Iron fumarate + Folic acid - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Macro and microelements

Stimulators of hematopoiesis

Included in the formulation

Ferretab® comp.

capsules inwards

VALEANT, LLC Russia

АТХ:

B.03.A.D.02 Iron fumarate in combination with folic acid

Pharmacodynamics:

Anti-anemic agent. Iron is a microelement that stimulates erythropoiesis. When iron is used in the form of salts, its deficiency in the body is rapidly replenished, which leads to a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, tenderness and dry skin) and laboratory symptoms of anemia.

Folic acid is necessary for the normal maturation of megaloblasts and the formation of normoblasts. Stimulates erythropoiesis, participates in the synthesis of amino acids, nucleic acids, purines and pyrimidines, in the exchange of choline. When pregnancy protects the body from the effects of teratogenic factors.

Pharmacokinetics:

Characterized by high bioavailability, since ferrous iron (ferrous) is easily absorbed, and fumaric acid enhances its absorption. C_max is achieved 4 hours after admission. Half-life is about 12 hours. With iron deficiency anemia, taking 350 mg once a day provides the minimum effective dose of iron. In this case, the level of hemoglobin (and iron) in the blood serum increases, the number of red blood cells increases; All hematologic and clinical symptoms of anemia regress after 3-4 weeks of treatment.

Folic acid is absorbed mainly from the upper parts of the digestive tract (duodenum). 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.

Indications:

Iron deficiency anemia with folic acid deficiency associated with pregnancy, impaired iron absorption from the gastrointestinal tract, prolonged bleeding, malnutrition (treatment and prevention), prevention of anemia, miscarriage, early birth.

ICD-10

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

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

III.D50-D53.D50.0 Iron deficiency anemia secondary due to loss of blood (chronic)

III.D50-D53.D50 Iron-deficiency anemia

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

Contraindications:

Hypersensitivity, aplastic anemia, hemolytic anemia, hemosiderosis, hemochromatosis, impaired iron absorption, anemia, not related to iron deficiency (including hemolytic anemia, lead anemia, megaloblastic anemia).

Contraindications for parenteral use: active hepatitis, expressed violations of liver function, acute glomerulonephritis, active pyelonephritis,severe renal dysfunction.

Carefully:

With caution apply for peptic ulcer of stomach and duodenum, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease), alcoholism (active or in remission - for solutions containing ethanol), bronchial asthma, hepatic or renal insufficiency, rheumatoid arthritis, blood transfusion.

Pregnancy and lactation:

Iron: studies in humans and animals have not been conducted. With daily intake in normal doses, no changes were found.

Folic acid: FDA recommendation category A.

Lactation. Iron: violations with daily intake in normal doses are not registered. Folic acid penetrates into breast milk.

It is possible to use the drug during pregnancy and lactation (breastfeeding) according to the indications.

Dosing and Administration:

Inside, 50 mg (in terms of Fe²⁺; 1 capsule contains 50 mg of Fe²⁺) a day on an empty stomach, drinking plenty of fluids; if necessary, increase the dose to 100-150 mg (2-3 capsules) per day. Supportive treatment - 4 weeks after the normal concentration of iron and hemoglobin in the blood serum.

Side effects:

On the part of the digestive system: in some cases - a feeling of overflow of the stomach, discomfort, nausea, vomiting.

Other: allergic reactions.

As a rule, the drug is well tolerated.

Overdose:

Symptoms: it is possible to intensify the manifestations of the described side effects.

Treatment: first of all, it is necessary to determine the content of iron and ferritin in the blood serum. If the normal values of ferritin content in the serum are significantly exceeded, deferoxamine in accordance with the manufacturer's recommended dose.

Interaction:

Specific antidote - deferoxamine.

Antacid agents, calcium preparations, ethidron, drugs that reduce the acidity of gastric juice (including histamine H blockers₂-receptors, M-cholinolytics, proton pump inhibitors, antacids, preparations containing carbonates, bicarbonates, phosphates, oxalates), pancreatin, pancreolipase reduce absorption (iron preparations should be taken 1 hour before or 2 hours after their use).

Ascorbic acid increases absorption.

Iron fumarate reduces the absorption of fluoroquinolones, penicillamine, tetracyclines (they are recommended to be taken 2 hours before or 2 hours after taking iron preparations).

Large doses of iron drugs reduce intestinal absorption of zinc preparations (the latter is recommended to be taken 2 hours after taking iron preparations). Ethanol increases absorption and the risk of toxic complications.

Pharmaceutically incompatible with other medicines.

With the simultaneous administration of glucocorticosteroids, the stimulation of erythropoiesis is possible.

Special instructions:

Therapy should be performed prior to the normalization of the blood picture. The benzidine test gives a false positive result.

Regular monitoring of hematological parameters is necessary: a sign of the effectiveness of treatment is an increase in the number of reticulocytes on the 7th-10th day from its beginning and normalization of the hemoglobin level in 3-4 (sometimes 6-8) weeks. If the tolerance is poor, the dose reduction, taking the drug during meals, as well as a short break in treatment are indicated.

Inclusion of other components (for example, vitamins of group B), with the exception of folic acid, when administered to pregnant women is not justified.

Instructions

Iron fumarate + Folic acid (Ferri fumaras + Acidum folicum)