Project Description

Tablets Selenobel

0,4 mg Tabulettae “Selenobel” 0,4

international nonproprietary name

Not established

Ref

BP-0129

Pharmacotherapeutic group

Mineral additives. Selenium agents.

Composition of the preparation

Active agent: diaceton-phenonil-selenide – 0,4 mg;

Auxilliary substances: lactobiose, potato starch, calcium stearate, polyvinylpyrrolidone.

Pharmacological action

Pharmacodynamics

Selenobel is a medicinal agent on the base of selenium organic compound of diaceton-phenonil-selenide (С16Н14О2Se), in the molecule of which 25% of inorganic microelement contains.

Selenium is one of the main microelements that are important for a normal functioning of essential organs and systems. The daily demand of the human organism makes about 2 mkg/kg of the body weight.

Seleniumisamicroelementmakingpartofglutathione-peroxidasethatisdetectedpracticallyinallcellsandbiologicalfluidsinhumansandanimals. The enzyme does not have a strict action selectivity and represents a first protection line of the organism from the damaging action of peroxide radicals that are formed in the organism in excess quantities on various pathological conditions, comprising hypoxemia, stresses, ionizing radiation exposure, etc.

The shortage of selenium in the organism induces the weakening of the organism resistance to hostilities (radiation, chemical and biological agents, meteorological conditions, etc.). The long shortage of microelement in the dietary intake in humans, especially in the young age, may result in the development of a very serious, sometimes a terminal disease that is dilated cardiomyopathy. More often this pathology develops in children and teenagers living in the areas with insufficient content of selenium in the soil. The symptoms of the disease are as follows: dizziness, faints, heart aches and cardiac performance outages, weakness, shivering, muscle pains, fatigability, breathlessness on physical exercise, performance degradation. The electrocardiogram in the patients reveals cardiac rhythm disturbances, conductivity disturbances and myocardium excitability. The peculiarity of this pathology is its reversibility on a timely prescription of selenium medication to the patients. It has been proved that clinical symptoms of the disease in a person who has come to the endemic area and intakes local food products may develop in 3 months.

It has been proved that selenium has a protection action on acute and chronic intoxications with xenobiotics. It can correct the dysimmunity in persons who do not receive the sufficient amount of selenium in the dietary intake.

Selenium is an effective antioxidant on the cell level. It can modify the phagocyte function activity and modulate the cell stress; smooth the oxidant status shifts accompanied by endocrine disturbances. Selenium increases the non-specific resistance of the organism on diseases accompanied by the exhaustion of the general resistance to extreme factors. Itcanstimulateerythrogenesisandleukopoiesis. It has been proved experimentally a significant increase (in 1,5 times) of the absolute number of erythroid cells in the marrow, a reliable increase in the absolute number of mature granulocytes and decrease in the lymphoid elements level.

It has been experimentally proved a direct damaging influence of selenium on the malignant cells in humans (either on proliferating cells, or interphase malignant cells).

Pharmacokinetics

Absorption of soluble forms of selenium in the gastrointestinal tract occurs at 80-100%. The experiments with introduction of 75Se isotope showed that 91-93% of the microelement is absorbed in the gastrointestinal tract. In adults from 76 to 100% of selenium is absorbed on oral administration. Organic compounds of selenium are absorbed better that inorganic ones.

The most intensive absorption of selenium takes place in the duodenum, and to a lesser extent – in the jejunum and ileum, as well as in the cross colon intestine. This microelement is practically not absorbed in the stomach. The intensity of the absorption of selenium depends on the character of the dietary intake. Prevalence of proteins, small amount of sulphates and heavy metals salts contributes to complete uptake of selenium.

Transport and deposit of selenium in the organism takes place either by specific proteins containing selenocysteins (selenoproteins), or by albumins, globulins, as well as by lipoproteins. The microelement is delivered by the blood to all the organs and tissues. It passes through the hematoencephalic, ophthalmologic and blood-testis barriers. The biggest concentration of selenium in humans is revealed in the myocardium, liver and skeletal muscles. It is revealed in small quantities in the adrenal glands and teeth. Selenium is excreted from the organism in three ways – through the kidney, intestinal and lungs. In nursing mother selenium is excreted with breast milk. In physiological conditions the homeostasis of selenium is regulated mainly by the microelement excretion with urine within 24 hours after its administration.

Indications 

Prophylaxis and treatment of selenium insufficiency; hostility exposure (radiation, chemical and biological).

Prophylaxis of toxic effects of polychemical courses for malignant tumors.

special indication

It is not recommended to exceed the recommended doses of the medication. On occurrence of symptoms of averdosing the administration of selenobel shall be stopped.

The medications of selenobel do not influence the capability to drive and operate the moving mechanisms.

Clinical experiments of effectiveness and security of selenobel in children have not been carried out. According to literature data, medications containing selenium are successfully used for treatment of endemic dilatation cardiomyopathy in children and teenagers.

Administration during pregnancy and lactation: selenobel is not recommended for pregnant women. If the medication is prescribed during the lactation period, lactation shall be ceased.

special warning

Not established

Dosage and method of administration

For prophylaxis of selenium insufficiency in the endemic areas in adults: the medication is used daily, 1 tablet of selenobel. In persons who stay in the endemic area during  short period it is recommended to use selenobel in the dosage as indicated above during his stay in the area.

On hostility exposure selenobel is recommended for adults in the dose of 1 tablet once a day.

The medication is administered after meals and washed down with a big amount of liquid.

On treatment of patients with the clinical presentation of selenium insufficiency selenobel is prescribed in the dose of 1 tablet three times a day. The duration of the course depends on the evidence level of clinical symptoms of the disease.

For prophylaxis of toxic effects of chemical therapeutic medications it is prescribed per 1 tablets once a day during the chemical therapy and in the intervals between the courses – 400 mkg/day. The duration of administration of selenobel is up to 60 days.

overdosage

On administration of big doses of selenobel it is possible the development of dermatitis, skinitching, increased nail fragility, hairloss, irritability, increased fatigue, weakness, metallic taste in the mouth, nausea, vomiting, odor of garlic in the expired air and excreted sweat, as well as the development of peripheral neuropathy.

Symptomatic treatment: stomach washing,  maintenance of essential functions. No specific antidote.

safety measures

No precautions are required on the administration of selenium.

Side effects

In rare cases allergic reactions, hyperaemia, itching are possible. On occurrence of allergic reactions the treatment shall be stopped, and in case of sharp reddening and itching desensitizing therapy shall be carried out.

Contraindications

Individual intolerance of selenium and other components; polyvalent allergy, pregnancy, lactation.

Interactions with other medicinal preparations

No negative symptoms on the administration of medications containing selenium against the background of therapy with other medication have been described.

It is not recommended to take selenobel simultaneously with other medications containing selenium (including vitamin and mineral complexes).

The form of release

Selenobel, tablets № 30.