Hemofer® Prolongatum (Hemofer® prolongatum)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron sulfateIron sulfate
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  • Hemofer® Prolongatum
    pills inwards 
    GlaxoSmithKline Trading, ZAO     Russia
  • Tardiferon®
    pills inwards 
    Pierre Fabre Medication Production     France
    • Dosage form: & nbsppills
    Composition:

    Components

    Content in 1 dragee (mg / dragee)

    Core

    Active substance:

    The iron sulfate monohydrate

    325,0*

    Excipients:

    Lactose Monohydrate

    11,1

    Methacrylate ammonium copolymer

    32,5

    Talc

    7,6

    Magnesium stearate

    3,8

    Mass of the core

    380,0

    Shell

    Sucrose

    145,96

    Talc

    63,48

    Acacia gum

    8,74

    Gelatin

    1,34

    Color Ponso 4R (E 124)

    0,48

    Capol 1295 **

    0,168

    Shell Weight

    220,0

    Weight of a tablet

    600,0

    * equivalent to 105 mg of iron ion (II) (Fe2+).

    ** Capol 1295 - a mixture of waxes for polishing (grinding) the shell dragees.

    Description:

    Two-convex round-shaped pellets coated with a red shell, the core of the dragee is yellowish or grayish-white in color.

    Pharmacotherapeutic group:The iron preparation
    ATX: & nbsp

    B.03.A.A.07   Iron sulfate

    Pharmacodynamics:

    Mechanism of action

    Iron is necessary for the formation of hemoglobin, myoglobin and ironporphyrinic enzymes involved in cellular respiration (cytochromes, catalase, peroxidase). Part of the iron is used directly for the synthesis of hemoglobin, the rest of iron is deposited in the body (mainly,in the liver and spleen) in the form of ferritin and hemosiderin.

    Pharmacodynamic effects

    Iron is released from the dragee during its passage through the gastrointestinal tract (GIT).

    The medicinal form of the preparation ensures a uniform and gradual release of iron ions (Fe2+), which promotes absorption and reduces its irritant effect on the mucosa of the gastrointestinal tract.

    Pharmacokinetics:

    Suction

    Absorption of iron increases with the depletion of its stores in the liver, spleen and bone marrow or with the strengthening of erythropoiesis. At a high concentration of iron in the serum, its absorption decreases. In individuals with iron deficiency, its absorption is 10-30% and is proportional to the degree of iron deficiency. In the absence of iron deficiency in the body absorbs 5-15% of iron consumed.

    Absorption of iron occurs mainly in the duodenum and in the upper parts of the small intestine.

    Distribution and Metabolism

    Only bivalent iron (Fe2+) is able to penetrate into the enterocytes of the small intestinal mucosa, where it binds to the carrier protein transferrin, thus forming a pool of transport iron.Transport iron, depending on the needs of the body, is transferred in the form of an iron-transferrin complex either to the reserve iron pool (liver, spleen, bone marrow) or to the functional iron pool (hemoglobin, myoglobin, respiratory enzymes). The binding of iron with proteins is 90% or more (most with hemoglobin and in smaller - with myoglobin, transferrin, ferritin and hemosiderin). Iron is deposited in the body in the form of ferritin or hemosiderin (mainly in hepatocytes, in the reticuloendothelial system and in the muscles).

    The half-life (T1/2) of iron is 6 hours.

    Excretion

    Iron can accumulate in the body, reaching toxic concentrations. Small amounts of iron are continuously removed through the skin, hair, nails, with sweat, and also through the intestine, with breast milk (0.5-1 mg per day), menstrual blood and kidneys.

    In healthy adults, the average daily loss of iron is: 1 mg in men and women in the postmenopausal period and 1.5-2 mg in healthy women who have not reached menopause.

    Indications:

    Prevention and treatment of iron deficiency anemia.

    Contraindications:
    • Hypersensitivity to any of the components of the drug;
    • hemosiderosis, hemochromatosis;
    • anemia, not associated with iron deficiency (including hemolytic anemia, thalassemia);
    • violation of iron utilization (lead anemia, sideroblastic and hemolytic anemia); stenosis of the esophagus and / or obstructive changes in the digestive tract; peptic ulcer of the stomach and duodenum in the stage of exacerbation;
    • malabsorption syndrome;
    • Late skin porphyria;
    • multiple blood transfusions;
    • application of iron preparations for parenteral administration;
    • children's age till 12 years;
    • intolerance to fructose, galactose, deficiency of sucrose-isomaltase or glucose-galactose malabsorption.
    Carefully:

    The drug contains cochineal carmine (E 124), which can cause allergic reactions.

