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The site provides background information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. A specialist consultation is required!
Berlition is a drug hepatoprotector improving the functioning of the liver and increasing the resistance of its cells to adverse effects. In addition, Berlition has detoxifying properties, improves the nutrition of nerve cells and takes part in the regulation of the metabolism of carbohydrates and lipids, including cholesterol. It is used in the complex therapy of atherosclerosis, liver diseases, poisoning and alcoholic or diabetic neuropathies.Names, release forms and composition of Berlition
Currently, the drug Berlition is available in two dosage forms:
1. Tablets;
2. Concentrate for preparation of solution for injection.
To indicate the dosage of the drug, the simplified names "Berlition 300" or "Berlition 600" are often used. The concentrate for solution preparation is often referred to simply as "Berlition ampoules". Sometimes you can hear about Berlition capsules, but such dosage form to date, no, and the person is referring to the variant of the drug for oral administration.
As an active ingredient, Berlition contains alpha lipoic acid which is also called thioktova... The concentrate for solution preparation contains propylene glycol and water for injection as auxiliary components. And Berlition's tablets contain the following substances as auxiliary components:
- Microcrystalline cellulose;
- Magnesium stearate;
- Croscarmellose sodium;
- Povidone;
- Hydrated silicon dioxide.
The concentrate is in hermetically sealed transparent ampoules. The concentrate itself is transparent, colored greenish-yellow. The tablets are round, biconvex and colored yellow. There is a risk on one surface of the tablets. At the fracture, the tablet has an uneven granular surface, colored yellow.
Therapeutic effects of Berlition
The therapeutic effects of Berlition are provided by its alpha-lipoic acid. Currently, the following Berlition effects have been experimentally confirmed:- Antioxidant action. The drug helps to destroy free radicals that damage cells, causing their premature death;
- Hepatoprotective action. Thioctic acid normalizes liver function and protects the organ from the negative effects of various factors, including alcohol and drugs;
- Lipid-lowering action. The drug reduces the concentration of harmful lipid fractions in the blood;
- Hypocholesterolemic action. The drug reduces the concentration of cholesterol in the blood;
- Hypoglycemic action. The drug reduces the concentration of sugar in the blood and prevents complications of diabetes mellitus;
- Detoxification action. The drug eliminates the symptoms of intoxication.
Achieving a decrease in blood sugar concentration occurs by increasing the sensitivity of cells to insulin and reducing resistance. As a result, in patients with diabetes mellitus, the deposition of glucose on the inner surface is reduced. blood vessels and the intensity of glycosylation and free radical damage to nerve cells decreases. This, in turn, reduces hypoxia of nerve fibers and cells, protects them from free radicals, and also improves their nutrition and functioning. As a result, neuropathy associated with excessive glycosylation of proteins is prevented in patients with diabetes mellitus. That is, Berlition improves the functioning of peripheral nerves, relieving the symptoms of polyneuropathy (burning, pain, numbness, etc.).
Indications for use
Berlition tablets and injections are indicated for use in the following diseases or conditions: - Diabetic neuropathy (impaired sensitivity and conduction of peripheral nerves against the background of glucose damage);
- Alcoholic neuropathy (impaired functioning and structure of peripheral nerves against the background of damage by alcohol metabolites);
- Hepatitis of various origins (viral, toxic, etc.);
- Fatty degeneration of the liver (hepatosis);
- Chronic intoxication (poisoning) with any substances, including salts of heavy metals;
- Atherosclerosis of the coronary vessels.
Instructions for use of the drug Berlition
As an independent drug, Berlition in the form of tablets and solution for injection is used for alcoholic or diabetic neuropathy. For the rest of the listed diseases, Berlition is used as part of complex therapy only in the form of tablets.Berlition pills
For the treatment of neuropathy, the drug should be taken two tablets once a day. That is, two tablets are taken at a time. Berlition should be swallowed without chewing and drinking plenty of water (at least half a glass). The tablets are taken in the morning, half an hour before the first meal. The duration of treatment depends on the speed of recovery, relief of symptoms and normalization of the condition. On average, therapy lasts from 2 to 4 weeks. After a course of neuropathy therapy, you can continue to take Berlition, one tablet per day, as a maintenance treatment aimed at preventing relapse.In addition, Berlition tablets can be taken as part of the complex therapy of liver diseases, poisoning and atherosclerosis, one piece per day. The duration of admission is determined by the speed of recovery.
Instructions for the use of Berlition in ampoules (Berlition 300 and 600)
The concentrate in ampoules is used to prepare a solution that is administered as an intravenous infusion (dropper). Moreover, concentrates with an active substance content of 300 mg and 600 mg are used in the same way. The choice is determined by what dosage a person needs at a given moment in time. Infusion is preferable to tablets for severe clinical symptoms of neuropathy. Berlition infusion is used mainly for the treatment of neuropathies. Therapy for poisoning, atherosclerosis and liver diseases is carried out with tablets. However, if a person cannot take pills, then Berlition is administered intravenously at a dosage of 300 mg per day (1 ampoule 12 ml).
To prepare a solution for intravenous infusion, it is necessary to dilute one ampoule of Berlition 12 ml or 24 ml (300 mg or 600 mg) in 250 ml of physiological solution. For the treatment of neuropathies, a solution containing 300 mg or 600 mg of Berlition is administered once a day for 2 to 4 weeks. Then they switch to taking Berlition in tablets at a maintenance dosage of 300 mg per day.
