Composition, form of production and packaging
Drops for ingestion in the form of a clear solution from greenish or yellowish green to yellowish-brown or orange-brown, with a raspberry-creamy smell, the test is organoleptically performed.
iron sulphate heptahydrate 4.72 g,
which corresponds to the content of iron (II) 0.948 g
D, L-serine 3.56 g
Auxiliary substances: ascorbic acid - 0.8 g, potassium sorbate 0.1 g, invert sugar (72.7% TS) 15.18 g, ethanol 96% 0.1563 g, cream flavor 0.0125 g, raspberry flavor 0.05 g, purified water 83.4 in
30 ml - bottles of dark glass with a stopper-dropper (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
The preparation of iron. 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, stimulates erythropoiesis.
Included in the preparation? -amino acid serine contributes to more efficient absorption of iron and its entry into the systemic bloodstream, which leads to a rapid recovery of normal iron content in the body. This provides a better tolerance of the drug and allows you to reduce the necessary dose of iron.
The daily need for iron in adults is 1-2 mg, in pregnant women - 2-5 mg, in children under 7 years - 0.5-1.5 mg. On average, 10% is absorbed, therefore, in order to meet the need for iron, the intake dose should exceed the daily requirement by 10 times.
After oral administration, about 10-15% of ferrous iron is absorbed from the duodenum and jejunum. Absorption of iron is also possible through the mechanism of passive diffusion. Absorption of iron significantly increases with its deficiency and with increased erythropoiesis. In patients with a low hemoglobin value and a depleted iron depot, absorption can increase to 50-60% and decrease with normalization of these parameters. C max of iron is reached in 2-4 hours after administration.
In the blood, iron binds to transferrin and in the trivalent form is transported to the sites of hemopoiesis and to specific depots. After binding of iron with apoferritin it is deposited in the liver, spleen and bone marrow in the form of ferritin. Iron penetrates the placental barrier, the minimum amounts are excreted in breast milk.
treatment of iron deficiency.
The daily dose is set at the rate of 5 drops per 1 kg of body weight, the frequency of reception is 2-3 times / day.
Breast children: the average dose is 10-15 drops 3 times / day.
Children of preschool age: the average dose is 25-35 drops 3 times / day.
Children of school age: the average dose - 50 drops 3 times / day.
To open the bottle, press the cap down and simultaneously turn in the direction of the arrow. After applying the medicine, the cap should be installed and tightened (prevents access for children).
The iron deficiency can be approximately calculated by the formula:
iron (mg) = body weight (kg)? 3.5 (16 - the amount of hemoglobin (g%))
Threshold values, below or above which iron deficiency is regarded as a condition requiring treatment:
Indicators Children Children of school age, adults
Hemoglobin (g%) <11 <12
Erythrocytes (million / Ојl) <3.5 <4
Reticulocytes (%)> 15> 15
Serum iron (Ојg%) <60 <80
Total iron content = transferrin (Ојg%)> 380> 400
Mean erythrocyte hemoglobin (pg) <25 <30
The average volume of erythrocytes <30 <30
To ensure a stronger response, iron therapy should be continued for at least 8 weeks; then, after the normalization of hemoglobin, treatment should continue for another 6-8 weeks to complete the depot of iron.
Control of laboratory indicators
If necessary, the degree of iron deficiency and the subsequent need for iron replacement should be monitored every 4 weeks according to the following laboratory indicators: hemoglobin, erythrocytes, reticulocytes, serum iron, transferrin, middle erythrocyte hemoglobin, average volume of erythrocytes.
Allergic reactions : rarely (> 1/10 000 and <1/1000) - cutaneous manifestations.
From the digestive system: very rarely (<1/10 000) - constipation, diarrhea, abdominal pain, nausea, vomiting. When taking iron-containing preparations, it is possible to stain the feces in a dark (black) color, which has no clinical significance.
Gastrointestinal disorders can be prevented by gradually increasing the dose at the beginning of treatment or by lowering the dose during treatment.
- hypersensitivity to the components of the drug;
- violations of iron absorption (sideroahrestic anemia, lead anemia, thalassemia);
- increased iron content in the body (hemochromatosis, hemolytic anemia);
- Anemia, not associated with iron deficiency.
Caution should be used iron preparations with dietary products and supplements containing iron salts (possible risk of overdose). In patients with inflammation and ulcerative lesions 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.
