Maltofer drops for oral administration 50mg/ml 30ml №1

NameMaltofer drops dpr.vn. 50mgml 30ml Main active ingredient Iron III hydroxide polymaltose Product form drops Dosage 50 mg / 1 ml 30 ml Pharmacodynamics Mechanism of action The polynuclear centers of iron (III) of polymaltose hydroxide are structurally similar to the natural iron depot protein ferritin. This macromolecular complex is stable and does not release large amounts of iron under physiological conditions. Due to its large size, the degree of diffusion of iron (III) polymaltose hydroxide through the mucosal membrane is approximately 40 times lower than the degree of diffusion of the iron (II) hexaaqua complex. Iron (III) hydroxide polymaltose comes from the intestines by active transport. Pharmacodynamic effects Absorbed iron binds to transferrin and is used to synthesize hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin. Pharmacokinetics Absorption The absorption of iron (III) polymaltose hydroxide occurs according to a controlled mechanism. An increase in the level of iron in the blood serum after taking the complex does not correlate with the total absorption of iron, assessed by its inclusion in Hb. Studies using radioactively labeled iron (III) polymaltose hydroxide showed a clear correlation between the percentage of iron absorption by erythrocytes (incorporation in Hb) and absorption in terms of the whole body. The most active absorption of the iron (III) hydroxide polymaltose complex occurs in the duodenum and jejunum. As with other oral iron preparations, the relative extent of absorption of iron from iron(III) polymaltose hydroxide, as measured by its incorporation into Hb, decreased with increasing doses of iron. A correlation was also observed between the degree of iron deficiency (i.e., serum ferritin level) and the amount of iron absorbed (i.e., the greater the iron deficiency, the better the absorption). When using the drug Maltofer®, the degree of absorption is about 10%. It has been shown that in patients with anemia, the absorption of iron from the polymaltose complex of iron (III) hydroxide, in contrast to iron salts, increases in the presence of food. Distribution (55Fe and 59Fe). The distribution of iron after absorption of iron(III) polymaltose hydroxide was demonstrated in a study using the dual isotope technique ferritin. Excretion Unabsorbed iron is excreted in the feces. Pharmacokinetics in special populations Renal, hepatic and heart failure. No data available. Indications for use Treatment of latent (hidden) iron deficiency and iron deficiency anemia (clinically expressed iron deficiency). Iron deficiency and its severity must be established and confirmed by appropriate laboratory tests. Method of administration and doses For oral administration. The daily dose of the drug depends on the degree of iron deficiency (see table of daily doses). Treatment of iron deficiency anemia in adults and children: Duration of treatment: until normalization of hemoglobin (Hb), an average of 3-5 months. After that, the drug is continued for several weeks at doses for the treatment of latent iron deficiency in order to create a reserve of iron. Treatment of iron deficiency without anemia (latent iron deficiency): Treatment lasts approximately 1-2 months. Pediatric patients For the treatment of children 12 years of age and younger, it is recommended to use Maltofer® syrup and drops. Method of application The daily dose should be taken all at once or divided into several doses. Chewable tablets can also be swallowed whole or chewed. Maltofer preparations should be taken during or immediately after meals. Maltofer® syrup and drops can be mixed with fruit or vegetable juices or bottled formula. A slight coloration of the mixture is possible, which does not reduce the effectiveness of the drug and does not change its taste. To ensure the accuracy of dosing of the drug Maltofer® in the form of drops for oral administration, it is recommended to hold the bottle in an upright position. Drops should begin to drip as soon as the vial is placed in this position. If this does not happen, gently tap the vial to form a drop. Do not shake the vial. If you forget to take Maltofer® (chewable tablets, syrup or oral drops) on time, continue taking the drug as usual. Do not take a double dose to make up for a single missed dose. Renal insufficiency No studies have been conducted in patients with renal insufficiency. No data available. Hepatic impairment No studies have been conducted in patients with hepatic impairment. No data available. Use during pregnancy and lactation Pregnancy To date, there have been no reports of the development of serious adverse reactions when taking the drug Maltofer® at the recommended therapeutic doses for the treatment of anemia during pregnancy. Animal studies have not shown any risk to mother or fetus. There are no data from clinical studies on the use of this drug in the first trimester of pregnancy. In clinical studies of taking the drug Maltofer® in the second and third trimesters of pregnancy, there was no undesirable effect of the drug on the body of the mother and / or newborns. Thus, the presence of a negative effect of Maltofer® on the health of the fetus seems unlikely. Breastfeeding Breast milk normally contains iron associated with lactoferrin. It is not known how much iron (III) polymaltose hydroxide passes into breast milk. It is unlikely that the intake of Maltofer® by lactating women can cause undesirable effects in infants. As a precautionary measure, women of childbearing age and women during pregnancy or breastfeeding, the use of the drug Maltofer® is recommended only after consultation with a doctor in order to assess the benefit / risk ratio. PrecautionsTreatment of anemia should always be under medical supervision. If there is no effect (the level of hemoglobin has not increased by about 20-30 g / l after 3 weeks), the treatment plan should be reviewed. Caution