The solution for intravenous administration must be prepared immediately before use, as it quickly loses its properties. The finished solution must be protected from sunlight by wrapping the container with it with foil or thick opaque paper. The diluted concentrate can be used for a maximum of 6 hours if the solution has been stored in a dark place.
If it is not possible to prepare a solution for infusion, then the undiluted concentrate can be injected intravenously using a syringe and a perfuser. In this case, the concentrate should be injected slowly, not faster than 1 ml per minute. This means that the 12 ml ampoule should be injected for at least 12 minutes, and 24 ml, respectively, for 24 minutes.
Berlition can be administered intramuscularly in 2 ml of concentrate per injection. More than 2 ml of concentrate cannot be injected into the same muscle site. This means that in order to inject 12 ml of concentrate (1 ampoule), it will be necessary to make 6 injections into different parts of the muscle, etc.
Berlition - rules for a dropper
A solution for intravenous infusion (droppers) is prepared based on the following ratio: 1 ampoule of 12 ml or 24 ml is dissolved in 250 ml of saline. A solution of one ampoule of Berlition concentrate is injected for at least half an hour at a rate of no more than 1.7 ml per minute.Only sterile saline can be used as a solvent for the concentrate.
special instructions
During the entire course of using Berlition, one should refrain from drinking alcoholic beverages, since they reduce the effectiveness of the drug. When alcohol and Berlition are taken in high dosages, severe poisoning can develop with a high probability of death.Patients suffering from diabetes mellitus, at the beginning of treatment with Berlition, should control the concentration of glucose in the blood 1 to 3 times a day. If the glucose concentration against the background of using Berlition has decreased to the lower limit of the norm, it is necessary to reduce the dosage of insulin or hypoglycemic agents.
With intravenous administration of Berlition, an allergic reaction in the form of itching or malaise may develop. In this case, it is necessary to immediately stop the administration of the solution.
If the solution is injected too quickly, a feeling of heaviness in the head, cramps and double vision may appear. These symptoms go away on their own and do not require discontinuation of the drug.
Throughout the entire course of using Berlition, care must be taken when driving a car and work that requires a high concentration of attention.
Overdose
An overdose of Berlition is accompanied by the appearance of nausea, vomiting and headaches. In case of an overdose, it is necessary to carry out symptomatic therapy until the painful manifestations completely disappear.When taking or intravenous administration of more than 5000 mg of Berlition, an overdose can develop with severe symptoms, such as:
- Psychomotor agitation;
- Clouding of consciousness;
- Seizures;
- Acidosis;
- A sharp decrease in the concentration of glucose in the blood up to hypoglycemic coma;
- Skeletal muscle necrosis;
- DIC syndrome;
- Hemolysis of erythrocytes;
- Suppression of the bone marrow;
- Insufficiency of several organs and systems.
The use of Berlition during pregnancy and lactation
Berlition should not be used by pregnant women and nursing mothers, since there are no reliable research data that confirm its safety. Interaction with other medicinal products
Berlition chemically interacts with ionic metal complexes, therefore, it can reduce the severity of the clinical effects of drugs that contain them, for example, Cisplastin, etc.Due to the ability to chemically interact with metal ions, it is not recommended to take magnesium, iron or calcium preparations after taking Berlition, since their absorption will be reduced. In this case, it is recommended to take Berlition in the morning, and preparations containing metal compounds in the afternoon or evening. The same goes for dairy products containing a large number of calcium.
Alcoholic beverages and ethyl alcohol contained in various tinctures reduce the effectiveness of Berlition.
Berlition's concentrate is incompatible with glucose, fructose, dextrose and Ringer solutions, since thioctic acid forms poorly soluble compounds with sugar molecules.
Berlition enhances the effect of hypoglycemic drugs and insulin, therefore, with simultaneous use, it is necessary to reduce their dosage.
Berlition side effects
Side effects when using Berlition in people of different ages and sexes are rare. Moreover, there is no relationship between the incidence of side effects and gender or age. That is, they are observed in young and old people, as well as in men and women, with the same frequency. Berlition can cause the following side effects on the part of various organs and systems:
1.
From the nervous system:
- Change or disturbance in taste;
- Seizures;
- Diplopia (double vision).
- Nausea;
- Vomit;
- The appearance of pathological forms of platelets (thrombocytopathy);
- Bleeding tendency due to platelet deformation;
- Hemorrhagic rash;
- Pinpoint hemorrhages in the skin or mucous membranes (single petechiae);
- Decrease in blood glucose concentration;
- Complaints related to low blood glucose levels (dizziness, sweating, headache).
- Skin rash;
- Itchy skin;
- Anaphylactic shock (isolated cases in people prone to allergic reactions).
- A burning sensation in the area of administration of the Berlition solution;
- Burning pain at the injection site;
- Exacerbation of eczema.
- A feeling of heaviness in the head, which occurs when the solution is administered intravenously too quickly due to an increase in intracranial pressure;
- Difficulty breathing.
