Actyferrin (Aktiferrin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron sulfate + SerineIron sulfate + Serine
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  • Actyferrin
    capsules inwards 
    Teva Pharmaceutical Enterprises Co., Ltd.     Israel
    • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    Active substances:

    Iron sulfate 113.85 mg (corresponding to iron II) 34.50 mg, D, L-serine 129.00 mg.

    Excipients:

    Lecithin (E322) 10.00 mg, rapeseed oil 142.15 mg, soya bean oil, hydrogenated 7.50 mg, soya beans partially hydrogenated oil 30.00 mg, beeswax yellow 7.50 mg.

    Capsule shell:

    Gelatin 161.64 mg, glycerol (85%) 40.23 mg, sorbitol 26.27 mg, iron dye oxide black (E172) 2.16 mg, iron oxide red oxide (E172) 0.90 mg.

    Description:

    Oblong opaque soft gelatin capsules № 6 of dark brown color. The contents of capsules are buttery paste of light beige color.

    Pharmacotherapeutic group:The iron preparation
    ATX: & nbsp

    B.03.A.E.10   Iron preparations in combination with other drugs

    Pharmacodynamics:

    Iron is the most important microelement of the body. As coenzyme of cytochrome oxidase, catalase and peroxidase, as well as a component of hemoglobin, myoglobin and cytochromes, it is involved in a variety of metabolic processes.

    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. The level of absorption of iron is on average 10%, so to meet the need for iron, the dose with oral intake should exceed the daily requirement by 10 times.

    The total iron content in adults is 3-5 g, the newborn - from 0.2 g to 0.3 g. About 60% of this amount is included in the hemoglobin of erythrocytes and participates in the transport of oxygen. Approximately 1 g is found in the cells of the reticuloendothelial system (RES) of the liver, spleen, bone marrow, in the form of hemosiderin or ferritin - (mobilized forms). Plasma iron transport is about 4 mg. Every day, 25 mg of iron, which is formed as a result of hemopoiesis, mainly as a result of the destruction of red blood cells, is transferred to the bone marrow.

    Pharmacokinetics:

    After oral administration, about 10-15% of the ferrous iron is absorbed in the 12-finger and jejunum. Absorption of iron is also possible through the mechanism of passive diffusion. Absorption of iron significantly increases with its deficiency and with increased erythropoiesis. In patients with a low hemoglobin level and a depleted iron depot, absorption can increase to 50-60% and decrease with normalization of these parameters. The peak plasma concentration of iron is reached in 2-4 hours after administration.

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

    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.

    The daily loss of iron is 1 mg and is carried out through desquamation of epithelial and mucosal cells with bile and urine. During menstruation, approximately 1 mg of iron is lost.

    A significant amount of iron that is released during the destruction of hemoglobin (20-30 mg daily) is re-assimilated in the body, mainly for the synthesis of hemoglobin.

    Indications:Treatment of iron deficiency.
    Contraindications:
    • hypersensitivity to the active or auxiliary components of the drug;
    • violations of iron absorption (sidero-sacrificial anemia, lead anemia, thalassemia);
    • elevated iron content in the body (hemochromatosis, hemolytic anemia);
    • anemia not related to iron deficiency;
    • congenital intolerance to fructose, a deficiency of sucrose-isomaltase, glucose-galactose malbosorption syndrome;
    • allergic reactions to soybean oil and peanut butter.
    Carefully:

    Caution should be exercised in the joint use of iron preparations with dietary products and additives containing iron salts (possible risk of overdose).

    In patients with inflammation and ulcers of the gastrointestinal mucosa, the relationship between the benefits of treatment and the risk of exacerbations of gastrointestinal diseases should be evaluated against the background of iron therapy.

    Pregnancy and lactation:

    Preclinical studies have no effect on reproductive function. Application during pregnancy and during lactation is possible if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

    Dosing and Administration:

    Adults and adolescents, over 50 kg of body weight: 1 capsule once or twice a day.

    Children (20 - 50 kg body weight): 1 capsule once a day.

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

    Threshold values, below or above which iron deficiency, are accepted as requiring treatment:


    Children

    Children of school age, adults

    Hb (r%)

    <11

    <12

    Erythrocytes (million / mm)З)

    <3,5

    <4,0

    Reticulocytes (%)

    >15

    >15

    Serum Fe (μg%)

    <60

    <80

    Total iron content = transferrin (μg%)

    >380

    >400

    Mean erythrocyte hemoglobin (pg)

    <25

    <30

    The average volume of red blood cells

    <30

    <30

    Actiferrin capsules should be swallowed whole, without chewing, and washed down with a small amount of liquid. Take half an hour before meals, between meals, with fruit juice containing vitamin C to improve absorption of iron.

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

    To ensure an adequate response, iron therapy should last at least 8 weeks. With the subsequent normalization of indicators Hb treatment should be extended for the next 6-8 weeks to replenish the iron depot.

    Indicators of monitoring

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

    Side effects:

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

    From the gastrointestinal tract: very rare (<1/10 000) constipation.

    When taking iron-containing drugs, stools may be stained dark (black), 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 dose during the treatment.

    Overdose:

    Symptoms

    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: nausea, vomiting, diarrhea, severe abdominal pain.

    In severe cases: collapse, drowsiness, oliguria and shock.

    There may be jaundice due to toxic hepatitis, in some cases - disorders of the central nervous system, such as paralysis, convulsions, coma. Blood clotting disorders occur rarely.

    Treatment

    Before carrying out specific therapy - measures to remove the drug from the digestive tract (for example, causing vomiting, washing the stomach with bicarbonate and phosphate buffer solutions) followed by the appointment of a raw egg, milk inside.

    Specific therapy:

    When the concentration of serum iron is higher than 300-350 mg / dl, intravenous drip 1 -2 g deferoxamine (Desferal) at a rate of 15 mg / kg body weight per hour.

    Patients with oligo- and anuria with an overdose of iron salts are prescribed hemodialysis.

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

    Special measures: with severe intoxication - DTPA (calcium diethylenetriamine pentaacetate) parenterally.

    Because of the potential for the formation of neurotoxic complexes, caution should be used diethylenetriaminepentaacetate calcium (Dimercaprol).

    Interaction:

    At simultaneous application of an iron salt reduce absorption of such preparations as tetracyclines, inhibitors of gyrase (for example, ciprofloxacin, levofloxacin, norfloxocin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa.

    Iron salts reduce the absorption of thyroxin in patients receiving thyroxine-replacement therapy.

    Iron salts reduce the absorption of zinc.

    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 non-steroidal anti-inflammatory drugs can enhance the damaging effect of iron on the mucosa of the gastrointestinal tract.

    In children with 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. In the case of simultaneous prescription of drugs, systematic clinical and laboratory monitoring should be carried out.

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

    Vitamin C and citric acid increase the absorption of iron.

    Effect on the ability to drive transp. cf. and fur:

    Not found.

    Form release / dosage:

    Capsules.

    Packaging:

    For 10 capsules in a PVDC / Al-foil blister.

    For 2 or 5 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015041 / 02
    Date of registration:15.12.2008 / 04.08.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp01.07.2017
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