Clinical and pharmacological group: & nbsp

Macro and microelements

Stimulators of hematopoiesis

Included in the formulation
АТХ:

B.03.A.E.10   Iron preparations in combination with other drugs

B.03.A.E.   Iron preparations in combination with other drugs

Pharmacodynamics:

Pharmacological action - anti-anemic, replenishing iron deficiency.

Combined drug. Contains iron, which is necessary for the synthesis of hem, which is part of hemoglobin, myoglobin, flavoproteins, iron-ferritin complexes and iron-transferrin, various enzymes; participates in a number of oxidation-reduction reactions.

Copper and manganese are microelements and are cofactors of certain enzymes.

When taking the drug, a gradual regression of clinical and laboratory symptoms of anemia occurs.

Pharmacokinetics:

Absorption of iron and trace elements occurs mainly in the duodenum and the upper part of the jejunum. Absorption is more intense, the more deficiency in the body.

Absorption of iron 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 alone) - 6 hours. There is no physiological elimination system (high risk of cumulation).

Absorption of manganese - 3-50%, copper - 40-60%. Copper binds to the carrier protein in metallothionein by 90-95%; in ceruloplasmin - 1-2%; the bond with amino acids and albumin is reversible. Deposition: manganese - brain, kidney, pancreas, liver; copper - liver, peripheral tissues (insignificant amount). Biotransformation: copper - in the liver. Elimination: manganese - with feces, copper - with feces, a small amount with kidneys, with sweat and epidermis.

Indications:

Treatment and prevention of iron deficiency anemia in adults and children from 3 months of age, caused by various causes:

bleeding;

- increased need for iron (pregnancy);

- Insufficiency of iron intake from food or a violation of its absorption.

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

XV.O20-O29.O25   Malnutrition in pregnancy

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

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

Contraindications:

- anemia, not associated with iron deficiency;

- hemochromatosis, hemosiderosis;

- thalassemia;

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- intoxication with lead;

- intoxication with copper or manganese, Wilson-Konovalov's disease;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption;

- Children's age up to 3 months;

- Hypersensitivity to the components of the drug.

Carefully:

With caution should prescribe the drug for diabetes. Patients with diabetes should take into account that 10 ml of the drug contains 3 g of sucrose.

Pregnancy and lactation:

The category of FDA recommendations is not defined. Adequate and well-controlled studies on humans and animals have not been conducted. When receiving therapeutic doses, no violations have been reported.

The use of the drug during pregnancy and during lactation is allowed according to the indications in the recommended doses.

Dosing and Administration:

Rules of application of the drug. Shake before use.It is necessary to tear off a piece of cardboard from the bundle along the dotted line, bend it in half to safely break the tip of the ampoule. Break the ampoule from two sides, pour the contents of the ampoule into a glass, dissolve in plain or sweetened water. Take in before eating. The contents of the ampoule should be used within 24 hours after opening.

To treat anemia, adults are prescribed a drug at the rate of 100-200 mg of iron (2-4 ampoules) per day; children older than 3 months - at a rate of 5-7 mg / kg body weight per day in 2-4 admission.

The drug is administered under the control of the iron content in the blood serum, the total iron-binding capacity of the serum before the start of treatment and thereafter with a frequency of 1 every 2 months.

With the preventive purpose, adults and pregnant women (starting from the 4th month of pregnancy) are prescribed 50 mg (1 ampoule) per day. Children depending on the age of the drug prescribed in a dose ranging from 1/4 to 1/2 daily therapeutic dose of adults.

The duration of treatment is determined individually. The average duration of the drug is from three to six months (before the restoration of iron stores in the body).

Side effects:

On the part of the digestive system: staining black stools (is normal), heartburn, nausea, vomiting, diarrhea, constipation, pain in the epigastric region, darkening of the enamel of the teeth.

Other: allergic reactions.

Overdose:

Symptoms: weakness, hyperthermia, convulsions, nausea, vomiting, constipation, diarrhea, epigastric pain. Cases of necrosis of the gastrointestinal wall and shock are described.

Treatment: gastric lavage with a 1% solution of sodium bicarbonate (drinking soda). When the concentration of iron in the serum is more than 5 μg / ml injected deferoxamine intravenously slowly: children - 15 mg / kg / h, adults - 5 mg / kg / h (up to 80 mg / kg / day); with mild poisoning intramuscularly: children - 1 g every 4-6 h, adults - 50 mg / kg (up to 4 g / day); conduct symptomatic therapy; when shock occurs, anti-shock therapy is administered.

Interaction:

Magnesium hydroxide and magnesium oxide impairs the absorption of iron gluconate. A combination of iron gluconate + manganese gluconate + copper gluconate not earlier than 2 hours after the intake of magnesium hydroxide.

Simultaneous application of the combination iron gluconate + manganese gluconate + copper gluconate leads to a decrease in the absorption of bisphosphonates, ciprofloxacin, and tetracyclines when ingested.

Iron: preparations of zinc - reduced absorption of zinc (taking 2 hours after ingestion of iron). It is impossible to combine the drug with other iron preparations, including those injected parenterally.

Copper: zinc preparations - reduced copper absorption when taking large doses of zinc.

Copper: penicillamine - Decrease in serum copper concentration (taking 2 hours before or after eating).

Manganese: reception of anticoagulants - an increased risk of side effects of anticoagulants.

Special instructions:

Control of the effectiveness of treatment should be conducted no earlier than 3 months after the start of treatment.

Excessive consumption of tea suppresses the absorption of iron.

To avoid darkening the enamel of the teeth, avoid prolonged residence of the drug solution in the oral cavity.

During treatment with iron preparations, black feces can be observed in patients, however, this does not require medical intervention. During treatment with iron preparations, analysis of feces for latent blood can give a false positive result.

Instructions
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