Contraindications for use
Berlition concentrate and tablets are contraindicated for use if a person has the following diseases or conditions:- Hypersensitivity to alpha-lipoic acid or auxiliary components of the drug;
- Age under 18;
- Breastfeeding period.
Berlition (300 and 600) - analogues
Currently, the pharmaceutical market in Russia and the CIS countries has analogues and synonyms of Berlition. Synonyms are preparations containing, like Berlition, alpha-lipoic acid as an active component. Analogues are drugs that have therapeutic effects similar to Berlition, but contain other active ingredients.Synonyms for Berlition
- Lipamid - tablets;
- Lipoic acid - tablets and solution for intramuscular injection;
- Lipothioxone - a concentrate for the preparation of a solution for intravenous administration;
- Neurolipon - capsules and concentrate for the preparation of a solution for intravenous administration;
- Octolipen - capsules, tablets and concentrate for the preparation of a solution for intravenous administration;
- Tiogamma - tablets, solution and concentrate for infusion;
- Thioctacid 600 T - solution for intravenous administration;
- Thioctacid BV - tablets;
- Thioctic acid - tablets;
- Tiolepta - tablets and solution for infusion;
- Tiolipon - a concentrate for the preparation of a solution for intravenous administration;
- Espa-Lipon - tablets and concentrate for the preparation of a solution for intravenous administration.
- Bifiform Kids - chewable tablets;
- Gastrikumel - homeopathic tablets;
- Curtain - capsules;
- Orfadin - capsules;
- Kuvan - pills.
Berlition (300 and 600) - reviews
There are few reviews of the drug Berlition, but most of them are positive. People who left positive reviews used Berlition mainly for the treatment of neuropathy of various origins, for example, after chickenpox, against the background of a herniated disc with compression of nerves, with diabetes mellitus, etc. Before starting therapy, people noted the presence of severe clinical symptoms of neuropathy with pain along the way nerves, a feeling of running shivers, numbness, tremors, etc. After the use of Berlition, these unpleasant symptoms of neuropathy either completely disappeared or were significantly alleviated. That is why people who used Berlition to treat neuropathies left mostly positive reviews about the drug. Some reviews indicate that the positive effect of the treatment was unexpected, since before that they had tried different methods elimination of symptoms of neuropathy.Negative reviews about Berlition are very few and are mainly due to the lack of the expected effect from him. In other words, people were counting on one effect, but the result was somewhat different. In such a situation, there is a strong disappointment in the drug, and people leave negative feedback.
In addition, negative reviews about Berlition are left by doctors who adhere to strict adherence to the principles of evidence-based medicine. Since the clinical efficacy of Berlition has not been proven, they believe that the drug is unreasonable and absolutely unnecessary to prescribe for the treatment of neuropathies in diabetes mellitus and other conditions or diseases. Despite the subjective improvement in a person's condition, doctors consider Berlition completely useless and leave negative reviews about him.
Berlition or Thioctacid?
Berlition and Thioctacid are synonymous drugs, that is, they contain the same substance as an active ingredient - alpha-lipoic acid, which is also called thioctic acid. Producers of both drugs quite reputable pharmaceutical concerns with a good reputation (Berlin-Chemie and Pliva), so the quality of Berlition and Thioctacid is the same. Thioctacid for intravenous administration is marketed under the commercial name Thioctacid 600 T, and contains 100 mg or 600 mg of the active substance per ampoule. And Berlition for injection is available in dosages of 300 mg and 600 mg. Therefore, when it is necessary to use lipoic acid in low dosages, Thioctacid is preferable. If you need to enter 600 mg of lipoic acid, then you can choose any agent based on personal preference. Both Berlition and Thioctacid are also available in tablet form, so if you need to use an oral agent, you can choose any drug.
For example, Thioctacid tablets are available in a dosage of 600 mg, and Berlition - 300 mg, so the first must be taken one per day, and the second, respectively, two. From the point of view of convenience, Thioctacid is preferable, but if a person is not embarrassed by the need to take two tablets at a time every day, then Berlition is perfect for him.
In addition, there is an individual tolerance of drugs, depending on the characteristics of the organism of each individual person. This means that one person is better able to tolerate Berlition, and the other - Thioctacid. In such a situation, it is necessary to choose the drug that is best tolerated and does not cause side effects. But this can only be found out experimentally, by trying to take different drugs.
However, if the clinical symptoms are severe enough or the pills do not help, then it is recommended to inject drugs containing alpha-lipoic acid intravenously. In such a situation, it is necessary to use Berlition in the form of a concentrate for the preparation of a solution for intravenous administration, or Thioctacid 600 T.
Berlition (tablets, ampoules, 300 and 600) - price
Berlition is produced by the German pharmaceutical concern "Berlin-Chemie" and, accordingly, is imported to the CIS countries. Therefore, differences in the cost of a drug in pharmacies are explained by transportation costs, currency fluctuations and trade margins of a particular pharmacy chain. Since all these factors do not affect the quality of the drug, there is no difference between Berlition, which is sold at a more expensive and cheaper price. Therefore, you can purchase the cheapest option.Currently, in pharmacies in Russian cities, the cost of Berlition is as follows:
- Berlition 300 mg tablets 30 pieces - 720 - 850 rubles;
- Berlition concentrate 300 mg (12 ml) 5 ampoules - 510 - 721 rubles;
- Concentrate Berlition 600 mg (24 ml) 5 ampoules - 824 - 956 rubles.
