Iron sulphate + Folic acid + Cyanocobalamin (Ferri sulfas + Acidum folicum + Cyanocobalaminum)

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

Stimulators of hematopoiesis

Macro and microelements

Included in the formulation
  • Ferro-Folgamma®
    capsules inwards 
    Wörwag Pharma GmbH & Co. KG. KG     Germany
    • АТХ:

    B.03.A.E.01   Preparations of iron in combination with vitamin B12 and folic acid

    Pharmacodynamics:

    Iron is a component of hemoglobin, myoglobin, cofactor of basic enzymes (including cytochromes). Stimulation of erythropoiesis, participation in oxygen transport.

    Folic acid is a stimulant of erythropoiesis, amino acid metabolism (glycine, methionine, histidine), involved in the synthesis of purines, thymidylates.

    Cyanocobalamin - coenzyme in metabolic processes (metabolism of lipids, carbohydrates, protein synthesis, cell growth and division, hematopoiesis).

    Pharmacokinetics:

    After taking the drug, iron is absorbed from the digestive tract. Bioavailability of iron is 10-30%. The gradual release of iron allows prolonging its absorption, mainly in the distal part of the small intestine. Folic acid absorbed mainly from the upper divisions of the digestive tract (duodenum).

    Binding of iron with plasma proteins - 90% or more. Deposited in the form of ferritin or hemosiderin in the cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in the muscles. Iron is excreted with feces, urine and sweat.

    The binding of folic acid with plasma proteins is 64%; biotransformation occurs in the liver. Folic acid is excreted mainly by the kidneys, partly by the intestine.

    Cyanocobalamin in the blood binds to the transcobalamin I and II, which transport it to the tissues. It is deposited mainly in the liver. The connection with plasma proteins is 90%. Cmax in blood plasma after subcutaneous and intramuscular injection is achieved after 1 hour.

    From the liver is excreted with bile into the intestine and again absorbed into the blood. It is excreted in normal kidney function - 7-10% by the kidneys, about 50% by the intestine. From 50 to 90% of cyanocobalamin, administered intramuscularly or intravenously at a dosage of 0.1 to 1 mg, are excreted by the kidneys within 48 hours. Penetrates through the placental barrier into breast milk.

    Indications:

    Deficiency of folic acid, cyanocobalamin and iron.

    Chronic hemorrhage (bleeding from the gastrointestinal tract, bladder, hemorrhoidal, meno- and metrorrhagia).

    Alcoholism, infections, taking anticonvulsants and contraceptives (inside).

    Anemia during pregnancy and lactation.

    Prevention of iron and folate deficiency in the II-III trimesters of pregnancy, the postpartum period, during lactation.

    ICD-10

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

    III.D60-D64.D64.9   Anemia, unspecified

    III.D60-D64.D63.8 *   Anemia in other chronic diseases classified elsewhere

    III.D60-D64.D63.0 *   Anemia in neoplasm (C00-D48 +)

    III.D60-D64.D61.1   Drug-induced aplastic anemia

    III.D50-D53.D52   Folic deficiency anemia

    III.D50-D53.D50.9   Iron deficiency anemia, unspecified

    III.D50-D53.D50   Iron-deficiency anemia

    XVIII.R50-R69.R58   Bleeding, not elsewhere classified

    XIV.N80-N98.N92.4   Abundant bleeding in the premenopausal period

    XI.K90-K93.K92.2   Gastrointestinal bleeding, unspecified

    XIV.N80-N98.N92.1   Abundant and frequent menstruation with an irregular cycle

    XIV.N80-N98.N92.0   Abundant and frequent menstruation with a regular cycle

    IX.I80-I89.I84.8   Hemorrhoids with other complications, unspecified

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

    IV.E50-E64.E53.9   Insufficiency of B vitamins, unspecified

    Contraindications:

    - anemia not associated with iron deficiency (hemolytic anemia, megaloblastic anemia caused by vitamin B deficiency12);

    - excess iron in the body (hemosiderosis, hemochromatosis);

    - violation of mechanisms of iron utilization (including anemia caused by lead poisoning, sidero-achestic anemia);

    - liver failure;

    - Hypersensitivity to the components of the drug.

    Carefully:

    With caution should take the drug for inflammatory bowel disease, alcoholism, liver or kidney failure.

    Pregnancy and lactation:

    Iron: studies in humans and animals have not been conducted. When taking daily normal quantities, no changes were detected.

    Folic acid: FDA recommendation category A.

    Cyanocobalamin: FDA recommendation category C.

    Lactation. Iron and cyanocobalamin: changes in the intake of daily normal quantities were not detected. Folic acid and cyanocobalamin penetrate into breast milk.

    The drug is prescribed for pregnancy and lactation according to the indications.

    Dosing and Administration:

    When anemia - 1-2 capsules per day for 3-16 weeks (possibly additional administration of cyanocobalamin). With hypovitaminosis and iron deficiency as a result of anemia caused by alcoholism, infections, operations on the gastrointestinal tract, polymenorrhea - 1 capsule 3 times a day. In the period of convalescence - 1 capsule 3 times a day. With diarrhea - 1 capsule 4 times a day for 10-30 days. During pregnancy (II-III trimesters) and breast-feeding - 1 capsule 2 times a day.

    Side effects:

    Nausea; allergic reactions: eczematous phenomena, urticaria, anaphylactic shock, anaphylactoid reactions.

    Overdose:

    Symptoms: epigastric pain, nausea, vomiting, diarrhea, drowsiness, pallor of the skin, development of shock, up to coma.

    Treatment: gastric lavage, deferoxamine administration, symptomatic and maintenance therapy.

    Interaction:

    Organic acids, calcium, phosphorus, phytin, colestramine, antacids containing aluminum, magnesium, calcium impair iron absorption due to the formation of insoluble complexes. Carbamazepine, colestramine, sulfasalazine, trimethoprim, triamterene, phenytoin, phenobarbital, hormonal contraceptives, antagonists of folic acid reduce the absorption of iron. Preparations of pancreatic enzymes can reduce iron absorption.

    With simultaneous application of the drug with phenobarbital, carbamazepine, sodium valproate, sulfasalazine, hormonal contraceptives, folic acid antagonists, trimethoprim, pyrimethamine, triamterene, absorption of folic acid decreases.

    Iron salts disrupt absorption from the gastrointestinal tract of antibiotics of the tetracycline group.

    Solid food, bread, raw cereals, dairy products, eggs reduce iron absorption when used during antibiotic treatment with tetracyclines and penicillamine, as complex compounds that reduce iron absorption and reduce antimicrobial activity of antibiotics are formed.

    Acetylsalicylic acid, H antagonists2histamine receptors, colchicine, neomycin reduce the absorption of cyanocobalamin.

    Glucocorticoids strengthen the stimulation of erythropoiesis.

    Chloramphenicol (parenteral administration) reduces the effect of cyanocobalamin in anemia.

    Special instructions:

    Before starting therapy with the drug it is necessary to determine the content of iron and ferritin in the blood serum.

    During the period of taking the drug, a dark colouration of the stool can be observed, which is due to the removal of not absorbed iron and has no clinical significance.

    Effective only with iron deficiency anemia and ineffective in anemia of other etiology.

    The intake of cyanocobalamin at a dose of more than 10 μg per day causes a hematologic response with a deficiency of folic acid.

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