Aktiferrin®, drops 30 ml

Pharmacotherapeutic group: iron drug.

The ATX code: B03AE10

Pharmacological action

.Pharmacodynamics

Iron is the body’s most important micronutrient. As a coenzyme of cytochrome oxidase, catalase and peroxidase, as well as a component of hemoglobin (Hb), myoglobin and cytochromes, it is involved in many metabolic processes and stimulates erythropoiesis.

The serine α-amino acid contained in the drug promotes more effective absorption of iron and its entry into the systemic bloodstream, resulting in rapid recovery of its normal content in the body. This provides better tolerability of the drug and reduces the amount of iron required.

The daily requirement for iron in adults is 1-2 mg, in pregnant women 2-5 mg, in children under 7 years of age 0.5-1.5 mg. On average, 10% is absorbed, so in order to meet the need for iron, the dose when taken orally must be 10 times the daily requirement.

Pharmacokinetics

After oral administration, about 10-15% of divalent iron is absorbed in the duodenum and jejunum. Absorption of iron is also possible through the mechanism of passive diffusion. Absorption of iron is significantly increased in iron deficiency and in increased erythropoiesis. In patients with low hemoglobin and depleted iron depot, absorption may increase up to 50-60% and decrease with normalization of these parameters. The maximum concentration of iron is reached 2-4 hours after intake.

In the blood, iron binds to transferrin and is transported in trivalent form to sites of hematopoiesis and to specific depots.

After iron binds to apoferritin, it is deposited in the liver, spleen and bone marrow in the form of ferritin. Iron penetrates the placental barrier and minimal amounts are excreted into breast milk.

Indications

Prevention of iron deficiency, Malnutrition, Weakness and fatigue, AnemiaTreatment of iron deficiency.

Active ingredient

Iron sulfate, Serine

Composition

100 ml contain: active ingredients: iron sulfate heptahydrate 4.720 g, (corresponds to iron II) 0.948 g, D,L-serine 3.560 g; excipients: ascorbic acid 0.8000 g, potassium sorbate 0.1000 g, invert sugar syrup (72.7% TS) 15.1800 g, ethanol (96%) 0.1563 g, cream flavoring 0.0125 g, raspberry flavoring 0.0500 g, purified water 83.4000 g.

How to take, the dosage

If the treating physician has not prescribed a different dose, the instructions below should be strictly followed:

The daily dose is set at the rate of 5 drops per 1 kg of body weight, the frequency of prescription is 2-3 times a day.

Infants: the average dose is 10-15 drops 3 times a day.

Preschool children: the average dose is 25-35 drops 3 times a day.

School-age children: the average dose is 50 drops 3 times a day.

To open the bottle, press the cap down and at the same time turn in the direction of the arrow. After applying the medicine, the cap should be installed and tightly screwed on (prevents access for children).

The iron deficiency can be roughly calculated:

mg iron = kg body weight x 3.5 x (16 – Hb in g %)

Thresholds below or above which iron deficiency is taken as requiring treatment:

.

The duration of treatment depends on the nature and severity of the disease.

In order to ensure a strengthened response, iron therapy should always be prolonged, lasting at least 8 weeks. If Hb values subsequently normalize, treatment should be extended for the next 6-8 weeks in order to replenish the iron depot.

Monitoring Indicators

If necessary, the degree of iron deficiency and subsequent need for iron replacement should be monitored by the following laboratory indicators at intervals of approximately 4 weeks: hemoglobin, erythrocytes, reticulocytes, serum iron, transferrin, mean erythrocyte hemoglobin, and mean erythrocyte volume.

Interaction

The specific antidote is deferoxamine (desferal).

When used concomitantly, iron salts reduce absorption of such drugs as tetracyclines, gyrase inhibitors (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa.

In patients receiving levothyroxine sodium replacement therapy, iron salts decrease its absorption.

High doses of iron preparations decrease renal absorption of zinc preparations (it is recommended to take these 2 hours after taking iron preparations).

The absorption of iron is reduced when colestyramine, antacids (containing aluminum, magnesium, calcium, bismuth), and calcium and magnesium supplements are taken at the same time.

The concomitant use of iron salts and nonsteroidal anti-inflammatory drugs may increase the damaging effects of iron on the gastrointestinal mucosa.