Where can I buy?
Berlition, according to the recommendations, should be sold with a doctor's prescription, but in reality, almost every pharmacy dispenses the drug without a prescription. Therefore, Berlition tablets and concentrate can be purchased at any regular pharmacy or through an online pharmacy. Berlition 600: instructions for use and reviews
Latin name: Berlithion 600
ATX code: A16AX01
Active substance: Thioctic acid
Producer: Jenahexal Pharma, EVER Pharma Jena GmbH, Haupt Pharma Wolfratshausen (Germany)
Description and photo update: 22.10.2018
Berlition 600 is an antioxidant and neurotrophic metabolic drug that regulates metabolism.
Release form and composition
Dosage form Berlition 600 - a concentrate for the preparation of a solution for infusion: transparent liquid, greenish-yellow [24 ml in glass ampoules (25 ml) of dark color with a break line (white marker) and green-yellow-green stripes, 5 pcs. in a plastic pallet, in a cardboard box 1 pallet].
1 ampoule contains:
- active substance: thioctic acid - 0.6 g;
- auxiliary components: ethylenediamine, water for injection.
Pharmacological properties
Pharmacodynamics
The active ingredient in Berlition 600 is α-lipoic (thioctic) acid, is a coenzyme of α-ketoacids decarboxylation reactions and an endogenous antioxidant of direct (binding free radicals) and indirect mechanisms of action. Promotes an increase in the content of glycogen in the liver, a decrease in the level of glucose concentration in blood plasma and insulin resistance. Participates in the regulation of metabolic processes of carbohydrates and lipids, stimulates cholesterol metabolism.
The antioxidant properties of thioctic acid make it possible to protect cells from damage by decay products, reduce (in diabetes mellitus) the formation of end products of progressive glycosylation of proteins in nerve cells, improve endoneural blood flow and microcirculation, and increase the physiological content of the antioxidant glutathione. By potentiating a decrease in the level of glucose in the blood plasma, in diabetes mellitus, it affects the alternative metabolism of glucose, reducing the accumulation of pathological metabolites (polyols), thereby reducing the edema of the nervous tissue.
The participation of thioctic acid in fat metabolism allows an increase in the biosynthesis of phospholipids (including phosphoinositides), improving the disturbed structure of cell membranes. It restores energy metabolism and normalizes the conduction of nerve impulses. Neutralizes the toxic effects of alcohol metabolites, such as acetaldehyde and pyruvic acid, reduces the excessive formation of free oxygen radicals. Weakening the manifestations of polyneuropathy (paresthesia, burning sensation, numbness and pain in the extremities), it reduces endoneural hypoxia and ischemia.
The use of thioctic acid for therapy in the form of ethylenediamine salt reduces the severity of possible side effects.
Pharmacokinetics
The maximum concentration of thioctic acid in the blood plasma 30 minutes after intravenous (iv) administration reaches about 0.02 mg / ml, the total concentration is about 0.005 mg / h / ml.
Berlition 600 undergoes presystemic elimination and is metabolized predominantly by the effect of the first pass through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. Vd (volume of distribution) - about 450 ml / kg. The total plasma clearance is 10-15 ml / min / kg. To a greater extent, 80–90% of the drug is excreted in the form of metabolites through the kidneys. The half-life is approximately 25 minutes.
Indications for use
- alcoholic polyneuropathy;
- diabetic polyneuropathy.
Contraindications
- age under 18;
- period of pregnancy;
- breast-feeding;
- an indication of a history of hypersensitivity to the components of Berlition 600.
Instructions for the use of Berlition 600: method and dosage
The ready-made solution of the drug is intended for infusion administration.
Immediately before use, 1 ampoule of the concentrate is dissolved in 250 ml of 0.9% sodium chloride solution. The solution should be injected intravenously, the duration of the infusion should be at least 0.5 hour. Since the active substance is light-sensitive, the vial with the prepared solution must be wrapped in aluminum foil to protect it from light exposure.
The duration of the course or the need to repeat it is determined by the doctor individually.
Side effects
- from the immune system: very rarely - allergic reactions (itching, skin rash, urticaria); in isolated cases - anaphylactic shock;
- from the nervous system: very rarely - diplopia, violation or change in taste, convulsions;
- from the side of metabolism: very rarely - a decrease in the level of glucose in the blood plasma; possibly dizziness, headache, sweating, visual impairment (symptoms of a hypoglycemic state);
- on the part of the hematopoietic system: very rarely - purpura (hemorrhagic rash), thrombocytopathy, thrombophlebitis;
- local reactions: very rarely - burning sensation at the injection site;
- other reactions: against the background of a high rate of intravenous injection - a transient increase in intracranial pressure, difficulty breathing.
Overdose
Symptoms of a thioctic acid overdose are: headache, nausea, vomiting. For severe cases of intoxication, including with the accidental administration of more than 80 mg of the drug per 1 kg of body weight, the appearance of generalized seizures, psychomotor agitation, and clouding of consciousness is characteristic. In addition, the development of severe violations of acid-base balance, hypoglycemia (up to the development of coma), lactic acidosis, acute necrosis of skeletal muscles, hemolysis, syndrome of deseminated intravascular coagulation, multiple organ failure, suppression of activity bone marrow.
