderosis, hemochromatosis); violation of the process of iron utilization; I trimester of pregnancy; hypersensitivity to the active substance.

Carefully:

With caution apply in patients with bronchial asthma, with eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations; in patients with low iron-binding capacity of serum and / or deficiency of folic acid; in patients with hepatic insufficiency, with acute or chronic infectious diseases, with an elevated serum ferritin content due to the fact that iron can have adverse effects with parenteral administration in the presence of a bacterial or viral infection.

Pregnancy and lactation:

FDA recommendations in Category B. No human studies. In experiments on animals, there is no evidence of an effect on reproductive function and fetus.The drug is contraindicated in the first trimester of pregnancy. In the II and III trimesters of pregnancy apply only if the intended benefit to the mother exceeds the potential risk to the fetus.

During lactation, the safety of the drug is not established. It is recommended to stop breastfeeding (if necessary, use the drug) or to cancel the drug.

Dosing and Administration:

Enter only intravenously (slowly drip or jet) or into the venous portion of the dialysis system. Not intended for intramuscular administration. Impossible one-stage administration of the full therapeutic dose.

Before the introduction of the first therapeutic dose, it is necessary to prescribe a test dose. If there are intolerance phenomena during the observation period, the administration should be stopped immediately.

The dose is calculated individually according to 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 - palpitation, tachycardia, lowering of arterial pressure, collapoid conditions,a feeling of heat, "flushes" of blood to the face.

On the part of the respiratory system: very rarely - bronchospasm, dyspnea.

From the digestive system: very rarely - distended pain in the abdomen, pain in the epigastric region, diarrhea, taste distortion, nausea, vomiting.

From the skin: very rarely - erythema, pruritus, rash, impaired pigmentation, increased 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.

Common reactions: very rarely - asthenia, chest pain, a feeling of heaviness in the chest, weakness, peripheral swelling, a feeling of malaise, pallor, fever, chills.

Local reactions: very rarely - pain and swelling at the injection site.

Overdose:

Overdose can cause acute overload with iron, which manifests itself with symptoms of hemosiderosis, a decrease in blood pressure (signs of collapse occur within 30 minutes).

Treatment: it is recommended to use symptomatic agents and, if necessary, iron-binding substances (chelates), for example, deferoxamine intravenously.

Interaction:

Do not use simultaneously with the medicinal forms of iron for oral administration, as the absorption of iron from the digestive tract decreases. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection.

You can mix in one syringe only with sterile saline. No other solutions for intravenous administration and therapeutic agents are added, since there is a risk of precipitation and / or other pharmaceutical interactions. Compatibility with containers of other materials than glass, polyethylene and polyvinyl chloride not studied.

Special instructions:

Applied only when confirming the diagnosis of anemia with appropriate laboratory data (for example, serum ferritin or hemoglobin and hematocrit, the number of erythrocytes and their parameters - mean erythrocyte volume, mean hemoglobin in erythrocyte).

Intravenous iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life threatening.

A higher incidence of undesirable adverse reactions (especially lower blood pressure), which may also be severe, is associated with an increase in dose.

It is necessary to avoid penetration of the drug into the circumveneous area, as getting the drug outside the vessel leads to tissue necrosis and brown staining of the skin. If this complication develops, it is recommended (if the needle is still in the vessel) to introduce a small amount of 0.9% sodium chloride solution. To accelerate the excretion of iron and prevent its further penetration into surrounding tissues, it is recommended to apply heparin-containing drugs to the injection site (gel or ointment is applied lightly without rubbing).

It is inadmissible to administer the drug in the presence of sediment.

Instructions

Iron (III) hydroxide sucrose complex (Ferri (III) hydroxidum saccharosum complexum)