Aktiferrin compositum (Aktiferrin compositum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron sulphate + Serine + Folic acidIron sulphate + Serine + Folic acid
Dosage form: & nbspcapsules
Composition:

1 capsule contains:

Active substances:

The iron sulfate monohydrate is 113.85 mg

(corresponding to iron II) 34.50 mg

D, L-serine 129.00 mg

Folic acid 0.50 mg

+ 15% surplus 0.575 mg.

Excipients:

Cranberry oil 123,96 mg, beeswax yellow 10,33 mg, soya beans hydrogenated oil 10,33 mg, soya beans oil partially hydrogenated 41,32 mg, lecithin soybean 10,635 mg.

Capsule shell:

Sorbitol 26.95 mg, glycerol (85%) 41.49 mg, gelatin 165.82 mg, iron dye oxide black (E172) 1.11 mg, titanium dioxide (E171) 0.93 mg, iron oxide pigment oxide yellow (E172 ) 0.15 mg, iron dye brown oxide (E172) 0.37 mg, iron oxide red (E172) 0.65 mg, white enough ink (titanium dioxide 37.96%, ethyl acetate 1.03%, shellac 26 , 62%, butanol 14.75%, methanol 19.64%).

Description:

Longitudinally colored capsules with an inscription white Aktiferrin F, No. 6. One half of the capsule is light brown, the other is of a dark brown color. The contents of the capsule are oily pasta greyish-yellow.

Pharmacotherapeutic group:The iron preparation
ATX: & nbsp

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

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

Pharmacodynamics:

Iron is the most important microelement of the body. As coenzyme of cytochrome oxidase, catalase and peroxidase, as well as a component of hemoglobin, myoglobin and cytochromes, it is involved in a variety of metabolic processes.

The daily requirement for iron in adults is 1-2 mg, in pregnant women - 2-5 mg, in children under 7 years - 0.5-1.5 mg. The level of absorption of iron on average - 10%, so to fill the need for iron dose for oral intake should exceed the daily requirement of 10 times.

The a-amino acid serine included in the preparation contributes to a more effective absorption of iron and its entry into the systemic bloodstream, leading to a rapid restoration of its normal content in the body. This ensures a better tolerance of the drug and allows to reduce the necessary dose of iron.

Folic acid, which is part of the drug, takes part in the synthesis of amino acids, nucleotides, nucleic acids; is necessary for normal erythropoiesis. During pregnancy, it performs a certain protective function in relation to the action of teratogenic factors.

Total iron in the body of adults 3-5 g, newborns - from 0.2 g to 0.3 g.About 60% of this amount is included in the hemoglobin of erythrocytes and participates in the transport of oxygen. Approximately 1 g is found in the cells of the reticuloendothelial system (RES) of the liver, spleen, bone marrow, in the form of mobilized forms of hemosiderin or ferritin. Plasma iron transport is about 4 mg. Every day, 25 mg of iron, which is formed mainly during the destruction of red blood cells, is transferred to the bone marrow.

Pharmacokinetics:

After ingestion, about 10-15% of ferrous iron is absorbed into 12 duodenum and jejunum. Absorption of iron is also possible through the mechanism of passive diffusion. Iron adsorption increases significantly with its deficiency and with increased erythropoiesis. In patients with a low hemoglobin level and a depleted iron depot, absorption can increase to 50-60% and decrease with normalization of these parameters.

The peak plasma concentration of iron is reached in 2-4 hours after administration.

In the blood, iron binds to transferrin and is transported to the hematopoiesis sites and specific depots in the trivalent form.

After binding with apoferritin it is deposited in the liver, spleen and bone marrow in the form of ferritin.Iron penetrates the placental barrier and minimal amounts are excreted into breast milk.

The daily loss of iron is 1 mg and is carried out through desquamation of epithelial and mucosal cells with bile and urine. During menstruation, approximately 1 mg of iron is lost. A significant amount of iron that is released during the destruction of hemoglobin (20-30 mg daily) is re-assimilated in the body, mainly for the synthesis of hemoglobin.

Indications:Treatment of iron deficiency anemia with concomitant deficiency of folic acid, conditions accompanied by increased body requirement in folic acid and serine, incl. during pregnancy.
Contraindications:
  • hypersensitivity to the active or auxiliary components of the drug;
  • violations of iron absorption (sidero-sacrificial anemia, lead anemia, thalassemia);
  • elevated iron content in the body (hemochromatosis, hemolytic anemia);
  • anemia not related to iron deficiency;
  • aplastic anemia;
  • megaloblastic B12-deficiency anemia;
  • children's age till 6 years;
  • deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.
Carefully:

Caution should be exercised while using iron preparations with dietary products and supplements containing iron salts (risk of overdose is possible).

In patients with inflammation and ulcers of the gastrointestinal mucosa, the relationship between the benefits of treatment and the risk of exacerbations of gastrointestinal diseases should be evaluated against the background of iron therapy.

Pregnancy and lactation:

Pregnancy

Iron preparations have not been adequately tested in studies of toxicity and effects on reproductive function. At the same time, reports of the occurrence of any undesirable phenomena against the background of taking Aktiferrin compositum during pregnancy have not been reported. Nevertheless, in the case of a decision to prescribe a drug, a thorough assessment of the benefit to the mother and the possible risks to the fetus should be carried out.

Lactation period

Aktiferrin compositum should be prescribed during the lactation period only after a thorough evaluation of the relationship of benefit to the mother and the possible risks to the child.