Treatment: due to the lack of a specific antidote, emergency symptomatic therapy is indicated in a hospital setting. Application of appropriate measures for the elimination of symptoms of poisoning, including methods of modern intensive care for the treatment of cases that threaten the patient's life.
The use of hemodialysis, hemoperfusion, or thioctic acid excretion filtration methods are ineffective.
special instructions
Patients with diabetes mellitus need to ensure regular monitoring of the level of glucose concentration in the blood plasma, especially at the beginning of the use of the drug. If necessary, the dose of oral hypoglycemic agent or insulin should be reduced to prevent the development of hypoglycemia.
Since ethanol reduces the clinical effect of Berlition 600, during the period of treatment and in the intervals between courses, you should not drink alcohol and take ethanol-containing drugs.
Against the background of intravenous administration of the drug, hypersensitivity reactions may develop, if the patient develops itching, malaise and other symptoms of drug intolerance, immediate termination of the infusion is required.
Dissolve the Berlition 600 concentrate only in 0.9% sodium chloride solution. It is allowed to store the prepared solution for about 6 hours, provided it is protected from light.
Influence on the ability to drive vehicles and complex mechanisms
Caution is advised when performing potentially hazardous activities and managing vehicles... The effect of Berlition 600 on the concentration of attention and the speed of the patient's psychomotor reactions has not been studied, but possible side reactions such as dizziness or visual impairment can affect these indicators.
Application during pregnancy and lactation
The use of the drug during the period of gestation and lactation is contraindicated, due to the lack of sufficient clinical experience in the treatment of this category of patients.
Childhood use
According to the instructions, Berlition 600 cannot be prescribed for the treatment of children and adolescents under the age of 18, since the safety of the drug and its effectiveness have not been established.
Drug interactions
When used simultaneously with Berlition 600:
- insulin, oral hypoglycemic agents for oral administration: enhance their clinical effect;
- ethanol: significantly reduces the therapeutic effect of thioctic acid;
- iron preparations: promote the formation of chelate complexes, therefore it is recommended to avoid such combinations;
- cisplatin: thioctic acid reduces its effectiveness.
Shelf life is 3 years.
An antioxidant drug that regulates carbohydrate and lipid metabolism
Active substance
Thioctic acid
Release form, composition and packaging
Concentrate for solution for infusion greenish yellow, transparent.
Excipients: ethylenediamine - 0.155 mg, water d / i - up to 24 mg.
24 ml - ampoules of dark glass with a volume of 25 ml (5) with a white mark indicating the break line and three stripes (green-yellow-green) - plastic pallets (1) - cardboard packs.
pharmachologic effect
Thioctic (alpha lipoic) acid is an endogenous direct antioxidant (binds free radicals) and indirect action... It is a coenzyme of decarboxylation reactions of alpha-keto acids. It helps to reduce the concentration in blood plasma and increase the concentration of glycogen in the liver, also reduces insulin resistance, participates in the regulation of carbohydrate and lipid metabolism, and stimulates cholesterol metabolism. Due to its antioxidant properties, thioctic acid protects cells from damage by their decay products, reduces the formation of end products of progressive glycosylation of proteins in nerve cells in diabetes mellitus, improves microcirculation and endoneural blood flow, and increases the physiological content of the antioxidant glutathione. By helping to reduce the concentration of glucose in the blood, it affects the alternative metabolism of glucose in diabetes mellitus, reduces the accumulation of pathological metabolites in the form of polyols, and thereby reduces the edema of the nervous tissue. Due to its participation in the metabolism of fats, thioctic acid increases the biosynthesis of phospholipids, in particular, phosphoinositides, thereby improving the damaged structure of cell membranes; normalizes energy metabolism and conduction of nerve impulses. Thioctic acid eliminates the toxic effect of alcohol metabolites (acetaldehyde, pyruvic acid), reduces the excessive formation of free oxygen radicals, reduces endoneural hypoxia and ischemia, weakening the manifestations of polyneuropathy in the form of paresthesia, burning sensation, pain and numbness of the extremities. Thus, thioctic acid has an antioxidant, neurotrophic effect, improves lipid metabolism.
The use of thioctic acid in the form of ethylenediamine salt can reduce the severity of possible side effects.
Pharmacokinetics
With intravenous administration of thioctic acid, C max in blood plasma after 30 minutes is about 20 μg / ml, AUC is about 5 μg / h / ml. Has a "first pass" effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. V d - about 450 ml / kg. The total plasma clearance is 10-15 ml / min / kg. It is excreted by the kidneys (80-90%), mainly in the form of metabolites. T 1/2 - about 25 min.
Indications
- diabetic polyneuropathy;
- alcoholic polyneuropathy.
Contraindications
- a history of hypersensitivity to thioctic acid or other components of the drug;
- age up to 18 years (the effectiveness and safety of the drug have not been established);
- pregnancy, period breastfeeding(there is no sufficient experience with the drug).
Dosage
The drug is intended for infusion administration.
At the beginning of treatment, the drug Berlition 600 is prescribed by intravenous drip in daily dose 600 mg (1 ampoule).