    Concomitant pathology

    Care should be taken when prescribing the drug with the following concomitant diseases:

    • hepatitis or liver dysfunction;
    • kidney disease;
    • inflammatory bowel disease;
    • alcoholism;
    • allergic diseases;
    • rheumatoid arthritis;
    • peptic ulcer of the stomach and duodenum.

    Gastrointestinal disorders

    The use of iron in a daily dose of more than 4 mg / kg body weight per day can cause unwanted effects from the gastrointestinal tract.

    Patients with difficulty swallowing

    This drug should be used with caution in patients with difficulty swallowing because of the risk of developing stomatitis and ulcers of the oral mucosa due to delayed pellet residues in the oral cavity.

    Pregnancy and lactation:

    Pregnancy

    Pregnant women are recommended to take iron in combination with folic acid, so iron monotherapy with sulfate is not enough for pregnant women.

    In the 1st trimester of pregnancy a well-balanced diet ensures the intake of a sufficient amount of iron. In the 2nd and 3rd trimesters of pregnancy, the need for iron increases, and it is recommended to fill its deficiency from the outside. If it is necessary to use iron-containing drugs during the first 13 weeks of pregnancy, such medications should be taken under medical supervision.

    Clinical studies of the safety of the use of the drug during pregnancy have not been conducted, but no adverse effects on the fetus have been reported as a result of the use of iron in therapeutic doses by pregnant women.

    Lactation

    Clinical studies of the safety of the drug during lactation were not carried out, but no adverse effects were reported on infants due to the use of iron in therapeutic doses by lactating women.

    Dosing and Administration:For oral administration.

    The use of the drug between meals or on an empty stomach ensures maximum absorption of iron; However, when taking the drug on an empty stomach undesirable phenomena from the gastrointestinal tract develop more often, in case of development of undesirable phenomena on the part of the digestive tract, the drug should be taken immediately after meals.

    Adults and children over 12 years of age
    The following doses are usually used:

    For the prevention of iron deficiency - I pills a day,

    To treat iron deficiency - 2 tablets per day between meals, at regular intervals.

    Special patient groups

    Elderly patients

    Older patients may need to administer the drug at higher doses due to a decrease in their iron absorption as a result of a decrease in gastric secretion and a decreased acidity of the gastric juice.

    Patients with impaired renal function

    Caution should be exercised when used in patients with kidney disease.

    Patients with impaired hepatic function

    Caution should be exercised when used in patients with liver disease.

    Relationship with food intake

    Consumption of tea, coffee, eggs, food or medicines containing bicarbonates, carbonates, oxalates or phosphates, as well as milk or dairy products, wholemeal bread, cereal flakes, or other fiber-containing products may reduce iron absorption. In this regard, iron-containing preparations for oral administration should not be taken within 1 hour before or 2 hours after taking the above drugs or food.

    Duration of treatment

    Depending on the degree of iron deficiency, the duration of treatment can be from 2 weeks to 6 months. The duration of treatment or prevention is set individually.

    Side effects:

    The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1 / 10), often (≥1 / 100 and <1/10),infrequently (≥1 / 1,000 and <1/100), rarely (≥ 1 / 10,000 and <1 / 1,000), very rarely (<1/10 000, including individual cases) is unknown (can not be estimated by data available). Frequency categories were formed on the basis of post-registration observation.

    Although iron preparations are best absorbed on an empty stomach, they can be taken after meals to reduce unwanted reactions from the digestive tract.

    The intensity of unwanted reactions from the gastrointestinal tract depends on the dose.

    The use of the drug with prolonged release, in which a small amount of the drug is released in the stomach, reduces the irritating effect on the gastric mucosa.

    Frequency of occurrence of undesirable reactions

    Immune system disorders

    Unknown: increased sensitivity (the severity of reactions varies from rash, sometimes severe, to anaphylaxis).

    Disorders from the gastrointestinal tract

    Very often: abdominal pain, nausea, diarrhea or constipation (constipation can be caused by prolonged use, especially in elderly patients, and can lead to coprostasis). Unknown: vomiting, pain in the upper abdomen, irritation of the gastrointestinal tract, black stools.

    Overdose:A relatively small overdose of iron can cause symptoms of toxicity.

    There are reports of cases of acute intoxication with iron sulfate intake at a dose of 200-250 mg / kg of body weight to adults and at a dose of 20 mg / kg of body weight by a child.

    Doses from 60 mg of Fe2+/ Kr Body weight is potentially fatal in children.

    Perennial intake of high dosage units if it is not related to the individual needs replenishing iron deficiency, can lead to chronic intoxication with the typical clinical picture of hemochromatosis.

