Instruction for use: Aktiferrin

Dosage form: Drops for oral administration; Capsules; syrup

Active substance: Ferri sulfas+Serinum

ATX

B03AE10 Iron preparations in combination with other drugs

Pharmacological groups

Iron preparation [Macro and microelements in combinations]

Iron preparation [Stimulants of hemopoiesis in combinations]

The nosological classification (ICD-10)

E61.1 Insufficiency of iron: Insufficient food intake of iron; Iron deficiency; Iron deficiency in women during pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency after surgery; Latent iron deficiency; Lack of iron during pregnancy and lactation; Inadequate intake of iron from food; Increased need for iron; Increased need for iron during menstruation; Disturbances of iron absorption from the digestive tract; Severe iron deficiency

Composition

Drops for oral administration 100 ml

Active substances: Iron sulphate heptahydrate 4.72 g

(Corresponding to 0.948 g of iron (II)

D, L-serine 3.56 g

Auxiliary substances: ascorbic acid - 0.8 g; Potassium sorbate - 0.1 g; Sugar invert syrup (72.7% TS) - 15.18 g; Ethanol (96%) - 0.1563 g; Flavoring creamy - 0.0125 g; Aroma of raspberry - 0,05 g; Purified water - 83.4 g

Description of dosage form

Transparent solution from greenish or yellowish green to yellowish brown or orange-brown with a raspberry-creamy smell. The test is performed organoleptically.

Pharmachologic effect

Mode of action - Replenishing deficiency of iron, hematopoietic.

Pharmacodynamics

Iron is the most important microelement of the body. As coenzyme of cytochrome oxidase, catalase and peroxidase, and also as an integral part of Hb, myoglobin and cytochromes, it is involved in a variety of metabolic processes, stimulates erythropoiesis. The α-amino acid-serine included in the preparation contributes to a more effective absorption of iron and its entry into the systemic bloodstream, leading to a rapid restoration of its normal content in the body. This provides a better tolerance of the drug and allows you to reduce 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 - 0.5-1.5 mg. On average, 10% is absorbed, therefore, in order to meet the need for iron, the intake dose should exceed the daily requirement by 10 times.

Pharmacokinetics

After oral administration, about 10-15% of bivalent iron is absorbed into the duodenum and jejunum. Iron absorption is possible through a passive diffusion mechanism. Absorption of iron significantly increases with its deficiency and increased erythropoiesis. In patients with a low Hb value and a depleted iron depot, absorption can increase to 50-60% and decrease with normalization of these parameters. Cmax of iron is reached in 2-4 hours after administration.

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

After binding of iron with 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 for the drug Aktiferrin

Treatment of iron deficien

Contraindications

Hypersensitivity to the active or auxiliary components of the drug;

Abnormalities of iron absorption (sideroachrestic anemia, lead anemia, thalassemia);

Increased iron content in the body (hemochromatosis, hemolytic anemia);

Anemia not related to iron deficiency;

Hereditary intolerance to fructose or galactose, absence of lactase, glucose-galactose impairment of absorption or sucrose-isomaltous deficiency.

With caution: simultaneous use of iron preparations with dietary products and supplements containing iron salts (possible risk of overdose); Patients with inflammation and ulcers of the gastrointestinal mucosa (the ratio of the benefits of treatment and the risk of exacerbations of gastrointestinal diseases should be evaluated against the background of iron therapy).

Application in pregnancy and breastfeeding

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

Side effects

From the side of the immune system: rarely (> 1/10000 and <1/1000) - skin allergic reactions.

From the digestive tract: very rarely (<1/10000) - constipation, diarrhea, abdominal pain, nausea, vomiting.

When taking iron-containing preparations, it is possible to stain the feces in a dark (black) color, which has no clinical significance.

Gastrointestinal disorders can be prevented by a gradual increase in dose at the beginning of treatment or by a decrease in the dose during treatment.

Interaction

Specific antidote - deferoxamine (desferal).

With simultaneous application of iron salt, the absorption of such drugs as tetracyclines, gyrase inhibitors (eg ciprofloxacin, levofloxacin, norfloxocin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa is reduced. In patients receiving substitution therapy with levothyroxine sodium, iron salts reduce its absorption.

Large doses of iron drugs reduce renal absorption of zinc preparations (the latter is recommended for 2 hours after taking iron preparations).

Absorption of iron decreases with the simultaneous administration of colestyramine, antacids (containing aluminum, magnesium, calcium, bismuth) and additives containing calcium and magnesium.

