2010/09/17

Aktiferrin

Composition, structure and packing

Capsules oblong, brown, opaque, the contents of capsules - oily paste light beige color.

1 capsule. iron sulfate dried 113.85 mg, including iron, 34.5 mg D, L-Serine 129 mg.

Excipients: colza oil, refined, hydrogenated soybean oil, partially hydrogenated soybean oil, lecithin, vegetable, yellow wax, 85% glycerol, sorbitol, gelatin, iron oxide red, iron oxide black.

Drops in the form of a transparent liquid from green to yellow-brown color, with raspberry cream flavor.

1 ml (18 drops) of iron sulfate (x 7H2 O) 47.2 mg, including iron, 9.48 mg D, L-serine 35.6 mg.

Excipients: ascorbic acid, invert sugar syrup, potassium sorbate, ethanol 94%, raspberry flavor, creamy flavor, purified water. Syrup is clear, from green to yellow-brown color, with raspberry cream flavor.

5 ml of iron sulfate (x 7H2 O) 171 mg, including iron, 34.35 mg D, L-Serine 129 mg.

Excipients: ascorbic acid, invert sirup (72.7% dry syrup), ethanol 96%, raspberry flavor, creamy flavor, purified water.

Clinico-pharmacological group: antianemic drug.

Pharmacological action

Iron. Iron is essential for the life of an organism: it is part of hemoglobin, myoglobin, various enzymes, reversibly binds oxygen and is involved in several redox reactions, stimulates erythropoiesis.

Incoming part Aktiferrina alpha-amino acid serine enhances the absorption of iron and its entry into the systemic circulation, which leads to a rapid restoration of normal iron content in the body. The inclusion of alpha-amino acid serine can reduce the dose of iron, providing better tolerability.

In applying the drug Aktiferrin a rapid replenishment of iron deficiency in the body, which leads to the gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, pain and dryness of the skin) and laboratory signs of anemia.

Pharmacokinetics

Absorption

After oral iron adequately absorbed from the gastrointestinal tract. Cmax serum iron is achieved within the first 2-4 hours after ingestion. There is a correlation between the degree of iron deficiency and the amount absorbed into the systemic circulation of iron (higher iron deficiency, the better absorption).

Withdrawal

We derive c urine, feces and sweat.

Statement
Iron deficiency anemia of different etiologies;
latent iron deficiency in the body associated with excessive loss of iron (bleeding, including uterine, permanent donation) or with increased demand for it (pregnancy, lactation, period of active growth, malnutrition;
chronic gastritis with secretory insufficiency; condition after gastrectomy;
gastric and duodenal ulcers; reducing resistance in adults and children with infectious diseases, tumors).

Dosage regimen

Adults and adolescents with drug, preferably in the form of capsules to appoint, at the beginning of therapy - to 1 cps. 2-3 times / day. When poor tolerability of the drug dose is gradually reduced until the maximum tolerated. The duration of therapy (up to normalization of hemoglobin) increases.

Children older than 6 years Aktiferrin appoint 1 kaps. / day.

Children older than 2 years is preferable to appoint a drug in syrup form. The daily dose is 5 ml/12 kg body weight. The average dose for children under school age is 5 mL 1-2 times / day, for school-age children - 5 ml 2-3 times / day.

Babies and young children Aktiferrin administered in the form of drops.

The daily dose set at the rate of 5 drops / 1 kg of body weight, the multiplicity of purposes - 2-3 times / day. The average dose for infants up to 10-15 drops 3 times a day, for preschool-age children - to 25-35 drops 3 times a day, for school-age children - 50 drops 3 times a day.

Drugs are taken by mouth immediately before eating or during meals. Capsules do not chew, washing it down with plenty of water. The drops and syrup are taking a small amount of liquid (fruit tea or water).

Treatment with still continue for at least 8-12 weeks after reaching normal values of serum iron and hemoglobin, appointing supporting dose.

Side effect

On the part of the digestive system: loss of appetite, bitter taste in the mouth, flatulence, constipation, diarrhea; rare - abdominal pain, nausea, vomiting. Allergic reactions: seldom - itching, rash, and in some cases - anaphylactic shock.

From the CNS: headache, dizziness, rarely - fatigue, irritability, and in some cases - with epileptic encephalopathy syndrome.

Other: flushing of the skin, rarely - toothache, sore throat, feeling of pressure behind the sternum. The drug is usually well tolerated by patients. The resulting side effects of the digestive system usually disappear at lower doses.

