Aktiferrin oral drops 30 ml — Made in Germany — Free Delivery

Pharmacological properties

Iron is essential for the life of the body: it is a part of hemoglobin, myoglobin, various enzymes, reversibly binds oxygen and participates in redox reactions, stimulates erythropoiesis. iron is also found in the tissues of the depot (bone marrow, liver, spleen). the amino acid serine, which is part of actiferrin, promotes more efficient absorption of iron and its entry into the systemic circulation, which causes a rapid restoration of its content in the body to the required parameters. this ensures a better preparation acceptance and allows you to reduce the required dose of iron.

Pharmacokinetics

Absorption. When taken orally, about 10-15% of ferrous iron is usually absorbed in the duodenum and upper small intestine. In addition, with an increased intake of iron, passive transport of iron occurs.

Iron absorption increases significantly with iron deficiency in the body, as well as in the case of increased erythropoiesis. The highest level of absorption (50-60%) is observed at low levels of hemoglobin and iron content in the blood, and the intensity of absorption decreases again as these indicators normalize.

Cmax of serum iron is achieved within 2-4 hours after taking the preparation.

Distribution. In the blood, iron in trivalent form binds to transferrin and is transported to the site of hemostasis or deposition. When fully saturated, total serum transferrin can bind a maximum of 12 mg iron. This value is relatively small, and in the case of iron intoxication as a result of ingestion or parenteral administration, the iron-binding capacity of transferrin may decrease, leading to the release of free unbound iron into the plasma, which is toxic.

After binding to apoferritin, iron is deposited in the form of ferritin, in particular in the liver, spleen and bone marrow.

Iron passes through the placental barrier and in small amounts into breast milk.

Excretion. Only about 1 mg of iron is excreted daily with dead cells of the skin and mucous membranes, with bile and urine. During menstruation, iron loss is about 1 mg / day.

Most of the iron formed as a result of the breakdown of hemoglobin (20–30 mg / day) is used by the body to re-synthesize hemoglobin.

Indications

Treatment of iron deficiency in the body.

Application

Actiferrin capsules should not be sucked, chewed, or held in the mouth. capsules must be swallowed whole with water. the preparation is taken 30 minutes before meals or during a meal (depending on the tolerance of the digestive tract), or with fruit juice containing ascorbic acid, which improves absorption in the small intestine. taking with meals improves compatibility in the digestive tract. determination of the daily dose depends on the level of hemoglobin, body weight and age of the patient.

For oral administration of capsules, the daily dose is 1.3–4 mg iron / kg body weight.

Children aged 6–12 years: 1 capsule 1 time per day.

Children aged 12 years: appoint 1 capsule 2 times a day.

Adults, depending on the severity of the patient's condition at the beginning of therapy, are prescribed 1 capsule 2-3 times a day, then, if long-term treatment is necessary, the dose is gradually reduced to 1 capsule 1 time per day.

Drops of Aktiferrin should be prescribed mainly to children of the first year of life. Actiferrin drops are taken immediately before meals or during meals with a small amount of liquid (with water or fruit tea). Determination of the daily dose depends on the level of hemoglobin, body weight and age of the patient.

For oral administration in the form of oral drops, the daily dose is 1.3–4 mg iron / kg body weight.

The approximate average dose for infants (children under the age of 1 year) is 10-15 drops 3 times a day.

The dose for children aged 1–2 years is 15–25 drops, 3 times a day.

The dose for children aged 2–6 years is 25–35 drops, 3 times a day.

For the treatment of children 6 years old and adults, it is advisable to take Aktiferrin in the form of capsules.

To normalize the iron content in the body, the recommended course of treatment, both when taking capsules and drops, is 8 weeks. After reaching normal levels of serum iron concentration, treatment should be continued for several more weeks to replenish iron stores in the body.

In case of impaired renal function and severe liver disease, the preparation should be taken only under medical supervision.

Contraindications

Hypersensitivity to active ingredients or other components of the preparation; hemosiderosis, hemochromatosis; anemia in violation of iron metabolism (iron deficiency anemia; sideroachrestic anemia; anemia associated with chronic lead intoxication; thalassemia); other types of anemias not associated with iron deficiency (hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency); simultaneous use of parenteral iron forms; esophageal stenosis and / or other obstructive diseases of the digestive tract; intestinal diverticulosis, intestinal obstruction; regular blood transfusions.

Side effects

From the digestive tract: when using high doses, mild gastrointestinal complications may occur, such as a feeling of heaviness in the stomach, flatulence, constipation or diarrhea, abdominal pain, nausea, epigastric pain, dyspepsia, vomiting. ingestion with food can reduce the incidence of these side effects (see application section). against the background of treatment, a dark color of the stool is possible due to the release of iron, which was not absorbed into the gastrointestinal tract. this change has no clinical significance.

From the immune system: allergic reactions, including anaphylactic reaction, skin rash, exanthema, urticaria, itching, cases of staining of tooth enamel in children.

Special instructions

To avoid the risk of possible overdose, special care must be taken when using food or other salt supplements.

If there is a history of inflammation or ulceration of the gastrointestinal mucosa, the possible risk of exacerbation of gastrointestinal disease and the potential benefit of treatment should be carefully evaluated.

In the case of a course appointment of Aktiferrin capsules, regular monitoring of serum iron and hemoglobin indicators is necessary.