Before use, the contents of 1 ampoule (24 ml) are diluted in 250 ml of a 0.9% solution and injected intravenously drip, slowly, for at least 30 minutes. Due to photosensitivity active substance, the solution for infusion is prepared immediately before use. The prepared solution must be protected from light, for example with aluminum foil.
The course of treatment with Berlition 600 is 2-4 weeks. As a subsequent maintenance therapy, oral thioctic acid is used in a daily dose of 300-600 mg. The duration of the course of treatment and the need to repeat it is determined by the doctor.
Side effects
Possible side effects when using the drug Berlition 600 are listed below in descending frequency of occurrence: often (≥1 / 100,<1/10), нечасто(≥1/1000, <1/100), редко(≥1/10000, <1/1000), очень редко(<1/10000), включая отдельные сообщения.Корреляции частоты возникновения побочных эффектов с полом или возрастом пациентов не наблюдается.
From the nervous system: very rarely - a change or violation of taste, diplopia, convulsions.
From the hematopoietic system: very rarely - thrombocytopathy, hemorrhagic rash (purpura), thrombophlebitis.
From the side of metabolism: very rarely - a decrease in the concentration of glucose in the blood plasma (due to improved absorption of glucose). Complaints indicative of a hypoglycemic state (dizziness, sweating, and blurred vision) have been reported.
From the immune system: very rarely - allergic reactions such as skin rash, hives, itching; in isolated cases - anaphylactic shock.
Local reactions: very rarely - a burning sensation at the injection site.
Others: with rapid intravenous administration, spontaneous increases in intracranial pressure (a feeling of heaviness in the head) and difficulty in breathing were observed.
Overdose
Symptoms: nausea, vomiting, headache.
In severe cases: psychomotor agitation or clouding of consciousness, generalized convulsions, severe acid-base balance disorders, lactic acidosis, hypoglycemia (up to the development of coma), acute skeletal muscle necrosis, disseminated intravascular coagulation syndrome, hemolysis, bone marrow suppression, multiple organ failure.
Treatment: If thioctic acid intoxication is suspected (for example, the administration of more than 80 mg of thioctic acid per 1 kg of body weight), emergency hospitalization is recommended and immediate application of measures in accordance with the general principles adopted in case of accidental poisoning. Therapy is symptomatic. Treatment of generalized seizures, lactic acidosis and other life-threatening consequences of intoxication should be carried out in accordance with the principles of modern intensive care. There is no specific antidote. Hemodialysis, hemoperfusion, or thioctic acid excretion filtration methods are not effective.
Drug interactions
Due to the fact that thioctic acid is capable of forming chelate complexes with metals, simultaneous administration with iron preparations should be avoided. The simultaneous use of the drug Berlition 600 with cisplatin reduces the effectiveness of the latter.
Thioctic acid forms poorly soluble complex compounds with sugar molecules. Berlition 600 is incompatible with solutions of glucose, fructose and dextrose, as well as with solutions that react with disulfide and SH-groups.
The drug Berlition 600 enhances the hypoglycemic effect of insulin and hypoglycemic agents for oral administration with simultaneous use.
Ethanol significantly reduces the therapeutic efficacy of thioctic acid.
special instructions
In patients with diabetes mellitus, constant monitoring of the plasma glucose concentration is necessary, especially at the initial stage of therapy with Berlition 600. In some cases, it may be necessary to reduce the dose of insulin or hypoglycemic agents for oral administration in order to avoid the development of hypoglycemia. Alcohol intake reduces the effectiveness of treatment with Berlition 600, therefore, patients during the period of therapy with Berlition 600 should refrain from drinking alcohol during the entire course of treatment, as well as, if possible, in between courses.
With parenteral administration, hypersensitivity reactions may occur. If symptoms of hypersensitivity (itching, malaise) appear, the drug should be discontinued immediately.
Only 0.9% sodium chloride solution can serve as a solvent for the preparation Berlition 600. The freshly prepared infusion solution must be protected from light, for example with aluminum foil.
Protected from light, the solution can be stored for about 6 hours.
Influence on the ability to drive vehicles and work with mechanisms
The effect of Berlition 600 on the speed of psychomotor reactions and the ability to perceive or assess the situation has not been specifically studied, therefore, during the period of treatment with Berlition 600, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Shelf life is 3 years. Do not use after the expiration date printed on the package.
3D images
Composition and form of release
in brown glass ampoules, 12 ml; in a cardboard box 5, 10 or 20 ampoules.
in a contour acheikova packing 10 pcs .; in a cardboard box 3, 6 or 10 packs.
Description of the dosage form
Injection: transparent liquid of light yellow color with a greenish tinge.
round, biconvex tablets of pale yellow color, with a notch for division on one side.
Characteristic
Thioctic acid is an endogenous antioxidant (it binds free radicals), in the body it is formed during the oxidative decarboxylation of alpha-keto acids.
pharmachologic effect
pharmachologic effect- hypoglycemic, hypocholesterolemic, hypolipidemic, hepatoprotective.As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Promotes a decrease in blood glucose and an increase in glycogen in the liver, as well as overcoming insulin resistance.
By the nature of the biochemical action, it is close to the vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. The use of thioctic acid trometamol salt (having a neutral reaction) in solutions for intravenous administration can reduce the severity of side reactions.
