Aktiferrin (Drops, Syrup) Instructions for Use

ATC Code

B03AE10 (Iron preparations in combination with other drugs)

Active Substances

Ferrous sulfate (USP)

Serine (Rec.INN)

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Hematopoiesis stimulant – iron preparation

Pharmacological Action

Iron preparation. Iron is an essential trace element in the body. As a coenzyme of cytochrome oxidase, catalase, and peroxidase, and as a component of hemoglobin, myoglobin, and cytochromes, it is involved in numerous metabolic processes and stimulates erythropoiesis.

The α-amino acid serine included in the preparation promotes more efficient absorption of iron and its entry into the systemic circulation, leading to a rapid restoration of normal iron levels in the body. This ensures better tolerability of the drug and allows for a reduction in the required dose of iron.

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 to meet the iron requirement, the oral dose must exceed the daily requirement by 10 times.

Pharmacokinetics

Absorption

After oral administration, about 10-15% of ferrous iron is absorbed from the duodenum and jejunum. Iron absorption is also possible through the mechanism of passive diffusion. Iron absorption increases significantly with its deficiency and with increased erythropoiesis. In patients with low hemoglobin levels and depleted iron stores, absorption can increase to 50-60% and decrease with the normalization of these parameters. The C_max of iron is reached 2-4 hours after administration.

Distribution

In the blood, iron binds to transferrin and is transported in the trivalent form to sites of hematopoiesis and specific depots. After binding iron to apoferritin, it is deposited in the liver, spleen, and bone marrow in the form of ferritin. Iron crosses the placental barrier, minimal amounts are excreted in breast milk.

Indications

• Treatment of iron deficiency.

ICD codes

Dosage Regimen

Drops

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

Infants average dose is 10-15 drops 3 times/day.

Preschool children average dose – 25-35 drops 3 times/day.

School-age children average dose – 50 drops 3 times/day.

To open the bottle, press the cap down and simultaneously turn it in the direction of the arrow. After using the medicine, set the cap and screw it on tightly (prevents access for children).

Iron deficiency can be approximately calculated by the formula: iron (mg) = body weight (kg) × 3.5 × (16 – hemoglobin level (g%)).

Threshold values below or above which iron deficiency is considered a condition requiring treatment:

To ensure an enhanced response, iron therapy should be long-term and continued for at least 8 weeks; then, after normalization of hemoglobin levels, treatment should be continued for another 6-8 weeks to replenish iron stores.

Monitoring of laboratory parameters

If necessary, the degree of iron deficiency and the subsequent need for iron replenishment should be monitored every 4 weeks using the following laboratory parameters: hemoglobin, erythrocytes, reticulocytes, serum iron, transferrin, mean corpuscular hemoglobin, mean corpuscular volume.

Syrup

Orally.

The daily dose for children over 2 years of age and adults is set at a rate of 5 ml per 12 kg of body weight.

Preschool children (over 2 years): average dose – 5 ml 1-2 times a day.

School-age children: average dose – 5 ml 2-3 times/day.

Adverse Reactions

Allergic reactions : rare (>1/10,000 and <1/1,000) – skin manifestations.

From the digestive system very rare (< 1/10,000) – constipation, diarrhea, abdominal pain, nausea, vomiting. When taking iron-containing drugs, stool may turn dark (black), which has no clinical significance.

Gastrointestinal disorders can be prevented by gradually increasing the dose at the beginning of treatment or by reducing the dose during treatment.

Contraindications

• Hypersensitivity to the components of the drug;
• Impaired iron absorption (sideroblastic anemia, lead anemia, thalassemia);
• Increased iron content in the body (hemochromatosis, hemolytic anemia);
• Anemia not associated with iron deficiency.

With caution, iron preparations should be used with dietary products and supplements containing iron salts (possible risk of overdose). In patients with inflammation and ulcerative lesions of the gastrointestinal mucosa, the benefit of treatment should be weighed against the risk of exacerbations of gastroenterological diseases during therapy with iron preparations.

The drug should not be prescribed to patients with hereditary fructose or galactose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrase-isomaltase deficiency.

Use in Pregnancy and Lactation

Use during pregnancy and lactation is possible if the potential benefit of therapy for the mother outweighs the possible risk to the fetus or breastfed infant.

Use in Hepatic Impairment

Prescribe with caution to patients with hepatitis, hepatic insufficiency.

