Sorbitrim (Sorbitrim)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron [III] hydroxide dextranIron [III] hydroxide dextran
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    • Dosage form: & nbsptoApli for oral administration
    Composition:

    1 ml of the preparation contains:

    Active substance: iron [III] hydroxide polymaltose - 166.67 mg (equivalent to 50.0 mg of iron [III]).

    Excipients: propylene glycol 100.00 mg; sucrose - 66.67 mg; methyl parahydroxybenzoate - 1.67 mg; propyl parahydroxybenzoate 0.20 mg; Chocolate flavoring - 3,00 mg: purified water - up to 1 ml.

    In 1 ml of 20 drops, 1 drop contains 2.5 mg of iron.

    Description:FThe liquid is brown in color, with a chocolate smell.
    Pharmacotherapeutic group:iron preparation
    ATX: & nbsp

    B.03.A.C   Preparations of iron for parenteral use

    B.03.A.C.06   Iron [III] hydroxide dextran

    Pharmacodynamics:

    In iron [III], the polymethyltosate hydroxide multinucleated iron hydroxide [III] is surrounded on the outside by a number of covalently bound molecules of polymaltosate, which gives a total average molecular weight of about 50 kDa. The structure of the multinucleated iron core [III] is similar to the structure of the core of the ferritin protein, the physiological depot of iron.

    Iron [III] hydroxide polymaltose is stable and in physiological conditions does not emit a large number of iron ions.Because of the size, the degree of diffusion of iron [III] hydroxide of polymalthosate through the mucosa is approximately 40 times less compared to the complex of iron hexavirus [II]. Iron from iron [III] hydroxide of polymaltose is actively absorbed in the intestine.

    Pharmacokinetics:

    Suction

    Iron from iron [III] hydroxide of polymaltose is absorbed in accordance with the controlled mechanism. The increase in serum iron content after administration of the drug is not correlated with total iron absorption, measured as incorporation into hemoglobin (Hb). Studies with a labeled radioisotope of iron [III] hydroxide with polymaltozate revealed a strong correlation between the incorporation of iron in erythrocytes and the iron content throughout the body. The maximum activity of iron absorption from iron [III] hydroxide polymaltose is noted in the duodenum and small intestine. As with other oral iron preparations, the relative absorption of iron from iron [III], the polymethyltosate hydroxide, defined as incorporation into hemoglobin, decreases with increasing iron doses. In addition, there was a correlation between the degree of severity of iron deficiency (in particular,serum ferritin concentration) and the relative amount of absorbed iron (i.e., the greater the iron deficiency, the better the relative absorption). In patients with anemia, absorption of iron from iron [III], polymethyltosate hydroxide, in contrast to iron salts, increased in the presence of food.

    Distribution

    Distribution of iron from iron [III] hydroxide of polymaltosate after absorption was studied in a study using the technique of double isotopes (55Fe and 59Fe).

    Biotransformation

    The absorbed iron binds to transferrin and is used to synthesize hemoglobin in the bone marrow or is stored, mainly in the liver, where it binds to ferritin.

    Excretion

    Non-sucked iron is excreted by the intestine (with feces).

    Indications:

    - Treatment of iron deficiency without anemia (latent iron deficiency) and treatment of clinically pronounced iron deficiency anemia.

    - Prevention of iron deficiency during pregnancy and during breastfeeding; in women of childbearing age, in children, in adolescence and in adults (for example, vegetarians and the elderly).

    Contraindications:

    - An established hypersensitivity to iron [III] hydroxide polymaltozate or to any auxiliary substance.

    - Iron overload (eg, hemosiderosis, hemochromatosis).

    - Impaired iron utilization (eg, lead anemia, sidero-achestic anemia, thalassemia).

    - Anemia not related to iron deficiency (eg, hemolytic anemia or megaloblastic anemia caused by a deficiency in the vitamin You).

    - Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

    Pregnancy and lactation:

    Pregnancy

    To date, there have been no reports of serious adverse reactions after taking the drug Sorbitom inside at therapeutic doses in the treatment of anemia during pregnancy. The data obtained from animal studies showed no danger to the fetus and the mother. Data of clinical studies on the use of the drug Sorbitrim in the I trimester of pregnancy are absent.

    In studies conducted in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of the drug Sorbitrim against mothers and / or newborns were found.In this regard, the adverse effect on the fetus when using the drug Sorbitrim is unlikely.

    Breastfeeding period

    Breast milk of a woman contains iron, associated with lactoferrin. The amount of iron transferred from iron [III] hydroxide of polymaltosate into breast milk is unknown. It is unlikely that the use of Sorbitrim with women breastfeeding can lead to undesirable effects in the child.

    As a precaution, women of childbearing age and women during pregnancy and breastfeeding should take the drug Sorbitrim only after consulting a doctor. It is recommended that the benefit / risk ratio be evaluated.

    Dosing and Administration:

    For oral administration.

    The daily dose can be divided into several doses or taken at a time.

