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Pharmacological properties

the active component of iron sucrose consists of multinuclear centers of iron (iii) hydroxide, surrounded on the outside by many non-covalently linked sucrose molecules. the mass of the complex reflects the average molecular weight, which is about 43 kda, which is a fairly high rate and this prevents its excretion by the kidneys.

The multi-core center of iron has a structure similar to that of the center of ferritin, which is a physiological iron-containing protein. The complex was designed to provide controlled absorption of iron for transporting iron and preserving proteins in the body (transferrin and ferritin, respectively).

Pharmacokinetics Evaluation of ferrokinetics 100 mg of iron hydroxide sucrose complex indicated 59Fe and 52Fe was conducted among 6 patients with iron deficiency, anemia, renal anemia, or functional iron deficiency. During a period of 2–4 weeks after administration, maximum absorption by red blood cells 59Fe ranged in the range of 59–97%.

Distribution. After iv administration of a single dose of Sufer containing 100 mg of iron, Cmax iron was noted 10 min after administration and reached an average value of 538 mmol / L. The volume of distribution of the central chamber corresponded well with the volume of blood plasma (about 3 l).

The introduced iron was rapidly excreted from the blood plasma, and the final T½ was 6 hours. The distribution volume in equilibrium concentration was 8 liters, which indicates a weak distribution of iron in biological fluids. The iron transported by transferrin was about 31 mg of iron / 24 hours.

Metabolism. After iv administration, iron from the complex is captured predominantly by the liver, spleen and bone marrow. In the second stage, iron is used to synthesize hemoglobin, myoglobin and other iron-containing enzymes, or is stored in the liver as ferritin.

The excretion of iron by the kidneys during the first 4 hours after injection corresponded to less than 5% of the total clearance. After 24 hours, the total concentration of iron in the blood plasma decreased to the initial level (before administration), and the excretion of sucrose by the kidneys amounted to about 75% of the administered dose.

Indications

Iron deficiency conditions:

  • - if necessary, quick replenishment of iron;
  • - patients who cannot tolerate or do not follow the regular intake of oral iron preparations;

    - in the presence of active inflammatory diseases of the digestive tract, when oral iron preparations are ineffective.

Application

The Sufer is entered only in / in. administration can be performed using slow injection, drip iv injection or direct injection into the venous section of the dialysis system. the product is not intended for i / m administration.

Before starting treatment with the first therapeutic dose of Sufer, a test dose should be given. It is necessary to have resuscitation facilities. If during the observation period, which should be at least 15 minutes, no side effects have occurred, you can enter part of the remaining treatment dose.

IV drip. It is advisable to administer the Sufer by drip infusion in order to reduce the risk of developing arterial hypotension and the risk of r-ra getting into the circulatory space.

Immediately before the introduction of Sufer, it is necessary to dilute in 0.9% sodium chloride solution in a ratio of 1:20, for example:

1 ml of Sufer (20 mg of iron) in a maximum of 20 ml of sterile 0.9% sodium chloride solution;

5 ml of Sufer (100 mg of iron) in a maximum of 100 ml of sterile 0.9% sodium chloride solution;

25 ml of Sufer (500 mg of iron) in a maximum of 500 ml of sterile 0.9% sodium chloride solution.

To ensure the stability of the solution, it is not allowed to breed the Sufer in larger than recommended volumes of the physiological solution.

The resulting solution is recommended to be administered at a rate of:

100 mg of iron for at least 15 minutes;

200 mg of iron for at least 30 minutes;

300 mg of iron for 1½ hours;

400 mg of iron for at least 2½ hours;

500 mg of iron for at least 3½ hours

The introduction of the maximum permissible single dose of 7 mg of iron per 1 kg of body weight should be carried out for at least 3.5 hours, regardless of the total dose of the drug. In the form of infusion, the maximum tolerated dose should be prescribed no more than 1 time per week.

Before starting the first drip infusion, it is necessary to conduct a test dose: 20 mg of iron for adults and children weighing more than 14 kg and half the daily dose (1.5 mg of iron / kg body weight) for children weighing less than 14 kg for 15 minutes. In the absence of adverse events, the remaining portion of the solution can be administered at a recommended rate.

In / in the jet introduction. The Sufer can be introduced slowly in the form of an undiluted solution at a rate of 1 ml / min (5 ml of Sufer (100 mg of iron) is administered in 5 minutes), but the maximum volume of the solution should not exceed 10 ml of Sufer (200 mg of iron) per 1 an injection.

Before the introduction, it is necessary to conduct a test dose: for adults and children with a body weight of more than 14 kg - 1 ml (20 mg of iron), and for children with a body weight of less than 14 kg - half the daily dose (1.5 mg of iron / kg of body weight) slowly for 1-2 minutes If during the observation period, which lasts at least 15 minutes, no side effects have occurred, you can enter the remainder of the treatment dose.