Dosing and Administration:

Adults and adolescents, over 50 kg of body weight: 1 capsule once or twice a day.

Children (20 - 50 kg body weight): 1 capsule once a day.

The iron deficiency can be approximately calculated by the formula:

mg of iron = kg of body weight x 3.5 x (16 - Hb in g%).

Threshold values, below or above which iron deficiency is accepted, as requiring treatment:

Children (up to 6 years)

Children of school age (children over 6 years), adults

Hb (g%)

<11

< 12

Erythrocytes (million / mm)3)

<3,5

<4,0

Reticulocytes (%)

> 15

> 15

Serum Fe (μg%)

<60

<80

Total iron content = transferrin (μg%)

>380

>400

Mean erythrocyte hemoglobin (pg)

<25

<30

The average volume of red blood cells

<30

<30

Aktiferrin compositum capsules should be swallowed whole, without chewing; with a small amount of liquid. Take half an hour before meals, between meals or with fruit juices containing vitamin C to improve absorption of iron in the intestine. Black tea, coffee and milk slow down the absorption of iron preparations, so you should avoid them at the same time.

The duration of treatment depends on the etiology and severity of the disease.

To ensure an adequate response, iron therapy should be at least 8 weeks.With subsequent normalization of hemoglobin parameters, treatment should be extended for the next 6-8 weeks to replenish the iron depot.

Indicators of monitoring

If necessary, the degree of iron deficiency and the subsequent need for iron replacement should be monitored at the following laboratory parameters at intervals of approximately 4 weeks: hemoglobin, erythrocytes, reticulocytes, serum iron, transferrin, middle erythrocyte hemoglobin, average volume of erythrocytes.

Side effects:

From the immune system: rarely (> 1/10 000 and <1/1000) allergic skin reactions.

From the gastrointestinal tract: very rarely (<1/10 000) constipation, diarrhea, abdominal pain, nausea, vomiting.

When taking iron-containing drugs, stools may be stained dark (black), which has no clinical significance.

Gastrointestinal disorders can be prevented by a gradual increase in dose at the beginning of treatment or by a decrease in dose during the treatment.

Overdose:

Children have a high risk of intoxication with iron. Life-threatening conditions can occur with the intake of 1 g of ferrous sulfate.In this regard, iron preparations should be stored out of reach of children.

Symptoms: when you receive very large doses of the drug, you may experience the following symptoms: nausea, vomiting, diarrhea, severe abdominal pain. In severe cases: collapse, drowsiness, oliguria and shock.

Perhaps the appearance of jaundice due to toxic hepatitis, in some cases - violations of the central nervous system. Blood clotting disorders occur rarely.

Lethal outcome mainly occurs when untimely therapy of patients in the background of shock.

Treatment: before the specific therapy - measures to remove the drug from the gastrointestinal tract (vomiting, gastric lavage with bicarbonate and phosphate buffer solutions) followed by the appointment of raw eggs, milk.

Specific therapy: at a serum iron concentration above 300-350 mg / dl, dropwise 1-2 g deferoxamine (Desferal) at the rate of 15 mg / kg body weight per hour: Repeat the next day.

Hemodialysis - ineffective for excretion of iron, but can be used to accelerate the excretion of iron-deferoxamine complex, and can also be prescribed for oligo- and anuria. It is also possible to use peritoneal dialysis.

At course treatment with iron preparations, systematic monitoring of serum iron and other serum levels is necessary.

Special measures:

with severe intoxication - Unithiol (sodium dimercaptopropanesulfonate) parenterally.

Due to the possibility of formation of neurotoxic complexes, Unitiol should be used with caution.

Interaction:

Specific antidote - deferoxamine (desferal).

With the simultaneous use of iron salts, the absorption of such drugs as tetracyclines, gyrase inhibitors (eg, cilrofloxacin, levofloxacin, norfloxocin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa.

In patients receiving substitution therapy with levothyroxine sodium, iron salts reduce its absorption.

Large doses of iron drugs reduce renal absorption of zinc drugs (the latter is recommended for taking 2 hours after taking iron preparations).

Absorption of iron decreases with the simultaneous administration of colestyramine, antacids (containing aluminum, magnesium, calcium, bismuth) and additives containing calcium and magnesium.Simultaneous use of iron salts and non-steroidal anti-inflammatory drugs can enhance the damaging effect of iron on the mucosa of the gastrointestinal

In children with simultaneous use of iron reduces the effectiveness of vitamin E.

Therefore, all of the above funds should be taken 3-4 hours before or after taking Aktiferrin. In the case of simultaneous prescription of drugs, systematic clinical and laboratory monitoring should be carried out.

Tea, coffee, vegetable food containing iron-chelating agents (such as phosphates, phytates, oxalates), milk, eggs reduce iron absorption.

Ascorbic acid and citric acid increase the absorption of iron.

Ethanol increases iron absorption and the risk of toxic complications.

Special instructions:

When applying the drug, a persistent darkening of the teeth is possible. Hepatic or renal insufficiency increases the risk of cumulation of iron. The use of the drug may exacerbate ulcerative and inflammatory bowel diseases.

Effect on the ability to drive transp. cf.and fur:Not found.
Form release / dosage:

Capsules.

Packaging:

10 capsules per blister PVDC / Al-Folga.

For 3 blisters together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:P N014776 / 01-2003
Date of registration:08.12.2008 / 18.05.2012
Expiration Date:Unlimited
The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
Manufacturer: & nbsp
Representation: & nbspTeva Teva Israel
Information update date: & nbsp01.07.2017
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