    Sorbitrim should be taken during or immediately after meals. Sorbitrim can be mixed with fruit and vegetable juices, or with baby food, or a baby formula, or non-alcoholic drinks. Light coloring of the mixture does not affect the taste of juice / baby food, nor the effectiveness of the drug.

    The daily dose of the drug depends on the degree of iron deficiency (see table of daily doses).

    Table of daily doses for children and adults according to age

    Category patients

    Treatment iron deficiency anemia

    Treatment deficiency of iron without anemia

    Prevention of iron deficiency

    Premature babies

    1-2 drops (2.5-5 mg of iron) per kg of body weight

    -

    -

    Children under 1 year old

    10-20 drops (25-50 mg of iron)

    6-10 drops (15-25 mg of iron)

    2-4 drops (5-10 mg of iron)

    Children from 1 to 12 years old

    20-40 drops (50-100 mg of iron)

    10-20 drops (25-50 mg of iron)

    4-6 drops (10-15 mg of iron)

    Children over 12 years, adults and women breastfeeding

    40-120 drops (100-300 mg of iron)

    20-40 drops (50-100 mg of iron)

    4-6 drops (10-15 mg of iron)

    Pregnant women

    80-120 drops (200-300 mg of iron)

    40 drops (100 mg of iron)

    40 drops (100 mg of iron)

    Treatment of iron deficiency anemia in children and adults

    Treatment until the normal hemoglobin content (Hb) takes about 3 to 5 months. After this, the treatment should be continued for 1-2 months at the dose described for the case of iron deficiency without anemia, in order to replenish iron stores.

    Treatment of iron deficiency anemia during pregnancy

    Treatment should continue until normal hemoglobin (Hb).After this treatment should be continued at least until the end of pregnancy in a dose described for the case of iron deficiency without anemia, in order to replenish iron stores and meet the increased requirements for iron in connection with pregnancy.

    Treatment and prevention of iron deficiency without anemia

    Treatment takes approximately 1 to 2 months.

    Side effects:

    The frequency of side effects is classified according to the recommendations of the World Health Organization: very often (≥ 1/10), often (≥1 / 100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (< 1/10000), the frequency is unknown (insufficient data to estimate the frequency of development):

    Disturbances from the nervous system: infrequently - a headache.

    Disorders from the gastrointestinal tract: very often - a change in stool color; often - nausea, diarrhea, indigestion; infrequent - vomiting, constipation, pain in the abdomen, discoloration of the tooth enamel.

    Disturbances from the skin and subcutaneous tissues: infrequently - skin rash, exanthema, itchy skin.

    The drug may cause delayed-type allergic reactions (for example, contact dermatitis) or (less often) immediate reaction (urticaria, bronchospasm) due to the presence of methyl and propyl parahydroxybenzoate in the composition.

    Overdose:

    In case of an overdose with Sorbitrim, iron overload or intoxication is unlikely, which is due to the low toxicity of iron [III], polymethyltosate hydroxide and controlled iron uptake. No cases of unintentional poisoning with a lethal outcome were reported.

    Interaction:

    The interactions of iron [III] hydroxide of polymaltose with tetracycline or aluminum hydroxide. There was no significant decrease in tetracycline absorption. The concentration of tetracycline in the blood plasma did not drop below the effective level. Absorption of iron from iron [III] hydroxide polymaltozate did not decrease under the influence of aluminum hydroxide or tetracycline. Thus, iron [III] hydroxide polymaltozate can be used simultaneously with tetracycline and other phenolic compounds, as well as with aluminum hydroxide.

    In studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin A D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofina no interactions with iron were observed [III | hydroxide with polymaltozate.

    Also, no interaction of iron [III] hydroxide of polymaltosate with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soy flour. These results suggest that iron [III] hydroxide polymaltose can be taken during or immediately after ingestion.

    Admission of the drug does not affect the results of the detection of hidden blood (with selective determination of hemoglobin), therefore, it is not necessary to interrupt treatment.

    It is necessary to avoid the simultaneous use of parenteral and oral iron preparations, since the absorption of iron taken orally slows down.

    Special instructions:

    It is assumed that taking Sorbithrim should not affect the daily need for insulin in patients with diabetes mellitus. 1 ml of drops contains 0.0056 bread units.

    Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can be used after eliminating the underlying cause of the disease, the relationship between the benefits and risks of treatment should be determined.

    During treatment with Sorbitrim, a dark colouration of the stool can be noted, but this has no clinical significance.

    The drug Sorbitrim contains sucrose, which can adversely affect the condition of the teeth.

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

    There was no negative effect of Sorbitrim on the ability to drive vehicles and mechanisms.

    Form release / dosage:

    Drops for oral administration, 50 mg / ml.

    Packaging:

    To 30 ml in bottles of dark glass, ukuporennyh polyethylene stopper-dropper, closed screwed plastic caps with a safety ring control the first opening.

    1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    The vial should be used within 6 months.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003960
    Date of registration:14.11.2016
    Expiration Date:14.11.2021
    The owner of the registration certificate:Medan Pharma, Joint Stock CompanyMedan Pharma, Joint Stock Company Poland
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp12.12.2016
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