Iron III hydroxide sucrose complex

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Available since: 2019-09-19

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Clinical Pharmacology

Pharmacotherapeutic group:

Iron preparation

ATH:

B.03.A.C.02 Iron oxide Saharat

Pharmacodynamics:

The multicore centers of iron (III) hydroxide are surrounded on the outside by many non-covalently bound molecules of sucrose. As a result, a complex is formed, the molecular weight of which is approximately 43 kDa, as a result of which its excretion through the kidneys in unchanged form is impossible. This complex is stable and under physiological conditions does not emit iron ions. The structure of the multicore iron-containing nucleus is similar to the structure of the core of ferritin - a physiological depot of iron. This complex is designed to create a controlled source of recyclable iron for transferrin and ferritin, which are responsible for the transport and storage of iron in the body.

After intravenous administration, iron from this complex is captured predominantly by the liver, spleen and bone marrow, and then used to synthesize hemoglobin, myoglobin and other iron-containing enzymes, or is stored in the liver in the form of ferritin.

Pharmacokinetics:

After a single intravenous administration of the Gland [III] preparation, the sucrose complex hydroxide containing 100 mg of iron, the maximum concentration of iron, on average, 538 μmol, is reached 10 minutes after the injection. The volume of distribution of the central chamber almost completely corresponds to the volume of serum (about 3 liters).

The half-life of about 6 hours. The volume of distribution in the equilibrium state is about 8 liters, which indicates a low distribution of iron in the body fluids, due to the low stability of iron of saharat in comparison with transferrin, there is a competitive exchange of iron in favor of transferrin and as a result, 24 About 31 mg of iron is tolerated.

The excretion of iron by the kidneys in the first 4 hours after injection is less than 5% of the total clearance. After 24 hours, the serum iron level returns to its original (before administration) value, and about 75% of sucrose leaves the bloodstream.

Indications

Iron [III] hydroxide sucrose complex is used to treat iron deficiency in the following cases:

if necessary, rapid replenishment of iron;
in patients who do not tolerate oral iron preparations or do not comply with the treatment regimen;
in the presence of active inflammatory bowel disease, when oral iron supplements are ineffective.

Composition

Each ampoule contains:

active ingredient: iron concentrate [III] hydroxide of the sucrose complex in an amount equivalent to 100 mg of iron;

excipients: sodium hydroxide - to adjust the pH to a value from 10.9 to 11.1, water for injection to 5 ml.

Iron III hydroxide sucrose complex is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Iron III hydroxide sucrose complex			solution
Venofer	Vifor (International) Inc	Switzerland	solution
Likferr100	Sotex	Russia	solution

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Dosage and Administration

Introduction: Iron [III] hydroxide sucrose complex is injected only intravenously - slowly with a jet or drip, as well as into the venous area of the dialysis system and is not intended for intramuscular administration. The simultaneous administration of a full therapeutic dose of the drug is unacceptable.

Before the introduction of the first therapeutic dose, you must assign a test dose. If intolerance occurs during the observation period, administration of the drug should be immediately discontinued. Before opening the ampoule, you need to inspect for the presence of possible sediment and damage. You can use only brown solution without sediment.

Drip injection: the preparation of Iron [III] hydroxide sucrose complex is preferable to enter during drip infusion in order to reduce the risk of pronounced reduction in blood pressure (BP) and the risk of solution falling into the near-venous space. Immediately before the infusion, the iron [III] hydroxide sucrose complex complex must be diluted with a 0.9% solution of sodium chloride in a ratio of 1:20 [for example, I ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution]. The resulting solution is injected at the following rate: 100 mg of iron - no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - for 1.5 hours; 400 mg of iron - for 2.5 hours; 500 mg of iron - for 3.5 hours. The administration of the maximum tolerated single dose of 7 mg of iron / kg of body weight should be made for at least 3.5 hours, regardless of the total dose of the drug.

Before the first drip of a therapeutic dose of Iron [III] hydroxide sucrose complex, a test dose must be administered: 20 mg of iron to adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron / kg) to children who have a body weight less than 14 kg, for 15 minutes In the absence of adverse events, the rest of the solution should be injected at the recommended rate.

Injection: The preparation of Iron [III] sucrose hydroxide complex can also be administered as an undiluted solution intravenously slowly, at a rate of (normal) 1 ml of the preparation of Iron [III] sucrose complex hydroxide (20 mg of iron) in one minute (5 ml of the preparation of Iron [ III] hydroxide sucrose complex (100 mg of iron) is introduced at least 5 minutes). The maximum amount of the drug should not exceed 10 ml of the preparation of Iron [III] sucrose hydroxide complex (200 mg of iron) per injection.

Before the first jet injection of a therapeutic dose of Iron [III] hydroxide sucrose complex, a test dose should be administered: 1 ml of the preparation Iron [III] sucrose hydroxide complex (20 mg of iron) to adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron / kg) for children with a body weight of less than 14 kg for 1-2 minutes. In the absence of adverse events over the next 15 minutes of observation, the remaining part of the solution should be injected at the recommended rate. After the injection, the patient is recommended for some time to fix the arm in an extended position.

Introduction to the dialysis system: Iron [III] sucrose hydroxide complex can be administered directly into the venous site of the dialysis system, strictly following the rules described for intravenous injection.

Dose calculation: The dose is calculated individually in accordance with the general iron deficiency in the body but the formula:

Total iron deficiency (mg) = body weight (kg) x (normal level of Hb - patient's Hb) (g / l) x 0.24 * + deposited iron (mg).

For patients with a body weight less than 35 kg: normal level Hb = 130 g / l, the amount of deposited iron = 15 mg / kg body weight.

For patients with a body weight of more than 35 kg: normal level Hb = 150 g / l, the amount of deposited iron = 500 mg.

* Coefficient 0.24 = 0.0034 x 0.07 x 1000 (Iron content in Hb = 0.34%; Blood volume = 7% of body weight; coefficient 1000 = translation “g” to “mg”).

The total amount of the preparation of Iron [III] hydroxide sucrose complex, which must be entered (in ml) = Total iron deficiency (mg) / 20 mg / ml.

Body weight (kg)	Cumulative therapeutic dose of Iron [III] sucrose hydroxide complex for administration:
	Hb 60 g / l		Hb 75g / l		Hb 90 g / l		Hb 105 g / l
	mg Fe	ml	mg Fe	ml	mg Fe	ml	mg Fe	ml
5	160	8	140	7	120	6	100	5
10	320	16	280	14	240	12	220	11
15	480	24	420	21	380	19	320	16
20	640	32	560	28	500	25	420	21
25	800	40	700	35	620	31	520	26