Do not prescribe the drug to patients with hereditary intolerance to fructose or galactose, a deficiency of lactase, glucose-galactose malabsorption, a deficiency of sucrose-isomaltase.
PREGNANCY AND LACTATION
Use during pregnancy and during lactation is possible if the potential benefit of therapy for the mother exceeds the possible risk to the fetus or infant.
APPLICATION FOR FUNCTIONS OF THE LIVER
Be wary appoint patients with kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Be wary of patients with. hepatitis, hepatic insufficiency.
APPLICATION FOR CHILDREN
For adolescents, the drug is preferably administered in the form of capsules, at the beginning of therapy - 1 caps. 2-3 times / day. With a poor tolerance of the drug, the dose is gradually reduced to the maximum tolerable. The duration of therapy (before the normalization of hemoglobin) is increased. Children over 6 years of ageAktiferrin appoint 1 caps. / Day.
Children older than 2 years are preferable to prescribe the drug in the form of a syrup. The daily dose is 5 ml / 12 kg of body weight. The average dose forpreschool children is 5 ml 1-2 times / day; for children of school age - 5 ml 2-3 times / day.
Newborns and young children Actiferrin is administered in the form of drops. The daily dose is set at the rate of 5 drops / 1 kg of body weight; multiplicity of appointment - 2-3 times / day. The average dose for infants is 10-15 drops 3 times a day; for children of preschool age - 25-35 drops 3 times / day; for children of school age - 50 drops 3 times / day.
Hepatic or renal insufficiency increases the risk of cumulation of iron.
The drug may cause an exacerbation of ulcerative and inflammatory bowel diseases.
When applying the drug, a persistent darkening of the teeth is possible.
Impact on the ability to drive vehicles and manage mechanisms
Children have a high risk of intoxication with iron preparations, life-threatening conditions can occur with the intake of 1 g of iron sulfate. Therefore, iron preparations should be stored out of the reach of children.
Symptoms: with the occasional use of the drug in very high doses, weakness, fatigue, paresthesia, pale skin, cold sticky sweat, decreased blood pressure, palpitation, acrocyanosis, abdominal pain, diarrhea with blood, cyanosis, confusion, weak pulse, hyperthermia , lethargy, convulsive seizures, symptoms of hyperventilation, coma. Signs of peripheral vascular collapse appear within 30 minutes after administration; metabolic acidosis, convulsions, fever, leukocytosis, coma - within 12-24 hours; acute renal and hepatic necrosis - after 2-4 days.
Treatment: before the specific therapy should be taken to remove from the stomach has not yet absorbed the drug (gastric lavage), give the patient to drink milk, raw egg. Specific therapy is carried out by the appointment of deferoxamine (desferal) inside and parenterally. In acute poisoning to bind iron, not yet absorbed from the gastrointestinal tract, inwardly 5-10 g deferoxamine (dissolve the contents of 10-20 ampoules in drinking water). To remove absorbed iron, deferoxamine is injected / m slowly, to children - 15 mg / h, to adults - 5 mg / kg / h (up to 80 mg / kg / day); with mild poisoning - in / m children 1 g every 4-6 h, adults - 50 mg / kg (up to 4 g / day). In severe cases, accompanied by the development of shock, injected / in a drip in a dose of 1 g and conduct symptomatic therapy. Lethal outcome mainly occurs with untimely anti-shock therapy.
Hemodialysis is 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. Possible peritoneal dialysis.
At course treatment with iron preparations, systematic monitoring of serum iron and other serum levels is necessary.
In severe intoxication appoint unitiol (sodium dimercaptopropanesulfonate) parenterally. Because of the possible formation of neurotoxic complexes, unitiol should be used with caution.
Specific antidote - deferoxamine (desferal).
With simultaneous application of iron salt, the absorption of such drugs as tetracyclines, gyrase inhibitors (eg, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), penicillamine, levodopa, carbidopa and methyldopa is reduced.
In patients receiving substitution therapy with levothyroxine sodium, iron salts reduce its absorption.
Iron preparations in high doses reduce the renal absorption of zinc preparations (the latter is recommended to be taken 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 NSAIDs can enhance the damaging effect of iron on the mucosa of the gastrointestinal tract.
In children with simultaneous use of iron reduces the effectiveness of vitamin E.
All of the above funds should be taken 3-4 hours before or after taking Aktiferrin. If it is necessary to prescribe drugs simultaneously, systematic clinical and laboratory testing should be carried out.
Tea, coffee, vegetable food containing iron-chelating substances (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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.