Monitoring during treatment: as needed, approximately every 4 weeks, the following parameters are assessed to determine the degree of iron deficiency, response to treatment and the need to continue replenishment of the body with iron: hemoglobin level, red blood cell count, average red blood cell volume (MCV), mean value the content of hemoglobin in erythrocytes (MCH), the number of reticulocytes, the content of serum iron, transferrin. Determination of serum ferritin makes it possible to assess the accumulation of iron; a serum ferritin value of 15 μg / l means that there is no iron stores in the body.

Capsules. Given the risk of oral ulcers and discoloration of the enamel of the teeth, capsules should not be sucked, chewed, or held in the mouth. The capsules should be swallowed whole with water.

Aktiferrin capsules contain sorbitol. Patients with rare hereditary fructose intolerance or glucose-galactose malabsorption should not take this preparation.

Drops. With the course appointment of Aktiferrin drops, systematic monitoring of serum iron and hemoglobin indicators is necessary. Patients with diabetes should take into account that the preparation contains carbohydrates: 18 drops (1 ml) contain 64 mg of glucose, which is equivalent to 0.0053 XE.

To prevent the appearance of dark plaque on the teeth of patients, Aktiferrin drops should not be taken undiluted; after taking the preparation, it is recommended to thoroughly brush your teeth.

Against the background of treatment with Aktiferrin, the stool may become black, due to the release of iron, which was not absorbed. It has no clinical significance.

To prevent a decrease in iron absorption, it is not recommended to drink Aktiferrin with black tea, coffee and milk. Decreased absorption can also be attributed to bread, raw cereals, dairy products and eggs; components of vegetarian food (substances that form complex iron compounds such as phosphates, phytates and oxalates).

Iron preparations are used with caution in patients with the following diseases: leukemia, chronic liver and kidney diseases, inflammatory gastrointestinal diseases, gastric ulcer and duodenal ulcer, bowel disease (enteritis, ulcerative colitis, Crohn's disease).

Application during pregnancy or lactation. There is evidence of impaired fetal development and spontaneous abortions due to iron intoxication. During pregnancy, Aktiferrin should be taken only if the potential benefit outweighs the possible risk.

Medicines containing iron have not been adequately studied in animal studies for embryotoxicity.

During breastfeeding, Aktiferrin should be taken only if the potential benefit outweighs the possible risk.

Children

The capsules are used in children ≥6 years of age.

Drops can be used in pediatric practice (see APPLICATION).

The ability to influence the reaction rate when driving or operating other mechanisms. Has not been investigated.

Interactions

With the simultaneous use of iron salts, the absorption of the following preparations is reduced: tetracycline, DNA gyrase inhibitors (for example, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), bisphosphonates, penicillamine, levodopa, carbidopa and methyldopa.

Iron salts reduce the absorption of thyroxine and zinc.

Iron absorption is reduced with the simultaneous use of cholestyramine, antacids containing aluminum, magnesium, calcium, bismuth), as well as calcium and magnesium supplements.

Iron absorption may be reduced when combined with chloramphenicol.

Aktiferrin should not be taken within 2-3 hours after using one of the above preparations. As far as possible, the effectiveness of the simultaneous use of preparations should be checked using clinical or laboratory diagnostic methods.

GCS can enhance stimulation of erythropoiesis by Aktiferrin.

Ascorbic / citric acid enhances iron absorption.

The simultaneous intake of vitamin E can reduce the pharmacological effect of iron in the child's body.

The simultaneous use of iron salts and NSAIDs can increase the irritating effect of iron on the gastrointestinal mucosa.

Overdose

Symptoms: abdominal pain, diarrhea, vomiting, cyanosis, confusion, symptoms of hyperventilation.

In young children, the risk of acute iron toxicity is particularly high; life-threatening intoxication is possible when taking 1 g of ferrous sulfate. After unintentionally taking a large amount of Aktiferrin, nausea, severe pain in the stomach area first occur, then diarrhea and vomiting of blood due to the development of hemorrhagic gastroenteritis. In severe cases, cyanosis, impaired consciousness and hyperpnea may develop as a result of the development of acidosis and impaired peripheral circulation. In about 4-6 hours, remission usually occurs. In the future, after 12–48 hours, severe shock may develop, accompanied by Cheyne-Stokes respiration, oliguria, toxic liver failure, and coagulopathy.

Treatment: before specific therapy, milk, raw eggs should be consumed.

Symptomatic therapy: rinse the stomach with water or solution of baking soda or phosphate-buffered solution. If necessary, treat shock and acidosis.

Specific therapy: Patients with symptoms of acute iron overdose with serum iron levels ≥300–350 mcg / dL should be given oral and parenteral deferoxamine. In acute poisoning, to bind iron that has not yet been absorbed in the gastrointestinal tract, 5–10 g of the preparation is prescribed orally (the contents of 10–20 ampoules should be dissolved in water). For the elimination of absorbed iron, deferoxamine should be administered intramuscularly at 1–2 g every 3–12 hours. In severe cases, accompanied by the development of shock, patients should be prescribed an intravenous infusion of 1 g of the preparation and symptomatic treatment.

The condition for effective treatment of overdose is the constant release of iron complexes from the body, therefore, patients with oliguria / anuria should be prescribed peritoneal dialysis or hemodialysis.

If necessary, during shock therapy, mechanical ventilation is used, X-ray monitoring of the elimination of toxins from the body and repeated monitoring of the level of serum iron and other indicators of blood serum are performed.

In case of severe intoxication, calcium diethylenetriaminepentaacetate should be administered parenterally.

Storage conditions

At a temperature not exceeding 25 ° c. the shelf life of vials with syrup and drops after opening is 1 year.