Ferrum Lek

Description overdue on 05/08/2014

• Latin name: Ferrum Lek
• ATC code: B03AB05
• Active substance: Polimaltozat iron hydroxide (III) (Ferric (III) hydroxide polymaltosate)
• Manufacturer: Lek Pharmaceuticals (Slovenia)

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• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Instructions for use (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Analogs
• Synonyms
• Babies
• With alcohol
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

1 chewable tablet   It includes components such as:

• polimaltozat trivalent iron hydroxide   - 400 mg (bulk portion contains, based on pure iron - 100 mg);
• dextrates   - 730 mg;
• macrogol   6000 - 37 mg;
• talc   - 21 mg;
• Aspartame   - 1, 5 mg;
• chocolate flavor   - 0 6 mg.

Composition Syrup   Ferrum Lek per 1 scoop (5 ml)

• iron hydroxide polimaltozat   (and tablets used ferric iron) - 200 mg (mass fraction of active trace elements of 50 mg);
• saccharose ;
• sorbitol solution ;
• methyl parahydroxybenzoate and propyl parahydroxybenzoate ;
• ethanol ;
• cream flavor ;
• sodium hydroxide ;
• purified water.

The aqueous isotonic solution for intramuscular injection   comprises:

• Trivalent iron hydroxide and dextran - 100 mg (per one ampoule 2 ml);
• 6 molar sodium hydroxide or concentrated hydrochloric acid to adjust the pH to isotonic;
• water for injection (pro injectionibus).

Product form

Iron supplements are very popular in the market of pharmaceutical products as well as the problem of deficiency of the trace element is very widespread, because Ferrum Lek comes in pharmacy kiosks in several pharmaceutical forms:

• Pills   Ferrum Lek chewable 100 mg - flat tablets dark brown color (light brown possible inclusions) with a typical circular shape on one of the chamfered surfaces. Fixed 10 pieces in blister aluminum foil or plastic. The cardboard package contains 3 or 5 strips.
• Syrup   Ferrum Lek - transparent brown liquid in bottles of dark glass of 100 ml. Packaging carton consists of a vial and measuring spoons.
• Solution for parenteral intramuscular   - Opaque liquid with virtually no visible floating particles (large number of them demonstrates the unsuitability of a pharmaceutical preparation) of a brown color, which is placed into 2 ml ampules. Blister designed for 5 or 10 vials. Depending on the capacity of the blister cardboard pack may contain one strip at 5 ampules or 5 plates of 10 vials.

Pharmacological action

Ferrum Lek ( The international brand name is not or INN - Iron [III] hydroxide polimaltozat) - a pharmaceutical preparation, the main active ingredient of which is complex salt of iron . This trace element - an important integral component of protein structures such as hemoglobin and myoglobin . Its physiological role is transport of oxygen As hemoglobin - a key part of red blood cells (also called cells - red blood cells, they are responsible for the transfer of oxygen and carbon dioxide in the respiratory cycle). In the process of cellular respiration iron promotes electron transport through the membrane during oxidative metabolism that occur during the growth and proliferation of young produced fabrics.

Also, iron is an essential   component of many enzymes , Normally contained in a human body. As part of biological catalysts, a trace element essential to accelerate processes oxidation and hydroxylation   at the subcellular level. Through these chemical reactions occur most metabolic pathways such as to maintain the normal functioning of further living organism.

Pharmacodynamics and pharmacokinetics

Chewable tablets and syrup   They are used for oral administration, because their pharmacokinetic abilities are very similar. The drug is slowly absorbed from the cavity of the gastrointestinal tract just by active suction   (iron-binding proteins located on the surface of the digestive tube absorbs trace element by competitive exchange ligands ) For two reasons:

• ferric molecular weight significantly greater than divalent;
• a complex compound that is used in a pharmaceutical preparation, similar in structure to the physiological iron transporter - ferritin .

Interestingly, the absorption of iron, as measured by the level of hemoglobin (to obtain this information, double-isotope method was used in clinical studies) is inversely proportional to the dose. I.e negative correlation   literally states that the higher the deficient state, the better the absorption capacity of iron in the duodenum and jejunum.

Most of the iron taken into the body from the gastrointestinal tract It accumulates in the liver   (associated with known carrier protein ferritin ), Which if required is delivered to the bone marrow and is included in the hemoglobin synthesis cycle during the active phase of hematopoiesis.

The remaining (non-absorbed iron) output   Exfoliating with intestinal epithelial cells and skin, as well as sweat, bile and urine in amounts of about 1 mg per day. In calculating the dosage of the drug should be taken into account that in women menstrual period   there is an additional loss of an important trace element.

Reduction of clinical manifestations of the underlying disease is observed gradually As for the development of the full pharmacological action of the drug is necessary to complete a full cycle of the synthesis of hemoglobin, which does not happen at once.