In children, concomitant use of iron reduces the effectiveness of vitamin E.

Therefore, all of the above remedies are recommended to be taken 3-4 hours before or after taking Aktiferrin. Systematic clinical and laboratory monitoring should be carried out if concomitant administration of drugs is necessary.

Tea, coffee, plant foods containing iron-chelating agents (such as phosphates, phytates, oxalates), milk, eggs reduce iron absorption.

Ascorbic acid and citric acid increase iron absorption.

Ethanol increases iron absorption and the risk of toxic complications.

Special Instructions

The use of the drug may cause persistent darkening of the teeth. Hepatic or renal insufficiency increases the risk of iron cumulation. Use of the drug may exacerbate ulcerative and inflammatory bowel disease.

Influence on the ability to drive and operate machinery

There are no identified effects.

Synopsis

Transparent solution from greenish or yellowish-green to yellow-brown or orange-brown in color with a crimson-creamy odor. The test is carried out organoleptically.

Contraindications

– hypersensitivity to the active or excipient components of the drug;

– disorders of iron absorption (sideroachrestic anemia, lead anemia, thalassemia);

– increased iron in the body (hemochromatosis, hemolytic anemia);

– anemia not related to iron deficiency.

Cautions

Caution should be exercised when iron preparations are used concomitantly with dietary products and supplements containing iron salts (possible risk of overdose).

In patients with gastrointestinal inflammation and mucosal ulcers, the benefit ratio of treatment versus risk of gastroenterological exacerbations with therapy with iron should be assessed.

Patients with hereditary fructose or galactose intolerance, lack of lactase, glucose-galactose malabsorption or sucrose-isomaltose deficiency should not take the drug.

Side effects

immune system disorders: rarely (> 1/10 000 and < 1/1000) skin allergic reactions.

Gastrointestinal tract:very rare (< 1/10,000) constipation, diarrhea, abdominal pain, nausea, vomiting.

When taking iron-containing drugs, staining of the stool dark (black) color is possible, which is not clinically significant.

The gastrointestinal disturbances may be prevented by gradually increasing the dose at the beginning of treatment or by reducing the dose during treatment.

Overdose

In children there is a high risk of intoxication with iron preparations, life-threatening conditions can occur when taking 1 g of iron sulfate. Therefore, iron preparations should be kept out of the reach of children.

Symptoms:the following symptoms may occur if very large doses of the drug are taken accidentally: weakness, fatigue, paresthesias, pale skin, cold clammy sweat, decreased blood pressure, palpitations, acrocyanosis, abdominal pain, diarrhea with blood mixed in, cyanosis, confusion, weak pulse, hyperthermia, lethargy, seizures, hyperventilation symptoms, coma.

The signs of peripheral circulatory collapse appear within 30 minutes after ingestion; metabolic acidosis, seizures, fever, leukocytosis, coma within 12-24 hours; acute renal and hepatic necrosis within 2-4 days.

Treatment:before specific therapy – take measures to remove from the stomach the drug has not yet been absorbed (gastric lavage), give milk, raw eggs. Specific therapy is carried out by prescribing deferoxamine (desferal) orally and parenterally. In acute poisoning to bind iron not yet absorbed from the gastrointestinal tract, 5-10 g of the drug are given by dissolving the contents of 10-20 ampoules in drinking water.

In case of poisoning phenomena, deferoxamine is administered slowly in v/m, in children – 15 mg/h, in adults – 5 mg/kg/h (up to 80 mg/kg/day); in mild poisoning – in v/m in children 1 g every 4-6 hours, in adults – 50 mg/kg (up to 4 g/day).

Hemodialysis is ineffective for iron excretion, but can be used to accelerate excretion of the iron-deferoxamine complex, and can also be administered in oligo- and anuria. Peritoneal dialysis may also be used.

The systematic monitoring of serum iron levels and other serum indices is necessary during the course of treatment with iron preparations.

Special measures:in severe intoxication – Unithiol (dimercaptopropane sodium sulfonate) parenterally.

Because of the possibility of formation of neurotoxic complexes, Unityol should be used with caution.

Pregnancy use

Use during pregnancy and lactation is possible if the potential benefit to the mother exceeds the potential risk to the fetus and child.