Iron sulfate (Ferri sulfas)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
Read on
Clinical and pharmacological group: & nbsp

Macro and microelements

Stimulators of hematopoiesis

Included in the formulation
  • Hemofer® Prolongatum
    pills inwards 
    GlaxoSmithKline Trading, ZAO     Russia
  • Tardiferon®
    pills inwards 
    Pierre Fabre Medication Production     France
    • АТХ:

    B.03.A.A.07   Iron sulfate

    Pharmacodynamics:

    Antianemic agent containing iron. Iron is a microelement that is part of hemoglobin, myoglobin, some enzymes. Reversibly connects oxygen, participates in a number of oxidation-reduction reactions, stimulates erythropoiesis.

    Pharmacokinetics:

    After ingestion, iron is absorbed completely completely from the digestive tract. Cmax iron in the blood plasma is reached within 2-4 hours.

    Absorption of iron occurs in proportion to the degree of its deficiency: with a deficit of 10-30%, in the absence of a deficit - 5-15%. In addition, it depends on food intake (better - on an empty stomach, in the presence of hydrochloric acid in the stomach). Distribution: bone marrow (transferrin-iron complex), depot (ferritin, hemosiderin) - hepatocytes, reticuloendothelial system, muscle tissue (insignificant amount). Connection with plasma proteins 90% or more (significant - with hemoglobin, less - with myoglobin, transferrin, ferritin, hemosiderin, enzymes). Half-life (iron sulfate only) - 6 hours.There is no physiological elimination system (high risk of cumulation).

    Physiological loss: the epidermis, hair, nails, faeces, sweat, breast milk, menstrual blood, urine - 1.1-1.4 mg per day (healthy men and postmenopausal women - 1 mg per day, healthy women of reproductive age - 1 , 5-2 mg per day).

    Indications:

    Treatment and prevention of iron deficiency anemia of various genesis in adults and children; violations of absorption of iron from the digestive tract.

    Conditions accompanied by increased body requirement in iron (pregnancy, lactation, period of active growth, malnutrition, certain stages of treatment B12-deficit anemia; chronic gastritis with secretory insufficiency; condition after resection of the stomach; peptic ulcer of the stomach and duodenum in the phase of exacerbation; in premature infants; decrease in the body's resistance in adults and children with infectious diseases, tumors).

    Bleeding (polymenorrhea, metrorrhagia, childbirth, hemorrhoids, peptic ulcer and duodenal ulcer, surgical interventions, frequent nasal bleeding, blood loss in other diseases).

    ICD-10

    XV.O95-O99.O99.0   Anemia complicating pregnancy, childbirth and the puerperium

    III.D50-D53.D51   Vitamin-B12-deficiency anemia

    III.D50-D53.D50   Iron-deficiency anemia

    IV.E50-E64.E61.1   Insufficiency of iron

    Contraindications:

    Hypersensitivity, violation of iron metabolism in the body, hemochromatosis, hemosiderosis, gastrointestinal dysfunction, iron absorption, late porphyria of the skin, chronic hemolysis, thalassemia, sideroblastic anemia (including lead poisoning), aplastic and hemolytic anemia, other anemias not associated with deficiency of iron.

    Carefully:

    Peptic ulcer of the stomach and duodenum, inflammatory bowel disease (enteritis, diverticulitis, ulcerative colitis, Crohn's disease), alcoholism (active or in remission), hepatitis, hepatic or renal failure, concomitant blood transfusion.

    Hepatic and / or renal failure increases the risk of cumulation of iron.

    Pregnancy and lactation:

    During pregnancy and during lactation, it is possible to use according to the indications. To determine and determine the duration of use, consideration should be given to the benefits of use and the need for use for the mother over the risk to the fetus.

    The appointment of iron preparations to pregnant women with a hemoglobin concentration of less than 110 g / l prevents the development of anemia in children at birth, reduces infant mortality (after admission after the 28th week of pregnancy and during the first 7 days of life of the child).

    Prescribing to pregnant women with a hemoglobin content above 110 g / L increases the risk of caesarean section and the appointment of blood transfusions.