Contraindications
hemochromatosis, hemosiderosis;
other types of anemia are not caused by iron deficiency in the body;
aplastic and hemolytic anemia;
sideroahresticheskaya anemia, anemia in lead poisoning;
Late skin porphyria;
chronic hemolysis;
Hypersensitivity to the drug's components.

Pregnancy and lactation

When prescribed iron deficiency in the body during pregnancy and lactation (breastfeeding) application Aktiferrina considered reasonable and safe.

Application for violations of liver function

With care be considered in patients with hepatitis, liver failure.

Application for violations of renal function

With care be considered in patients with renal insufficiency.

Cautions

Precautions designate patients with gastric ulcer and duodenal ulcer with inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease), chronic alcoholism, allergies, asthma, hepatitis, hepatic and renal failure, rheumatoid arthritis, blood transfusion .

Caution must be exercised in the appointment Aktiferrina in the form of syrups and drops of diabetics since the drug include carbohydrates: 1 teaspoon of the syrup contains 1.8 g of glucose, and 18 drops (1 ml) - 64 mg, equivalent to 0.15 HEH HEH and 0.0053, respectively . Aktiferrin not washing it down with black tea, coffee, milk in order to avoid reducing the absorption of iron. In addition, the decrease in absorption might lead to solid food, bread, raw cereals, dairy products, eggs. The interval between admission Aktiferrina and use these products should be 1-2 hours

To prevent the appearance in the teeth of patients reversible dark raid syrup and drops Aktiferrina should not be taken in undiluted form, after ingestion recommend thoroughly cleaning your teeth.

When you receive Aktiferrina marked staining of stool in black color that has no clinical significance.

Monitoring of laboratory parameters

In exchange application Aktiferrina requires systematic monitoring of performance of serum iron and hemoglobin.

Overdose

Symptoms: When you receive a random drug in very high doses may be weakness, fatigue, paresthesia, pallor of the skin, reducing blood pressure, heart rate, acrocyanosis, abdominal pain, diarrhea mixed with blood, vomiting, cyanosis, confusion, weak pulse, pyrexia, lethargy , seizures, symptoms of hyperventilation, coma. Symptoms of peripheral vascular collapse occur within 30 min after administration, metabolic acidosis, convulsions, fever, leukocytosis, coma - for 12-24 h, acute renal and hepatic necrosis - 2-4 days.

Treatment: before specific therapy - gastric lavage, reception of milk, raw eggs. Specific therapy hold the appointment of deferoxamine (desferal) oral and parenteral. In acute poisoning to bind iron is absorbed from the gastrointestinal tract, given by mouth 5-10 g deferoxamine by dissolving the contents of 10-20 vials in drinking water.

To remove the absorbed iron is introduced into the deferoxamine / m slowly, the children - 15 mg / h, the adults - 5 mg / kg / h (80 mg / kg / day) in mild poisoning - a / m children under 1 g every 4 - 6 h, adults - 50 mg / kg (up to 4 g / d). In severe cases, accompanied by the development of shock, carry in / drip of the drug in a dose of 1 g and spend symptomatically. Hemodialysis is not effective for removing iron, but can be used to accelerate the elimination of iron-deferoksaminovogo complex, and may be appointed in oligo-and anuria. Possible to carry out peritoneal dialysis.

Drug Interactions

Antacid, calcium preparations, tools that reduce gastric acidity (including cimetidine, drugs that contain carbonates, bicarbonates, phosphates, oxalates), pancreatin, pankreolipaza, etidron, caffeine, reduce the absorption of Aktiferrina (the interval between doses of these medicines funds should be 1-2 hours).

When the joint application of ascorbic acid increases iron absorption. Aktiferrin reduces the absorption of fluoroquinolones, penicillamine, tetracycline (these drugs are recommended to take 2 hours before or 2 hours after supplementation with iron). Aktiferrin in high doses reduces the renal absorption of zinc supplementation (these drugs recommended to take 2 hours after supplementation with iron). Ethanol increases the absorption of iron and increases the risk of toxic complications.

Terms and Conditions of storage

Capsules should be stored in a secure dry place at temperatures not above 25 ° C. The drops and syrup at a temperature not exceeding 25 ° C. Shelf life - 2 years. After opening the package shelf syrup and drops - 1 month.