Pharmacokinetics
When taken orally, it is rapidly and completely absorbed from the gastrointestinal tract (intake with food lowers absorption). Time to reach C max - 40-60 minutes. Bioavailability - 30%. Has a "first pass" effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. The volume of distribution is about 450 ml / kg. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). T 1/2 - 20-50 min. Total plasma Cl - 10-15 ml / min.
Indications of the drug Berlition ® 300
Diabetic and alcoholic polyneuropathy, steatohepatitis of various etiologies, fatty degeneration of the liver, chronic intoxication.
Contraindications
Hypersensitivity, pregnancy, breastfeeding. Cannot be prescribed to children and adolescents (due to the lack of clinical experience of using this drug in them).
Application during pregnancy and lactation
Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued (there is not enough experience in using in these cases).
Side effects
Injection: sometimes a feeling of heaviness in the head and difficulty in breathing (with rapid intravenous injection). Allergic reactions are possible at the injection site with the appearance of urticaria or a burning sensation. In some cases - convulsions, diplopia, punctate hemorrhages in the skin and mucous membranes.
Film-coated tablets: in some cases - allergic skin reactions.
Possible lowering of blood sugar levels.
Interaction
Weakens the effect of cisplatin, enhances - hypoglycemic drugs.
Method of administration and dosage
I / O, inside... In severe forms of polyneuropathy IV, 12-24 ml (300-600 mg of alpha-lipoic acid) per day for 2-4 weeks. To do this, 1-2 ampoules of the drug are diluted in 250 ml of physiological 0.9% sodium chloride solution and injected drip for about 30 minutes. In the future, they switch to maintenance therapy with Berlition 300 in the form of tablets at a dose of 300 mg per day.
For the treatment of polyneuropathy - 1 table. 1-2 times a day (300-600 mg alpha lipoic acid).
Overdose
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic therapy. There is no specific antidote.
Precautionary measures
During the period of treatment, one should refrain from taking alcoholic beverages (alcohol and its products weaken the therapeutic effect).
When taking the drug, you should regularly monitor the blood sugar level (especially in the initial stage of therapy). In some cases, it may be necessary to reduce the dose of insulin or an oral antidiabetic agent to prevent symptoms of hypoglycemia.
special instructions
The infusion solution must be protected from light with aluminum foil. The infusion solution, protected from light, can be stored for 6 hours.
Manufacturer
Berlin-Chemi AG / Menarini Group, Germany.
Storage conditions of the drug Berlition ® 300
In a dark place at a temperature not exceeding 25 ° C. Ready solution - in a dark place for no more than 6 hours.Keep out of the reach of children.
Shelf life of the drug Berlition ® 300
coated tablets 300 mg - 2 years.
concentrate for preparation of solution for infusion 25 mg / ml - 3 years.
Do not use after the expiration date printed on the package.
Synonyms for nosological groups
| ICD-10 heading | Synonyms of diseases according to ICD-10 |
|---|---|
| G62.1 Alcoholic polyneuropathy | Alcoholic polyneuritis |
| Alcoholic polyneuropathy | |
| G63.2 Diabetic polyneuropathy (E10-E14 + with common fourth character. 4) | Pain syndrome in diabetic neuropathy |
| Pain in diabetic neuropathy | |
| Pain in diabetic polyneuropathy | |
| Diabetic polyneuropathy | |
| Diabetic neuropathy | |
| Diabetic neuropathic ulcer of the lower extremities | |
| Diabetic neuropathy | |
| Diabetic polyneuropathy | |
| Diabetic polyneuritis | |
| Diabetic neuropathy | |
| Peripheral diabetic polyneuropathy | |
| Diabetic polyneuropathy | |
| Sensory-motor diabetic polyneuropathy | |
| K71 Toxic liver damage | The effect of drugs on the liver |
| Effects of toxins on the liver | |
| Medicinal hepatitis | |
| Hepatitis toxic | |
| Hepatotoxic effect of drugs | |
| Medicinal liver damage | |
| Medicinal hepatitis | |
| Medicinal liver damage | |
| Medicinal hepatitis | |
| Drug-induced hepatitis | |
| Liver dysfunction of toxic etiology | |
| Toxic hepatitis | |
| Toxic liver damage | |
| Toxic hepatitis | |
| Toxic liver disease | |
| Toxic liver damage | |
| K76.0 Fatty degeneration of liver, not elsewhere classified | Fatty hepatosis |
| Fatty liver dystrophy | |
| Fatty liver degeneration | |
| Fatty degeneration of the liver | |
| Fatty liver infiltration | |
| Fatty degeneration of the liver | |
| Fatty hepatosis | |
| Lipidosis | |
| Liver lipid metabolism disorders | |
| Non-alcoholic steatohepatitis | |
| Acute yellow liver atrophy | |
| Steatohepatitis | |
| Steatosis | |
| Steatous conditions |
Berlition is a drug, the action of which is aimed at eliminating the manifestations of diabetic polyneuropathy - a syndrome that develops in patients with diabetes mellitus and is characterized by ischemia and metabolic disorders in the peripheral nervous system arising on the background of hyperglycemia.
