Sorbifer Durules (Sorbifer Durules)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron sulphate + Ascorbic acidIron sulphate + Ascorbic acid
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    • Dosage form: & nbspThe tablets covered with a cover.
    Composition:

    Each coated tablet contains ferrous sulfate 320 mg in an amount equivalent to 100 mg of Fe2+ and 60 mg of ascorbic acid, as well as: magnesium stearate, povidone K-25, polyethylene powder, carbomer 934 R. The shell contains: hypromellose, macrogol 6000, titanium dioxide, iron oxide yellow, paraffin hard.

    Description:Round biconvex tablets covered with a light yellow color, engraved "Z" on one side, on the fracture core of gray color, with a characteristic odor.
    Pharmacotherapeutic group:The preparation of iron.
    ATX: & nbsp

    B.03.A.E.03   Iron preparations in combination with multivitamins

    Pharmacodynamics:

    Iron - an indispensable component of the body, necessary for the formation of hemoglobin and the flow of oxidative processes in living tissues. The drug is used to eliminate iron deficiency. Durules technology provides a phased release of the active ingredient (iron ions) for a long time.Plastic matrix tablets Sorbifer Durules completely inert in the digestive juice, but completely disintegrates under the action of intestinal peristalsis, when the active ingredient is completely released.

    Pharmacokinetics:

    Durules is a technology that provides a gradual release of the active substance (iron ions), a uniform intake of the drug. Admission to 100 mg 2 times a day provides a 30% greater absorption of iron from the drug Sorbifer Durules compared with conventional iron preparations.

    Absorption and bioavailability of iron - high. Iron is absorbed mainly in the duodenum and the proximal part of the jejunum. The connection with plasma proteins is 90% or more. Deposited in the form of ferritin or hemosiderin in hepatocytes and cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in the muscles. The half-life is 6 hours.

    Indications:

    Iron-deficiency anemia. Iron deficiency. Preventive use in pregnancy, lactation and blood donors.

    Contraindications:

    • Hypersensitivity to the components of the drug.
    • Stenosis of the esophagus and / or obstructive changes in the digestive tract.
    • Elevated iron content in the body (hemosiderosis, hemochromatosis).
    • Disruption of iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia).
    • Children under 12 years of age (due to lack of clinical data).

    Carefully:Peptic ulcer of stomach and duodenum, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).
    Pregnancy and lactation:

    Sorbifer Durules can be used for pregnancy and lactation.

    Dosing and Administration:

    The tablets covered with a cover, accept inside. They can not be divided or chewed. The tablet should be swallowed whole and washed with at least half a glass of liquid.

    Adults and teenagers:

    1 tablet 1-2 times a day.

    If necessary, patients with iron deficiency anemia can increase the dose to 3-4 tablets per day for 2 doses (morning and evening) for 3-4 months (before replenishing the iron depot in the body).

    In pregnancy and lactation:

    Prophylaxis: 1 tablet a day.

    Therapeutic dose: 1 tablet 2 times a day (morning and evening).

    Treatment should continue until the optimal level of hemoglobin. For further replenishment of the depot, it may be necessary to continue taking the drug for another 2 months.

    Side effects:

    Nausea, vomiting, abdominal pain, diarrhea, constipation. The frequency of side effects from the gastrointestinal tract may increase with increasing doses from 100 to 400 mg.

    Rarely (<1/100) the following side effects can occur: ulcerative esophagitis, esophageal stenosis, allergic reactions (pruritus, rash), skin hyperthermia, headache, dizziness, weakness.

    Overdose:

    Symptoms: abdominal pain, vomiting and diarrhea with blood, fatigue or weakness, hyperthermia, paresthesia, pale skin, cold sticky sweat, acidosis, weak pulse, lowering of blood pressure, palpitations. In severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma may appear after 6-12 hours.

    Treatment: In case of an overdose, immediately consult a doctor. It is necessary to wash the stomach, inside the raw egg, milk (for binding of iron ions in the digestive tract); introduce deferoxamine. Symptomatic therapy.

    Interaction:

    Sorbifer Durules can reduce the absorption of concurrently used enoxacin, clodronate, grepafloxacin, levodopa, levofloxacin, methyldopa, penicillamine, tetracyclines and thyroid hormones.

    Simultaneous use of the drug Sorbifer Durules and antacid preparations containing aluminum hydroxide and magnesium carbonate can reduce iron absorption. Between taking the drug Sorbifer Durules and any of these drugs should be kept as long as possible. The recommended minimum time interval between doses is 2 hours, except for tetracyclines, when the minimum interval should be 3 hours.

    Sorbifer Durules should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin.

    Special instructions:

    There may be a darkening of the stool, which has no clinical significance.

    Form release / dosage:

    The tablets covered with a cover.

    Packaging:

    For 30 or 50 tablets in a brown glass bottle with a polyethylene lid with a control of the first opening and an accordion-shock absorber.

    1 bottle together with instructions for medical use is put in a cardboard box.

    Storage conditions:

    At a temperature of 15-25 ° C, out of reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N011414 / 01
    Date of registration:07.05.2010
    The owner of the registration certificate:Egis Pharmaceutical Plant OJSCEgis Pharmaceutical Plant OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp05.10.2015
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