    Reduces the risk of anemia in the second trimester of pregnancy compared with placebo.

    Dosing and Administration:

    Iron deficiency anemia with malaria - 200 mg of ferrous sulfate; course - 16 weeks (does not affect the course of malaria).

    Pregnancy - 20-100 mg per day of elemental iron; The hematologic response is more pronounced when combined with folic acid.

    Iron deficiency anemia in pregnant women (treatment) - 60 mg per day of elemental iron; course - 8 weeks (more effective than placebo). Admission in a dose of 60 mg of elemental iron 3 times a day inferior to intravenous injection iron (III) hydroxide of sucrose complex.

    Donation - 300 mg per day (105 mg per day of elemental iron); course - 4 weeks (before taking blood); is inferior in effectiveness to the use of carbonyl iron.

    Peritoneal hemodialysis (outpatient) - 195 mg 3 times a day; is inferior to iron dextran.

    Inadequate intake of iron from food or a violation of its absorption (chronic diarrhea, achlorhydria, gastrectomy, celiac disease, Crohn's disease, enteritis, malabsorption syndrome). Inside (1 hour before meals or 2 hours after it). For 100-200 mg per day (based on the calculation of the dose on Fe2+); the maximum dose is 300-400 mg per day for 1-2 months. After the normalization of the hemoglobin content, the dose is reduced to 30-60 mg per day.

    For the prevention of anemia - 325 mg once a day; for the treatment of anemia - 325 mg 2 times a day. The course of treatment is 2-6 months.

    When administered orally, the minimum effective dose of elemental iron for adults is 100 mg. The maximum dose is 300-400 mg.

    When used for the purpose of prevention, the dose of elemental iron is 30-60 mg per day.

    Children

    When prescribing the drug, the children need a conversion to elementary iron (3 mg / kg per day).

    Iron deficiency: 3-6 mg / kg per day (the maximum dose is 200 mg) of elemental iron.

    Prophylaxis of iron deficiency in children on breastfeeding - 5 mg per day of elemental iron (the drug is assigned to the mother).

    1-3 years (improvement of cognitive functions and psychomotor development in iron deficiency anemia): 3 mg / kg per day or up to 45 mg per day (combination with ascorbic acid is possible). The course of treatment lasting 5-11 days is ineffective; the effectiveness of treatment for 1 month or more is not clear.

    In children aged 6-35 months with anemia, hematologic parameters improve with the combination of the drug with zinc and vitamin intake.

    Children breastfed (aged 1-6 months): 6 mg per day in the first 3 months and 3 mg / kg per day - maintenance treatment.

    5-10 years (iron-deficiency anemia): 200 mg of ferrous sulfate daily (comparable to weekly intake); course of treatment - 2 months.

    Schoolchildren: 10-50 mg of elemental iron; course of treatment - 12 weeks. Girls 12-18 years: 60 mg per day of elemental iron; course of treatment - 17 weeks.

    Preterm: 4 mg / kg per day; combination with vitamin E is ineffective.

    Anemia in children who underwent surgery for congenital heart disease - 5 mg / kg per day on the 9th day after surgery (superior to placebo).

    Side effects:

    Irritation, a feeling of heaviness in the epigastric region, spasms and abdominal pain. Nausea and vomiting, diarrhea, flatulence, constipation.

    Contact irritation (pain in the throat, chest), especially when swallowing, irritation in the areas of ulcerative lesions (with prolonged passage of the drug through the gastrointestinal tract).

    Prolonged intake of iron sulfate: nausea, vomiting, constipation, diarrhea, darkening of the urine (dose-dependent effect), staining of the enamel of the teeth (only after ingestion of liquid forms), heartburn.

    Overdose:

    Occurs with admission of 200-250 mg / kg of iron sulfate to adults, 20-30 mg / kg or 3-4 tablets of iron sulfate (200 mg of elemental iron) by children (the risk of death is higher in young children).