A solution for administration by the intramuscular route   It has different pharmacokinetic abilities. First of all, a complex with dextran allows for faster fill micronutrient deficiencies at all sorts of anemia, in this form the active ingredient is delivered not only in the bone marrow, bypassing the stage of the deposit in the liver, but also other peripheral tissues (eg, containing myoglobin) by another carrier - transferrin   (one molecule of beta-globulin binds two iron atoms). Since 15 percent of the used dose enters the main circulation within 15 minutes, and the next 44 percent - in half an hour. The half-life of 3-4 days, as Ferrum complex with dextran   It has too large to output through the kidneys.

Indications

Tablets and syrup   Oral develop its action is gradually because used in the following pathological situations:

• latent iron deficiency ;
• iron deficiency anemia ;
• prevention of micronutrient deficiencies during pregnancy.

Solution   for intramuscular injections acts somewhat faster than oral forms of a pharmaceutical preparation because indications for its use also include the following disease entities:

• severe iron deficiency due to bleeding (eg haemorrhagic anemia);
• impaired ability to trace element absorbed   through the gastrointestinal tract;
• can not be treated   Patient iron preparations for oral use (surgery of the digestive tube, cancer of the esophagus or stomach, a variety of mechanical barriers and so on).

Contraindications

• increased individual sensitivity   or intolerance   acquired or hereditary character to the constituent components of the drug;
• hemosiderosis   - Pigmentary dystrophy, characterized by the deposition of hemosiderin;
• hemochromatosis - A hereditary disease in which iron accumulates throughout the body in an excess amount;
• violation of mechanisms waste iron ;
• anemia, which are not accompanied by a deficiency of trace elements ( thalassemia   or hemolytic anemia).

For the preparation of injectable solution is somewhat broader list of contraindications:

• first trimester of pregnancy;
• Osler-Weber-Rendu - Hereditary pathology of the vascular bed, characterized by copious amounts of angiomas   and telangiectasia   ;
• Infectious diseases of the kidneys in the acute stage;
• hyperparathyroidism (disease, with enhanced functional capacity parathyroid glands), intractable medical control;
• decompensated phase of development of liver cirrhosis;
• Hepatitis infectious nature.

All the pharmaceutical forms of the drug should be used with caution (recommended treatment in a hospital for overnight care by skilled health personnel) under the following comorbidity:

• bronchial asthma;
• chronic polyarthritis;
• heart failure ;
• folic acid deficiency or low iron binding capacity of another etiological origin;
• the drug is not used in pediatric patients until the child reaches the age of 4 months.

Side effects

Adverse effects of medical treatment with oral forms of the drug, as a rule, are weak and are alone in the short term, but in clinical practice may experience the following side effects:

• gastrointestinal disturbances (indigestion dyspeptic);
• feeling of fullness, severity   or epigastric pain (in the field of projection of the stomach and duodenum);
• constipation or diarrhea;
• dark staining chairs Which has no clinical significance, since no evidence of excretion of absorbed iron.

So how solution for intramuscular administration   in ampoules slightly more active, because the side effects of drug therapy of the pharmaceutical form of the drug is slightly better expressed and may appear as:

• hypotension ;
• muscle and joint pain;
• swollen lymph nodes;
• hyperthermia   - A slight increase in body temperature;
• headache or dizziness;
• malaise;
• allergic reactions up to anaphylactic shock (rarely seen).

Violation of technology introduction   the drug can lead to such consequences:

• staining the injection site;
• local tenderness;
• the development of inflammation at the injection site.

Instructions for use (method and dosage)

Instructions on Ferrum Lek is divided into several parts - general provisions, valid for all types of pharmaceutical preparation scheme of therapy and dosage at each pathology for different forms of the drug.

The oral form taken with food or immediately after meals. The tablets can be chewed like, and swallow whole. If the taste of syrup causes discomfort, it can be mixed with fruit or vegetable juices (baby food, when it comes to pediatric for children under age category). Daily dose   It can be divided into several stages or to use at a time (if the solution is used for intramuscular injection, the injections is best done in the morning, introducing all the daily amount of the drug at once).

When iron deficiency anemia   duration of conservative therapy is 3-5 months depending on the severity of micronutrient deficiencies. After normalization of hemoglobin level should continue medical treatment even for a few weeks, in order to make up for all the physiological iron stores.

Dosage of syrup for the treatment of this nosological unit:

• children younger than 1 year - 2, 5-5 ml of the syrup (half or whole scoop);
• from 1 to 12 - 5.10 ml syrup per day (one or two dimensional units);
• Children older than 12 years and adult patients - 10-30 ml of the syrup (2-6 scoops).