    Symptoms

    Overdose of oral iron preparations can lead to the development of hemosiderosis.

    Symptoms of acute poisoning include nausea, vomiting, abdominal pain, diarrhea, increased capillary permeability, rectal bleeding, dehydration, weakness, palpitations, acute vascular insufficiency, hyperthermia, weak pulse, pale skin, cold clammy sweat. Perhaps the development of hyperglycemia and metabolic acidosis.

    In severe overdosage of drugs iron sustained release first 24-48 hours after administration of the drug can be asymptomatic, and then can develop: lowering blood pressure, coma, liver and kidneys.

    Treatment

    In case of an accidental overdose of the drug, if the patient is conscious and has not had vomiting, it is necessary to call it, resort to medical help and / or go to the poison control center.

    When treating acute poisoning with iron preparations, it is necessary to block as quickly as possible the absorption of iron from the digestive tract. The evaluation of the concentration of serum iron can help in assessing the severity of the poisoning. It is recommended that deferoxamine (a means capable of binding ionized iron). In case of severe overdosage of iron (serum iron concentration exceeds 142 μmol / L) it is necessary to maintain vital functions, intravenous deferoxamine administration.

    Metabolic and cardiovascular disorders should be treated symptomatically.

    Interaction:

    Ascorbic acid

    Joint application with ascorbic acid increases the absorption of iron.

    Penicillamine and zinc salts

    Ferrous sulfate reduces the absorption of penicillamine derivatives and zinc salts.

    Tetracyclines

    The combined use of iron preparations reduces the absorption of tetracycline derivatives.Tetracycline antibiotics also reduce iron absorption, they should be taken 2 hours before or 3 hours after iron supplementation, when joint application is necessary.

    Thyroid hormones

    When oral intake of iron preparations is reduced absorption of levothyroxine (thyroxine), so they should be taken with a time difference of at least 2 hours.

    Methyldopa

    Iron sulfate also reduces the hypotensive effect of methyldopa.

    Entacapone, levodopa

    Ferrous sulphate can also reduce the absorption of entacapone and levodopa.

    Bisphosphonates

    Iron sulphate reduces the absorption of bisphosphonates.

    Antacids, calcium and magnesium preparations, colestyramine

    Absorption of iron can decrease with simultaneous reception of preparations of iron with antacids, preparations of calcium (carbonates and phosphates) and magnesium, and also kolshiraminom. It is not recommended to take the drug for 1 hour before or 2 hours after using the listed medications.

    Quinolones

    At the absorption stage, iron preparations can interact with certain quinolones, (for example, ciprofloxacin, norfloxacin, ofloxacin and levofloxacin), leading to a decrease in serum and urine concentrations.If necessary, quinolones should be taken 2 hours after taking iron preparations.

    Chloramphenicol

    Chloramphenicol can slow the rate of onset of the effect of iron preparations.

    Mycophenolate mofetil

    Iron sulfate reduces the absorption of mycophenolate mofetil. It should be avoided simultaneous application with mycophenolate mofetil.

    Ethanol

    With chronic alcohol consumption, absorption and cumulation of iron in the liver increase and, accordingly, the risk of toxic complications.

    Dimercaprol

    Use with dimercaprol should be avoided.

    Combinations that may require dose adjustment

    When iron sulfate is used, it may be necessary to correct the dose of the following drugs: alendronic acid, captopril, clodronic acid, risedronic acid.

    Special instructions:

    Medical surveillance

    Treatment of any form of anemia should be carried out under the supervision of a doctor. Before starting treatment, it is important to exclude any underlying cause of anemia (eg, gastric erosion, colon cancer).

    Overdose

    Do not exceed the recommended dose.

    Children

    Prolonged use or overdose in children without medical supervision can result in cumulation that has a toxic effect, up to a lethal outcome.

    Laboratory research

    The analysis of feces for latent blood can give false positive results.

    Other

    The use of iron preparations can lead to a temporary change in the color of the teeth and to a darkening of the stool. Dragee particles may be present in the stool, which, however, does not affect the effectiveness of therapy.

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

    This drug does not affect the ability to drive vehicles or any other moving mechanisms.

    Form release / dosage:

    Dragee, 325 mg.

    Packaging:For 10 dragees in a blister of PVC / aluminum foil. For 3 blisters together with instructions for use in a cardboard bundle.
    Storage conditions:

    At a temperature of no higher than 25 ° C, in a dry place.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012020 / 01
    Date of registration:12.05.2008
    Expiration Date:Unlimited
    Date of cancellation:2017-05-26
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline group of companies GlaxoSmithKline group of companies Unknown
    Information update date: & nbsp26.05.2017
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