should be exercised when prescribing the drug to patients who have had multiple blood transfusions, since iron enters with red blood cells, which can cause iron overload. Infections or tumors can cause anemia. Since iron can only be used if the underlying disease is under control, a benefit/risk assessment is recommended in these situations. During the period of treatment with Maltofer®, it is possible that the staining of feces in a dark color is not of clinical significance. Drops for oral administration Excipients such as sodium methyl-and-hydroxybenzoate and sodium propyl-and-hydroxybenzoate can cause allergic reactions (possibly delayed). Maltofer® oral drops contain sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltose malabsorption should not take this drug. Sucrose can have a negative effect on tooth enamel. It is assumed that taking the drug Maltofer® will not affect the regimen of insulin administration in patients with diabetes mellitus. One ml of drops for oral administration (20 drops) contains 0.05 g of sucrose, which is equivalent to 0.01 bread units. Syrup Excipients such as sodium methyl-p-hydroxybenzoate and sodium propyl-p-hydroxybenzoate can cause allergic reactions (possibly delayed). Maltofer® syrup contains sucrose and sorbitol. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltose malabsorption should not take this drug. Sucrose can have a negative effect on tooth enamel. It is assumed that taking the drug Maltofer® will not affect the regimen of insulin administration in patients with diabetes mellitus. One ml of syrup contains 0.2 g of sucrose and 0.28 g of sorbitol, which is equivalent to 0.04 bread units. This drug contains a small amount of ethanol (less than 100 mg in 30 ml). Chewable tablets It is not expected that taking the drug Maltofer® will affect the regimen of insulin administration in patients with diabetes mellitus. One chewable tablet contains 0.03 bread units. Interactions with other drugs The interaction of iron (III) polymaltose hydroxide with tetracycline and aluminum hydroxide was studied in 3 clinical studies in humans. There was no significant reduction in tetracycline absorption. The concentration of tetracycline in blood plasma did not fall below the level that provides the required effectiveness. Aluminum hydroxide and tetracycline did not reduce the absorption of iron (III) polymaltose hydroxide. Therefore, iron (III) polymaltose hydroxide can be taken simultaneously with tetracycline or other phenolic substances, as well as aluminum hydroxide. Studies conducted in rats did not reveal any interactions with tetracycline, aluminum hydroxide, acetylsalicylates, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin . Also, no in-vitro interactions were found with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and its salts, vitamin A, vitamin D3, vitamin E, soybean oil and soy flour. These results suggest that iron(III) hydroxide polymaltose can be taken with or immediately after meals. The drug does not affect the results of the test for the presence of occult blood (selective hemoglobin test), so there is no need to stop treatment for analysis. Simultaneous parenteral and oral administration of iron preparations should be avoided, since this significantly reduces the absorption of oral iron. Contraindications History of hypersensitivity to iron (III) polymaltose hydroxide or any of the excipients; iron overload (eg, hemochromatosis or hemosiderosis); violations of iron utilization (anemia associated with lead poisoning, sideroahrestic anemia, thalassemia); anemia not associated with iron deficiency (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency). Composition Drops for oral administration 50 mg / ml One milliliter of solution contains: active substance: 50 mg of iron in the form of iron (III) polymaltose hydroxide (178.6 mg); excipients: sucrose, sodium methyl-n-hydroxybenzoate (E219), sodium propyl-n-hydroxybenzoate (E217), cream flavor, sodium hydroxide, purified water. In 1 ml 20 drops, 1 drop contains 2.5 mg of iron. Overdose In case of an overdose of iron (III) polymaltose hydroxide, signs of poisoning and iron overload are unlikely, due to the low toxicity of the drug and controlled absorption of iron. There are no reports of accidental poisoning with a fatal outcome. Side effects The safety and tolerability of iron(III) hydroxide polymaltose has been evaluated in numerous clinical trials and published reports. The assessment of the frequency of adverse reactions is given on the basis of the following classification: often (?1/100, <1/10), infrequently (?1/1000, <1/100), rarely (?1/10000, <1/1000), very rarely (<1/10000). The following side effects have been reported in these trials: Gastrointestinal disorders Very common: Discoloration of stools1 Common: Diarrhoea, nausea, dyspepsia Uncommon: Vomiting, constipation, abdominal pain, tooth staining2 Skin and subcutaneous tissue disorders Uncommon : rash3, pruritus Nervous system disorders Uncommon: headache "Discoloration of feces" has been reported very frequently as an adverse reaction (23% of patients) and is a well-known adverse effect of oral iron preparations. "Tooth staining" has been reported as an adverse reaction observed in 0.6% of patients and is a known adverse effect of oral iron preparations. The term "exanthema" has been combined with the term "rash" and is referred to as "rash". Adverse reactions reported in the post-marketing period No additional adverse reactions were identified. Impact on the results of laboratory and instrumental studies No data available. If the listed adverse reactions occur, as well as a reaction not indicated in the instructions for use, you should consult a doctor. Storage conditions In a place protected from light at a temperature not exceeding 25 ° C. Keep away from children. Buy Maltofer drops for oral administration 50mg / ml 30ml No. 1 Price for Maltofer drops for oral administration 50mg / ml 30ml No. 1