Instructions for Cefasel tablets 100 mcg No. 20
Composition
active ingredient: sodium selenite;
1 tablet of Cefasel 100 mcg contains 0.219 mg of sodium selenite (corresponding to 100 mcg of selenium);
1 tablet of Cefasel 300 mcg contains 0.657 mg of sodium selenite (corresponding to 300 mcg of selenium);
excipients: povidone, mannitol (E 421), sucrose, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round tablets with a biconvex surface, white in color.
Pharmacotherapeutic group
Mineral supplements. Other mineral supplements. Selenium. Sodium selenite.
ATX code A12C E02.
Pharmacological properties
Pharmacodynamics
Selenium is one of the most important trace elements.
Selenium has various functions in the body, which are usually carried out in connection with proteins in the form of the amino acid selenocysteine, which is an integral component of selenium-containing proteins, the so-called selenoproteins. More than 25 selenium-containing proteins and protein subunits have been identified to date. These include glutathione peroxidase, selenoprotein P, deiodinases, thioredoxin reductase or methionine sulfoxide reductase.
Glutathione peroxidase accelerates, for example, the formation of hydroperoxides and helps protect cells from oxidative damage (for example, thyroid cells during the synthesis of thyroid hormones).
Selenoprotein P is the major fraction of selenium in blood plasma and is, among other things, a selenium-transporting protein. Among the functions of selenium-containing deiodinases is the acceleration of the conversion of thyroxine (T4) to triiodothyronine (T3), the active thyroid hormone.
Selenium intake from food is generally sufficient in Central Europe. Foods rich in selenium include, for example, egg yolk, fish and meat, especially chicken and pork, as well as offal. The European Food Safety Authority recommends an adequate daily selenium intake of 70 mcg for adults and pregnant women; 85 mcg for breastfeeding women. The German Nutrition Association recommends a daily selenium intake of 60-70 mcg.
Insufficient selenium intake leads to a decrease in glutathione peroxidase activity in humans and animals, but symptoms are not clinically evident. Selenium-dependent glutathione peroxidase affects the metabolism of leukotrienes, thromboxanes and prostacyclins. Selenium deficiency activates and inhibits immune responses and affects the activity of some liver enzymes. Selenium deficiency also potentiates oxidative or chemical damage to the liver, as well as the toxicity of heavy metals such as mercury and cadmium.
In humans, Keshan disease, endemic cardiomyopathy, and the so-called Kashin–Beck disease, as well as endemic osteoarthropathy with severe joint deformity, have been described as diseases resulting from selenium deficiency.
In cases of clinical manifestations of selenium deficiency, which was also observed as a result of prolonged parenteral nutrition and unbalanced nutrition, in addition to changes in hair and nails, cardiomyopathy and skeletal muscle myopathy occurred.
Selenium deficiency can be diagnosed by a decrease in selenium levels in whole blood or plasma or by a decrease in glutathione peroxidase activity in whole blood, plasma, or platelets. Decreased plasma selenium levels can be observed in patients with renal failure, as well as in patients with gastrointestinal disorders.
Pharmacokinetics
After oral administration, sodium selenite is absorbed in the small intestine. In the blood, selenium is absorbed mainly by erythrocytes and reduced by enzymes to selenide. Selenide is the central reservoir of selenium for specific binding to selenoproteins and for excretion from the body. The total amount of selenium in the body of an adult is about 5−15 mg.
Excess selenide is metabolized primarily to selenosugars and/or methylselenium compounds such as dimethylselenide or trimethylselenide ions. Selenium undergoes enterohepatic cycling. Selenium is excreted in the feces or urine, depending on the selenium status in the body and the dose taken. When a toxic dose is absorbed, excretion occurs through the lungs in the form of volatile methylated selenium-containing compounds.
Indication
A selenium deficiency has been identified that cannot be compensated for through food.
Selenium deficiency can occur in the following cases:
- digestive disorders and malabsorption,
- malnutrition (e.g., total parenteral nutrition).
Contraindication
Hypersensitivity to the components of the drug, intoxication due to selenium poisoning.
Interaction with other medicinal products and other types of interactions
There are no clinical studies of the interaction of the drug Cefasel with other drugs. Simultaneous administration with ascorbic acid should be avoided, since the possibility of precipitation of elemental selenium cannot be excluded. Elemental selenium is insoluble in water and is not bioavailable. Therefore, an interval of at least 1 hour should be observed between the administration of the drug Cefasel and ascorbic acid.
Application features
During therapy, serum/blood selenium levels should be monitored regularly.
Children (under 18 years of age)
There is insufficient data on the use of the drug in this age group, therefore use is not recommended.
Use during pregnancy or breastfeeding
Pregnancy
Selenium crosses the placenta. Data on the use of sodium selenite in pregnant women are limited. Animal studies are insufficient regarding reproductive toxicity.
Given that the drug Cefasel is used only in case of established selenium deficiency, no adverse effects on pregnancy or the fetus are expected, but the drug should be used only after assessing the benefit-risk ratio.
Breastfeeding period
Selenium passes into breast milk, but in therapeutic doses, the drug Cefasel does not have a negative effect on a breastfed child.
Fertility
There are no clinical data on the effects of selenium on fertility. In animal studies, effects were only observed at very high doses. In general, doses to compensate for selenium deficiency do not cause adverse reactions that affect fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted. Given the pharmacological properties of the drug, no effect on driving or other mechanisms is expected.
Method of administration and doses
The tablets should be taken whole, without chewing, with a small amount of liquid, after meals. Unless otherwise prescribed, the dose is 100 mcg of selenium per day. This dose can be increased for a short time to 300 mcg of selenium. Treatment should be continued until the level of selenium in the blood plasma is normalized to 80-120 ng/ml, in the blood - 100-140 ng/ml.
Patients with impaired liver or kidney function.
Since the dose is determined by measuring the actual selenium content in the patient's blood, there are no recommendations for dose reduction for specific patient groups, such as those with impaired liver or kidney function.
Children
The drug is not intended for children (under 18 years of age).
Overdose
Symptoms of acute overdose may include garlic breath, fatigue, nausea, diarrhea, and abdominal pain. In case of chronic overdose, nail and hair growth disorders, as well as peripheral polyneuropathies, are noted.
Selenium levels in the blood should be checked at appropriate intervals. Possible treatments include forced diuresis or high doses of ascorbic acid. In case of acute overdose, selenite can be removed by dialysis. Dimercaprol is not recommended as it increases selenium toxicity.
Adverse reactions
When using the drug Cefasel as prescribed, no adverse reactions have been reported to date.
Expiration date
5 years.
Storage conditions
No special storage conditions are required. Keep out of the reach and sight of children.
Packaging
20 tablets in a blister; 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Cefak KG.
Location of the manufacturer and address of its place of business
Ostbahnhofstrasse 15, 87437 Kempten, Germany.