Use in Renal Impairment

Prescribe with caution to patients with renal insufficiency.

Pediatric Use

For adolescents, the drug is preferably prescribed in the form of capsules, at the beginning of therapy – 1 capsule 2-3 times/day. If the drug is poorly tolerated, the dose is gradually reduced to the maximum tolerated. In this case, the duration of therapy (until hemoglobin normalization) increases. Children over 6 years Aktiferrin is prescribed 1 capsule/day.

Children over 2 years are preferably prescribed the drug in the form of syrup. The daily dose is 5 ml/12 kg of body weight. Average doses for preschool children are 5 ml 1-2 times/day; for school-age children – 5 ml 2-3 times/day.

Newborns and young children Aktiferrin is prescribed in the form of drops. The daily dose is set at a rate of 5 drops/1 kg of body weight; frequency of administration – 2-3 times/day. Average doses for infants are 10-15 drops 3 times/day; for preschool children – 25-35 drops 3 times/day; for school-age children – 50 drops 3 times/day.

Special Precautions

Hepatic or renal insufficiency increases the risk of iron accumulation.

The drug may cause exacerbation of ulcerative and inflammatory bowel diseases.

When using the drug, persistent darkening of teeth is possible.

Effect on ability to drive vehicles and operate machinery

Not identified.

Overdose

Children have a high risk of intoxication with iron preparations, life-threatening conditions can occur when taking 1 g of ferrous sulfate. Therefore, iron preparations should be stored out of the reach of children.

Symptoms with accidental ingestion of the drug in very high doses: weakness, fatigue, paresthesia, pale skin, cold clammy sweat, decreased blood pressure, palpitations, acrocyanosis, abdominal pain, bloody diarrhea, cyanosis, confusion, weak pulse, hyperthermia, lethargy, convulsive seizures, hyperventilation symptoms, coma. Signs of peripheral vascular collapse appear within 30 minutes after ingestion; metabolic acidosis, convulsions, fever, leukocytosis, coma – within 12-24 hours; acute renal and hepatic necrosis – after 2-4 days.

Treatment before specific therapy, measures should be taken to remove the drug that has not yet been absorbed from the stomach (gastric lavage), give the patient milk, raw egg. Specific therapy is carried out by prescribing deferoxamine (desferal) orally and parenterally. In acute poisoning, to bind iron that has not yet been absorbed from the gastrointestinal tract, 5-10 g of deferoxamine is prescribed orally (dissolve the contents of 10-20 ampoules in drinking water). To remove absorbed iron, deferoxamine is administered intramuscularly slowly, to children – 15 mg/hour, to adults – 5 mg/kg/hour (up to 80 mg/kg/day); in mild poisoning – intramuscularly to children 1 g every 4-6 hours, to adults – 50 mg/kg (up to 4 g/day). In severe cases accompanied by shock, administer 1 g intravenously by drip and carry out symptomatic therapy. Lethal outcome mainly occurs with untimely anti-shock therapy.

Hemodialysis is not effective for removing iron, but can be used to accelerate the elimination of the iron-deferoxamine complex, and can also be prescribed for oligo- and anuria. Peritoneal dialysis is possible.

During course treatment with iron preparations, systematic monitoring of serum iron levels and other blood serum parameters is necessary.

In severe intoxications, unithiol (sodium dimercaptopropanesulfonate) is prescribed parenterally. Due to the possibility of forming neurotoxic complexes, unithiol should be used with caution.

Drug Interactions

Specific antidote – deferoxamine (desferal).

With simultaneous use, iron salts reduce the absorption of drugs such as tetracyclines, gyrase inhibitors (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa.

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

Iron preparations in high doses reduce the renal absorption of zinc preparations (the latter are recommended to be taken 2 hours after taking iron preparations).

Iron absorption is reduced with simultaneous use of cholestyramine, antacids (containing aluminum, magnesium, calcium, bismuth) and supplements containing calcium and magnesium.

Simultaneous use of iron salts and NSAIDs may enhance the damaging effect of iron on the gastrointestinal mucosa.

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

All of the above agents are recommended to be taken 3-4 hours before or after taking Aktiferrin. If simultaneous administration of drugs is necessary, systematic clinical and laboratory monitoring should be carried out.

Tea, coffee, plant foods containing iron-chelating substances (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.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

AKT-RU-00002-DOK-PHARM

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.