Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
A remedy for iron deficiency disorders. The multinucleated 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 weight 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 IV injection at a dose containing 100 mg of iron, C max iron, an average of 538 Ојmol, is reached 10 minutes after the injection. V d of the central chamber almost completely corresponds to the volume of the serum - about 3 liters. V d in 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. T 1/2 - 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.
DOSING MODE
Enter only in / in (slowly drip or jet) or in the venous section of the dialysis system. Not for intravenous 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 EFFECT
From the nervous system: very rarely - dizziness, headache, loss of consciousness, paresthesia.
On the part of the cardiovascular system: very rarely - palpitations, tachycardia, lowering blood pressure, collapsoid 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 extremities.
Allergic reactions: very rarely - anaphylactoid reactions, edema 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.
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.
PREGNANCY AND LACTATION
Contraindicated in the first trimester of pregnancy.
Limited experience in pregnancy showed no adverse effects of iron sugarate on pregnancy and fetal / newborn health. To date, there have not been well-controlled studies in pregnant women.
In experimental studies of the effect on reproduction, no direct or indirect adverse effects on embryo / fetal development, childbirth, or postnatal development have been observed in animals.
The intake of unmetabolized iron saccharate in breast milk is unlikely. It is believed that this drug is not dangerous for infants who are breastfed.
SPECIAL INSTRUCTIONS
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; patients with hepatic impairment, with acute or chronic infectious diseases, with an elevated serum ferritin content due to the fact that iron during parenteral administration may have adverse effects in the presence of a bacterial or viral infection.
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).
In / in iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life-threatening.
A higher incidence of undesirable adverse reactions (especially BP reduction), which may also be severe, is associated with an increase in dose.
DRUG INTERACTION
Do not use concomitantly with the medicinal forms of iron for oral administration. decreases the absorption of iron from the digestive tract. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection.