The Sufer can be injected directly into the venous section of the dialysis system, strictly following the rules described for iv injection.

Dose calculation. The dose is calculated individually in accordance with the total iron deficiency in the patient’s body according to the formula: total iron deficiency (mg) = body weight (kg) · (normal level of Hb (g / l) - patients Hb level (g / l)) · 0, 24 * + deposited iron (mg).

For patients weighing less than 35 kg: the normal level of Hb is 130 g / l, the amount of deposited iron is 15 mg / kg of body weight. For patients weighing more than 35 kg: the normal level of Hb is 150 g / l, the amount of deposited iron is 500 mg.

* Coefficient 0.24 = 0.0034 · 0.07 · 1000 (iron content in Hb = 0.34%, blood volume = 7% of body weight, coefficient 1000 = conversion of “g” to “mg”).

The total amount of Sufer to be administered (ml) = total iron deficiency (mg) / 20 mg / ml.

Body weight Cumulative therapeutic dose of Sufer for administration
HB 60 g / l HB 75 g / l HB 90 g / l HB 105 g / l
Sufer, ml Fe, mg Sufer mg Fe, mg Sufer, ml Fe, mg Sufer, ml Fe, mg
5 8 160 7 140 6 120 5 100
10 16 320 14 280 12 240 11 220
15 24 480 21 420 19 380 16 320
20 32 640 28 560 25 500 21 420
25 40 800 35 700 31 620 26 520
30 48 960 42 840 37 740 32 640
35 63 1260 57 1140 50 1000 44 880
40 68 1360 61 1220 54 1080 47 940
45 74 1480 66 1320 57 1140 49 980
50 79 1580 70 1400 61 1220 52 1040
55 84 1680 75 1500 65 1300 55 1100
60 90 1800 79 1580 68 1360 57 1140
65 95 1900 84 1680 72 1440 60 1200
70 101 2020 88 1760 75 1500 63 1260
75 106 2120 93 1860 79 1580 66 1320
80 111 2220 97 1940 83 1660 68 1360
85 117 2340 102 2040 86 1720 71 1420
90 122 2440 106 2120 90 1800 74 1480

In the case when the full required dose exceeds the maximum permissible single dose, fractional administration of the drug is recommended.

If within 1–2 weeks after the start of treatment no improvement in hematological parameters has been revealed, the initial diagnosis must be reviewed.

Calculation of the dose to replenish the level of iron after blood loss or donation: the dose of Sufer necessary to compensate for iron deficiency is determined by the following formula:

  • if the amount of blood lost is known: iv administration of 200 mg of iron (= 10 ml of Sufer) leads to the same increase in Hb concentration as transfusion of 1 unit of blood (= 400 ml with a Hb concentration of 150 g / l);

amount of iron to be compensated (mg) = number of units of blood lost · 200 or

necessary amount of drug Sufer (ml) = number of units of blood lost · 10.

  • with a decrease in Hb level, the previous formula is used, but it should be borne in mind that it is not necessary to replenish iron depot.

Amount of iron to be compensated (mg) = body weight (kg)· 0,24 · (normal Hb level (g / l) - patients Hb level) (g / l). For example: body weight = 60 kg, deficiency Hb = 10 g / l → the required amount of iron = 150 mg → the required volume of the drug Sufer = 7.5 ml.

Standard dosage. Adults and elderly patients: 5-10 ml of Sufer (100-200 mg of iron) 1-3 times a week, depending on the level of Hb.

Children: there is only limited data on the use of the drug in children. In case of clinical need (for quick replenishment of the body with iron), it is recommended to administer no more than 0.15 ml of Sufer (3 mg of elemental iron) per 1 kg of body weight 1-3 times a week, depending on the level of hemoglobin.

The maximum single dose. Adults and elderly patients:

  • for injections - 10 ml of Sufer (200 mg of iron), the duration of administration is at least 10 minutes, prescribed no more than 3 times a week;
  • for infusion: depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg of iron per 1 kg of body weight and is administered 1 time per week, but it should not exceed 25 ml of Sufer (500 mg of iron). The time of administration of the drug and the method of dilution see above.

Contraindications

Non-iron deficiency anemia (e.g. hemolytic anemia, megaloblastic anemia, erythropoiesis disorders, bone marrow hypoplasia);

oversaturation of the body with iron (hemosiderosis, hemochromatosis) or a violation of the utilization of iron (e.g. siderohrestichnoe anemia, lead poisoning anemia, skin porphyria, thalassemia);

hypersensitivity to the components of the drug;

I trimester of pregnancy.

Side effects

The most common adverse reactions to the drug that have been reported include dysgeusia, arterial hypotension, pyrexia and chills, reactions at the injection site, and nausea that occurred in 0.5–1.5% of patients. anaphylactoid reactions are rare, but may be the most

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