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

In children with the simultaneous use of iron reduces the effectiveness of vitamin E. Therefore, all of the above funds should be taken 3-4 hours before or after taking Aktiferrin. If it is necessary to prescribe drugs simultaneously, systematic clinical and laboratory testing should be carried out.

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

Ascorbic acid and citric acid increase the absorption of iron.

Ethanol increases iron absorption and the risk of toxic complications.

Dosing and Administration

Inside.

Deficiency of iron can be approximately calculated by the formula: iron, mg = body weight, kg × 3.5 × (16-Hb in g%).

Threshold values, below or above which iron deficiency is accepted as requiring treatment, are indicated in the table.

Table

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

To ensure an adequate response, iron therapy should last no less than 8 weeks. With subsequent normalization of Hb indices, treatment should be prolonged for the next 6-8 weeks to replenish the iron depot.

Indicators of monitoring. If necessary, the extent of iron deficiency and the subsequent need for iron replacement should be monitored at the following laboratory parameters at intervals of approximately 4 weeks: Hb, red blood cells, reticulocytes, serum iron, transferrin, middle erythrocyte Hb, mean red blood cell volume.

If the doctor has not prescribed other dosages, then follow the instructions given below.

Inside. The daily dose is set at the rate of 5 drops / kg, the frequency of the appointment is 2-3 times a day.

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

Children of preschool age: the average dose is 25-35 drops 3 times a day.

Children of school age: the average dose - 50 drops 3 times a day.

To open the bottle, you must press the cap down and simultaneously turn in the direction of the arrow. After applying the medicine, the cap should be installed and tightened (prevents access for children).

Overdose

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

Symptoms: with the chance of taking very large doses of the drug - weakness, fatigue, paresthesia, pale skin, cold sticky sweat, decreased blood pressure, palpitations, acrocyanosis, abdominal pain, diarrhea with blood, cyanosis, confusion, weak pulse, hyperthermia, Lethargy, convulsive seizures, symptoms of hyperventilation, coma. Symptoms of peripheral circular collapse appear within 30 minutes after administration; Metabolic acidosis, convulsions, fever, leukocytosis, coma - for 12-24 hours; Acute renal and hepatic necrosis - after 2-4 days.

Treatment: before the specific therapy is taken to remove from the stomach is still non-sucking drug (lavage of the stomach), give milk, raw eggs.

Specific therapy is carried out by the appointment of deferoxamine (desferal) inside and parenterally. In acute poisoning for binding of iron, still not sucked from the gastrointestinal tract, give 5-10 g of the drug by dissolving the contents of 10-20 amp. In drinking water. With the development of poisoning phenomena, deferoxamine is administered in / m slowly, to children - 15 mg / h, to adults - 5 mg / kg / h (up to 80 mg / kg / day); With mild poisoning - in / m children 1 g every 4-6 h, adults - 50 mg / kg (up to 4 g / day).

In severe cases, accompanied by the development of shock in patients, 1 / g drip intravenous administration and symptomatic therapy.

Lethal outcome is mainly possible with untimely therapy of patients in the background of shock. Hemodialysis is ineffective for excretion of iron, but can be used to accelerate the excretion of iron-deferoxamine complex, and can also be prescribed for oligo- and anuria. It is also possible to use peritoneal dialysis. At course treatment with iron preparations, systematic monitoring of serum iron and other serum levels is necessary.

Special measures: with severe intoxication - Unithiol (sodium dimercaptopropanesulfonate) parenterally.

Because of the possible formation of neurotoxic complexes, Unithiol (sodium dimercaptopropanesulfonate) should be used with caution.

Special instructions

When applying the drug, persistent darkening of the teeth is possible. Hepatic or renal insufficiency increases the risk of cumulation of iron. The use of the drug can exacerbate ulcerative and inflammatory bowel diseases.

Influence on the ability to drive vehicles and control cars and mechanisms. Not found.

Release form

Drops for oral administration. In a bottle of dark glass, sealed with a stopper-dropper and plastic screw cap, 30 ml. 1 fl. Placed in a cardboard box.

Manufacturer

"Merkle GmbH". Ludwig-Merkleshtrasse 3, 89143, Blaubeuren, Germany.

The owner of the registration certificate: Teva Pharmaceutical Enterprises Ltd., Israel.

Address for receiving claims: 119049, Moscow

Conditions of supply of pharmacies

On prescription.

AKT-RU-00001-DOK-PHARM

Storage conditions of the drug Aktiferrin

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Aktiferrin

2 years.

Do not use after the expiry date printed on the package.