Pharmacological properties of Berlition
As an active component in the preparation, alpha-lipoic (otherwise - thioctic) acid is used - a biologically active substance that belongs to the group of conditional vitamins. The mechanism of its effect on the body is reduced to the performance of a number of main physiological functions:
- Firstly, alpha-lipoic acid, which is part of Berlition, has a powerful antioxidant effect, which manifests itself in protecting the cellular structures of the body from peroxide damage, reducing the risk of developing diseases caused by the aggressive effects of free radicals, as well as slowing down the aging process;
- Secondly, alpha-lipoic acid acts as a cofactor involved in mitochondrial metabolism;
- Third, it potentiates the action of insulin. In people suffering from diabetes mellitus, oxidative stress (the process of cell damage due to oxidation), to which they are constantly exposed, can provoke the development of a large number of complications, including insulin resistance, polyneuropathy, kidney pathology, etc. And the intake of alpha-lipoic acid improves the condition of patients, has a beneficial effect on the course of diseases associated with the aggression of free radicals, weakens the manifestations of existing complications and prevents the development of new ones. While taking alpha-lipoic acid in patients, there is a weakening of insulin resistance and an improvement in the processes of glucose uptake by the cells of the body.
In addition, the action of the active substance Berlition is aimed at improving the functional state of peripheral nerves and normalizing liver function.
Release form and composition
According to the instructions, Berlition belongs to the group of drugs based on pancreatic hormones and is a synthetic hypoglycemic agent that regulates the carbohydrate and lipid balance in the body and performs the function of a hepatoprotector.
The drug is available in the form:
- Concentrate for the preparation of solution for infusion in ampoules with a capacity of 12 ml. The content of thioctic acid in each ampoule is 300 mg (Berlition 300 U);
- Pale yellow, round, biconvex film-coated tablets. The content of thioctic acid in each tablet is 300 mg (Berlition 300 Oral);
- Softgels, each containing 300 mg of thioctic acid (Berlition 300);
- Concentrate for preparation of solution for infusion in ampoules with a capacity of 24 ml. The content of thioctic acid in each ampoule is 600 mg (Berlition 600 U);
- Softgels each containing 600 mg of thioctic acid (Berlition 600).
Indications for use of Berlition
The use of Berlition is advisable for the treatment of patients suffering from manifestations of alcoholic or diabetic polyneuropathy, which is characterized by paresthesia - a type of sensitivity disorder, accompanied by numbness, tingling and creeping.
In addition, in some cases, the drug is prescribed to patients suffering from liver pathologies of varying severity.
Method of administration and dosage
In the form of film-coated tablets and capsules, Berlition is taken orally. Moreover, it is important to remember that it is forbidden to chew them. It is recommended to take the daily dose of the drug at one time, optimally on an empty stomach, half an hour before breakfast.
The course of treatment usually takes a long period. In each case, it is compiled by the attending physician based on the individual characteristics of the patient and the severity of his disease.
Adult patients with diabetic polyneuropathy are usually prescribed alpha-lipoic acid at a dosage of 600 mg / day. These are 2 tablets / capsules Berlition 300 or one tablet / capsule Berlition 600.
If the course of the disease is characterized as severe, the course of treatment begins with the appointment of the drug in parenteral forms (those that allow it to be administered bypassing the digestive tract).
In accordance with the instructions, Berlition in the form of a concentrate for the preparation of a solution for infusion can only be used in combination with 0.9% sodium chloride. The prepared solution is injected into the vein by drip, and it is necessary to remember two important nuances:
- 250 ml of the drug is injected for at least half an hour;
- The bottle with the ready-made solution is covered with foil to avoid exposure to the contents of ultraviolet rays.
The daily dose of Berlition for adult patients with severe forms of diabetic polyneuropathy ranges from 300 to 600 mg. In severe liver pathologies, the dose is doubled, and it ranges from 600 to 1200 mg / day.
The duration of the course of treatment with the drug in parenteral form should not exceed 2-4 weeks, depending on the severity of the clinical manifestations of the disease.
Side effects
The instructions for Berlition describe a number of potential side effects that can be triggered by taking the drug. Among them:
- Dysfunction of the digestive tract: attacks of nausea, vomiting, upset stools, manifestations of dyspepsia, changes in taste;
- Dysfunctions of the central and peripheral nervous system: a feeling of heaviness in the head, double vision (diplopia), as well as convulsions;
- Dysfunctions of the cardiovascular system: hyperemia of the skin of the face, tachycardia, a feeling of chest tightness;
- Allergic reactions: rashes, pruritus, urticaria, eczema. Against the background of the introduction of a high dose of Berlition, in some cases the development of anaphylactic shock is possible;
- Other disorders: worsening of symptoms of hypoglycemia and, in particular, increased sweating, increased headache, blurred vision and dizziness. Sometimes patients have difficulty breathing, symptoms of thrombocytopenia and purpura. At the beginning of the course of treatment, the administration of the drug can provoke an increase in paresthesias, accompanied by a feeling of crawling on the skin.
Contraindications
Berlition is contraindicated in children under 18 years of age, in patients with hypersensitivity to its active substance, in women during pregnancy and lactation.
Tablets are not prescribed in case of impaired absorption of glucose-galactose, as well as those suffering from lactase deficiency and galactosemia. Capsules are not recommended for fructose intolerance.
For patients with diabetes mellitus, the drug is prescribed with caution and at the same time, the level of glycemia is regularly monitored.