Several different scheme used pills . Instructions for use of tablets Ferrum Lek   prescribes the following dosing pharmaceutical products - the first 2-3 months prescribed 1 tablet 2-3 times a day, depending on the degree of severity of micronutrient deficiencies and the accompanying symptoms. After reaching the level of physiological iron dosage is reduced to 1 1 pill once a day for the next few months until the attending physician deems it necessary cessation of conservative treatment.

Latent iron deficiency - A course usually lasts 1-2 months, in order to eliminate all the symptoms and make up for the natural depot trace element in the human body. Use the following regimen:

• in the age group of 1 to 12 years - the syrup at a dose of 2, 5-5 ml (half or whole scoop) daily;
• children over 12 and adults (including mothers who breastfeed and women during pregnancy) - 5-10 ml syrup (1-2 measuring unit) of the drug Ferrum Lek;
• number of received chewable tablet can vary from 1 to 2 hours, but such a pharmaceutical form is used only to achieve patient 12 years.

For pregnant women   Dosage and dosage regimen varies somewhat. So when iron deficiency anemia using 2-3 chewable tablets or syrup to 20-30 ml until the laboratory tests did not testify about the normalization of hemoglobin and serum iron. Next, apply a maintenance therapy: 1 tablet or 10 ml syrup to the end of the gestation period (so as anemia or lack of trace elements can be resumed again).

The solution in the ampoules   use a little more complicated, because its application requires some knowledge and skills of a qualified health care professional. If there are indications for the use of such a pharmaceutical form, recommended to contact the hospital and hold a course under the supervision of medical specialists.

Before the introduction of a solution for intramuscular injection is carried out, so-called test dose That is, half or quarter of a drug ampoule (25-50 mg calculated as "iron powder") used for infusion. If the next 15 minutes, no adverse reactions, specific complaints or sensation is observed, the remaining amount of use of the daily dose.

The amount of drug to be collected individually counting dose according to the following formulas :

Total iron deficiency (lack of which makes up a drug) = body weight (kg) x (the estimated level of hemoglobin (g / l) 0 x 24) + iron deposited (mg).

Number of vials = total iron deficit (mg) / 100 mg

Overdose

Symptoms of iron toxicity Orally   drug Ferrum Lek as chewable tablets or syrup   not observed Since excessive amounts of the active ingredient is not absorbed from the gastrointestinal tract. If a dose greater than necessary, the composite material passes through the digestive tube in bound form, and are not subject to absorption by passive diffusion.

For parenteral injection routes of administration pharmaceutical preparation may cause an increased concentration of iron in the trunk and the peripheral circulation. Overdose leads to severe iron overload of the body, and exogenous development of these storage diseases like hemosiderosis or hemochromatosis .

As a pharmaceutical antidote used by slow intravenous infusion Deferoxamine   ( chelating agent Which it binds and removes iron from the body active) - 15 mg / kg per hour, but not more than 80 mg / kg, even with severe clinical picture of intoxication. Also used symptomatic drug treatment   identified manifestations. Hemodialysis in the pathological situation is not efficient.

Cooperation

Because clinically significant drug interactions identified only strengthening systemic effects injection at the same time use it to angiotensin converting enzyme   (a group of cardiac drugs for lowering systemic blood pressure). It should not be combined in the conservative therapy, oral dosage forms with a solution for intramuscular injection.

Terms of sale

Ferrum Lek is sold only with a prescription from your doctor.

Storage conditions

Keep out of reach of children at or above 25 degrees Celsius.

Shelf life

3 years.

Cautions

In pure iron may affect the normal color of teeth, however, the oral pharmaceutical forms are used special salt of the trace element, so that when applying a medicament through the gastrointestinal tract   Teeth are not darken .

If   Anemia is caused by an infectious agent   or malignancy, the Ferrum Lek will act immediately. First of all, active ingredients accumulate in the reticuloendothelial system, and only after an effective therapy are mobilized from the underlying pathology of the depot and all show the breadth of its pharmacological action.

For patients with diabetes should be aware that 1 chewable tablet and 1 ml of syrup Ferrum Lek contain 0, 4 BU (bread unit) that is required to be taken into account when calculating the daily diet and taking anti-diabetic drugs.

The drug has no effect on the fine motor skills, ability to concentrate, because drive   or other potentially dangerous machinery during the course of conservative treatment is permitted.

Analogs of Ferrum Lek

Match code ATC 4th level:

• Ferlatum

Analogs of the drug few Since the pharmacological action of the drug and pharmacokinetic ability to meet all the needs of both patients and professionals of medical affairs. When individual contraindications therapeutic effects can be replaced with the following medications: Maltofer . Fenyuls Complex . Ferry   and Polymaltose iron .

Synonyms

Monofer

Babies

In pediatric patients the drug is used only after the age of 4 months.

With alcohol

 

During pregnancy (and lactation)

  drug  

Solution    

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