SORBIFER® DURULES®

General characteristics. Structure:

Active ingredient: each tablet, coated, contains sulfate of bivalent iron in the quantity equivalent to 100 mg of Fe2 + and 60 mg of ascorbic acid, and also: magnesium powder, carbomer 934 R. Obolochk contain stearate, K-25 povidone, polyethene: gipromelloza, macrogoal 6000, titanium dioxide, ferrous oxide yellow, hard paraffin.

Description: round biconvex tablets, coated light-yellow color, with an engraving of "Z" on one party, on a break a kernel of gray color, with a characteristic smell.

Pharmacological properties:

Pharmacodynamics. Iron - the irreplaceable component of an organism necessary for formation of hemoglobin and course of oxidizing processes in living tissues. Drug is used for elimination of deficit of iron. The technology Durules provides step-by-step release of active ingredient (iron ions) for a long time. The plastic matrix of tablets Sorbifer Durules is completely inert in digestive juice, but completely breaks up under the influence of an intestinal vermicular movement when active ingredient is completely released.

Pharmacokinetics. The Durules is a technology which provides gradual release of active agent (iron ions), uniform intake of medicine. Reception on 100 mg twice a day provides for 30% bigger absorption of iron from drug Sorbifer Durules in comparison with usual iron preparations. Absorption and bioavailability of iron - high. Iron is soaked up preferential in a 12-perstny gut and a proximal part of a jejunum. Communication with proteins of plasma - 90% and more. The insignificant quantity - in the form of a mioglobii in muscles is deposited in the form of ferritin or hemosiderin in hepatocytes and cells of system of the englobing macrophages. The elimination half-life makes 6 h.

Indications to use:

Iron deficiency anemia. Deficit of iron. Preventive use at pregnancy, a lactation and at blood donors.

Route of administration and doses:

Tablets, coated, accept inside. They cannot be divided or chewed. The tablet should be swallowed entirely and to wash down not less than a half of a glass of liquid.

To adults and teenagers:
On 1 tablet 1-2 times a day.
If necessary, the patient with an iron deficiency anemia, it is possible to raise a dose to 3-4 tablets a day for two receptions (in the morning and in the evening) within 3-4 months (before completion of depot of iron in an organism).

At pregnancy and a lactation:
Prevention: on 1 tablet a day.
Medical dose: on 1 tablet 2 times a day (in the morning and in the evening).
Treatment should be continued before achievement of optimum level of hemoglobin. For further replenishment of depot continuation of administration of drug for 2 months can be required.

Features of use:

Darkening a calla is possible that has no clinical value. Pregnancy and the period of a lactation Sorbifer Durules can be applied at pregnancy and feeding by a breast.

Side effects:

Nausea, vomiting, abdominal pains, diarrhea, lock. Frequency of side effects from digestive tract can increase with increase in a dose from 100 to 400 mg. Seldom (<1/100) the following side effects can be observed: gullet canker, gullet stenosis, allergic reactions (itch, rash), skin hyperthermia, headache, dizziness, weakness.

Interaction with other medicines:

The Durules can reduce absorption at the same time applied an enoksatsina, clodronate, a grepafloksatsin, a levodopa, a levofloksatsina, Methyldopums, Penicillaminum, tetracyclines and hormones of a thyroid gland. Simultaneous use of drug Sorbifer Durules and the antiacid drugs containing aluminum hydroxide and magnesium carbonate can reduce iron absorption. Between administration of drug Sorbifer Durules and any of these drugs it is necessary to sustain the greatest possible interval of time. The recommended minimum interval of time between receptions makes 2 hours, except cases of reception of tetracyclines when the minimum interval has to make 3 hours. Sorbifer the Durules should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin

Contraindications:

Hypersensitivity to drug components. Stenosis of a gullet and/or obstructive changes of a digestive tract. The increased content of iron in an organism (a hemosiderosis, hemochromatosis). Iron utilization disturbance (lead anemia, sideroblastny anemia, hemolitic anemia). Children's age up to 12 years (due to the lack of clinical data).

Overdose:

Symptoms: an abdominal pain, vomiting and diarrhea with blood impurity, fatigue or weakness, a hyperthermia, parasthesias, pallor of integuments, a cold clammy sweat, acidosis, a low pulse, a lowering of arterial pressure, heartbeat. At heavy overdose symptoms of a peripheral circulator collapse, a coagulopathy, a hyperthermia, a hypoglycemia, damage of a liver, a renal failure, muscular spasms and a coma can be shown in 6-12 hours.

Treatment: in case of overdose immediately to see a doctor. It is necessary to wash out a stomach, inside crude egg, milk (for binding of ions of iron in a GIT); enter Deferoxaminum. Symptomatic therapy.

Storage conditions:

At a temperature of 15 - 25 °C, in the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, on 30 or 50 tablets in a brown glass bottle. 1 bottle together with the instruction for a medical use is put in a cardboard pack.