    Early Symptoms (only with ingestion): diarrhea (sometimes with blood), fever, acute pains and spasms in the stomach, severe nausea and vomiting (sometimes with blood). Perhaps the emergence of leukocytosis and hyperglycemia.

    Late symptoms: cyanosis of the lips, palms and terminal phalanges of the hand, drowsiness, pale and clammy skin, increased respiration and palpitation, weakness, lethargy, convulsions, metabolic acidosis, hypotension, hypoglycemia, toxic hepatitis, hepatic insufficiency, collapse, GI disorder.

    Treatment: induction of vomiting and gastric lavage (according to the state), correction of electrolyte disorders, blood transfusion, enema.Antidote - deferoxamine (contraindicated in renal failure!). With anuria and oliguria - removal of hemodialysis.

    Interaction:

    Contraindicated concomitant administration of parenteral forms and preparations of iron for oral administration.

    Antacids, pancreatin, preparations containing calcium, bicarbonates, carbonates, oxalates, phosphates - decrease in iron absorption (iron is recommended 1 hour before or 2 hours later). Antacids do not affect the absorption and effectiveness of iron in combination with ascorbic acid.

    Acetohydroxamic acid (urease inhibitor) is a reduction in absorption and efficacy of both drugs (if necessary, iron intake during treatment with acetohydroxamic acid is administered parenterally).

    Vitamin E, chloramphenicol - Decreased hematologic response to iron therapy.

    Sodium dimercaptopropanesulfonate - the formation of a toxic complex. Do not use at the same time! When severe iron deficiency is recommended, blood transfusion is recommended.

    Deferoxamine and other chelate compounds - decrease in iron absorption (reception of the latter after 2 hours).

    Doxycycline, tetracycline - decrease in absorption and efficacy of both drugs (iron intake 3 hours before or 2 hours).

    Levodopa - when combined intake decreases the bioavailability of levodopa; it is recommended that the reception and control of the response to levodopa be disconnected.

    Levothyroxine sodium, penicillamine, etidronic acid - Decrease in their effectiveness (maximally dissociated intake of iron, at least after 2 hours).

    Methyldopa - a decrease in absorption, iron - an antagonist of the hypotensive effect of methyldopa (the most disconnected reception, with the impossibility of control - the choice of another antihypertensive drug).

    Alcohol (a significant amount, a long reception) - increased absorption and deposition of iron, the risk of toxic effects of the latter.

    Quinolones (hemifloxacin, ofloxacin, norfloxacin) - a decrease in the bioavailability of quinolones (simultaneously it is impossible to take, iron intake 3 hours before receiving hemifloxacin or 2 hours after it).

    Ranitidine, famotidine, cimetidine - decrease in iron absorption (reception of the latter 2 hours before or after H2-gistaminoblockers).

    Zinc-containing drugs - reduced absorption of zinc (intake 2 hours after the introduction of iron-containing drugs).

    Food products (coffee, tea, eggs, milk and dairy products containing carbonates, oxalates, phosphates, bread, cereals containing phytates, dietary fiber); with joint admission - reducing iron absorption (taking the drug last for 1 hour before or 2 hours after eating food).

    Special instructions:

    Parenteral forms of iron preparations are used only after laboratory confirmation of the deficit of the latter and with intolerance of the forms for oral administration.

    The combination of an iron salt and folic acid more preferably in iron deficiency anemia with a deficiency of folic acid.

    When the course is used, systematic monitoring of serum iron and hemoglobin levels is necessary.

    Monitoring hemoglobin, hematocrit, the number of reticulocytes (in the first 2 months - with an interval of 3 weeks, for parenteral forms - a few days), total iron-binding capacity, transferrin content and saturation rate (monthly and when overdose is suspected), ferritin, serum iron (with suspected hemosiderosis, in patients with chronic renal failure on chronic dialysis, Hodgkin's disease, rheumatoid arthritis,with the appointment of high doses of iron dextran). The absence of a hematologic response in 1-2-3 weeks requires a revision of the diagnosis.

    Iron preparations can not be administered with frequent blood transfusions.

    Instructions
    Up